PHARMACEUTICAL LEGISLATION IN INDIA

Contents
• Purpose of Pharmaceutical legislation

• Chopra Committee

• Drug Enquiry Committee

• Bhore committee

• Bhatia committee

• Mudaliar committee

• Hathi committee

Legislation
• Legislation is law which has been enacted by a legislature or other governing body

• Legislation aids government in organising society and protecting citizens

• It determines the rights and responsibilities of individuals and authorities to whom the legislation applies

Legislation Vs Regulation
Legislation Regulation
Passed by the legislative body of a country Regulations are issued by the government, by an
individual minister
General framework of principles within which the It's a part of legislation
government is expected to act
The process of preparing or reviewing legislation is The preparation and updating of regulations is a
usually long and complex more dynamic process

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What is the purpose of Pharmaceutical legislation?

To ensure that we receive drugs of required quality, tested and evaluated for safety and efficacy for their intended
result

History of Pharmaceutical units

Year Name of Founder Name of shop/ Industry
1811 Mr. Bathgate (East India Company) Chemist Shop in Calcutta
1821 Mr. Smith Stainstreet and Co. Apothecary Shop
1901 Acharya Praffula Chandra Ray (Calcutta) The Bengal Chemicals and Pharmaceutical
Works
1903 Prof. T.K Gajjar Factory at Parel
1907 Prof. Kotibhaskar Alembic Chemical works, Baroda
1943 Amba lal Sarabhai Sarabhai chemical Works

R. N. Chopra Committee
Reasons for formation of R. N. Chopra Committee:

1. Units were not sufficient to fulfill the requirements of Indian Public

2. Drugs were imported form UK, Germany and France

3. During first world war cheaper drugs were imported into India, which increased the demand for indigenous
drugs

4. Unhealthy competition grew up and Indian market was flooded with inferior quality drugs

5. Public pressurized government to introduce effective legislation to control import, manufacture, distribution
and sale of drugs

6. There was no legal and effective control on pharmacy profession

7. Hence to have a comprehensive legislation, the Indian government appointed a 'Drug Enquiry Committee'
under the chairmanship of Col. R.N. Chopra in 1931. this was formally known as Chopra Committee

Recommendations of Drug Enquiry Committee

1. Formation of Central Pharmacy Council (PCI) and State Pharmacy Council

2. Creation of Drug Control Machinery (DCM)

3. Establishment of well-equipped Central Drug Laboratory (CDL) and State Drug Laboratory

4. A central law to control drugs and pharmacy profession

5. Appointment of an advisory board to advise Government in making rules

6. Setting up the courses for training of pharmacists and prescribing minimum qualifications for registration as
pharmacists

7. Registration of every patents and proprietary medicines manufactured in India and imported from abroad

8. Bringing of crude single drugs as well as compounded medicines used in the indigenous systems of treatment
under control

9. Development of the drug industry in India

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 10. Compilation of an Indian Pharmacopoeia

Implementations:-

 Due to Second World War in 1939, there was delay in introduction of the legislation

 Government was reluctant to implement the recommendations of DEC and the public was pressurizing the
government

 Finally an Import of Drug Bill was introduced in 1937

 This bill dealt with only import of drugs and manufacturing and sale of drugs was not included

Scope and objective

• Drug bill was introduced in 1940 in legislative assembly, and Drug Bill 1940 was passed, which came to force in
1947

• Since then act was amended many times and at present it covers the provisions related to Drugs, Cosmetics,
Ayurvedic, Unani and Homeopathic medicines

• The present Drug and Cosmetic Act is an improved version of the Drug Act, 1940. The main objective of this act
was to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India

• The Central Government made several rules entitled the Drug and Cosmetic Rules 1945. These act and rules
were amended from time to time

• The Pharmacy act 1948 was passed with the main objective to regulate the profession of Pharmacy in India

• In 1954 the Drug and Magic Remedies Act was passed with the main aim to control certain types of
advertisements related to drug and to prohibit certain types of advertisements related to magic remedies

• Medicinal and Toilet Preparations (Excise duty) Act, 1955 was passed providing for the levy and collection of
duties of excise on medicinal and toilet preparations containing alcohol, opium Indian hemp or other narcotic
drugs

• Central government implemented Drug Price Control order 1987

• In 1985 the Narcotic and Psychotropic Substance Act, was passed. The main objective of this act was to
consolidate and amend the laws relating to narcotic drugs and Psychotropic substance

Bhore committee
• In 1943 under the chairmanship of Sir Joseph Bhore

• To make a survey of existing position in respect to health care delivery in India

• 7 key recommendations:
• Establishment of All India Pharmaceutical Council and Provincial Pharmaceutical Council

• Enactment of legislation designed to protect the public from incompetence, safeguard the interests of
qualified pharmacists and to raise the professional standard of pharmacists

• Suitable measures for maintaining disciplinary control over the practice and profession of pharmacy and
for registration of pharmacists

• Starting of revised courses of study for Licentiate Pharmacists, Graduate Pharmacists, Pharmaceutical
Technologies

• Setting up of Central Drugs Laboratory

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 • Rigid enforcement of Drugs and Cosmetics Act 1940 throughout the country

Bhatia committee
• In 1953 under the chairmanship of Major General [Link] formed Pharmaceutical Enquiry committee to
enquire into the working of pharmaceutical industry and to recommend what steps the Govt. should take to
establish it on sound lines to improve the country's economy

• In June 1954, 212 recommendations were submitted and most of the recommendations were implemented

Mudaliar committee
• In 1959 under the chairmanship of Dr. [Link] Mudaliar

• Inclusion of indigenous systems of medicine under the purview of Drugs Act

Hathi committee
• Under the chairmanship of Jaisukh Lal Hathi to review the various facets of drug industry in India

• Report covers licensing, price control, imports, QC, role of foreign sector etc

• Encourages development of indigenous industries

• Controlled the prices of large number of drugs in public interest

Indian Pharmacopoeia
 Bengal Pharmacopoeia and General Conspectus of Medicinal Plants - 1844

 1st Pharmacopoeia of India - 1868

 British Pharmacopoeia -1885

 Indian Pharmacopoeia Committee - 1948

 The Indian Pharmacopoeia (1st Edition) - 1955

 The Indian Pharmacopoeia (2nd Edition) - 1966

 The Indian Pharmacopoeia (2nd Edition) - 1975 - Supplement

 The Indian Pharmacopoeia (3rd Edition) - 1985

 The Indian Pharmacopoeia (4th Edition) - 1996

 The Indian Pharmacopoeia (5th Edition) - 2007

 The Indian Pharmacopoeia (6th Edition) - 2010

 The Indian Pharmacopoeia (7th Edition) - 2014

 The Indian Pharmacopoeia (8th Edition) - 2018

Other acts included were

 Prevention of food Adulteration act, 1954 and rules.

 The Industries (Development and Regulations) Act, 1951.

 The Industrial Employment (Standing order) Act 1946 and rules.

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  Industrial Dispute Act, 1947.

 Factory Act, 1948.

 The Indian Patent and Design Act 1970.

 The Trade and Merchandise Mark, 1958.

 Shops and Establishment acts of respective states.

Indian Pharmaceutical Industry

Industry background

The Indian pharmaceuticals market increased at a CAGR of 17.46 per cent during 2005-16 with the market increasing
from US$ 6 billion in 2005 to US$ 36.7 billion in 2016 and is expected to expand at a CAGR of 15.92 per cent to US$ 55
billion by 2020.

By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest
market globally in absolute size.

India's cost of production is significantly lower than that of the US and almost half of that of Europe. It gives a
competitive edge to India over others.

Issues for the Industry

► Between 2012-2018, the "patent cliff" will wipe an estimated $148 billion off pharmaceuticals industry revenues
due to many drugs coming out of patents

► Rising cost of R&D, the cost of bringing a molecule to market globally is estimated to be from $800 million to $4
billion.

► On average, out of every 10,000 molecules been developed; only one or two are likely to reach the market.

► Increasing government pressure, with harsher price controls and taxes.

► European Medical Agency (EMA) and the US Food and Drug Administration (USFDA) are focusing on risk
management; thereby putting pressures on profitability of pharmaceutical companies.

► Reaching the rural market, which is very large in India, the pharmaceutical companies have to work with
innovative marketing and sales tools to reach these markets.

► The contribution from the government in the areas of health care is not satisfactory, which is only 1.2 percent of
the GDP and healthcare infrastructure development not up to the expectation in India.

Summary
• To ensure that the patients receive drugs of required quality, tested and evaluated for safety and efficacy for
their intended result

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• Formation of Central Pharmacy Council and State Pharmacy Council. (PCI)

• Creation of Drug Control Machinery (DCM)

• Establishment of well-equipped Central Drug Laboratory, and State Drug Laboratory (CDL)

 The Indian Pharmacopoeia (2nd Edition) - 1966

 The Indian Pharmacopoeia (2nd Edition) - 1975 - Supplement

 The Indian Pharmacopoeia (3rd Edition) - 1985

 The Indian Pharmacopoeia (4th Edition) - 1996

 The Indian Pharmacopoeia (5th Edition) - 2007

 The Indian Pharmacopoeia (6th Edition) - 2010

 The Indian Pharmacopoeia (7th Edition) - 2014

 The Indian Pharmacopoeia (8th Edition) - 2018

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 Code of Pharmaceutical Ethics
Contents
 Introduction to code of pharmaceutical ethics
 Code of ethics framed by the Pharmacy Council of India

Introduction
 Ethics may be defined as "the code of moral principles" or as "the science of morals"
 The conduct of individuals, in any society, is governed by the governmental control as well as society lays down
a code of conduct to help the individuals differentiate between right and wrong
 Such a code when practised for a long time by the society results in the development of culture of conscience
 This code when practised in relation to a particular profession is known as professional ethics

Code of ethics by PCI

This is meant to guide the pharmacist about his/her conduct in relationship to himself, his patrons, general public, co-
professionals and other health professionals

The profession of pharmacy , apart from being a career for livelihood, it has inherent in it, the attitude of service and
sacrifice in the interests of the suffering humanity in handling, selling, distributing, compounding and dispensing medical
substances, including poisons and patent drugs

A pharmacist in collaboration with medical men and others is charged with the responsibility of safeguarding the health
of people

Standards of professional conduct for pharmacy are necessary in the public interests to ensure an efficient
pharmaceutical service

Every pharmacist should not only be willing to play his part in offering such a service but should also avoid such acts or
omission which would hamper the giving of the services or impair confidence in any respect for pharmacists as a body

The essential features of the code of pharmaceutical ethics formulated by the pharmacy council of India are as follows:

1. Pharmacists in relation to his job

2. Pharmacists in relation to his trade

3. Pharmacists in relation to Medical Profession

4. Pharmacists in relation to his profession

Pharmacist in relation to his job

Scope of Pharmaceutical Services

Supply of commonly required medicines

Willing to furnish emergency supplies at all times

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Conduct of the Pharmacy

Error of accidental contamination in the preparation, dispensing and supply of medicines are avoided
Appearance of the premises should reflect the professional character of pharmacy
Should be clear to the public that the practice of pharmacy is carried out in the establishment
In every pharmacy, there should be a pharmacist in personal control of the pharmacy
A notice stating that dispensing under (Employees State Insurance Scheme) E.S.I.S. or any other such other
schemes sponsored by Government is carried out may be exhibited at the premises.

Handling of prescriptions

When a prescription is presented for dispensing it should be received by a pharmacist without any discussion or
comment over it regarding the merits and demerits of its therapeutic efficiency.

The Pharmacist should not show any expression of alarm or astonishment upon the receipt of a prescription; as
such things may cause anxiety in patients or their agents and may even shake their faith in their physician.

Any question on a prescription should be answered with every caution and care; it should neither offend a
patron nor should it disclose any information, which might have been intentionally, withheld from him.

It is not within the privilege of a Pharmacist to add, omit or substitute any ingredient or alter the composition of
a prescription without the consent of the prescriber, unless the change is emergent or is demanded purely by
the technique of the pharmaceutical art and does not cause any alteration in the therapeutic action of the
recipe.

In case of any obvious error in it, due to any omission, incompatibility or over dose, the prescription should be
referred back to the prescriber for correction or approval of the change suggested. While such an act is
imperative in the best interest of the patient, in no case should it be done in a manner, which may endanger the
reputation of the prescriber concerned.

In matter of refilling prescriptions a pharmacist should solely be guided by the instructions of the prescriber and
he should advise patients to use medicines or remedies strictly in accordance with the intention of the physician
noted on the prescription.

Handling of Drugs

All possible care should be taken to dispense a prescription correctly by weighing and measuring all ingredients
in correct proportions by the help of scale and measures: visual estimations must be avoided.

Further, a Pharmacist should always use drugs and medicinal preparations of standard quality available.

He should never fill his prescriptions with spurious, sub-standard and unethical preparations.

A Pharmacist should be Judicious in dealing with drugs and medicinal preparations to be used for addiction or
any other abusive purposes.
Such drugs and preparations should not be supplied to any one if there is reason to suppose that it is required
for such purpose.

Apprentice Pharmacists:

While in-charge of a dispensary, drugstore or hospital pharmacy where apprentice pharmacists are admitted for
practical training, a pharmacist should see that the trainees are given full facilities for their work so that on the
completion of their training they have acquired sufficient technique and skill to make themselves dependable
pharmacists.

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 No certificate or credentials should be granted unless the above criterion is attained and the recipient has
proved himself worthy of the same.

Pharmacist in relation to his Trade

Price Structure:

Prices charged from customers should be fair and in keeping with the quality and quantity of commodity
supplied and the labor and skill required in making it ready for use, so as to ensure an adequate remuneration to
the pharmacist taking into consideration his knowledge, skill, the time consumed and the great responsibility
involved, but at the same time without unduly taxing the purchaser

Fair Trade Practices

• No attempt should be made to capture the business of a contemporary by cut-throat competition, that is, by
offering any sort of prizes or gifts to patronizers or by knowingly charging lower prices for medical commodities
than those charged by fellow pharmacist if they are reasonable.

• In case any order or prescription genuinely intended to be served by some dispensary is brought by mistake to
another, the latter should refuse to accept it and should direct the customer to the right place.

• Labels, trademarks and other signs and symbols of contemporaries should not be imitated or copied.

• Purchase of Drugs:
Drugs should always be purchased from genuine and reputable sources and a pharmacist should always be on
his guard not to aid or abet, directly or indirectly the manufacture, possession, distribution and sale of spurious
or sub- standard drugs

• Hawking of Drugs:

Hawking of drugs and medicinal should not be encouraged nor should any attempt be made to solicit orders for
such substances from door to door. 'Self-service' method of operating pharmacies and drug - stores should not
be used as this practice may lead to the distribution of therapeutic substances without an expert supervision
and thus would encourage self-medication, which is highly undesirable.

• Advertising and Displays:

No display material either on the premises, in the press or elsewhere should be used by a pharmacist in
connection with the sale to the public of medicines or medical appliances which is undignified in style or
which contains:-

A. Any wording design or illustration reflecting unfavorably on pharmacist's collectivity or upon any group or
individual.
B. A disparaging reference, direct of by implication to other supplier
C. Misleading or exaggerated statements or claims
D. The word "Cure" in reference to an ailment or symptoms of ill-health
E. A guarantee of therapeutic efficacy
F. An appeal to fear
G. An offer to refund money paid.
H. A prize, competition or similar scheme.

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 I. Any reference to a medical practitioner or a hospital or the use of the terms "Doctor" or "Dr." or "Nurse" in
connection with the name of the preparation not already established.
J. A reference to sexual weakness, premature ageing or loss of virility.
K. A reference to complaints of sexual nature in terms, which lack the reticence proper to the subject.

• Contraceptive preparations and appliances or their illustration except a notice approved by regulations or
bearing the words Family planning requisite should not be exhibited.

• Contraceptive preparations and appliances or their illustrations should not be exhibited except a notice
approved by regulations or bearing the words "Family Planning Requisites".

• Under no circumstances should lustful obscene and indecent publications of any kind or description be sold or
distributed.

• As this practice is highly detrimental to the moral welfare of the Nation

Pharmacists in Relation to Medical Profession

Limitation of Professional Activity:

Whereas it is expected that medical practitioners in general would not take to the practice of pharmacy by
owing drug stores, as this ultimately leads to coded prescriptions and monopolistic practices detrimental to
the pharmaceutical profession and also to the interest of patients

It should be made a general rule that pharmacists under no circumstances take to medical practice, that is to
diagnosing diseases and prescribing remedies therefore even if requested by patrons to do so

In cases of accidents and emergencies a pharmacist may, however, render First Aid to the victim

Clandestine Arrangements:

No pharmacist should enter into any secret arrangements or contract with a physician to offer him any
commission or any advantage of any description in return for his favor of patronage by recommending his
dispensary or drugstore.

