FDA Mission

The Food and Drug Administration is responsible for protecting the public health by ensuring the
safety, efficacy, and security of human and veterinary drugs, biological products, and medical
devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit
radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco
products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical
products more effective, safer, and more affordable and by helping the public get the accurate,
science-based information they need to use medical products and foods to maintain and improve
their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfils this
responsibility by ensuring the security of the food supply and by fostering development of medical
products to respond to deliberate and naturally emerging public health threats.

Laws Enforced by FDA

The Pure Food and Drug Act of 1906 was the first of more than 200 laws that constitute one of the
world's most comprehensive and effective networks of public health and consumer protections. Here
are a few of the congressional milestones:

 The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic
elixir killed 107 people, including many children. The FD&C Act completely overhauled the
public health system. Among other provisions, the law authorized the FDA to demand
evidence of safety for new drugs, issue standards for food, and conduct factory inspections.

 The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy
in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States),
strengthened the rules for drug safety and required manufacturers to prove their drugs'
effectiveness.

 The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical
devices had caused 10,000 injuries, including 731 deaths. The law applied safety and
effectiveness safeguards to new devices.

 The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted
in 2009, giving FDA authority to regulate the manufacture, distribution, and marketing of
tobacco products
The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to
those of several other government agencies. Often frustrating and confusing for consumers is
determining the appropriate regulatory agency to contact. The following is a list of traditionally-
recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an
exhaustive list.

In general, FDA regulates:

Foods, including:

 dietary supplements

 bottled water

 food additives

 infant formulas

 other food products (although the U.S. Department of Agriculture plays a lead role in
regulating aspects of some meat, poultry, and egg products)

Drugs, including:

 prescription drugs (both brand-name and generic)

 non-prescription (over-the-counter) drugs

Biologics, including:

 vaccines for humans

 blood and blood products

 cellular and gene therapy products

 tissue and tissue products

 allergenics

Medical Devices, including:

 simple items like tongue depressors and bedpans

 complex technologies such as heart pacemakers

 dental devices

 surgical implants and prosthetics

Electronic Products that give off radiation, including:

 microwave ovens

 x-ray equipment

 laser products

 ultrasonic therapy equipment

 mercury vapor lamps

  sunlamps

Cosmetics, including:

 colour additives found in makeup and other personal care products

 skin moisturizers and cleansers

 nail polish and perfume

Veterinary Products, including:

 livestock feeds

 pet foods

 veterinary drugs and devices

Tobacco Products, including:

 cigarettes

 cigarette tobacco

 roll-your-own tobacco

 smokeless tobacco

 Cigars

 Hookah

 E-cigarettes (tobacco and non-tobacco derived nicotine)

The following contact information is for government agencies that have functions related to that of
FDA.

Advertising

The Federal Trade Commission is a federal agency that regulates many types of advertising. The FTC
protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace.

Alcohol

The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates aspects
of alcohol production, importation, wholesale distribution, labelling, and advertising.

Consumer Products

The Consumer Product Safety Commission (CPSC) works to ensure the safety of consumer products
such as toys, cribs, power tools, cigarette lighters, household chemicals, and other products that
pose a fire, electrical, chemical or mechanical hazard.
Drugs of Abuse

The Department of Justice’s Drug Enforcement Administration (DEA) works to enforce the controlled
substances laws and regulations of the United States, including as they pertain to the manufacture,
distribution, and dispensing of legally produced controlled substances

Meat and Poultry

The U.S. Department of Agriculture's Food Safety and Inspection Service regulates aspects of the
safety and labelling of traditional (non-game) meats, poultry, and certain egg products.

Pesticides

The Environmental Protection Agency (EPA) regulates many aspects of pesticides. EPA sets limits on
how much of a pesticide may be used on food during growing and processing, and how much can
remain on the food you buy.

Vaccines for Animal Diseases

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), Center for
Veterinary Biologics, regulates aspects of veterinary vaccines and other types of veterinary biologics.

Water

The Environmental Protection Agency (EPA) regulates aspects of drinking water. EPA develops
national standards for drinking water from municipal water supplies (tap water) to limit the levels of
impurities.
FDA Commissioner
Dr. Martin A. Makary

Commissioner of Food and Drugs

CDSCO
The Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health
Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory
Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi. It has
also six zonal offices, four sub zonal offices, thirteen Port offices and seven laboratories spread across
the country.
The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central &
state regulators for regulation of drugs & cosmetics. It envisages uniform implementation of the
provisions of the Act & Rules made there under for ensuring the safety, rights and well being of the
patients by regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out
transparency, accountability and uniformity in its services in order to ensure safety, efficacy and
quality of the medical product manufactured, imported and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical
Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country
and coordination of the activities of State Drug Control Organizations by providing expert advice with
a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain
specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and
Sera.

The Centre has appointed Rajeev Singh Raghuvanshi as the new Drug Controller General of India
(DCGI) at the Central Drugs Standard Control Organisation (CDSCO).

The current Director General of Health Services (DGHS) in India is Dr. Sunita Sharma