ABOUT FDA MAHARASHTRA

• Food and Drug Administration Maharashtra State is the State

prime instrument for consumer protection. 

• Commissioner is the head of the Administration and Drug
Control Laboratory. FDA ishaving its Head Quarter at
Mumbai and offices at Division and District Places. The
Divisional Offices are headed by the Joint Commissioner
and District offices are headed by the Assistant
Commissioner.
•
• It has dedicated professionals working to protect, promote and
enhance the health of people. 

• It is a trusted agency to enforce the Food, Drug, and Cosmetic
Act fairly, upholds safety standards, and protects
consumers. 

• It studies the existing provisions of law and suggest necessary
amendments.
•
• It gives prompt and elaborate comments on the proposed
changes, draft rules circulated by the Government of India
from time to time.
•
• FDA M .S .plays a pivotal role in the Drug Technical Advisory
Board, Drugs Consultative Committee, Indian
Pharmacopoeia Committee and Central Committee for Food
Standards.
•
• FDA as a part of regulatory authority also analyses samples of
Drugs. This activity is done by the Drug Control Laboratory
at Mumbai and Aurangabad.
•
• First state to set up independent Intelligence Branch with
separate police wing to assist investigation under Acts
enforced by FDA .
•
• Uniformity of implementation of various laws through written
guidelines.

• Additional revenue generation through increase in fees 

• Emphasis on Human resources Development through training
and encouraging self developmental efforts of employees.
•
• Dissemination of useful information to public, industry and trade
through meetings, lectures, organization of seminars,
exhibition, workshops and brains storming sessions.

HISTORY
• Food and Drug Administration, Maharashtra State, the State's
prime instrument for consumer protection, is a scientifically
based law enforcement agency.
•
• Initially, this Administration came into being as Directorate of
Drugs Control which was meant for enforcing mainly the
Drugs and Cosmetics Act and Rules there under.
•
• Later in the year 1970, Government entrusted the responsibility
of enforcement of the Prevention of Food Adulteration Act,
1954, to this Directorate and then it was renamed “Food
and Drug Administration “. The post of the Director of
Drugs Control Administration was designated as the
Commissioner, Food and Drug Administration (M. S.) on
06.04.1970.
•
• During this period, the Commissioner, Food and Drug
Administration was the Licensing Authority for the grant of
the drug manufacturing licences under the Drugs and
Cosmetics Act, 1940 for the entire State and Assistant
Commissioners at Divisional places were Licensing
Authorities for grant of the drug selling licenses under the
said Act for the respective divisions.
• In 1971, circle offices at places like Akola, Kolhapur, Nashik,
were created and the Assistant Commissioners at these
circle offices were declared as the Licensing Authorities to
grant selling licenses under the Act, for the respective
circles. During this period the district office was headed by
a Drugs Inspector.

• In the year 1975, there was considerable expansion of the

Administration and posts of the Joint Commissioners and
Assistant Commissioners were created at divisional places
and district places respectively. the Joint Commissioner (H.
Q.) was declared as the Licensing Authority for grant of
manufacturing licenses under Drugs and Cosmetics Rules,
1945, for the entire State and the Joint Commissioners/
Assistant Commissioners were declared as the Licensing
Authorities for grant of selling licenses under the said
Rules, for their respective area .
•
• From 1990, the divisional Joint Commissioners are declared as
Licensing Authorities for grant of drug manufacturing
licenses for their respective divisions. Thus, Maharashtra
State is the only State where the work of Licensing
pertaining to manufacturing licenses under Drugs and
Cosmetics Rules, 1945, is decentralized at seven divisional
levels places.
•
• From 1996 FDA took the task to computerize the entire
structure of the system. The drug sample coding and
analysis reporting has been computerized.
•
• In year June 2001 one more branch of Drug Control Laboratory
was established at Aurangabad.
VISION

Vision

 It is envisaged that the FDA in the year 2020 will be… 


• A strong science-based agency-to accurately detect and assess

health risks of various drugs and food, and set appropriate
standards;
•
• A trusted agency - to enforce statutes relating to food, drug,
and cosmetics, and protect the welfare of the consumers,
and
•
• A collaborative agency - to strengthen ties with scientific world,
the health care providers and the regulatory communities,
both nationally and internationally.
Towards the above vision,FDA strives to ensure that


• Food are safe and wholesome .