Liaison With Public:

Being a liaison between medical profession and people, a pharmacist should always keep himself abreast with the
modern developments in pharmacy and other allied sciences by regularly reading books, journals, magazines and other
periodicals , so that on the one hand he may be in a position to advise the physician on pharmaceutical matters like
those of colors, flavors, vehicles and newer forms of administration of medicines, on the other, he may be able to
educate the people for maintaining healthy and sanitary conditions of living

• Thus a pharmacist can contribute his share in the nation-building activities of the country

• A pharmacist should at all times endeavour to promote knowledge and contribute his quota in the
advancement of learning

• A pharmacist should never disclose any information which he has acquired during his professional activities to
any third party or person unless requires by law to do so

• He should never betray the confidence which his patrons repose in him or which he has won by virtue of his
eminent character and conduct

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 •

Pharmacist in relation to his Profession

 Professional Vigilance:

It is not only sufficient for a pharmacist to be law-abiding and to deter from doing things derogatory to Society
and his profession, but it should be his duty to make others also fulfill the provisions of the pharmaceutical
and other laws and regulations
He should not be afraid of bringing or causing a miscreant to be brought to book, may be a member of his own
profession
Whereas it is obligatory for a pharmacist to extend help and cooperation to a fellow member in his legitimate
needs, scientific, technical or otherwise, he is to be, at the same time, vigilant to weed the undesirable out of
the profession and thus help to maintain its fair name and traditions

Law-abiding Citizens:

A pharmacist engaged in profession has to be an enlightened citizen endowed with a fair knowledge of the land
and he should strive to countenance and defend them
He should be particularly conversant with the enactments pertaining to food, drug, pharmacy, health, sanitation
and the like and endeavor to abide by them in every phase of his life
A pharmacist is a unit whole and his life cannot be divided into compartments

Relationship with Professional Organizations:

In order to inculcate a corporate life in his own professional colleagues, a pharmacist should join and advance the cause
of all such organizations, the aims and objects of which are conducive to scientific moral and cultural well-being of
pharmacists and at the same time are in no way contrary to the code of pharmaceutical ethics

Decorum and Propriety:

A pharmacist should always refrain from doing all such acts and deeds which are not in consonance with the decorum
and propriety of pharmaceutical profession or which are likely to bring discredit or upgrade to the profession or to
himself

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 Pharmacy Act 1948
Contents
• Definitions

• History & Amending of act

• Pharmacy Council of India and its functions

• State Pharmacy Council

• Constitution of Joint State Pharmacy Council

• Functions of Joint State Pharmacy Council

• Registration of Pharmacists

• Preparation of First and subsequent register

• Deletion of names from register

• Offences and penalties

HISTORY OF PHARMACY ACT

► In India there was no restriction to practise the profession of Pharmacy

► One could practise this profession as any other profession

► Persons, having no knowledge and having no education in pharmacy or pharmaceutical chemistry or

pharmacology, were engaged in this profession

► Hundreds of cases were found by Government wherein the compounding, mixing, or dispensing of medicines
was being done by persons who were not adequately educated in this line

► These causing great harm to the health of people

► It was found necessary to enact a law for the regulation of the profession and practice of pharmacy
List of amending acts & adaptation orders
■ The Adaptation of Laws Order, 1950

■ The Adaptation of Laws (No.3) Order, 1956

■ The Pharmacy (Amendment) Act, 1959

■ The Pharmacy (Amendment) Act, 1976

■ The Pharmacy (Amendment) Act, 1982

■ The Delegated Legislation Provisions (Amendment) Act, 1985

OBJECTIVES
► To restore the Pharmacy profession in its due place in the health services

► Raising the status of the profession of Pharmacy in India

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 ► To regulate the practice of Pharmacy in India

► To provide uniform education and training throughout India

► To maintain control over persons entering the profession of pharmacy

► To Protect the Public Health

- Medical Use of Drugs

- Drug Abuse

DEFINITIONS
► "Pharmacy Act" :

An Act to regulate the profession of pharmacy.

► "Medical practitioner "--

■ A person,

(i) Holding a qualification granted by an authority notified under section 3 of the Indian Medical Degrees Act, 1916
or specified in the Schedules to the Indian Medical Council Act 1956; OR

(ii) Registered or eligible for registration in a Medical register of a State, meant for the registration of persons practicing
the Modern scientific system of medicine; OR

(iii) Registered in a medical register of a State, who, although not falling within above first and second clause, but is
declared by a general or special order made by the State Government; OR

(iv) Registered or eligible for registration in the register of Dentists for a State under the Dentists Act, 1948; OR

(v) Who is engaged in the practise of Veterinary medicine and who possesses qualifications approved by the State
Government?

► "REGISTERED PHARMACIST"

A person whose name is for the time being entered in the register of the State in which he or she is for the time being
residing or carrying on his profession or business of pharmacy.
PHARMACY COUNCIL OF INDIA (PCI)
► The central council (P.C.I) is constituted by the Central government

► First central council was constituted in 1949

► It is reconstituted every five years

CONSTITUTION OF PCI
■ It consists of three different types of members:

A. Elected member

B. Nominated member

C. Ex-officio member

A. Elected members 08:

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 1) Six members, elected by the University Grant commission (U.G.C) There is at least one teacher of each of
the pharmaceutical chemistry, pharmacy, and pharmacognosy and pharmacology

2) One member , elected by Medical Council of India

3) One member , elected by State Council ,who shall be a registered Pharmacist

B. Nominated members 08:

1) Six members, nominated by the Central Government; of whom at least 4 shall be persons possessing a
degree or diploma in, and practicing pharmacy or pharmaceutical chemistry

2) A Representative of the U.G.C. and a representative of the All India Council for Technical Education(A.I.C.T.E.)

3) One member nominated by each State Government, who shall be a registered pharmacist

C. Ex-officio members:

1) The Director General of Health Services

2) The Director of the Central Drugs Laboratory

3) The Drugs Controller of India

► Executive Committee consisting of:

■ President

■ Vice-president

■ Five members elected by central council from its members

► President and Vice-President of Central Council shall be elected by the members of the Council from themselves.

► The council shall appoint,

-A registrar, act as secretary

-Other officer and personnel

FUNCTIONS OF PCI
A) Education Regulations (E.R.) -

Minimum standard of education laid down by P.C.I. are known as the "Education Regulation".

■ They include,

i. Minimum qualification for registration as a Pharmacist

ii. Minimum qualification for admission to Diploma in Pharmacy

iii. Duration of training and course of study to be covered

iv. Condition to be fulfilled by the academic Institution and by the Examining Authority

v. Nature and period of practical training

vi. The subjects of examination and minimum standard of passing

vii. Condition to be fulfilled by the institution to be recognized for giving practical training

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viii. Practical training contract form for pharmacists

B) To regulate the Education Regulation in the states.

C) Approval of the Institutions providing course and examination for the pharmacists.

■ Procedure:

i) Institution has to apply to P.C.I/A.I.C.T.E.

ii) P.C.I/A.I.C.T.E. deputes its inspector to visit the institution.

iii) Inspector then reports to council on which if council is satisfied, it approves the course of examination.

PROVINCIAL PHARMACY COUNCIL

Provincial Pharmacy Council

Separate state council Interstate agreement

(SPC)

Joint state council state council of

(JPC) one state serve the need of other state

CONSTITUTION OF STATE PHARMACY COUNCIL

► It consists of three different types of members:

A. Elected member

B. Nominated member

C. Ex-officio member
A. Elected member:

1) Six members, elected from amongst themselves by registered pharmacists of the State;

2) One member elected from amongst themselves by the members of each Medical Council of the state.

B. Nominated member

Five members, of whom at least three shall be possessing a degree or diploma in pharmacy or pharmaceutical chemistry
or be Registered Pharmacists, nominated by the State Government

C. Ex-officio member

1) Chief administrative medical officer of the State

2) Government analyst nominated by State government under the D & C act 1940

3) Officer in charge of drugs control organisation of the State

Joint State Pharmacy Council

► Two or more State Governments can agree that the State Council of one State is to serve the needs of the

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 participating States

► Composition of Joint State Councils:

It consists of three different types of members:

A. Elected member

B. Nominated member

C. Ex-officio member

A. Elected member:

1) 3-5 members elected amongst themselves by the Registered Pharmacists of each of the participating States

2) One member elected from amongst themselves by the members of each Medical Council of each Stat

B. Nominated member:

2-4 members nominated by each participating state, of whom more than half possess degree or diploma in pharmacy
or be Registered Pharmacist

C. Ex-officio member:

1) The Chief administrative medical officer of each participating state

2) The Government Analyst of each participating state.

3) The officer in-charge of drugs control organisation of each participating state

► Executive Committee consisting of:

■ President

■ Vice-president

■ The such other number of the member

REGISTRATION OF PHARMACISTS

► The Pharmacy Act, 1948, provides for the registration of pharmacists.

► There are two types of register,

1) First register

2) Subsequent register

► The Preparation and maintenance of Register:

The Register shall include the following particulars:

a) The full name and residential address of the registered person;

b) The date of his first admission to the register;

c) His qualifications for registration;

d) His professional address, and if he is employed by any person, the name of such person;

e) Such further particulars as may be prescribed.

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PREPARATION OF FIRST REGISTER

► For the preparation of the first register, the State Government has to constitute a Registration Tribunal.

► The Tribunal consisting of :

- Three persons,

- A Registrar, act as Secretary.

► Tribunal fixes the date on or before which all applications for registration with prescribed fees are accepted.

► All applications are examined.

► If tribunal is satisfied, it directs the entry of the name of the applicant on the register.

Qualifications for entry on first register

► Applicant should be at least 18 years old.

► Applicant should reside or carries on the business or profession of pharmacy in the concerned State.

► Applicant should hold,

a) A degree or diploma in pharmacy OR pharmaceutical chemistry OR

b) Chemist and Druggist diploma OR

c) Qualification granted by authority outside India which is adequate for registration. OR

d) Degree of an Indian universities with not less than 3 years' experience in dispensing in hospital. OR

e) Passed an examination for dispensers recognized by state government. OR

f) Not less than 5 years' experience of compounding prior to the date notified by Tribunal.
SUBSEQUENT REGISTERS

► Procedure for subsequent registration:

From the registered pharmacists of the first register constitution of State council take place

Application are invited within fix date, addressed to the registrar

If registrar found that applicant has requisite qualification, he may direct his/her name to be entered in register.

If application has been rejected by registrar, he/she may appeal to state council within 3 months of the rejection.

The decision of the state council shall be final.

REQUIREMENTS FOR SUBSEQUENT REGISTRATION

► Applicants should be at least 18 years of the age.

► Applicants should carry on the profession of the pharmacy in the concerned state.

QUALIFICATIONS FOR SUBSEQUENT REGISTRATION

► There are 3 different types of qualifications prescribed:

1) After the preparation of first register and before E.R. take effect.

2) After E.R. take effect.

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3) Special provisions.

1) After the preparation of First register and before E.R. take effect

a) Satisfies the conditions prescribed by the Central Council OR

b) A registered pharmacist in another State OR

c) Possesses a qualification for registration granted outside the states and are at least matriculates.

2) After the Education regulations take effect:

► Those who have passed an approved examination OR

► Those who possesses a qualification granted by authority outside India and recognize by the P.C.I OR

► Those who are Registered Pharmacist in another State

3) Special provisions:

► Provision made under The Pharmacy Act 1959, apply to persons;

■ Affected by the partition in 1947

■ Due to reorganization of the state in 1956

■ Migrated to India

► Provision made under The Pharmacy Act 1976;

■ Those who possess degree or diploma in Pharmacy or Pharmaceutical chemistry. OR

■ Chemist & druggist diploma of Indian University OR

■ Passed an examination recognized for dispenser by State government. OR

■ Person approved as "Qualified persons" before 31st December 1969 under D & C Act.

■ Any displaced persons from Bangladesh, Burma, Uganda, Sri Lanka, were carrying profession of pharmacy for
period of 5 years prior to date of application.

RENEWAL FEES
► Retention of a name on the register, subject to the payment of prescribed fee annually before the 1st day of April.

► If a renewal fee is not paid by the due date, the Registrar shall remove the name of the defaulter from the register.

► Provided that a name so removed may be restored to the register on such conditions as may be prescribed.

► On payment of the renewal fee, the Registrar shall issue a receipt therefore and such receipt shall be proof of
renewal of registration.

► Entry of additional qualifications obtained by registered pharmacist shall be entered in the register on payment of
prescribed fees.

REMOVAL OF NAME FROM REGISTER

► The name of Pharmacist may be removed from register,

i) If his name has been entered into the register by error OR

ii) If he has been convicted of any offence in any professional respect which renders him unfit to be kept in the register

Page 12 of
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OR

iii) If the employed person is registered pharmacist, his name may be removed from register If,

■ Convicted of offence or held guilty of infamous conduct

■ Offence was investigated by registered pharmacist himself

■ If the repetition of similar offence or conduct during the period of 12 month

■ Pharmacist may go to the appeal to the State Government within 30 days.

■ A person whose name has been removed from the register is required to surrender his certificate or registration
to the Registrar.

► Issue of duplicate certificates of registration:

Where it is shown to the satisfaction of the Registrar that a certificate of registration has been lost or destroyed, the
Registrar may, on payment of the prescribed fee, issue a duplicate certificate in the prescribed form.

OFFENCES PENALTIES

1. Falsely claiming to be a registered pharmacist. 1. (a) Fine up to Rs. 500.00 on first conviction.

(b) Fine up to Rs. 1000.00 and/or 6 months imprisonment of

any subsequent conviction.

2. Dispensed by unregistered persons. 2. 6 months imprisonment OR Fine up to Rs. 1000.00 OR Both.

Exception: Medical practitioners.

3. Failure to surrender certificate of registration. 3. Fine up to Rs. 50.00

4. Obstructing State pharmacy council 4. 6 months imprisonment OR Fine up to Rs. 1000.00 OR Both.
Inspectors.

Summary
• Registered Pharmacist - A person whose name is for the time being entered in the register of the State in
which he or she is for the time being residing or carrying on his profession or business of pharmacy.

• PCI has a constitution of Elected members, Nominated members and Ex-officio members

• PCI regulates Education Regulations which is minimum standard of education laid down by P.C.I. are known as
the "Education Regulation".

• It includes Minimum qualification for registration as a Pharmacist and Minimum qualification for admission to
Diploma in Pharmacy

• Joint State Pharmacy Council has a constitution of Elected members, Nominated members and Ex-officio
members

• The Register shall include the following particulars: full name and residential address of the registered person;
date of his first admission to the register; qualifications for registration; professional address

• Retention of a name on the register, subject to the payment of prescribed fee annually before the 1 st day of

Page 13 of
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April.

Page 14 of
9
 DRUGS AND COSMETICS ACT
History
 British misrule-Providing poor healthcare system to Indian citizens
 Observations made by-Drugs Enquiry Committee, Indian Medical Association
 Reports in- Indian Medical Gazette during 1920-30
 1940 - Drugs and Cosmetics Act
 1945 - Rules under the Act
 Extended to whole of India..

LIST OF AMENDING ACTS AND ADAPTATION ORDERS

1. The Drugs (Amendment} Act, 1955

2. The Drugs (Amendment} Act, 1960

3. The Drugs (Amendment} Act, 1962

4. The Drugs and Cosmetics (Amendment} Act, 1964

5. The Drugs and Cosmetics (Amendment} Act, 1972

6. The Drugs and Cosmetics (Amendment} Act, 1982

7. The Drugs and Cosmetics (Amendment} Act, 1995

8. The Drugs and cosmetics (Amendment} Act, 2008

9. The Drugs and cosmetics (Amendment} Act, 2013

Objectives
 To regulate the import, distribution and sale of drugs & cosmetics through licensing in order to
prevent substandard or harmful drugs and cosmetics.

 Excise control over the production of drugs and cosmetics in the country.

 To distribution and sale of drugs and cosmetics by qualified persons only.

 To prevent substandard in drugs.

 To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.

 To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic
and allied drugs and cosmetics.

Definitions
Drugs:

All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the
diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including
preparations applied on human body for the purpose of repelling insects like mosquitoes.

Page 15 of 42
Cosmetic:

Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the
human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
includes any article intended for use as a component of cosmetic.

Ayurveda Sidha and Unani Drugs:

Include all medicines indented for internal or external use for or in diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals & manufactured exclusively in accordance with the formulae prescribed
in authoritative books of Ayurvedic, siddha and Unani-Tibb systems of medicines.

Central License approving authority:

Means Drug Controller of India appointed by the Central Government.

Drug: Includes

a} all medicines used for the internal or external use of human beings or animals and all substances indented to be
used for or in diagnosis, treatment , mitigation or prevention of any disease or disorder in human beings or
animals including preparation applied for repelling mosquitoes

b} substances indented to affect the structure or any function of human body or indented to be used for the
destruction of vermin or insects that cause disease in human beings or animals

c} all substances indented for use as components of drug including empty gelatin capsules

d} Devices indented for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals.
Manufacture:

Include any process or part of process for making, altering, ornamenting, finishing, packing, labeling, breaking up or
otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the
compounding or dispensing of any drugs or packing of any cosmetics or drug in ordinary course of retail process.

Patent or Proprietary Medicine:

In relation to Ayurveda, Sidha or Unani systems of medicine all formulations containing only such ingredients mentioned
in the formulae described in authoritative books of Ayurveda, Sidha or Unani- Tibb systems of Medicine specified in the
first schedule but does not include medicine which is administered by parenteral route also formulations included in
authoritative books as mentioned in the first Schedule.

In relation to any other system of medicine, a drug which is a remedy or prescription presented in form ready for
internal or external administration of human beings or animals and which is not included in edition of the Indian
Pharmacopoeia for the time being or any Pharmacopoeia authorized in this behalf by the Central Government after
constitution with the DTAB.

