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.