•
• Drugs and medical devices are safe and effective.
•
• Cosmetics are safe.
•
• Products are in compliance with the law and FDA regulation;
non-compliance is identified and corrected.
•
• Regulatory decisions are based on a strong ,legal, scientific and
analytical base
•
• It is a proactive force in making safe and effective products
available to the consumers
•
• It provides clear standards of compliance to the industry and
advise it on how to meet those Standards
•
• It identifies and effectively addresses critical public health
problems, if any, arising from use of FDA regulated
products
•
• It operates with close collaboration and co-operation with the
local authorities, national and international agencies,
industry and academia , consumer groups and health
professionals in realizing its vision.
Mission
To protect, promote and enhance the health of Indian People

To achieve this mission, it needs to be ensured that

• Food is safe, wholesome and prepared in good and hygienic
condition.
• Human, veterinary drugs and biological products are safe, stable
and efficacious and medical devices are safe and effective.
• Cosmetics are safe and stable.
FDA ensures that these products are in compliance with the
law and FDA regulations. Non compliance will be promptly
identified and corrected, and any unsafe or unlawful product
will be removed from the market place and appropriate
action will be taken against all concerned.

Authorities

Statutory Authorities and their Functions

Commissioner 
 
 Head of the Department of the Administration

and Drug Control Laboratory and the Food Health Authority for
the State of Maharashtra under the Prevention of Food
Adulteration Act, 1954. 
 
 Joint Commissioner ( Vigilance )

 
 Investigates the complaints against Officers and other staff of
Administration. Conducts enquiry related to Corruptions and
overall supervision of intelligence branch of FDA
 
 Joint
Commissioner ( HQ )

• The Controlling Authority for the Maharashtra State under

Drugs and Cosmetics Act 1940 and Rules, 1945. Licensing
Authority for grant of Drugs Manufacturing Licenses for
Mumbai city area (Greater Bombay).
•
• To formulate policies for effective implementation of Drugs and
Cosmetics Act 1940 and Rules, 1945.
•
Joint Commissioner ( Law )

• In charge of administration .
• To give advice and guidance to officers of the Food and Drug
administration in the Maharashtra State in the investigation
work under the relevant Acts enforced by the Food and
Drug Administration and to give legal opinions before the
cases any instituted in the Courts.
•
Joint Commissioner ( Food )
• Local Authority under the Prevention of Food Adulteration Act.
1954.
• To formulate policies for effective implementation of Prevention
of Food Adulteration Act. 1954 and other allied acts and
orders.
• To supervise and conduct training programmers of Food
Inspector, Food Supervisor.
•
•
Joint Commissioner ( Greater Bombay ) 
 
 Administrative
Head for the Division. 
 
 Divisional Joint Commissioners

(Except Joint Commissioner for Greater Mumbai Division)


 Administrative Head for the Division and Licensing Authority for
grant of Drugs Manufacturing Licenses under Drugs and
Cosmetics Act 1940. 
 
 Assistant Director ( Drug Control
Laboratory )

• In charge of Drug Control Laboratory.

• To co-ordinate and direct the work of testing samples in various
sections received under Drugs & Cosmetics Act.
• To under take any other work assigned by the Commissioner
Food and Drug Administration.
• To perform the duties of Government Analyst as per the Drugs
and Cosmetics Act 1940 and Rules, 1945.
•
•
District Assistant Commissioners 
 
 Licensing Authority for
grant of Drugs Sale Licenses under Drugs and Cosmetics Act,
1940 and Rules, 1945. 
 
 Supervisors (Food)

• Licensing Authority under the Prevention of Food Adulteration

Act, 1954 for the district (Excluding Municipal Corporations
and Cantonment Area).
• Local Health Authority for their respective districts under the
Prevention of Food Adulteration Act, 1954 for the
respective Area.
•
•
Drugs Inspectors

• Empowered to carry out search, seizure, inspections, draw

samples and to institute prosecutions under Drugs &
Cosmetics Act, 1940
• To perform such other duties as may be entrusted to him by
Assistant Commissioner, Joint Commissioner and
Commissioner.
•
•
Food Inspectors
• Empowered to carry out search, seizure, inspections to draw
samples and to institute prosecutions under Prevention of
Food Adulteration Act, 1954.
• To perform such other duties as may be entrusted to him by
Supervisor Food, Assistant Commissioner, Joint
Commissioner and Commissioner.
•
•
Technical Officer (Allopathy):

• To scrutinize the formulations of drugs for their efficacy,

pharmacology, toxicology, etc and grant permission.
• To reject permission for products that are banned ,irrational etc.
•
•
Technical Officer (Ayurved) : 
 
 Licensing Authority for
Ayurvedic Drug Manufacturing for the entire State. To scrutinize
formulations, ingredients as per authoritative books and
grant/reject the permissions.