Misbranded drugs: A drug is deemed to be misbranded -

 If it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of better or
great therapeutic value than it really is.
 If it is not labeled in prescribed manner; or
 If its label or container or anything accompanying the drugs bears any statement, design or device which makes
any false claim for the drug or which is false or misleading in any particular.

Adulterated Drugs: A drug is deemed to be adulterated -

Page 16 of 42
  If it consists in whole or in part, of any filthy, putrid or decomposed substance; or
 If it has been prepared, packed or stored under insanitary conditions whereby it may have been rendered
injurious to health; or
 If its container is composed in whole or in part, of any poisonous or delirious substances which may render the
contents injurious to health.
 If it bears for purpose of coloring only a color other than one which is prescribed.
 If it contains any harmful or toxic substance which may render it injurious to health; or
 If any substance has been mixed there with so as to reduce its quality or strength.

Spurious Drugs: A drug is deemed to be spurious -

 If it is imported or manufactured under a name which belongs to another drug.; or

 If it is an imitation or is a substitute for, another drug or resembles another drug in a manner likely to deceive or
unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such
other drugs; or
 If the label or container bears the name of an individual or company purporting to be the manufacture of the
drug, which company or individual is fictious or does not exist.
 If it has been substituted wholly or in part by another drug or substance; or
 If it purports to be the product of a manufacturer of whom it is not truly a product.
Misbranded Cosmetics: A cosmetic is deemed to be misbranded -

 If it contains color which is not prescribe; or

 If it is not labeled in prescribed manner; or
 If the label or container of anything accompanying the cosmetic bears any statement which is false or misleading
in particular.

Spurious Cosmetics: A cosmetic is deemed to be spurious -

 If it is imported under a name which belongs to another cosmetic; or

 If it is an imitation of, or a substitute for, or resembles another cosmetic in a manner likely to deceive or bears
upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously
marked so as to reveal its true character and its lack of identity with such other cosmetic; or
 If the label of the container bears the name of an individual or company purporting to be the manufacturer of
the cosmetic, which individual or company is fictitious and does not exist; or
 If it purports to be the product of a manufacturer of whom it is not truly a product.

GMP Guidelines
GMP as per Schedule "M"

[Link]

GMP as per WHO

[Link]

Page 17 of 42
GMP as per MCA now known as MHRA

[Link]

GMP as per TGA

[Link]

GMP as per US FDA

[Link]

GMP as per ICH guidelines

[Link]

GMP
 GMP in solid dosage forms
 GMP in semisolid dosage forms
 GMP in Liquid orals
 GMP in Parenterals Production
 GMP in Ayurvedic medicines
 GMP in Bio technological products
 GMP in Nutraceuticals and cosmeceuticals
 GMP in Homeopathic medicines

Principles of GMP
1. Design and construct the facilities and equipments properly

2. Follow written procedures and Instructions

3. Document and validate work

4. Monitor facilities and equipment

5. Write step by step operating procedures and work on instructions

6. Design, develop and demonstrate job competence

7. Protect against contamination

8. Control components and product related processes

9. Conduct planned and periodic audits

10 Attributes of a Good Document

1. Accurate

2. Clear

3. Complete

4. Consistent

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 5. Indelible

6. Legible

7. Timely

8. Direct

9. Authentic

10. Authorized

Schedule M
 Good Manufacturing Practices (GMP}
 Guidelines are meant to assure the quality of drugs.
 Draft of GMP was prepared in 1975 & finalized & implemented in 1988
 Part I deals with Good manufacturing practices relating to factory premises.
 Part II deals with plant & equipment for the manufacture of drugs.
Schedule M - cGMP for Finished Pharmaceuticals
1. General Provision

2. Organization & Personnel

3. Building & Facilities

4. Equipment

5. Control of Components & Drug Product Containers & Closures

6. Production & Process Control

7. Packaging & Labeling Control

8. Handling & Distribution

9. Laboratory Control

10. Records & Reports

11. Returned & Salvaged Drugs

General Provision

1. General requirements

Organization & Personnel

1. Responsibilities of quality control unit

2. Personnel qualifications

3. Personnel responsibilities

4. Consultants

Building & Facilities

1. Design and construction features

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 2. Lighting

3. Ventilation, air filtration, air heating and cooling

4. Plumbing

5. Sewage

6. Washing and toilet facilities

7. Sanitation

8. Maintenance

Equipment

1. Equipment design, size, and location

2. Equipment construction

3. Equipment cleaning and maintenance

4. Automatic, mechanical, and electronic equipment

5. Filters

Control of Components & Drug Product Containers & Closures

1. General requirements

2. Receipt & storage of untested components, drug product containers, and closures

3. Testing and approval or rejection of components, drug product containers, and closures

4. Use of approved components, drug product containers, and closures

5. Retesting of approved components, drug product containers, and closures

6. Rejected components, drug product containers, and closure

7. Drug product containers and closures

Production & Process Control

1. Written procedures; deviations

2. Calculation of yield

3. Equipment identification

4. Sampling and testing of in-process materials and drug products

5. Time limitations on production

6. Control of microbiological contamination

7. Reprocessing

Packaging & Labeling Control

1. Materials examination and usage criteria

2. Labeling issuance

3. Packaging and labeling operations

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 4. Tamper-evident packaging requirements for over-the-counter (OTC} human drug products

5. Drug product inspection

6. Expiration dating

Laboratory Control

1. General requirements

2. Testing and release for distribution

3. Stability testing

4. Special testing requirements

5. Reserve samples

6. Laboratory animals
7. Contamination

Records & Reports

1. General requirements

2. Equipment cleaning and use log

3. Component, drug product container, closure, and labeling records

4. Master production and control records

5. Batch production and control records

6. Production record review

7. Laboratory records

8. Distribution records

9. Complaint files

Factory Premises

General Requirements

Location of factory & its surroundings should ensure freedom from contamination due to sewage drain, etc &
obnoxious odors or fumes, or large quantity of soot, dust or smoke.

Factory building should be constructed to ensure production of drugs under hygienic conditions.

 Operations such as manufacturing, processing, packing labeling & testing should be carried out in such a way that
mix up & cross contamination are prevented.
 Premises should be constructed and maintained as to prevent entry of insects & rodents, Interior surface should be
smooth & free from cracks & permit easy cleaning disinfection. Adequate lighting, ventilation & humidity must be
maintained. Drainage systems should be underground, the sanitary fitting & electrical fixtures in the manufacture
area must be concealed. Water used must be free of pathogenic microorganisms and of drinkable quality. Waste
water should be treated before disposal.
 There should be a validated system for the treatment of water so as to produce purified water confirming to IP

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 specification. Water should be stored in tanks and freedom from microbial growth must be ensured. The tanks
should be cleaned periodically and the records should be maintained.
 Provisions should be made for the roper storage of the materials awaiting disposal. The disposal of sewage and
effluents shall be as required under the Environmental Pollution control board while all biomedical waste must be
destroyed as per the rules of Biomedical Waste Management and Handling rules.

Warehousing Area

 Adequate areas shall be designed & provided with proper bins, racks & platforms for the storage and warehousing
of all materials & products, machine & equipment's etc. Warehousing area must be clean, dry & maintained within
acceptable temperature limits. Storage areas should have appropriate housekeeping & rodents, pests & vermin
control procedures & records should be maintained.
 Active raw materials and excipients must require separate sampling and warehousing area.
 Regular checks should be made to ensure adequate steps taken against spillage, breakage and leakage of containers.

Production Area

 Should be designed to allow the production preferably in uni-flow & with logical sequence of operations.
 The equipment's and materials must be placed orderly & the movement of personnel must be restricted to
avoid cross contamination.
 Separate dedicated self-containing facilities should be made available for the production of sensitive pharmaceutical
products like penicillin or biological preparations with live microorganisms.
 Pipe works, electrical fittings, ventilations, openings & similar service lines must be designed to avoid creation of
recesses.
 Service lines shall preferably identified by colors & nature of supply and direction of flow shall be indicated.

Quality control area

 Should be independent of production area & divided to separate sections for physio-chemical, biological,
microbiological & radio isotope analysis.
 Laboratories shall be designed to avoid mix-ups and cross-contamination. Separate instrument room with adequate
area shall be provided for sensitive & sophiscated instruments employed for analysis.
 Suitable storage space shall be provided for test samples, retained samples, reference standards, reagents &
records.

Personnel

 Manufacture/testing shall be conducted under the direct supervision of competent technical staff & head of quality
control laboratory shall be independent of manufacturing unit.
 Personnel in quality control and quality control operations shall be suitably qualified & experienced & appropriate
training must be given to them in the duties & responsibilities assigned to them.

Health, Clothing & Sanitation of workers

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 All personnel coming to contact with products & raw materials should be free from contagious diseases &
should undergo periodic health checkup. Just before entry to manufacturing area, room with facility for
personnel cleanliness should be provided.
 Prior to employment, personnel shall undergo medical examination & shall be free from TB, skin and other
communicable/contagious diseases.
 Periodical medical examination at least once a year may be necessary.
 All persons prior to & during the employment shall be trained in practices that ensure personnel hygiene.
 Persons handling beta lactam antibiotics shall be tested for penicillin sensitivity before employment and those
handling sex hormones, cytotoxic substances & other potent drugs shall be periodically examined for adverse
effects.
 Direct contact shall be avoided b/w unprotected hands of personnel 7 raw materials, intermediate, or finished
unpacked products.
 All persons should wear clean body coverings.
 Smoking, eating, drinking, chewing or keeping plants or food & personnel medicines shall not be permitted in
production, laboratory storage & other areas.

Ancillary Areas

 Rest & refreshment rooms should be separate & should not lead directly to the manufacturing area.
 Facilities for changing, storing of clothes & for washing & toilet purposes should be provided and must be adequate
for the number of users.

Sanitation in manufacturing premises:

 Manufacturing area should not be utilized for any other purposes & should be maintained clear & in orderly manner
free from accumulated waste, dust, debris etc. A routine sanitation program must be exercised.
 Production areas shall be well lit, particularly where visual online controls are carried out.

Raw Materials: All raw materials must be:

 Purchased from approved sources under valid purchase vouchers, possibly from producers directly.
 Identified & their containers examined for damage& assigned control number.
 There shall be separate areas for materials under test, approved & rejected raw materials.
 All incoming materials shall be quarantined immediately after receipt.
 Materials must be stored in such a way that first in/first expiry, first out principle can be applied.
 Only raw materials released by QC department & which are within their shelf life shall be used.

Sterile Products

 Separate enclosed areas provided with air locks, dust free, ventilated with air supply through HEPA filters are
recommended.
 Routine microbial counts of area are necessary during manufacturing operation.

Page 23 of 42
 Design of area must avoid possibility of mix up between sterile & non sterile products.
 Access to manufacturing area must be restricted to authorized personnel only.

Working Space

 Adequate working space & adequate room for orderly placement of equipment & materials should be provided to
eliminate mix up between different drugs & cross contamination.
Medical Services: Manufacturer must provide facilities for

 Adequate facilities for first aid.

 Medical examination of workers at time of employment & periodic check up there after once in a year.
 Facilities for vaccination or other exigencies.

Equipment: Equipment used for manufacture must be constructed, designed, installed & maintained to:

 Achieve operational efficiency to attain the desired quality.

 Prevent physical, chemical or physiochemical change through surface contact.
 Prevent contact of any substances required for operation of equipment's such as lubricants.
 Facilitate thorough cleaning whenever necessary.
 Minimize any contamination of any drugs and their containers during manufacture.

Master Formula Records: The Licensee'd maintain master formula records relating to all manufacturing procedures for
each product. The master formula record shall give:

 Patent or proprietary name of product along with generic name. Strength & dosage form
 Description of final containers, packaging materials. Labels & closures to be used.
 Identity, quality & quantity of each raw materials to be used.
 Description of all equipment's & vessels & the size used in the process.
 Manufacturing & control instructions along with parameters for critical steps such as mixing, drying, blending,
sieving, and sterilizing the product.
 Theoretical yield to be expected from the formulation
 Detailed instructions & precautions to be taken in manufacture, storage of drugs & of semi-finished products & the
requirements in process quality control tests & analysis to be carried out during each stage of manufacture.

Batch Manufacturing Records: Licensee 'd maintain batch manufacturing records for each batch of drugs as per
Schedule U. it 'd provide complete account of manufacturing history of each batch showing that it has been
manufactured, tested & analyzed in accordance with manufacturing procedures & written instructions as per master
formulae.

Manufacturing Operations & Control: All manufacturing operations must be carried out under the supervision of
competent technical staff. Critical steps in the process related to selection, weighing & measuring of raw materials must
be done under the direct supervision of competent technical staff.

Product containers & closures: 'd comply with Pharmacopoeial requirements. Suitable test methods, cleaning &
sterilization procedures 'd be used to assure that components, closures & other component part of drug packages are
suitable & they are not reactive, additive, absorptive, or leach to an extent that significantly affects the quality or purity

Page 24 of 42
of the drug.

Labels & other printed materials: Printed labels & packaging materials including leaflets 'd be handles & accounted to
ensure that they do not become intermixed. Prior to issue, they should be examined & released as satisfactory for use
by quality control personnel.

Distribution of Records: Records for the distribution of each batch of drug should be maintained in order to facilitate
prompt & complete recall of the batch if necessary.
Quality control system: Principal duties of quality control department are:

 Prepared detailed Instruction for carrying out each tests & analysis.
 To release or reject i} each batch of raw material, ii} semi-finished products if necessary, iii} packaging &
labeling materials & final containers, iv} each batch of finished products ready for distribution.
 Evaluate adequacy of conditions under which raw materials, semi-finished products & finished products are stored.
 Evaluate quality & stability of finished products.
 To establish, & when necessary revise, procedure & specifications.
 To examine returned products as to whether such products'd be released, reprocessed or destroyed.

Schedule M Part II Plant & Equipment

Recommends the requirements of plant & equipment for the manufacture of drugs under the following sections.

i} Ointments, emulsions, lotions & suspensions,

ii} Syrups, elixirs & solutions,

iii} Pills, compressed tablets & hypodermic

needles, iv} Powders,

v} Hard gelatin capsules,

vi} Surgical dressings other than absorbent cotton,

vii} Eye ointments,, eye lotions & other preparations for external use,

viii} pessaries & suppositories,

ix} inhalers,

x} repacking of drugs,

xi} Parenteral preparations.

SALE OF DRUGS
■ Classes of drugs prohibited to be sold

■ Wholesale of biological (C/C1}

■ Wholesale of other than those specified in C/C1 and X

Class of drug prohibited to sale

• Misbranded, spurious, adulterated and drugs not of standard quality

Page 25 of 42
 • Patent/Proprietary drugs with undisclosed formula

• Sch-J drugs

• Expired drugs.

• Drugs used for consumption by government schemes such as, Armed force.

• Physician's samples
Wholesale of biological (C/C1)
 Adequate premises, with greater than 10 M2 area, with proper storage facility
 Drugs sold only to retailer having license
 Premises should be in charge of competent person who is Reg. Pharmacist.
 Records of purchase & sale
 Records preserved for 3 years from date of sale
 License should be displayed on premises
 All the conditions as discussed in for biological.
 Compounding is made by or under the direct and personal supervision of a qualified person.

Retail Sale

For retail sale, two types of licenses are issued:

i} General licenses

ii} Restricted licenses

Restricted license:

Granted to those dealers who do not engage the services of a qualified person and only deal with such classes of drugs
whose sales can be effected without qualified person and vendors who do not have fixed premises

Labeling & Packaging

All the general and specific labeling and packaging specified to all classes of drugs and cosmetics should be as per the
provisions made under the act.

Labeling in India

All labels of a drug should conform as per the specifications under the Drugs and Cosmetics Rules 1945.

► That no person sell or distribute any drug unless it is labeled in accordance with the Rules (Rule 95 of D&C Act}.

Labeling - is the norm in this context that provide comprehensive and concise statement of a drug's Quality Safety and
Efficacy.

-it includes information regarding indications, effects, dosage form, frequency and duration of administration, warnings,
hazards, contraindications, side effects, precautions and other relevant information.

Importance of labeling

The safe use of all medicines depends on users reading the labeling and packaging carefully and accurately and being
able to assimilate and act on the information presented.

All labels must be clear and concise and must bear all necessary information regarding the safe use of a product.

Prescription Drug Labeling

■ These cannot be used safely by consumers without the diagnosis and supervision of a physician.

Page 26 of 42
 ■ These have unavoidably adverse effects, but the benefits of using such drugs outweigh the accompanying risks.

■ It is the expert judgment of a practitioner to decide the use of a drugs for a particular patient.
■ Thus, the manufacturer of a prescription drug is required to provide adequate labeling for practitioners to be
able to administer or dispense the drug safely and for the purposes for which it is intended.

Components of Labeling

The prescription drug labeling consists of following components:-

► Container/ Carton Label

► Package Insert

A. Regulatory Requirements for Label :-

Rule 96 of the Drug and Cosmetic Rules (manner of labelling} mandates the minimum information which needs to be put
on the label of all medicines.

■ Misbranded drug if it is not labelled in the prescribed manner as in drug and cosmetic rules(chapter 3 section
9(b} of D&C act}.

■ The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous
manner on the label of the innermost container of any drug and on every other covering which the container is
packed, namely :-

1} Name of the drug:-

■ For drug included in the schedule F /F(1}, the name given therein.
■ For drugs included in the Indian Pharmacopoeia or the official pharmacopoeia and official compendia of drug
standards prescribed in the rule 124, the name or synonym specified in the respective followed by letters 'I.P.'
■ It entered on the label of the drug only for the purpose of indicating that the drug is in accordance with
standards set out in the Indian Pharmacopoeia.
■ for drugs included in the National Formulary of India, the name or synonym specified therein followed by the
letters 'N.F.I.'

