DRAP Alternative Medicines and Health

Products Enlistment Rules 2014

 DRAP Alternative Medicines and Health
Products Enlistment Rules 2014
 Drug Regulatory Authority of Pakistan
 Guidelines for Manufacturer/Importer of "Food Supplement"
or "Dietary Supplement" or "Health Supplement" or
Nutraceuticals & Medicated Cosmetics as to what is meant by
“Pharmaceutical Dosage Forms“
Vision:
 Health for all by 2025 through Access to medicine,
contributing to advancement in health care in Pakistan
 Consistent with the Pakistan Vision 2025, in line with United
Nations commitment and 11th Five Year domestic Plan and
other priorities of the Government
Mission
 To ensure access of safe, quality and efficacious medicine at

affordable prices and earliest availability of new treatment

opportunities for the people of Pakistan, Working as a highly
Professional & world class Regulatory Organization at par with
international standards and best practices, through effective
management, regulations and enforcement and to support
national health system management through effective
therapeutic goods management and strategies
Objectives for the Mission:
 Restructuring, transforming regulations and operation of
DRAP on rationale and modern scientific basis and current
trend of global regulatory environment, in line with Stringent
Regulatory Agencies, to comply the mission of DRAP
 Induction, training and development of human resource to
strengthen, operationalize and manage effectively present and
new areas of regulations and enforcement
 Development and up gradation of available facilities of
Laboratories of DRAP and introduction of new facilities and
laboratories, especially for market surveillance, forensic
investigation and for new regulations enforcement for Medical
Devices, health & OTC (Non drug), Nutraceuticals, Alternate
medicine, Traditional Ayurvedic, Homeopathic, etc., in
addition to routing functions
 Effective and result oriented management and professional
working environment with equivalent growth opportunities,
transparency and accountability in DRAP head quarter, its field
offices and laboratories
Rules
Short title and commencement
 These rules may be called the Alternative Medicines and Health
Products (Enlistment) Rules, 2014.
Definitions:
 In these rules, unless there is anything repugnant in the subject
or the context.-
 “Acceptance Criteria” means numerical limits, ranges, or
other suitable measures for acceptance of the herbal substance,
preparation ,medicines and health products based on the results
of analytical procedures
 Advertisement means the publication, dissemination,
conveyance of information for the purpose of promoting,
whether directly or indirectly, the sale or use of any product
by any means or in any form including the following namely:-
a) publication in a news paper, magazine, journal or periodical
b) display of poster or notices
c) letters addressed to individuals, bodies corporate or uni-
corporate
d) photographs or documentary or cinematographs films
e) sound broad-casting through television or any other media;
and
f) public demonstration for use of the product offer of trial of
the product to the member of the public
 “Adulterated alternative medicine or health product”
means alternative medicine or health product shall be deemed
to be adulterated if
a) It consists, in whole or in part, of any filthy, putrid or
decomposed substance
b) It has been prepared, packed or stored under insanitary
conditions
c) Its container is composed in whole or in part, of any
poisonous
d) Deleterious substance which may render the contents
injurious to health
e) It bears or contains, for purposes of colouring only, a colour
other than one which is prescribed
f) It contains any harmful or toxic substance which may render
it injurious to health
 “Allersode” means homeopathic preparations of antigens,

(substances which, under suitable conditions, can induce the

formation of antibodies). Antigens include toxins, ferments,
precipitinogens, agglutinogens, opsonogens, lysogens, venins,
agglutinins, complements, opsonins, amboceptors, precipitins
and most native proteins
 “Allopathic Ingredients” means ingredients used in
allopathic or western system which are chemically defined
ingredients and synthetically manufactured, excluding
naturally occurring ingredients obtained from natural sources
 "Alternative Medicine" means medicinal products which
include, indigenous medicine, imported medicinal product,
homeopathic medicines, new medicines, herbal preparation,
herbal substance, proprietary medicines, herbal medicinal
product, phyto-medicines or any other product meant for
therapeutic or preventive use which have been derived from
plant, animal or mineral ingredients alone or their
combinations but does not contain chemically defined
synthetic ingredients
 “Adverse Reaction” means a noxious and unintended
response to a product that occurs at any dose used to test for
the diagnosis, treatment or prevention of a disease or for
modifying an organic function
 “Baby milk and foods" means infant formula as a breast-milk
substitute specially manufactured to satisfy, by itself, the nutritional
requirements of infants during the first months of life up to the
introduction of appropriate complementary feeding and includes
infant or baby formulae, follow up formulae, formulae for special
medical purposes
 “Clinical trial” means an investigation with respect to a product that
involves human subjects and is intended to discover or verify its
clinical, pharmacological or pharmacodynamic effects, to identify
any adverse events that are related to its use, to study its absorption,
distribution, metabolism and excretion, or to ascertain its safety or
efficacy
 “Contract Acceptor” means a manufacturer who
manufacturers the finished product under the label and brand
of contract giver. He is responsible for the following, namely
a) he must have adequate premises and equipment, knowledge
and experience, and competent personnel to carry out
satisfactorily the work ordered by the Contract Giver.
Contract manufacture may be undertaken only by a
manufacturer who is the holder of a manufacturing
authorization
b) he should ensure that all products or materials delivered to
him are suitable for their intended purpose
c) he should not pass to a third party any of the work entrusted
to him under the contract without the Contract Giver’s prior
evaluation and approval of the arrangements.
 “Contract Giver” means the person who awards the contract of
particular products under his brand .Contract Giver is
responsible:
a) For assessing the competence of the Contract Acceptor to carry
out successfully the work required and for ensuring by means
of the Contract that the principles and guidelines of GMP are
followed
b) The Contract Giver should provide the Contract Acceptor with
all the information necessary to carry out the contracted
operations correctly in accordance with the marketing
authorization and any other legal requirements
c) The Contract Giver should ensure that the Contract Acceptor is
fully aware of any problems associated with the product or the
work which might pose a hazard to his premises, equipment,
personnel, other materials or other products
 “Expiry date”

