Maharashtra has always remained the financial hub of India. Various industries started their plants in the state and grew substantially cashing in on the favourable industrial policies offered by the state government. However, among all the industries the pharma industry might have been the biggest gainer of these policies. Today almost all the major pharma companies have been headquartered in Mumbai. Pharma industry stalwarts unanimously vote for the FDA Maharashtra as a key facilitator of their growth in the state. The pharma industry in Maharashtra is the largest in the country. To address its grievances and prepare it for the global challenges is a tough job, which FDA Maharashtra has been successfully doing for a long time.
While projecting Maharashtra as a favourable destination for the pharma industry, Mahesh Zagade, Commissioner, FDA, Maharashtra, opines, “Despite the tax holidays given by other states we continue to host largest number of pharma facilities. Now, as the tax incentives given by other states been over, many pharma companies are again tapping Maharashtra to set up their manufacturing bases. Mumbai is the major exporter of pharma drugs. Regulatory system in Maharashtra is one of the best in the world.” He adds, “India has the highest number of USFDA approved plants outside the US. Maharashtra has the highest number of these plants in India. We have employed a proper regulatory mechanism. We try to help companies if they face any kind of difficulties. Quality pharma production has always remained Maharashtra’s feature. The percentage of substandard drugs produced in Maharashtra is very less. Besides this, Maharashtra has skilled man power, reputed pharma colleges, laboratories etc. We are also becoming leaders in recombinant DNA technology and stem cell technology.”
Maharashtra is home to around 3,139 pharmaceutical units and corporate offices, with major centres in Mumbai, Thane, Tarapur, Nashik, Aurangabad and Pune. The state also leads in vaccine production. A number of Special Economic Zones (SEZs) have also been notified, like Navi Mumbai Ajanta Projects and Wockhardt at Aurangabad, a dedicated SEZ at Nanded, and Serum Bio Pharma Park at Pune. Maharashtra is also the first state to set up independent Intelligence Branch with separate police wing to assist investigation under Acts enforced by FDA
Tax incentives offered by other states definitely convinced many pharma companies to move out of Maharashtra. However, despite this transition Maharashtra continued to dominate India’s pharma market. As informed by Zagade, many pharma companies are slowly relocating themselves in Maharashtra. In the years to come situation would improve further provided the Maharashtra government and FDA work together to offer special benefits to the pharma industry.
About FDA Maharashtra
| Mahesh Zagade, Commissioner, FDA, Maharashtra |
FDA Maharashtra, 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 meant for enforcing mainly the Drugs and Cosmetics Act. In 1970, the 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 April 6, 1970.
During this period, the Commissioner, FDA, 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 (HQ) 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 is the only state where the work of licensing pertaining to manufacturing licenses under Drugs and Cosmetics Rules, 1945, is decentralised at seven divisional levels places. From 1996 FDA took the task to computerise the entire structure of the system. The drug sample coding and analysis reporting has been computerised.
Vision 2020…
FDA Maharashtra does not want to lag behind in the global race. By 2020 it’s objective is to be a strong science-based agency to accurately detect and assess health risks of various drugs and food, and set appropriate standards. It also wishes to be a trusted agency to enforce statutes relating to food, drug, and cosmetics, and protect the welfare of consumers, and a collaborative agency to strengthen ties with the scientific world, healthcare providers and regulatory communities, both nationally and internationally.
Towards this vision, FDA strives to ensure that drugs and medical devices are safe and effective, cosmetics are safe, products 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. FDA will be the proactive force in making safe and effective products available to the consumers. It provides clear standards of compliance to the industry and advise on how to meet them. Identification and effective address of critical public health problems, if any, arising from use of FDA regulated products is also an FDA responsibility. Itworks in close collaboration and co-operation with local authorities, national and international agencies, industry and academia, consumer groups and health professionals to realise its vision.