2. Net Quantity of contents

3. The content of active ingredients

4. Name and Address of manufacturer

5. Batch or lot number(Batch No.)

6. Manufacturing license number ("Mfg. Lic. No.")

7. Import License No. (if applicable}:- the no. of license under which the drug is imported, preceded by words
"Import Lic. No."

8. Manufacturing date, Expiry date and Storage conditions

9. Other Specific Requirements

i. Physician Sample - 'Not to be sold'.

ii. Alcohol content

Package Inserts

■ The Package insert is considered "adequate direction for use".

■ It is also directed to healthcare professional and help him in making correct decision regarding the prescribing of
Page 27 of 42
 drug to a particular patient.

■ In India, it is governed by the 'Drugs and Cosmetics Act(1940} and Rules(1945}' .Schedule D 11 (section 6} of the
rules including the heading to which information to be provided in the Package Inserts.

■ It is divided into two parts:

-Therapeutic indications

-Pharmaceutical information

Drug Labeling Regulation in India

Rule 97 requires specific caution statements to be present on label for the different drug schedules.

Prescription drugs in India are those that fall under two schedules of the Drug and Cosmetics Rules, 1945 :

- Schedule H

- Schedule X

But drugs falling under Schedule G require the following mandatory text on the label: "Caution: It is dangerous to take
this preparation except under medical supervision".

For Allopathy

For Ayurvedic, Siddha, Unani, Homoepathy and Cosmetics

Page 28 of 42
Drugs and Cosmetics (Amendment) Act, 2008
Salient features of the Act:-

► Substantial enhancement in punishment

► Life imprisonment for offenders involved in manufacture, sale and distribution of spurious and adulterated drug
likely to cause grievous hurt

► Minimum punishment of seven years which may extend to life imprisonment

► Provision for compensation to affected person

Drugs Manufacturing License

 Own License (Form}
Drugs (25 & 28}
Cosmetics (32}
Homeopathic (25C}
Ayurvedic (25D}
Blood Bank (28C}

• Loan License (Form}

Drugs (25A & 28A}

Cosmetics (32A}

Ayurvedic (25E}

• Allopathic License (25, 28, 28C)

Condition of License

Premises

Technical Staff

Plant & Machinery

Documents

• Trading License

Allopathic

Retailer - Form 20, 21 & 20C (Homeopathic}

Wholesaler - Form 20B, 21B & 20D (Homo.}

Note -

No trading license for sale of Ayurvedic Drugs as per Drugs & Cosmetics Act.

No trading license required for sale of cosmetics.

Page 29 of 42
Documents

 Requisite Drugs Trading License

Premises/ ownership document of premises
Pharmacist or Competent person.
Partnership deed/Memorandum of Article etc
Pharmacist appointment & acceptance letter
Refrigerator purchase receipt

Administration of the act and rules

A) Advisory :

1}Drugs Technical Advisory Board-DTAB

2}Drugs Consultative Committee-D.C.C.

B) Analytical :

1}Central Drugs Laboratory - CDL

2}Drug Control Laboratory in states

3}Government Analysts

C) Executives:

1} Licensing authorities

2} Controlling authorities

3} Drug Inspectors

Drugs Technical Advisory Board (DTAB)

Ex-Officio Members:

(i} Director General of Health Services (Chairman}

(ii} Drugs Controller, India

(iii} Director of the Central Drugs Laboratory, Calcutta

(iv} Director of the Central Research Institute, Kasauli

(v} Director of Indian Veterinary Research Institute, Izatnagar

(vi} President of Medical Council of India

(vii} President of the Pharmacy Council of India

(viii}Director of Central Drug Research Institute, Lucknow

Nominated Members:

1} Two persons by the Central Government.

2} One person by the Central Government from the pharmaceutical industry

3} Two persons holding the appointment of Government Analyst under this Act

Page 30 of 42
Elected Members:

1} One person, to be elected by the Executive Committee of the Pharmacy Council of India,

2} One person, to be elected by the Executive Committee of the Medical Council of India,

3} One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

4} One person to be elected by the Central Council of the Indian Medical Association;

5} One person to be elected by the Council of the Indian Pharmaceutical Association;

Functions:

• To advise the Central Government and the State Governments on technical matters

• To carry out the other functions assigned to it by this Act

Drugs Consultative Committee (DCC)

It is also an advisory body constituted by central government.

Constitution:

Two representatives of the Central Government

One representative of each State Government

Functions:

■ To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other
matter tending to secure uniformity throughout India in the administration of this Act

■ The Drugs Consultative Committee shall meet when required

■ Has power to regulate its own procedure

Central Drug Laboratory (CDL)

Established in Calcutta, under the control of a director appointed by the Central Government.

Functions:

• Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts

• Analytical Q.C. of the imported samples

• Collection, storage and distribution of internal standards

• Preparation of reference standards and their maintenance

• Maintenance of microbial cultures

• Any other duties entrusted by Central Government

• Acting as an appellate authority in matter of disputes

The Central Drugs Laboratory

• Provides for the establishment of a Central Drugs Laboratory under the control of a director appointed
by Central Government

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 • The Laboratory established in Calcutta has been entrusted with the following functions

1} to analyze or test samples of drugs or cosmetics sent to it by the cosmetics collectors or

courts

2} to carry out such other duties entrusted to it by the Central Government or with its permission, by State
Governments, after consultation with DTAB

• The Central Research Institute, Kasauli carries out functions in respect of sera, solutions of serum, proteins for
injections, vaccines, toxins, antigens, antitoxins, sterilized surgical ligatures and sutures and Bacteriophages

• Vetenary Research Institute, Izantnagar and Mukteshwar carries out functions in respect of antisera, vaccines,
toxoids & diagnostic antigens, all for Vetenary Use

Drug Control Laboratories in State

In Karnataka three laboratories established which collect, analyze and report the various sample of the drugs and food

The laboratory has the following divisions:-

• Pharmaceutical Chemistry Division

• Pharmacology Division

• Pharmacognosy Division

• Food Division

• Ayurvedic Division

Functions:

• Testing of drug sample

• Analysis of food sample

• Analysis of excise sample

Government analyst
These officers are appointed by the central or state government and perform the duties

• State Government by notification in the Official Gazette, appoint persons having sufficient qualifications to be
government Analysts for such areas in state & in respect of such drugs and classes

• Central Government may also similarly appoint Government Analysts in respect of such drugs or classes of
drugs or cosmetics as specified

• No person having any interest in the import, manufacture or sale of drugs or cosmetics or is directly or indirectly
engaged in any trade or business connected with manufacture of drugs can be appointed as Government
analysts

Qualifications

• A graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized University and have 5 yrs

post graduate experience in testing of drugs in a laboratory under the control of 1}a Government Analyst or 2}
head of approved Institution or testing laboratory.

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 • A Post Graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized University with at least
3 years of experience in the testing of drugs in a laboratory under the control of 1}a Government Analyst or 2}
head of approved Institution or testing laboratory.

Duties of Government Analyst

• Analyze or test samples of drugs/cosmetics sent to him by inspectors or other persons under the act and to
furnish reports of the results of test or analysis.

• Forward to Government from time to time, reports giving the results of analysis works and research with a view
to their publication at the discretion of Government.

Procedure

• On receipt of package of sample from an Inspector the Government Analyst should compare the seals on the
package with the specimen seals and note its condition. On completion of test, reports in triplicate together
with full protocols of the tests or analysis should be sent to the Investigator.

• Government Analyst has to submit a report in form 1 and unless full protocols are supplied, the report cannot
be regarded as conclusive evidence.

Licensing authority

Qualification:

• (i} Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical

pharmacology or microbiology from a University established in India by law; and

• (ii}Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the
requirements as to the academic qualification shall not apply to those inspectors

Duties:

• (1} to inspect all establishments licensed for the sale of drugs within the area assigned to him;

• (2} to satisfy himself that the conditions of the licenses are being observed;

• (3} to procure and send for test or analysis, if necessary, imported packages.

• (4} to investigate any complaint.

• (5} to maintain a record of all inspections made and action taken by him in the performance of his duties,

• (6} to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to
the Act;

Controlling authority

Qualification:

Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or

microbiology from a University established in India by law and experience in the manufacture or testing of drugs or
enforcement of the provisions of the Act for a minimum period of five years

Schedule DII
Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the
registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in
and, may be furnished on a Computer Floppy.

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General requirement

1.1 Name of the drug/formulation/special product, a brief description and the therapeutic class to which it belongs.

1.2 Regulatory status of the drug. Free Sale Certificate and/ or Certificate of Pharmaceutical Products (CPP} issued by
the Regulatory Authority of the country of origin.

1.3 Drugs Mater File (DMF} for the drug to be registered (duly notarized}.

1.4 GMP by National Regulatory Authority of the country of origin (duly notarised}. 1.5 List of countries where
marketing authorization or import permission for the said drug is granted with date

1.6 List of countries where marketing authorization or import permission for the said drug is cancelled/withdrawn with
date.

1.7 List of countries where marketing authorization or import permission for the said drug is pending since (date}.

1.8 Domestic price of the drug in the currency following in the country of origin.

1.9 List of countries where the said drug is patented.

Requirements of Schedule D II

Chemical & Pharmaceutical Information of the drugs-

i} chemical name, generic name ii} dosage form, composition, source, specifications & tests for identification iii}
documentation on pack size, storage condition, safety documents on containers & closures, iv} manner of labeling &
package v}three samples of drug/product & outer packing with batch certificate to be submitted, vi} batch test reports
of five consecutive production batches to submitted for every site of manufacturing.

Biological & Biopharmaceutical information of drugs-

i} biological control tests applied on starting material/intermediate products/finished products, ii} stability of
finished product, iii} sterility & pyrogen test specification & protocol designs, iv} acute & sub acute toxicity test &
specification & protocol, v} date relating to bioavailability studies & bio equivalence, vi} any other relevant information

Labeling & packaging information of drugs-

i} labels should as per specification under the acts & rules, ii} package inserts 'd be in English & include following
therapeutic indications: posology & method of administration, contraindications, special warnings & special precautions,
interactions, whether pregnancy & lactation contraindicated, undesirable effects, antidote for over poisoning, effects on
ability to drive & use machines, iii} package insert 'd include information on list of exepients, incompatibilities, shelf life,
special precautions for storage, name & specification of the container & instruction for use/handling.

Specific information for special products- to be supplied separately in annexures A,B & C.

Import of Drugs
-Classes of drugs prohibited to import

-Import of drug under license

1} Specified in Schedule-C/C1

2} Specified in Schedule-X

3} Imported for Test/Analysis

4} Imported for personal use

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 5} Any new drugs

-Offences and Penalties

Import & Registration of Drug & Cosmetics

-Drugs/cosmetics may be imported to India under the authority of a license excepting those whose import is prohibited.

-Some drugs/cosmetics can be imported without any permit, providing they are of standard quality & statement that
they comply with the provisions relating to import has been given to the Customs Collector by manufacturer or
importer.

Registration:

Requirement of registration of premises & drugs manufactured & meant for the import to India was introduced with
effect from 1.1.2003

- Registration Certificate means a certificate issued by the LA for the registration of premises & drugs manufactured by
the manufacturer meant for import into & use in India.

- An application for the issue of a registration certificate should be made to LA along with the information & undertaking
specified in Schedule DI & DII. Registration certificate remains valid for a period of 3 years.

-Requirements of Schedule D I are as follows

I. Particulars of manufacturer & manufacturing premises- i} name & address of manufacturing premises to be
registered. Ii} name & address of partners/directors iii} name & address of authorized agents in India. Iv}
brief profile of manufacturer's business & research activity v} copy of plant master file. vi} copy of plant
registration/approval issued by authority of concerned foreign country.

II. 2. Particulars of manufactured drugs to be registered under registration certificate- i} name of drug to be
registered for import into & use in India. ii} a copy of approval list of above drugs showing permission for
manufacturing/marketing in the country of origin. iii} a copy of GMP certificates as per WHO guidelines. iv}
domestic prices of drugs to be imported in the currency of country of origin, v} names of drugs which are original
products of the manufacturer.

III. 3. Undertaking to declare that- i} that applicant shall comply with the conditions imposed under acts & rules,
ii} applicant report from time to time any changes pertaining registration certificate or any administrative
action taken due to ADR, iii} applicant shall allow LA to enter & inspect manufacturing premises & to examine
process or procedures & allow to take samples of drugs concerned for test, analysis or examination, in respect
to any drug manufactured for which application for registration certificate has been made.

Classes of Drugs Prohibited to Import

 Any Misbranded drugs

 Any drug of substandard quality
 Drugs claiming to cure diseases specified in Schedule-J
 Adulterated drugs
 Spurious drugs
 Drugs whose manufacture, sale/distribution are prohibited in original country, except for the purpose of test,
examination and analysis.
 Patent/Proprietary medicines whose true formula is not disclosed.

Page 35 of 42
Import of the biological drugs(C/C1)

 Separate import licenses are granted for the import of biologicals and other special products and for
drugs specified in Schedule X.
 Conditions to be fulfillled:
 Licensee must have adequate and proper facility for the storage.
 Licensee must maintain a record of the sale.
 Licensee must allow an inspector to inspect premises and to check the records.
 Licensee must furnish the sample to the authority.
 Licensee must not sell drugs from which sample is withdrawn and he is advised not to sale, and recall the batch
from the market.

Import of the Schedule-X drugs (Narcotic & Psychotropic drugs)

 Conditions to be fulfilled:
 Licensee must have adequate storage facility.
 Applicant must be reputable in the occupation, trade or business.
 The license granted even before should not be suspended or cancelled.
 The licensee has not been convicted any offence under the Drugs and Cosmetics Act or Narcotic and
Psychotropic Substances Act.

Drugs Imported for examination, test or analysis

 Small quantities of drugs whose import is otherwise prohibited can be imported for the purpose of examination,
test or analysis
 Conditions to be fulfilled:
 License is necessary under form-11 from the licensing authority
 Must use imported only for said purpose and at the place specified in the license.
 Must keep the record with respect to quantities, name of the manufacturer and date of import.
 Must allow an inspector to inspect the premises and check the records.

Drugs imported for personal use

 Conditions to be fulfilled:
 Up to 100 average doses may be imported without any permit, provided it is part of passenger's luggage.
 More than 100 doses imported with license. Apply on form no.-12-A,12-B
 Drugs must be bonafide personal use.
 Drugs must be declared to the custom officers if so directed.

Import of drugs without license

■ Substances not used for medicinal purpose

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 ■ Drugs in Sch-C1 required for manufacturing and not for medicinal use.

■ Substances which are both drugs and foods such as:

Condensed/Powdered Milk

Malt

Lactose

Farex/Cereal

Oats

■ Predigested foods

■ Ginger, Pepper, Cumin, Cinnamon

Penalties related to Import

OFFENCES PENALTIES

Import of spurious OR adulterated drug OR a} 3 years imprisonment and 5000 Rs. fine on first conviction
drug which involves risk to human beings
or
b} 5 years imprisonment OR 10000 Rs. fine OR both for
animals OR drug not having therapeutic
values subsequent conviction

Any drug other than referred above, the a} 6 months imprisonment OR 500 Rs. fine OR both for first
import of which is prohibited conviction
1 year imprisonment OR 1000 Rs. fine for subsequent
b}
offence
Cosmetics prohibited to import

 Misbranded cosmetics
 Spurious cosmetics
 Cosmetic containing harmful ingredients
 Cosmetics not of standard quality
 which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals

Places through which drugs may be imported in India

Ferozpur cantonment & Amritsar Railway station In respect to drugs imported by rail across the frontier
with Pakistan
Ranaghat, Bongaon & Mohiassan Railway Stations In respect to drugs imported by rail across the frontier
with Bangladesh
Raxaul In respect to drugs imported by road & rail connecting
India & Nepal
Chennai, Kolkata, Mumbai, Cochin & Kandla In respect to drugs imported by sea into India
Chennai, Kolkata, Mumbai, Delhi, Ahmedabad & In respect to drugs imported by air into India
Hyderabad

Page 37 of 42
Application of laws relating to Sea & customs

The Customs Collector & other Officers authorized in this behalf by the Central Government may detain any imported
packages which he suspects to contain any drug or cosmetic the import of which is prohibited under this act, and report
such detention to the drugs Controller, India & if necessary forward any package or sample to Central Drugs Laboratory
for analysis.

MANUFACTURE OF DRUGS
Manufacture in relation to any drug or cosmetic, includes any process or part of process for making, altering,
ornamenting, finishing, packing, labeling, braking up or otherwise treating any drug or cosmetic with a view to its sale &
distribution but does not include the compounding or dispensing of any drug or packing of any drug in ordinary course
of retail business

Following licenses are provided for manufacture of drugs under D&C Act
1.
Drugs other than those specified in Schedule C, C1 & X
2.
Drugs specified in Schedule C, C1 but not specified in Schedule X
3. Drugs specified in Schedule C, & C1
4. Drugs specific in Schedule X but not in Schedule C & C1
5.
Drugs specified in Schedule C, C1 and X
6.
Drugs for the purpose of examination, test or analysis
7.
Loan Licenses
8.
Repacking Licenses
9.
Blood products

Repacking is also a manufacturing for the purpose of the act.