 The date, expressed at minimum as a year and month, up to and

including which a medicine or a health products maintains its

purity and physical characteristics and its medicinal ingredients
maintain their quantity per dosage unit and their potency

OR
 The date, expressed at minimum as a year and month, after which

the manufacturer recommends that the medicine and health

products should not be used
 “Finished Product” means alternative medicine or health

product which is ready for use after release certificate based on

conformance to specifications by the quality control department
 “Healthcare professional” means professionals who render

their services for betterment of human healthcare and are

registered with their respective Council under the law as
medical doctor, dentist, pharmacist, homeopathic doctor, hakim
or nurse
 “Health related purpose” means a therapeutic, curative,

preventive, palliative, or cosmetic purpose or for promotion and

well being of humans and animal health
 “Herbal medicinal products” means any medicinal product,

exclusively containing as active substances one or more herbal

substances or one or more herbal preparations, or one or more
such herbal substances in combination with one or more such
herbal preparations
 “Herbal preparations” means preparation obtained by
subjecting herbal substances to treatment such as extraction,
distillation, extraction, fractionation, purification, concentration
or fermentation, including comminuted or powdered herbal
substances, tinctures, extracts, isolates, essential oil, expressed
juices and processed exudates
 “Label claim” means any representation made on a product in

relation to its indication, benefits or actions. Claims could be

stated directly or inferred in-directly but not limited to the
following:-

a) Graphic or logos on the product packaging;

b) Product or branding

c) Media advertisement (print, sound, light and sound)

d) Point of sales materials

e) Product broachers or information sheets distributed with or

separately from the product

 “Misbranded alternative medicine or health products”

means an alternative medicine or health product which is;-

a) So coloured, coated, powdered or polished that damage is

concealed or if it is made to appear of better or greater

therapeutic value than it really is

b) Not labelled in the prescribed manner

c) Label or container or anything accompanying it bears any

statement, design or device which makes any false claim for

the product or which is false or misleading in any particular
 “Structure-Function Claim” a claim which describes the

effect of a product on a structure or physiological function in

the human body, or a product’s support of an anatomical,
physiological, or mental function
 “Nosode” homeopathic preparations of pathological organs or

tissues, causative agents such as bacteria, fungi, ova,

parasites, virus particles and yeast, disease products,
excretions or secretions
 “Medicated cosmetics” means health product used for

cleansing, fragrencing, deodorizing, beautifying, preserving,

improving, altering or restoring complexion of skin, hair, nail
or teeth of human containing ingredients of natural origin
 Procedure for Enlistment
 The Authority shall enlist alternative medicine and health
products, their manufacturers and importers subject to fulfillment
of the criteria prescribed below.
(2) The following shall be eligible to apply for enlistment namely;--
a) Manufacturers having manufacturing and quality control
facilities
b) Contract giver
c) Importers authorized by the overseas principal manufacturer
d) Manufacturers holding manufacturing license under the Act
may also apply for approval of dedicated sections for
manufacturing of alternative medicines
(3) Application for enlistment shall be made to the Authority,
addressed to the Director of Division of Health and OTC Products
(non-drugs) in the following manner
(4) Application evaluation. - (1) Applications shall be
scrutinized by the Division of Health and OTC Products (non-
drugs) for conformance to the evaluation criteria.
(5) Evaluation criteria- (1) Applications shall meet the
following criteria, namely:-
a) applications shall be complete and meet all the criteria
prescribed
b) applicants shall possess manufacturing and quality control
facilities
c) applicants shall submit necessary evidence to support
applications for manufacturing unit, import or products as
defined in the rules
d) applicants shall conform to the principles of quality
assurance for contract manufacturing or contract testing and
analysis
a) application containing false, incorrect or misleading
information shall be liable to rejection
b) the formulation of the applied product shall not contain
prohibited substance or ingredient or ingredients that have
been declared dangerous or injurious to health by any
international body or as may be prescribed
 Contract manufacturing. - (1) The application for enlistment
of product for manufacturing on contract basis submitted to the
Authority shall be reviewed and decided in the light of
fulfillment of criteria prescribed
a) Contract acceptor shall have pre-determined surplus capacity
in terms of manufacturing facilities, sections, equipment,
testing procedures, qualified technical personnel and quality
control operations
 b) Contract acceptor shall be possessing established systems of
quality assurance and validation of manufacturing process and
testing methods and no major deficiencies or non conformities has
been identified during the inspection of manufacturing unit of the
contract acceptor
c) Every operation of cleaning and sanitization, validation,
calibration, manufacturing, in-process controls, quality control,
stability protocol, packaging and release shall be clearly defined
and documented through standard operating procedures
d) Quality control laboratory shall be equipped with Chemistry,
Pharmacognosy and Microbiology facilities and equipment, as
applicable
 Evaluation Committee

 Quorum to constitute a meeting shall be above fifty per cent of

the total membership

 The evaluation committee shall evaluate the applications as per

criteria and may grant approval or rejection of the application

recording reasons