If drugs are manufactured in more than one set of premises, a separate application is to be made & separate license
shall be issued in respect of each such premises.

Licenses for manufacture or sale or distribution of drugs are granted or renewed by Central License Approving Authority
(CLAA} appointed by the central government.

CLAA can delegate his power of signing licenses to any other person under his control with approval of the Central
Government.

Manufacture

■ Prohibition of manufacture

■ Manufacture of other than in Schedule-C/C1

■ Manufacture of those in Schedule-C/C1

■ Manufacture of Schedule-X drugs

■ Loan license

■ Repackaging license

■ Offences & Penalties

Page 38 of 42
Types of manufacturing licenses

Prohibition of manufacture

■ Drug not of standard quality or misbranded, adulterated or spurious.

■ Patent or Proprietary medicine

■ Drugs in Schedule-J

■ Risky to human beings or animals

■ Drugs without therapeutic value

■ Preparation containing cyclamates

Prohibition for the manufacture & sale of Certain Drugs

■ From the date notified by the State Government, no person shall himself manufacture for sale or distribution or
sell or distribute-

 Any drug which is not of standard quality or is misbranded, adulterated or spurious;

 Any cosmetic which not of standard quality or is misbranded, adulterated or spurious;

 Any patent or proprietary medicine whose formulae is not disclosed on label or the container;

 Any drug which purports to cure, mitigate or prevent any disease specified in Schedule J;

 Any cosmetic containing any ingredient which may render it unsafe or harmful for use;

 Any drug or cosmetic in contravention of this act or rules thereunder;

 Any drug or cosmetic which has been imported or manufactured in contravention of the provisions of
this Act or Rules thereunder or in contravention of the conditions of a license.

■ Every person not being manufacturer of a drug or cosmetic or his agent for the distribution shall if so required
disclose to the inspector the name address and other particulars of the person from whom he procured the drug
or cosmetic.

Page 39 of 42
 ■ A drug or cosmetic shall not be rendered to be misbranded, adulterated or spurious or below
standard quality, if-

-There has been added thereto some innocuous substance or ingredient required for its manufacture or preparation as
an article of commerce in state fit for carriage or consumption, & not to increase the bulk, or weight or measure of the
drug or cosmetic or to conceal its inferior quality or other defect.

-In process of manufacture, preparation or conveyance some extraneous substance has been unavoidably become
inter-mixed with it, however this does not apply in relation to any sale or distribution of the drug or cosmetic occurring
after the vendor or distributor becomes aware of such inter-mixture.

■ There are two types of conditions for all manufacturing licenses

-Conditions which are to be satisfied before a license is granted

-Conditions which are to be satisfied after the license is granted.

Manufacture of Drugs other than those specified in Schedule C & C1

■ Application for the grand or renewal of license for the manufacture of drugs other than those specified in
schedule C, c1 & X 'd be made to LA in Form 24 & for manufacture of Schedule X drugs in Form 24F. Respective
licenses are issued in form 25 & 25F

■ Application for grand/renewal of such license shall be made for up to 10 items in each category in Form 24-A
accompanied by fee of 6000 & an inspection fee of Rs. 1500 to LA & license shall be issued in Form 25A.

■ Additional fee of Rs 300 per item is payable for each additional item

■ License in form 25 or 25F remains valid for a period of 5 years on and from the date on which it is issued.

■ If application for renewal is made before its expiry, or application made within 6 months of expiry, after
payment of additional fee, the license shall continue to be valid

■ License shall deemed to have expired if the application for its renewal is not made within 6 months of its expiry.

Conditions

■ Premises should comply with schedule 'M'

■ Adequate facility for testing, separate from manufacturing

■ Adequate storage facility

■ Records maintained for at least 2 years from date of Exp.

■ Should provide sample to authority

■ Furnish data of stability

■ Maintain the inspection book

■ Maintain reference samples from each batch

Manufacture of drugs those in Schedule-C/C1(Biological)

Conditions

■ Drugs must be issued in previously sterilized sealed glass or suitable container

■ Containers should comply with Schedule-F

Page 40 of 42
 ■ Some classes should be tested for aerobic & anaerobic [Link]. Sera, Insulin, Pituitary hormones.

■ Serum should be tested for abnormal toxicity

■ Parenteral in doses of 10 ml or more should be tested for freedom from Pyrogens

■ Separate lab. for culture & manipulation of spore bearing Pathogens

■ Test for sterility should be carried out.

Manufacture of drugs specified in Schedule C, C1 & X

■ Application for the license of manufacturing drugs specified in Schedule C, C 1 excluding those specified in
Schedule X should be made to the LA in Form 27 & for manufacture of drugs specified in Schedule C, C 1 & X in
for 27B. Respective licenses are issued in Form 28 & 28B.

■ Application for including any additional drug in the license should be accompanied by a fee of Rs.50 for each
drug subject to a maximum of Rs.500

■ Conditions for the grant of license: Before the grand of license, the following conditions must be complied by
the applicant

1. The manufacture will be conducted under the active direction of a competent technical staff consisting at least one
person who is a full time employee & who is

-A graduate in pharmacy/pharmaceutical chemistry of a recognized University with at least 18 months practical

experience after graduation in manufacture of drugs to which this license applies.

-A graduate in science of a recognized University who passed in degree with chemistry or microbiology as principal
subject & had al least 3 years experience in the manufacture of drugs to which the license applies.

C,C1 .27 C,C1,X. ..........................27B

-A graduate in medicine of a recognized University with at least 3 years' experience in manufacture of relevant drugs; or

-A graduate in chemical engineering of a recognized University with at least 3 years' experience in manufacture of
relevant drugs; or

-Holding any foreign qualification comparable in quality, content and training with above qualifications & is permitted to
work as competent staff by Central Government

2. The factory conditions must comply with the conditions prescribed in Schedule M and M3

3. Applicant should provide adequate space, plant & equipment for any or all manufacturing operations as prescribed in
Schedule M & M3

4. Applicant should provide adequate staff, premises and laboratory equipment for carrying out such tests for strength,
quality & purity of substances as required under the rules.

5. Adequate facilities for the storage of manufactured drugs should be provided.

6. Data on stability of drugs that may deteriorate, for fixing the date of expiry shall be furnished to LA.

7. Licensee shall comply with requirements of GMP.

8. For manufacture of patent or proprietary medicines, data should be provided to LA that justifies that the
medicines are: stable under conditions of recommended storage.

contains such ingredients & in such quantities for which there is therapeutic justification

Page 41 of 42
 ■ License in form 28 & 28B remains valid for a period of 5 years on and from the date on which it is issued.

■ If application for renewal is made before its expiry, or application made within 6 months of expiry, after
payment of additional fee, the license shall continue to be valid

■ License shall deemed to have expired if the application for its renewal is not made within 6 months of its expiry.

■ Large Volume Parenteral means the sterile solutions indented for parenteral administration with a volume of
100 ml or more in one container of the finished dosage form indented for single usage.

Conditions of the License

1. Licensee should provide & maintain, adequate staff & adequate premises and plant for the proper manufacture
& storage of substances

2. Licensee should maintain records of the manufacture as per particulars given in schedule U.

3. Licensee should allow Inspectors to enter any premises where manufacture is carried on & to inspect the process
of the manufacture.

4. Licensee should allow inspectors to inspect all registers and records maintained under these rules & to take
samples of manufactured product

5. should allow the LA to inspect if any changes in expert staff & any material changes in premises or plant since
date of last inspection.

6. On request by LA licensee should furnish form every batch, a sample of adequate quantity for any examination

7. If any batch has been found out by LA not to confirm with the standards, licensee should withdraw the remainder
of batch from sale.

8. should maintain a Inspection book to enable inspector to record his impression.

9. should maintain reference samples of each batch of drugs manufactured by him, in a quantity twice than
that sufficient for conducting all tests.

10. should forward to LA of state a statement of sales effected to manufacturers, wholesalers, retailers, hospitals,
nursing homes, dispensaries every three months.

Manufacture of Schedule-X drugs

Conditions

■ Accounts of all transactions regarding manuf. should be maintained in serially.(Preserved for 5 years}
■ Have to sent invoice of sale to licensing authority every 3 months
■ Store drugs in direct custody of responsible person.
■ Preparation must be labeled with XRx
■ Marketed in packings not exceeding
■ 100 unit dose -Tablets/Capsules
■ 300 ml- Oral liquid
■ 5 ml - Injection

Manufacture of Drugs for Examination, Tests or Analysis

Page 42 of 42
 ■ License is necessary for the manufacture of any drug in small quantity for the purpose of examination, test
or analysis.

■ If a person proposing to manufacture does not hold license i} to manufacture drugs other than those specified
in Schedule C, C1 & X, or ii} to manufacture drugs specified in Schedule C, C1 in respect to such drugs; he should
obtain license in Form 29.

■ If drug is not recognized as safe for use, license in Form 29 is only granted after producing no objection
certificate from LA appointed by Central Government.

■ License remains valid for a period of one year time

■ Drugs should be kept in containers bearing labels indicating the purpose for which it has been manufactured.

■ If the drugs are to be supplied, it should bear label stating name & address of manufacturer, scientific name of
substance & purpose for which it has been manufactured.

Conditions for License

1. Drugs should be used exclusively for the purpose for which they are manufactured

2. Licensee should allow inspector to inspect the premises & satisfy himself that only examination, test or
analysis is being conducted.

3. Licensee should keep record of quantity of drugs manufactured and supplied to any person.

4. Licensee should maintain inspection book to enable inspector to record his impression and defects
noticed.

5. Licensee must comply with any rules made subsequently and of which the LA has given him NLT one
months' notice.

Manufacture of New Drugs

■ Defined as a drug the composition of which is such that it is not generally recognized among experts as safe for
use under conditions recommended; or

■ Suggested on the label & includes any drug the composition of which is such that the drug as a result of
investigations for determining its safety for use under such conditions, is so recognized but which has not
otherwise than during course of such investigations, been used to any large extend for any appreciable length
of time under the said conditions

■ Provisions applicable for the manufacture of new drugs whether classifiable under schedule C & C1 or otherwise:

-No new drug can be manufactured unless prior approval of the LA has been taken.

-Applicant should produce all documentary & other evidence relating to the standards of quality, purity, strength & such
other information as may be required including the results of therapeutic trials carried out on the new drug.

-While applying for a license to manufacture a new drug, or its preparations an applicant should produce along with his
application evidence that the drug has already been approved.

Loan License

Definition:

A person (applicant} who does not have his own arrangements (factory} for manufacture but who wish to manufacturing
facilities owned by another licensee. Such licenses are called Loan licenses.

Page 43 of 42
Licence is obtained from licensing authority (FDA} on application in prescribed forms (24-A, 27-A) with prescribed fees.

Loan licenses are issued for:

1} Drugs other than specified in C/C1 & X.

2} Drugs specified in Schedule-C/C1

■ A loan license means a license which a LA may issue to a applicant who does not have his own arrangements for
manufacture but who intends to avail himself of the manufacturing facilities owned by another licensee.

■ Issued for the manufacture for sale or distribution of drugs other than those specified in Schedule C, C1 & X.

■ Application for license is made in Form 24-A & the license is issued in Form 25-A.

■ Before grant of license, the LA shall get the premises inspected by one or more inspectors.

■ Inspector shall check into all the portions of the plant & shall also inquire in professional qualification for
the technical staff employed.

■ For the manufacturing of additional items, an application must be made to LA.

■ Licensee is required to test each batch of raw materials & finished products & the records must be maintained
for a period of 5 yrs from the date of manufacture. (2yrs in case of drugs having expiry date, from the date of
expiry}

■ Loan license is deemed to be cancelled or suspended if license owned by loan licensee, whose manufacturing
facilities is been availed by licensee is cancelled or suspended.

Repacking Licenses

Repacking license are granted for breaking up of any drug other than those specified in Schedule C, & C 1, on application
to LA in Form 24B & license is issued in Form 25B subject to satisfying the following conditions:

1. The repacking operation must be carried out under hygienic conditions & under supervision of competent staff
namely,

a} A person who holds an approved Diploma in Pharmacy or is an Registered Pharmacist.

b} A person who has passed intermediate examination with Chemistry as principal subject.

c} A person who has passed matriculation & has at least 4 yrs. practical experience in manufacturing,
dispensing or repacking of drugs.

2. Factory conditions must specify conditions prescribed in Schedule M.

3. Applicant must have in his premises adequate facilities for the testing of drugs. Which is separate from
the repacking unit.

4. License must be kept at licensed premises & produced on request of DI

5. 5. Any change in competent staff must be reported to LA

6. 6. For repacking of any additional items, application must be made to LA.

7. 7. The label on repacked drugs should mention the name & address of the licensee & his license number
preceded by the word 'Rpg. Lic. No."

8. 8. The license remains valid up to 31st December of the year following the year in which it is grated.

Page 44 of 42
Definition:

Process of breaking up any drug from a bulk container into small packages and labeling with a view to their sale and
distribution.

Repackaging of drugs is granted of drugs other than Schedule-C/C1 and X.

Penalties Related to Manufacture

OFFENCES PENALTIES

1-3 years imprisonment and Rs.5000 fine

a}
Manufacture of any spurious drugs 2-6 years imprisonment & Rs.10000 fine on
b}
subsequent conviction

1 year imprisonment & Rs.2000 fine

a}
Manufacture of adulterated drugs 2 years imprisonment & Rs.2000 fine for
b}
subsequent conviction

Imprisonment up to 3 months & Rs.500 fine

Manuf. of drugs in contravention of a}
the provisions Imprisonment up to 6 months & Rs.1000
b}
fine on subsequent conviction

Manufacture of cosmetics

Prohibited for the following classes :

■ Misbranded or spurious cosmetics and of substandard quality

■ Cosmetics containing hexachlorophene or mercury compounds

■ Cosmetics containing color which contain more than-

- 2 ppm of arsenic

- 20 ppm of lead

- 100 ppm of heavy metals

■ Eye preparations containing coal-tar color

Drugs Inspector
Qualification

1 Persons having qualification for appointment as government, as Governmental Analysis for allopathic drugs; or

2 having a degree in ayurveda, siddha or unani system and not less than three years of post-graduate experience in
the analysis of drugs in a laboratory under control of (a} a government analyst, or (b} a chemical examiner, or (c}
head of an institution specially approved for this purpose.

Page 45 of 42
Power:

a} Inspect, --

(i} Any premises where in any drug or cosmetic is being manufactured.

(ii} Any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed;

Take samples of any drug or cosmetic,--

(i} Which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;

(ii} From any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a
purchaser or a consignee.

Provision
of Act

Import Manufactur &

Sales
ing Packagin

Appointed by Central and State Governments.

He should be a person with out any financial interest in the import, manufacture or sale of drugs or cosmetics.

They are deemed as public servants and are officially subordinate to the Controlling Authority.

Qualifications

For appointment as DI, person must have a degree in Pharmacy/Pharmaceutical Chemistry/Medicine with specialization
in Clinical Pharmacology/Microbiology from a recognized University;

For inspection of manufactured substances in Schedule C, the DI must have 1} at least 18 months experience in
manufacture of at least one of the substance specified in schedule C 2} at least 18 month experience in testing one of
the item in schedule C 3} gained experience of NLT 3 yrs in inspection of firms manufacturing any of the substances of
Schedule C during their tenure as services as DI

Powers of DI

He can Inspect

 any premises wherein any drug or cosmetic is being manufactured and the means employed for
standardizing and testing the drug or cosmetic;
 any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or
distributed ;

Page 46 of 42
Take samples of any drug or cosmetic

 which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;
 from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a
purchaser or a consignee;

At all reasonable times with necessary assistance

search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of
which an offence relating to manufacture sale or distribution has been, or is being, committed; or

 enter and search any place in which he has reason to believe an offence relating to manufacture, sale or
distribution of drugs or cosmetics has been, or is being committed; or

 stop and search any vehicle, vessel, or other conveyance which, he has reason to believe, is being used for
carrying any drug or cosmetic in respect of which an offence has been, or is being, committed, and order in
writing the person in possession of the drug or cosmetic not to dispose of any stock that of for a specified period
not exceeding 20 days or, unless the alleged offence is such that the defect may be removed by the possessor of
the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by means of which
the offence has been ,or is being, committed

 examine any record, register, document or any other material object with any person or in any place mentioned
above and seize the same if it is likely to furnish the evidence as an offence

 require any person to produce any record, register, or other document relating to the manufacture for sale or
for distribution of any drug or cosmetic with respect to which an offence has been committed

 exercise such other powers as may be necessary for carrying out the purposes of the Acts or Rules.

Duties of Inspectors

A) Inspection of premises licensed for sale:

■ Inspect NLT twice an year all establishments licensed for sale of drugs within the area assigned to him and
to satisfy himself that the conditions of license are being observed.

■ Procure and send for tests or analysis, if he has reason to think that the drugs are sold in contravention of
provisions of Acts or Rules.

■ To investigate any complaints made to him in writing & to institute prosecutions in respect to the breaches of
the act.

■ To maintain all records of inspections made & actions taken by him including taking of samples and seizure of
stocks & to submit copies of such records to the Controlling Authority

■ To make enquiries and inspections as may be necessary to detect sale of drugs in contravention to the Act.

■ When so authorized by State Governments to obtain imported packages which he has reason to suspect to
contain drugs whose import is prohibited.

B) Inspection of Manufacture of Drugs

► Inspect NLT twice a year all premises licensed for the manufacture of drugs within

the area allotted to him and satisfy himself that the condition of license and provisions of Acts and Rules are observed.

Page 47 of 42
 ► In establishments licensed to manufacture products specified in Schedule C and C1 inspect the process of
manufacture, means employed for standardizing and testing of drugs, methods & place of storage, technical
qualifications of staff employed & all details of location, construction & administration of establishment likely to
affect the potency or purity of drug.

► To send controlling authority after each inspection a detailed report indicating conditions of license & provisions
of Acts & Rules which are being observed & which are being not observed.

► To take samples of drugs manufactured on premises & send them for test or analysis.

► To institute prosecutions in respect of breaches of Act and Rules.

Procedure for Drug Inspectors

► An Inspector taking any samples must pay its fair price & may require written acknowledgement for the same. If
price tendered is refused or when Inspector seizes any stock of any drug or cosmetic, he should issue the receipt
for the same in prescribed form. (Form 16}

► He should inform the concerned person, the purpose of taking the sample in form 17 & divide the sample to
four parts In his presence. Each portion is then sealed & suitably marked. The person from whom the sample is
taken must also be allowed to add his mark of seal on the packet. If sample taken from a manufacturing
premises, it should be divided to three portions only.

► The sample if made into small volume is likely to deteriorate, Inspector can take three or more containers when
necessary after suitably marking it.

► One portion of sample is to be restored to the person, second part send to Government analyst and third oneis
preserved for production before the court, if required & fourth is sent to warrantor if any.

► Inspector should sent sample to Government Analyst by registered post or by hand in sealed packet
enclosed together with memorandum in Form 18 in an outer cover addressed to Government analyst.

► If the confiscated drug is not of standard quality, it should be reported to court accordingly & court may order
destruction of drug under the supervision of Inspector in presence of such authority that the court may
prescribe.

► If confiscated drug is of standard quality, Inspector may report court accordingly and court may order sale of
drugs by public auction to any party holding a requisite license.

► Any record, register or any other document sized by the Inspector should be returned to the persons from
whom they where seized or who produce the same within a period of 20 days of such seizure or produce.

► When an Inspector seizes any record, register or document, or any other material object, he should as soon as
inform the same to the judicial magistrate & take his orders to the custody thereof.

► Every person for time being in charge of any premises where any drug or cosmetic is manufactured or is kept for
sale or distribution, on being required by the Inspector is legally bound to disclose to the inspector the place
where drug or cosmetic is being manufactured or kept.

► Willfully obstructing the Inspector or refusing to provide any record or register is punishable with imprisonment
up to three years, or with fine or both.

Page 48 of 42
Schedules to the rules
TYPE CONTENT
"A" Performa for forms( Application, issue, renewal, etc.} manufacture for sale/distribution of
Allopathic drugs, Loan Licence, re-packing for sale, operate a Blood Bank , manufacture for sale or
for istribution of LVPs etc
"B" Rates of fee for test or analysis by CDL or Govt. analysts
"C" List of Biological and special products (Injectables) applicable to special provisions. Sera.
Solution of serum proteins intended for injection, Vaccines for parenteral injections. Toxins,
[Link]
"C1" List of Biological and special products (non-parenteral) applicable to special provisions. Ergot
preparations, Adrenaline, Fish liver oil, Vaccines etc
"D" List of drugs that are exempted from provisions of import
"E1" List of poisonous substances under the Ayurvedic , Siddha and Unani systems
"F" Provisions applicable to blood bank
"F1" Special provision applicable to biological and special products, eg. Bacterial and viral vaccines,
sera from living animals, bacterial origin diagnostic agents
"F2" Standards for surgical dressings, Gauze or other dressings used to cleanse a wound, Skin sealants
or barriers, Solutions used to moisten gauze
"F3" Standards for sterilized umbilical tapes
"FF" Standards for ophthalmic preparations
"G" List of substances required to be used under medical supervision and labelled accordingly
"H" List of substances (prescription} that should be sold by retail only on prescriptions of R.M.P.
TYPE CONTENT
"J" List of diseases and ailments that drug should not claim to cure. AIDS, Angina Pectoris, Appendicitis,
Arteriosclerosis, Blindness, Blood poisoning, Bronchial asthma, Cancer and benign tumour, Cataract,
Spondylitis, Stammering, Stones in gall-bladder, kidney, bladder, Vericose vein
"K" List of drugs that are exempted from certain provisions regarding manufacture. Analgesic Balms, Antacid
preparations, Gripe Water for use of infants, Inhalers, containing drugs for treatment of cold and nasal
congestion, Syrups, lozenges, pills and tablets for cough, Liniments for external use, Skin ointments and
ointments for burns, Absorbent cotton wool, bandages absorbent guaze and adhesive plaster.
"M" Requirements of manufacturing premises, GMP requirements of factory premises, plants and equipments
"M1 Requirements of factory premises for manufacture of Homeopathic medicines
"
"M2 Requirements of factory premises for manufacture of cosmetics
"
"M3 Requirements of factory premises for manufacture of medical devices
"
"N" List of equipment to run a Pharmacy
TYPE CONTENT
"O" Standards for disinfectant fluids
"P" Life period(expiry} of drugs
"Q" Coal tar colors permitted to be used in cosmetics. Guinea GreenB, Tartrazine, Sunset yello FCF,
Amaranth, Erythrosine etc
"R" Standards for mechanical contraceptives
"R1" Standards for medical devices
"S" Standards for cosmetics

Page 49 of 42
"T" Requirements (GMP} of factory premises for Ayurvedic, Siddha, Unani drugs
TYPE CONTENT
"U" Manufacturing and analytical records of drugs
"U1" Manufacturing and analytical records of cosmetics
"V" Standards for patent or proprietary medicines
"W" List of drugs marketed under generic names- Omitted
"X" List of narcotic drugs and psychotropic substances
"Y" Requirement and guidelines on clinical trials for import and manufacture of new drugs

The Drugs and Magic Remedies

(Objectionable Advertisement) Act 1954
Objectives
• The Drugs and magic remedies act came into force on 1st April 1955

• The objective is to prohibit certain kinds of advertisements relating to drugs and magic remedies which make
false claims and are likely to mislead the public

• The prohibitions do not apply to the advertisements sent to medical practitioners or chemists or advertisements
made on behalf of the governments

• The act extends to the whole of India except the state of Jammu and Kashmir

Definitions
1. Advertisements: are defined to include all notices, circulars, labels, wrappers or other documents and all
documents and all announcements made orally or by means of producing or transmitting light, sound or smoke

2. 2. Drugs: include substances intended for the diagnosis , cure, mitigation, prevention or treatment of diseases
in human beings or animals or for altering any structure or functions of the body of human beings or animals
except food articles

3. 3. Magic remedies: includes talismans, mantras, kavachas and substances or charms of any kind which claim to
possess miraculous powers of prevention or cure of diseases or of affecting or altering any of the functions of
the bodies of human beings or animals

Prohibited advertisements
The following classes of advertisements are prohibited to be made under the act:

• Advertisements relating to drugs , which are likely to lead to their use in the following ailments or conditions:

a) The procurement of miscarriage in women or prevention of conception in women

• Advertisements relating to drugs , which are likely to lead to their use in the following ailments or conditions:
b) The maintenance or improvement of the capacity of human beings for sexual pleasure;

c) The correction of menstrual disorder in women; or

d) The diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the
Schedule J

2. Advertisements which directly or indirectly give false impression regarding the true character of the drug or make any
false claims for it or are otherwise false and deceptive

Page 50 of 10
3. Advertisements relating to magic remedies claiming their efficacy for any of diseases listed in Sch J

Schedule j
• The Schedule J of the Drugs and Cosmetics Act 1945 of India- contains a list of diseases and ailments which
a drug may not claim to prevent or cure

Exempted advertisements
• Sign boards or notices, displayed by the RMP on their premises indicating that treatment is undertaken for the
diseases or disorders, advertisements relating to which are otherwise prohibited
• Book or treatises related to diseases, ailments- provided they are published from bonafide scientific or social
standpoint
• Advertisements relating to drugs which are sent confidentially, in the prescribed manner, to RMP ( with the label
" For the use of Registered Medical Practitioners")
• Advertisements relating to drugs printed or published by the govt. or by any other person, with the prior
permission of govt.
• Advertisement, labels or sets of instructions which are permitted under the D& C act

Penalties
• Imprisonment which may extend upto 6 months or a fine or both on first conviction
• Imprisonment upto one year or a fine or both on any subsequent conviction

The people at Andhashraddha Nirmoolan Samiti (ANS) have published some illustrations to further awareness on the
recently passed Maharashtra Prevention and Eradication of Human Sacrifice and other Inhuman Evil and Aghori
Practices and Black Magic Act,

Page 51 of 10
 Narcotic Drugs and Psychotropic Substances Act, 1985
Introduction
• India had no legislation regarding narcotics until 1985.

• Cannabis and its derivatives (marijuana, hashish/charas and bhang} were legally sold in India until 1985, and
their recreational use was commonplace

• Consumption of cannabis was not seen as socially deviant behaviour, and was viewed as being similar to
the consumption of alcohol

• Ganja and charas were considered by upper class Indians as the poor man's intoxicant, although the rich
consumed bhang during Holi

• The United States began to campaign for a worldwide law against all drugs, following the adoption of the Single
Convention on Narcotic Drugs in 1961

• However, India opposed the move, and withstood American pressure to make cannabis illegal for nearly 25
years
• American pressure increased in the 1980s, and in 1985, the Rajiv Gandhi government succumbed and
enacted the NDPS Act, banning all narcotic drugs in India

• State regulation and community tolerance ceased after the enactment of the Narcotic Drugs and Psychotropic
Substances Act (NDPS} in 1985, which created a restrictive regime around drugs

• Clampdown on cannabis and opium in the late 1980"s purportedly triggered more dangerous use - chasing and
injecting heroin and other opioids

• Narcotic Drugs and Psychotropic Substances Act is popular as NDPS Act

• It was passed to tackle an important social problem: drug trafficking

Objectives
• To consolidate and amend the existing laws related to Narcotic Drug

• To make stringent provisions for the control and regulation of operation

• To enhance the penalties for trafficking offences

• To make provisions for the implementation of International Conventions relating to NDPS to which India is a
party

Definitions
Cannabis

Charas, the separated resin, obtained from the cannabis plant, includes concentrated preparation and resin
known as hashish oil or liquid hashish

Ganja, the flowering fruiting tops of the cannabis plant, excludes the seeds and leaves when not accompanied
by the tops

Any mixture, with or without any neutral material, or any of the above forms of cannabis or any drink prepared
from it
Page 52 of 10
Coca Derivatives

Crude cocaine, any extract of coca leaf, which can be used for manufacture of cocaine

Ecgonine and all derivatives of ecgonine

Cocaine, i.e, methyl ester of benzonyl-ecgonine and its salts

All preparations containing more than 0.1% of cocaine

Controlled substances: means any substance which the Central Government may, having regard to the available
information as to its possible use in the production or manufacture of narcotic drugs or Psychotropic substances or to
the provisions of any International Convention, by notification in the official gazette, declare to be a controlled
substance

Illicit traffic

Cultivating or gathering any portion of any coca plant

Cultivating the opium poppy of any cannabis plant
Engaging in the production, manufacture, possession, sale, purchase, transportation, warehousing,
concealment, use or consumption, import or export inter-state, import into India , export from India or
transhipment of NDPS

Dealing in any activities in NDPS other than those referred above

Handling or letting out any premises for carrying out the above activities

Manufacture

-All processes other than production by which such drugs or substances may be obtained

-Refining of such drugs or substances

-Making or preparation containing such drugs or substances

Manufactured Drugs

All coca derivatives, medicinal cannabis, opium derivatives and poppy concentrate

Any other preparation which the Central Government may by notification declare to be a manufactured drug

Medicinal Cannabis or medicinal hemp means any extract or tincture of cannabis

Narcotic Drugs means coca leaf, cannabis, opium straw and includes all manufactured goods

Opium Poppy

The plant of the species Papaver somnifera L

The plant of the any other species of Papaver from which opium or any other phenanthrene alkaloid can
be extracted

Opium

The coagulated juice of opium poppy

Any mixture, with or without any neutral material, of the coagulated juice of the opium poppy

Poppy Straw means all parts of the opium poppy after harvesting whether in their original or cut, crushed or powdered

Page 53 of 10
and whether or not juice has been extracted thereform

Poppy Straw Concentrate means the material arising when poppy straw has entered into a process for the
concentration of its alkaloids

Opium Derivatives

Medicinal opium, that is opium which has undergone the processes necessary to adapt it for medicinal use in
powder form or granulated form

Prepared opium, that is any product of opium designed to transform opium into extract suitable for smoking
and other residue remaining after smoking

Phenanthrene alkaloids, namely morphine, codeine, thebaine and their salts

Diacetylmorphine, the alkaloid also known as dia-morphine or heroin and its salts

Psychotropic Substances means any substance, neutral or synthetic, or any natural material or any salt, or preparation
of such substance or material included in the list of psychotropic substances specified in the schedule
Examples of Psychotropic Substances

Licensed cultivation, production and sale of Opium

• Legal cultivation of opium for medicinal purposes is carried out in India, only in selected areas, under a license
granted for the purpose

• Legal cultivation for medical use is permissible within the ambit of United Nations, Single Convention on
Narcotic Drugs 1961

• Some place where opium is grown are Chittourgarh in Rajasthan; Mandsaur, Ratlam, Neemuch in Madhya
Pradesh; and Barabanki, Bareilly, Lucknow & Faizabad in Uttar Pradesh.

Page 54 of 10
A. Cultivation of Opium poppy

• Each year the Central Government notifies the selected tracts where such cultivation will be permitted, and the
general conditions for eligibility of the licence.

• The essential condition for issue of licence is, fulfillment of minimum qualifying yield (MQY} criterion, specified
in number of kilogrammes per hectare

• Cultivators who have tendered at least this quantity in the previous year are eligible for licence

• The licence among other conditions, specifies the maximum area in which the opium crop can be sown

• The crop year starts from 1 September and ends on 30 October each year.

• Officers of CBN (CENTRAL BOARD OF NARCOTICS} measure each field and exercise controls to ensure that no
excess cultivation takes place

• The licenses are granted by the District Opium officers (DPO}

• The licenses granted by DPO can be cancelled or withdrawn by higher officers

• The DPO will designate one of the licensed cultivators as Lambardars who may discharge duties as specified by
the Narcotics Commissioner

• If any opium is cultivated without license or under a cancelled license, the crop will be destroyed

• The extraction of opium takes place during the months of February and March

• Farmers still use the traditional method where they lance each poppy capsule manually with a special blade like
tool, a process known as lancing

• The lancing is done in late afternoon or evenings.

• The opium latex which oozes out and congeals in the night is scraped and collected manually the next morning

• Each poppy capsule is given three to four lancings.

B. Production of Opium

• Cultivators during harvesting should take each days collection to the Lambardar for weighing and entry
in records

• The records are jointly attested each day by the Lambradar and the cultivator

• These records may be checked during inspections

• Any discrepancy between quantity produced and quantity entered, could lead to an enquiry and lead
to punishment

• All opium produced has to be delivered to the DPO who will weigh, examine and classify the same

• A cultivator who is dissatisfied with the classification can have the opium forwarded to the Government Opium
and Alkaloid factory where it will be classified by the factory's general manager

• If the DPO suspects that any opium sent to him is adulterated, he may collect the samples, seal it in the
presence of the Lambardar and the cultivator and send it seperately to the government factory for analysis

• Adulterated opium is liable for confiscation after giving a hearing to the cultivator

• The price of the opium is fixed from time to time by the central government

C. Manufacture of opium

Page 55 of 10
 • Only central govt. can manufacture opium at its two factories at Ghazipur and Neemuch

D. Sale of opium

• Sale of opium to the state government or manufacturing chemists can be made only from the factory at
Ghazipur

• Manufacturing chemists should obtain a permit from State govt. - three copies of which are sent to the
opium factory

Manufacture of manufactured drugs and psychotropic substance

• Manufacture should be conducted in accordance with a license granted by the Narcotics Commissioner or any
other officer authorized by the central govt.
• License will be issued only to those persons holding license for the manufacture of drugs under the Drugs
and Cosmetics Act 1940
• A security deposit of Rs. 10,000 should be paid
• The quantities manufactured cannot exceed the limits permitted by the licensing authority
• The licensee also has to ensure adequate security in the premises
• 15 days' notice should be to the govt. before commencement of manufacture and one month notice before
cessation
• True accounts of all transactions should be maintained and returns submitted to the Narcotics commissioner
• Sale and distribution has to be done in accordance with the rules made by the state government

Administration of NDPS act

1. Narcotics Comissioner
2. The Narcotic Drugs and Psychotropic Substances Consultative Committee
3. Deaddiction centres

The Narcotic Drugs and Psychotropic Substances Consultative Committee

• The Central Government may constitute and advisory committee to advise it on matters related to the act

• The committee shall consists of a Chairman and such other members, not exceeding twenty

• It shall meet when required to do so by the Central Government and shall have the power to regulate its own
procedure

• The committee may constitute sub-committee/s for the efficient discharge of functions, and may appoint new
members

• All rules pertaining to the committee are made by the Central Government

• The members of the Committee shall be appointed by the Central Government

• No member shall be appointed to the Committee unless he or she is willing to serve on it

• Casual vacancies in the Committee, caused due to resignation or otherwise of non-official members, shall be
filled from amongst persons of eminence possessing expertise and background in the field of drug abuse
prevention; but shall, as far as possible, be sponsored by the Ministries concerned of the Government of Jammu
and Kashmir.

• The term of official members of the Committee shall be ex -officio

• The term of non-official members of the Committee shall, unless extended or otherwise, be for a period of
three years.

Page 56 of 10
• The period of extension shall not be for more than a year at a time, subject, however, to a maximum of 2 years.

• The Minister for Finance or Minister of State in the Ministry of Finance (in-charge of Department of
Revenue} shall be the Chairman of the Committee

Page 57 of 10
 • If the Chairman is, for any reason, unable to act, the Committee shall choose any other member to act as
Chairman for that sitting

• The Committee may appoint Sub-Committees-whether generally or for consideration of any particular matter.

• The Sub-Committees, to be appointed for the purpose, shall be as follows:

a. a Sub-Committee, to be headed by Secretary in the Department of Revenue for looking into the various aspects
of enforcement, and
b. a Sub-Committee, to be headed by Secretary in the Ministry of Health and Family Welfare for looking into the
various aspects of deaddiction treatment, rehabilitation, social reintegration of drug addicts and other
connected matters

• The Sub-Committees shall be assisted by the Director General, Narcotic Control Bureau and the Medical
Superintendent Safdarjung Hospital, New Delhi, who shall act as Member-Secretaries of the respective
Committees

• The Committee may, if it deems necessary so to do for the efficient discharge of any of its functions, constitute
more sub-committees for the purpose, and may appoint to any such subcommittee, any person (including a
nonofficial} who is not a member of the Committee.

Prohibition, Control and Regulation

• The following operations are prohibited under the NDPS Act

Cultivation of any coca plant or gathering of any portion of coca plant

Cultivation of opium poppy or any cannabis plant

Production, manufacture, possession, sale, purchase, transportation, warehousing, consumption, import,

export, etc. of any NDPS substances

Power of Central government

1. The Central government may, by rules, permit and regulate:

The cultivation of or gathering of any portion of coca plant, or the production, possession, sale, purchase,
transport, import, export, use or consumption of cocoa leaves
The cultivation of opium poppy
The production and manufacture of the opium and production of poppy straw
Cultivation of cannabis plant for industrial purpose
The sale of opium and opium derivatives from the Central Government factories for the export from India or
sale to the State Government or to manufacturing chemists

The manufacture, possession, transport, import, import inter-state, export, sale, purchase, consumption or use
of Psychotropic substances

The import into India and export from India and transhipment of Narcotic drugs and Psychotropic substances

Page 58 of 10
2. The central government may by rules, prescribe any other matter required to render effective the control of the
Central Government over any of the matter specified above

The central government may permit, with or without conditions, and on its behalf, the cultivation of any coca
plant or gathering of any portion thereof or the production, possession, sale, purchase, transport, import
interstate, export inter stae, or import into India of coca leaves for use in the preparation of flavouring agents

Power of State Government

1. The state Government may by rules permit or regulate ;

The possession, transport, import inter-state, export inter-state, warehousing, sale, purchase, consumption and
use of poppy straw
The possession, transport, import inter inter-state, export inter-state, warehousing, sale, purchase, consumption
and use of opium
The cultivation of any cannabis plant, production, manufacture, possession, transport, import inter inter-state,
export inter-state, sale, purchase, consumption and use of cannabis
The manufacture of medicinal opium or any preparation containing any manufactured drug from materials
which the maker is lawfully entitled to possess
The possession, transport, purchase, sale, import inert-state, export inert-state, use or consumption of
manufactured drugs other than prepared opium and of coca leaf and any preparation containing any
manufactured drug
the manufacture and possession of prepared opium lawfully possessed by an addict registered with the State
Government on medical advice for his personal consumption

Offences and Penalties

• Offences punishable with rigorous imprisonment for 10 to 20 years and a fine of not less than one lakh rupees
on first conviction and with rigorous imprisonment for 15 to 30 years and a fine of not less than two lakh
rupees on second and subsequent conviction :

a. Contravention of provisions of the act or rules

b. Embezzlement of opium by cultivator
c. Illegal import to India, export from India or transhipment of narcotic drugs and psychotropic substances
d. External dealings in narcotic drugs and psychotropic substances
e. Allowing use of premises, conveyance etc., for commission of an offence under the Act
f. Financing illicit traffic and harbouring offenders

• Death penalty for certain offences after previous conviction :

If any person who has been convicted of the commission of, or attempt to commit, or abetment of, or criminal
conspiracy to commit, any of the offences listed above, is subsequently convicted of similar offences with
respect to the narcotic drugs or psychotropic substances specified and which is equal to or more than the
quantity specified in this behalf, shall be awarded death penalty

Page 59 of 10
• Offences punishable with rigorous imprisonment upto 5 years and fine upto 50,000 rupees on first conviction
and with rigorous imprisonment upto 10 years and fine upto 1 lakh rupees on second and subsequent
conviction

a. Contravention of the provisions in the Act or Rules in respect of cannabis plant and cannabis related to ganja

• Offences by licenses or their employees punishable with imprisonment upto 5 years or fine or both:

a. Failure without any reasonable cause, to maintain accounts or to submit any return in accordance with the
provisions of this Act
b. Failure to produce, without any reasonable cause, licence, permit or authorisation on demand by an authorised
person
c. Keeping of false accounts or making of false statements
d. Wilful and deliberate indulgence in breach any of the conditions of licence, permit or authorisation for which
no penalty has been provided elsewhere in the Act

• Offences punishable with imprisonment upto 1 year or fine or both

Illegal possession in small quantities for personal consumption or consumption of cocaine, morphine, diacetyl
morphine or any other narcotic drug or psychotropic substances specified in this behalf

• Offences punishable with imprisonment upto 6 months or fine or both

Illegal possession in small quantities for personal consumption or consumption of substances other than those
mentioned above

Offences for which no penalty is provided separately in the Act

• Punishment for attempt to commit offence

Same as that of commitment of the offence itself

• Punishment for abetment of criminal conspiracy

Same as that of commitment of the offence itself

• Punishment for preparation of an offence but where circumstances have prevented the commitment of the
offence itself

Half of that for the commitment of the offence itself

• Punishment of offences by companies

The court have been empowered to impose a fine higher than the maximum provided under the Act
The reason for imposing such a fine has to be recorded in the judgement
Persons who are convicted outside India for similar offences are liable to enhanced punishment for
subsequent offences of the same kind in India

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Summary
• NDPS Act, as it is known popularly, is meant to face a very important social problem: drug trafficking

• Charas, the separated resin, obtained from the cannabis plant, includes concentrated preparation and resin
known as hashish oil or liquid hashish

• Illicit Traffic is engaging in the production, manufacture, possession, sale, purchase, transportation,
warehousing, concealment, use or consumption, import or export inter-state, import into India , export from
India or transhipment of NDPS

• Medicinal opium, that is opium which has undergone the processes necessary to adapt it for medicinal use in
powder form or granulated form

• Poppy Straw means all parts of the opium poppy after harvesting whether in their original or cut, crushed or
powdered and whether or not juice has been extracted therefrom

• The Central Government may constitute and advisory committee to advise it on matters related to the act

• The committee shall consists of a Chairman and such other members, not exceeding twenty

• The following operations are prohibited under the NDPS Act

Cultivation of any coca plant or gathering of any portion of coca plant

Cultivation of opium poppy or any cannabis plant

Production, manufacture, possession, sale, purchase, transportation, warehousing, consumption, import,

export, etc. of any NDPS substances

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 DRUG PRICE CONTROL ORDER (DPCO)
History of Price regulation in India

Drug Price Control Order 1995

• The drug price control order {DPCO) is an order issued by the government under the Essential Commodities
Act, 1955 which enables it to fix the prices of some essential bulk drugs and their formulations.
• The origin of this control dates back to 1970 when for the first time the government placed limits on profitability
of pharmaceutical companies.

Why under Essential Commodities act????

• Since drugs are essential for the health of the society

Are all the drugs marketed under price control???

• Only 74 out of about 500 commonly used bulk drugs are kept under statutory price control

DPCO provides
• The list of price controlled drugs.
• Procedures for fixation of prices of drugs.
• Method of implementation of prices fixed by Government.
• Penalties for contravention of provisions

**All formulations containing the bulk drugs either in a single or combination form fall under the price control
category.

Objectives
 To achieve adequate production
 To regulate equal distribution
 To maintain and increase supply of bulk drugs
 To make at fair prices.

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  To ensure availability, at reasonable prices of essential and life-saving and prophylactic medicines of good
quality.
 Promoting the rational use of drugs in the country
 To encourage cost-effective production with economic sizes

National Pharmaceutical Pricing Authority (NPPA)

• Is an independent body of experts established on 29th August 1997 entrusted with
---- The task of fixation/ revision of prices of pharmaceutical products {bulk drugs and formulations)
---- Enforcement of provisions of the DPCO
---- Monitoring of the prices of controlled and decontrolled drugs in the country

DEFINITIONS
Bulk Drugs:-

It means any pharmaceutical, chemical and biological or plant product that conforms to Pharmacopoeial standards
specified in D&Cact, 1940.

Ceiling Price:-

Price fixed by government for scheduled formulation.

A single maximum selling price that is applicable throughout the country

Drug:- Substance intended to be used for or in the diagnosis, treatment, or prevention of any disease or disorder in
human or animal.
Retail price:-

Retail price of drug fixed in accordance with provisions of DPCO 1995 and include ceiling price.

Scheduled bulk drug:-

It means bulk drug specified in first schedule.

DPCO 2013
► The DPCO 2013 empowers the National Pharmaceutical Pricing Authority {NPPA) to regulate prices of 348
essential drugs along with their specified strengths and dosages under NLEM 2011.

 Main Features of the DPCO 2013 IMP

1) The new order will bring 348 drugs & their 652 formulations under price control.

2) The new policy uses a market-based pricing mechanism against the earlier proposed cost-plus method. The
ceiling price would be calculated by taking the simple average of prices of all brands of a drug with a market
share of 1% or more.

3) All strengths and dosages specified in the NLEM {National list of Essential Medicines) will be under price control

4) 4) Margins of wholesalers & retailers have been cut down to 8% & 16% respectively.

5) 5) Companies selling medicines above the government-mandated ceiling rated would have to slash prices to
meet the demands of new rules, but those selling drugs below the ceiling price wouldn't be allowed to raise
prices.

6) 6) Firms that launch new medicines can sell them at or below government-set price caps.

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 7) 7) Existing firms will not be allowed to stop production of any drug without permission from the government.

8) 8) Drug producers will be permitted an annual increase in the retail price in sync with the wholesale price index.

Which drugs will come under price control?

• This order doesn't cover patented drugs. Earlier in March this year the Department of pharmaceuticals {DOP)
had issued a draft proposal on price negotiation of patented drugs.

• Prices of 652 formulations spanning over 27 therapeutic classes are regulated by DPCO 2013.

• Prices of some additional anti-cancer drugs including the much talked about Imatinib, Carboplatin, Dacarbazine,
Daunorubicn, Chlorambucil, Oxaliplatin and some anti-retroviral cocktails like Zidovudine-Lamivudine-
Nevirapine and Stavudine- Lamivudine will now be regulated by the current order.

• However in certain emergency case, the patents can be broken down and the drugs can be released into the
market.

Prices of Bulk Drugs

 Government has power to fix the maximum sale price.

While fixing the sale price government shall take into following considerations:-

► Post-tax return of 14% on net worth.

► Return of 22% on capital employed.

► On the basic stage of production, post tax return of 18% on net worth or 26% on capital employed
► At the time of production of drug, manufacturer fill detail in form-1 and give necessary information to
government within 15 days.

► Make necessary inquiry and then government fix maximum sale price if bulk drug and noted in official gazette.

► Govt. also fix or revise the price of non-scheduled bulk drugs.

Information Required from Manufacturer to Government

► For the both scheduled and non-scheduled bulk drugs

► List of drug produced with cost in form 1 and 2 resp.

► But for scheduled bulk drugs it should given by 30 september every year.

► RETAIL PRICE OF FORMULATION - DPCO 1995

► FORMULA FOR CALCULATION OF RETAIL PRICE:

► R.P. = ( M.C.+C.C.+P.M.+P.C. )X( 1+ MAPE / 100 ) + ED.

► WHERE, R.P. = RETAIL PRICE

► M.C.= MATERIAL COST

► C.C.= CONVERSION COST

► P.M.= PACKAGING MATERIAL COST

► P.C.= PACKING CHARGES

► ED = EXCISE DUTY (Taxes )

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 ► MAPE= MAXIMUM ALLOWABLE POST MANUFACTURING EXPENSES

How Prices are Calculated & Fixed - DPCO 2013

The ceiling price of a scheduled formulation of specified strengths and dosages as specified under the first schedule shall
be calculated as under:

Step1: First the Average Price to Retailer of the scheduled formulation i.e. P{s) shall be calculated as below:

Average Price to Retailer, P(s) = (Sum of prices to retailer of all the brands and generic versions of the medicine having
market share more than or equal to one percent of the total market turnover) / (Total number of such brands and
generic versions of the medicine having market share more than or equal to one percent of total market turnover on
the basis of moving annual turnover for that medicine.)

Step2: Thereafter, the ceiling price of the scheduled formulation i.e. P{c) shall be calculated as below:

P(c) = P(s).(1+M/100), where

P{s) = Average Price to Retailer for the same strength and dosage of the medicine as calculated in step1 above.

M = % Margin to retailer and its value =16

DPCO 2013

Margin to retailer: While fixing a ceiling price of scheduled formulations and retail prices of new drugs, sixteen percent
of price to retailer as a margin to retailer shall be allowed.
Maximum retail price:

{1) The maximum retail price of scheduled formulations shall be fixed by the manufacturers on the basis of ceiling price
notified by the Government plus local taxes wherever applicable, as under:

Maximum Retail Price = Ceiling price + Local Taxes as applicable

{2) The maximum retail price of a new drug shall be fixed by the manufacturers on the basis of retail price determined by
the Government plus local taxes wherever applicable, as under:

Maximum Retail Price = Retail Price + Local Taxes as applicable

What's new in this DPCO?

• New Pricing methodology: Earlier method used manufacturing costs as a basis to calculate ceiling prices

• This DPCO 2013 excludes bulk drugs from price alterations but formulation prices will fall

What this means: API/Bulk Drug Manufacturing, which has seen declining trend for the past many years now will have
an upsurge {hopefully)

• DPCO 2013 promotes R&D by excluding new drug, new process or NDDS from DPCO for 5 years

Power to Fix Retail Price of Scheduled Formulation

► Government fix the retail price of bulk drug.

► Manufacturer use drugs in scheduled formulation.

► For price revision of such formulation manufacturer should apply within 30 days.

► From date of receipt of complete information govt. Fix retail price within 2 months.

• Without approval of government,

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 • Manufacturer should not increase retail price of drug.

• Manufacturer should not marketed new formulation.

• No person shall sell imported scheduled formulation.

Power to Fix Ceiling Price of Scheduled Formulation

► Government fix the ceiling price of scheduled formulation.

► Ceiling price for formulation including those sold under generic name.

► Fixed revised ceiling price for schedule formulation either on it's own motion or on application made in
prescribed form.

Power to Revise Price of Bulk Drug and Formulation

► Government fix or revise retail price of one or more formulation.

► As the pre-tax return on sales turnover of formulation then the scheduled and non-scheduled formulation.

Fixation of Price Under Certain Circumstances

► If any manufacturer of bulk drug fails to submit the application for fixation or revision of price or fails to give
information within specified time period.
► Then government fix price of the bulk drug.

Power to Recover Overcharged Amount

► If any manufacturer or importer charging higher price than the price fixed by government

► Then government may recover the overcharged amount.

Control of Sale Prices of Bulk Drug and Formulation

► No person or retailer shall sale the drug/ formulation

► To any customer at increasing price specified in current price list indicated on container label.

Sale of Split Quantity of Formulation

► No dealer shall sell the loose quantity of formulation

► At price exceeding pro-rata prices of formulation plus 5%.

Schedules Related to DPCO act, 1995

FIRST SCHEDULE

■ First Schedule includes 76 bulk drugs.

■ Eg. Penicillin, ranitidine, chloroquine etc

SECOND SCHEDULE

 Different forms included :-

■ Form- 1 :- application for fixation/ revision of price.

■ Form- 2 :- information related with price of non-scheduled bulk drug.

■ Form-3 :- application for approval/revision of price of scheduled formulation.

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 ■ Form-4 :- application for approval/revision of price of scheduled formulation imported in finished form.

■ Form-5 :- form of price list

■ Form- 6 :- yearly information on turnover and allocation of sales and expenses.

THIRD SCHEDULE

■ Category A :- Large unit with turnover exceeding rs. 6 crores per annum.

■ Category B :- Medium sized unit turnover between rs. 1 crore to 6 crore per annum.

■ Category C :- Other units with turnover of less than rs. 1 crore per annum.

OFFENCES AND PENALTIES

Penalties-

 Shall be punishable with imprisonment for one year and also liable to fine.

 In the case of any other order, with imprisonment for not less than three months but which may extend
to seven years and also be liable to fine.
What companies do to avoid getting into DPCO

• Changing the composition of the formulation by putting in ingredients {if possible) that are not subject to price
control.

• Transferring the brand to a small-scale unit, which produces the product for a subsidiary.

• Case studies:

• Pfizer for instance did change the composition of its B-complex vitamin brand Becousules {which ranks second
in branded sales in the country). However the DPCO clamped down on this move and brought the entire range
of B-complex vitamins under its purview.

Summary
• Bulk drug means any pharmaceutical, chemical and biological or plant product conform to Pharmacopoeial
standards specified in d & c act, 1940.

• Ceiling Price is Price fixed by government for scheduled formulation

• Drug is a Substance intended to be used for or in the diagnosis, treatment, or prevention of any disease or
disorder in human or animal

• To achieve adequate production, regulate equal distribution, maintain and increase supply of bulk drugs and
make at fair prices

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 Medicinal and Toilet preparations (Excise duties) act, 1955 and Rules
Objectives
• To provide for the collection of levy and duties of excise on medicinal and toilet preparations containing alcohol,
narcotic drugs or narcotics

• To provide for uniformity in the rules and rates of Excise duties leviable on such preparations throughout the
country
Definitions
• Alcohol means ethyl alcohol of any strength and purity having the chemical composition C2 H5 OH

• Absolute alcohol means ethyl alcohol containing less than 1% by weight of water

• Dutiable Goods means the medicinal and toilet preparations specified in the Schedule as being subject to the
duties of excise levied under the Act

• Medicinal Preparation includes all drugs which are a remedy or prescription prepared for internal or external
use of human being or animals and all substances intended to be used for or in the treatment, mitigation or
prevention of disease in human beings or animals

• Toilet Preparation means any preparation which is intended to cleanse, improve or alter the complexion, hair,
skin, or teeth, and includes deodorants and perfumes

• Bonded Manufactory means the premises approved and licensed for the manufacture and storage of medicinal
and toilet preparations containing alcohol, opium, Indian hemp or any other narcotic drug or narcotics on which
duty has not been paid

• Non- bonded Manufactory means the premises approved and licensed for the manufacture and storage of
medicinal and toilet preparations containing alcohol, opium, Indian hemp or any other narcotic drug or narcotics
on which duty has been paid

• Denatured Alcohol or denatured spirit means alcohol of any strength which has been rendered unfit for human
consumption by the addition of substances approved by the Central Government or by the State Government
with approval of the Central Government

• Rectified Spirit means plain denatured alcohol of a strength not less than 50.00 over proof and includes absolute
alcohol. It is highly concentrated ethanol which has been purified by means of repeated distillation, a process
that is called rectification.

• Restricted Preparation means every medicinal and toilet preparation specified in the Schedule and includes
every preparation declared by the Central Government as restricted preparation

• Unrestricted Preparation means any medicinal or toilet preparation containing alcohol but other than restricted
preparation or a spurious preparation

What is an Excise?
• Is an inland tax on the sale, or production for sale, of specific goods or a tax on a good produced for sale, or
sold, within a country or licenses for specific activities?

• It is different from Customs duties ( border taxes)

• An excise tax is distinguished from a sales tax or VAT in three ways:

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 • (i) an excise typically applies to a narrower range of products;

• (ii) an excise is typically heavier, accounting for a higher fraction of the retail price of the targeted products; and

• (iii) an excise is typically a per unit tax, costing a specific amount for a volume or unit of the item purchased,
whereas a sales tax or VAT is proportional to the price of the good

• An excise is considered an indirect tax1 meaning that the producer or seller who pays the tax to
the government is expected to try to recover or shift the tax by raising the price paid by the buyer
Central Board of Excise and Customs
• Central Board of Excise and Customs (CBEC) is a part of the Department of Revenue under the Ministry of
Finance, Government of India
• It deals with the tasks of formulation of policy concerning levy and collection of Customs & Central Excise duties
and Service Tax, prevention of smuggling and administration of matters relating to Customs, Central Excise,
Service Tax and Narcotics to the extent under CBEC's purview
• The Board is the administrative authority for its subordinate organizations, including Custom Houses, Central
Excise and Service Tax Commissionerates and the Central Revenues Control Laboratory.

Licensing
• Manufacturing of alcoholic and narcotic preparations can only be undertaken under the authority of a licence
granted for this purpose
• A license will be granted only if the applicant holds the requisite license for the manufacture of drugs under the
Drugs and Cosmetics act.
• The act also specifies procedures to be followed for the manufacture of Homeopathic and Ayurvedic
preparations, removal of goods from bonded labs, interstate movement of preparations etc.
• Application for the licence or for its renewal is to be made to Licensing authority who is the EXCISE
COMMISSIONER
• A separate application is to be made if more than one kind of licence is desired
• The application for the licence should be submitted in the prescribed form accompanied with the prescribed fee

• The particulars required to fill in the application for obtaining the licence are:

Name and address of the applicant and place and site on which the manufacturing unit is situated
The amount of the capital proposed to be invested in the venture
Approximate date from which the applicant desires to commence the manufactory
The number and full description of vats, still and other permanent apparatus and the machinery which the
applicant wishes to get together with the maximum quantity of alcohol
The site and the elevation plans of the manufactory/building and also similar plans for the quarters of the
Excise Officer together with relevant records
The amount on cash or Government Promissory Notes which the applicant is prepared to furnish for the due
performance of the conditions on which the licence may be granted
The kind and number of each licence under the Drugs and Cosmetics Act held by the applicant
A list of all preparations which the applicant proposes to manufacture and /or those manufactured during the
preceding year showing the percentage or proportion of alcohol in preparations or opium, indian hemp or other
narcotic drug

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Manufacture outside Bond
• Preparations are deemed to be manufactured in bond when they are manufactured in a premise, licensed or
approved for this purpose and on which the excise duty has been paid at the time of spirit purchase

• A license is required for undertaking the manufacture of medicinal and toilet preparations without a bond

• The application for the licence should be submitted in the prescribed form accompanied with the prescribed fee
at least 2 months before the date of commencement of the manufacture

• The conditions are similar to that of manufacture in bond

Conditions of License

The form of application and other conditions for license is the same as that of manufacture in bond

Non- bonded laboratory should be separate from the rest of the business premises and should be used
exclusively for the manufacture of spirituous medicinal and toilet preparations

Design and construction of a non-bonded laboratory

A non- bonded lab should consist of the compartments as per the following diagram

1. A Spirit Store

2. A room for the manufacture of medicinal preparations

3. One or more rooms for the storage of finished medicinal preparations

The manufacture and sale in a non- bonded lab should be conducted between sunrise and sunset only and on
days as fixed by the excise commissioner for the purpose.
There should be only one entrance to the lab and only one door for each of its compartments
Every window in the bonded premises should be provided with maleable iron rods, not less than 1.9 cm in
thickness and set not more than 10 cm apart

The rods should be embodied in brick work to a depth of atleast 5 cm and covered on the inside with strong
netting or expanded metal of a mesh not more than 2.5 cm in diameter in length

Each room in the lab should bear a board indicating its serial number and purpose

The pipes from sinks inside the laboratory should be connected to the general drainage of the premises

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 The gas and electric connections in the lab should be arranged in such a way that their supply can be cut off at
the end of a day's work

Permanent vessels should be provided for the storage of alcohol and other narcotic substances received under
bond

All vessels should bear a distinctive serial number and a statement of their full capacity

Manufacture in a non-bonded laboratory

The essential steps are :

1. Obtaining raw spirit from distillery after duty payment

2. Manufacture

3. Storage of finished preparations

4. Returns

1. Obtaining raw spirit from distillery

Raw spirit is obtained from a distillery approved by the Excise commissioner

An indent is sent in the prescribed form, countersigned by the officer in charge of the lab ( in Duplicate)

One copy to the distiller or warehouse keeper and the other to the excise officer in charge of the distillery or
warehouse

Before sending a copy to the officer in charge of the distillery, the manufacturer should pay the excise duty on
the alcohol to be purchased

The treasury challan of the payment should be enclosed with the indent

The treasury officer shall also send an advice to the Excise officer in charge of the distillery

After verification of the payment details, the excise officer shall issue the spirit along with a permit covering the
issue

The spirit will then be transferred to the spirit store and entered in the register

2. Manufacture of alcoholic preparations

The manufacture of preparations from duty paid spirit should be carried out only at the licensed premises

Each preparation, soon after its manufacture, should be registered and given a distinctive batch number

3. Storage of finished preparations

All finished preparations should be transferred from the lab to the finished goods store and so arranged that
they can be easily checked from the stock register

Preparations stored in bulk should be measured in the storage vessel nearest to 28.350 ml

The quantities taken out from time to time should be entered in the stock maintained for the purpose

4. Sampling

The excise officer of the concerned jurisdiction, without any previous notice to the manufacturer, shall take
samples of not less than 10% and more than 15% of the total batches manufactured during the month

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 All such samples should be taken personally by the officer in the presence of the manufacturer

Every sample shall be taken in duplicate and the labels of the bottles should be signed by the officer taking the
samples

The cork of every bottle should be fixed with the seal of the officer

The manufacturer can also add his seal to the sample bottles

If the alcoholic content differs by more than 30 proof on either side from the strength declared by the
manufacturer, he shall pay a penalty at the rate of 10 times the duty payable

5. Returns

The manufacturer should maintain up to date and proper accounts of all transactions and deliver them to the
concerned officers on the 5th of each month

Any change in staff should be intimated to the excise commissioner

6. Inspection

The non-bonded lab shall be open to inspection by officers of the excise department

It shall be inspected at least once every month

Fees

• The fees to be paid for obtaining a license are:

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Page 73 of 13
Offences and Penalties
OFFENCES PENALTIES

I. BY LICENSEES

a) Failure to follow licence conditions/pay duty Imprisonment up to 6 months or fine up to Rs. 2000

b) Disorderly keeping of stocks or accounts Fine up to Rs. 2000

c) Illegal sale of dutiable goods Fine up to Rs. 1000

d) Failure to furnish export proof Fine up to Rs. 2000

e) Obstruction to officers/ false information Fine up to Rs. 5000

f) Failure to provide/ maintain weighing or measuring Fine up to Rs. 1000

devices

g) Failure to provide / maintain facilities for locking Fine up to Rs. 200

II. BY EXCISE OFFICERS

a) Failure to do duty Imprisonment up to 3 months or fine or both

b) Vexatious searches / seizures Fine up to Rs. 2000

c) Disclosure of information Fine up to Rs. 1000

III. BY PUBLIC

a) Malicious information Imprisonment up to 2 years or fine upto Rs.

2000or both

b) Connivance of owners/ occupiers of land Imprisonment up to 6 months or fine upto Rs. 500 or
both

Latest amendments
• Amendment of Article 268 (1) (Duties levied by the union but collected by the States): -

Article 268 (1) provides the provision of levy of stamp duty and excise duty on medicinal and toilet preparation
by union government and collection by state (In case of State) or by union (In case of union territory).
Now, the duties of excise on medicinal and toilet preparation has been omitted and same is been amalgamated
in GST.

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Manufacture in Bond
• Preparations are deemed to be manufactured in bond when they are manufactured in a premise, licensed or
approved for this purpose and on which the duty has not been paid until the finished products are removed
from the licensed premises

• Every person interested in manufacturing preparations containing alcohol or other narcotic substances
should obtain a license for the Excise Commissioner of the concerned state

• The application for the license should be submitted in the prescribed form accompanied with the prescribed fee
at least 2 months before the date of commencement of the manufacture

Licensing

• The particulars required to fill in the application for obtaining the licence are:

Name and address of the applicant and place and site on which the bonded lab is proposed to be situated
The amount of the capital proposed to be invested in the venture
Approximate date from which the applicant desires to commence the manufacture, stating the % of alcohol in
each
The number and full description of vats, still and other permanent apparatus and the machinery which the
applicant wishes to get together with the maximum quantity of alcohol to be used
The site and the elevation plans of the manufactory/building, showing the different rooms, doors and windows,
along with similar plans for the quarters of the Excise Officer together with relevant records
The kind and number of each licence under the Drugs and Cosmetics Act held by the applicant
In case of a firm1 copy of the partnership deed and in the case of companies1 the list of directors
and managers.
A list of all preparations which the applicant proposes to manufacture and Ior those manufactured during the
preceding year showing the percentage or proportion of alcohol in preparations or opium, indian hemp or other
narcotic drug

Processing of application

On receipt of application, the licensing authority will enquire into the

1) The qualifications and experience of the technical personnel involved in the manufacture

2) The equipment of the bonded laboratory

3) Suitability of the proposed building for the establishment of bonded laboratory

4) Applicants financial position

Conditions of License

If the Excise commissioner is satisfied with the enquiries made, he may issue directions for license to be issued
and approve the plans of the building and equipments

On completion of the construction, the licensing authority will ascertain whether the construction has been
done in accordance with the approved plan

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 Separate licenses should be obtained for separate premises of business

If the licensee desires to transfer his business to another person, the transferee should obtain a fresh license
which shall be granted free of fee for the residue of the period covered by the original license

Any transfer in premises should be notified to the licensing authority 10 days in advance and obtain an
amended license

The license is valid for a period of 1 year and should be renewed thereafter

The application for renewal should be submitted one month before the due date

The license should be displayed in a prominent place within the premises

The licensee should allow his premises and goods to be inspected by the licensing authority

A visit book should be maintained to enter the remarks of the visiting officers

All invoices and documents related to the business should be maintained

Design and construction of a bonded laboratory

A bonded lab should consist of the compartments as per the following diagram

1. A Spirit Store

2. A room for the manufacture of medicinal preparations

3. One or more rooms for the storage of finished medicinal preparations

4. If the manufacture of toilet preparations is also carried on, a separate manufacturing room for these together
with a separate room for the storage of finished toilet goods

5. Accommodation , with necessary furniture for the excise officer in charge of the bonded lab, near its entrance

There should be only one entrance to the lab and only one door for each of its compartments
The lab can be opened only in the presence of the excise officer and during his absence, all the doors should be
secured with excise ticket locks

Every window in the bonded premises should be provided with maleable iron rods, not less than 1.9 cm in
thickness and set not more than 10 cm apart

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 The rods should be embodied in brick work to a depth of at least 5 cm and covered on the inside with strong
netting or expanded metal of a mesh not more than 2.5 cm in diameter in length

Each room in the lab should bear a board indicating its serial number and purpose

The pipes from sinks inside the laboratory should be connected to the general drainage of the premises

The gas and electric connections in the lab should be arranged in such a way that their supply can be cut off at
the end of a day's work

Permanent vessels should be provided for the storage of alcohol and other narcotic substances received under
bond

All vessels should bear a distinctive serial number and a statement of their full capacity

All vessels, containing preparations on which duty has not been paid should be secured with excise ticket
locks.

Manufacture of preparations in bonded laboratory

The essential steps are :

1. Obtaining raw spirit from distillery without duty

2. Verification of raw spirit by excise officer

3. Storage of raw spirit in raw spirit store

4. Manufacture

5. Storage of finished preparations

6. Issue of preparations from bonded lab

1. Obtaining raw spirit from distillery

Raw spirit is obtained from a distillery approved by the Excise commissioner

An indent is sent in the prescribed form, countersigned by the officer in charge of the lab ( in Duplicate)

The distiller will receive the duplicate copy of the indent and issue the spirit in duly sealed containers along with
the advice of consignment to the excise officer in charge of the bonded lab

There should be no wastage of spirit during transportation from the distillery to the lab

In case there is a loss of contents due to negligence by the manufacturer, the manufacturer will be asked to pay
duty on the total loss in the amount of spirit

However if the Excise commissioner is satisfied that the loss has occurred in spite of all care taken by the
manufacturer, he may waive off the duty on the lost spirit

2. Verification and storage of raw spirit

The consignment of the spirit has to be verified in volume and strength by the Excise officer on its arrival in the
bonded lab and the amount entered in the register maintained for the purpose

The spirit will then be stored in the spirit store

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3. Manufacture of alcoholic preparations

Whenever the manufacturer wants to manufacture any preparation, he must calculate the requirements of the
spirit and hand it over to the officer in charge

The officer will then issue the spirit

Before requesting for the spirit, all the other ingredients of the preparation should be kept ready

The spirit is then mixed with the ingredients in the presence of the officer in charge

The finished product is then moved to the finished goods store, measured and stored in the vessels provided for
the purpose

It should also be entered in a register and given a batch number

The officer in charge may permit the manufacturer to take a sample upto a max of 250 ml from each batch of
the finished preparation, free of duty for determination of its alcoholic strength

A separate account should be entered for samples used for analysis and any amount left over after analysis
should be mixed with the main batch

4. Storage of finished preparations

All finished preparations should be stored in bulk in jars and bottles, each containing not less than 2.25 litres of
the preparation

Every container should be labeled with the name of the preparation, batch number, strength, date of storage
and actual content

Preparations may be issued in containers not less than 50 ml capacity

The stored preparations should be entered in a stock ledger which should be updated with manufacture of
each batch

5. Issue of finished preparations

Whenever the manufacture wishes to take out any preparation from the bonded lab, he must present an
application to the excise officer and pay duty for it

The officer will check the entries, realize the duty and allow the preparations to be removed from the bonded
lab

Before issue of preparations, an issue pass has to be written out by the Excise officer

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Summary

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