Pramod K Jain is currently, director, Directorate of Food & Drugs Administration, - Government of Goa. He joined the FDA in 1985 as assistant drugs controller and served in the capacity as deputy director and director. A post graduate in pharmaceutics from the University of Sagar, Jain has over 12 years experience in manufacturing and testing of pharmaceutics and regulatory management in food and drugs quality control systems. Excerpts from an e-mail interview with Gireesh Babu A N
As the new drug regulator, how do you see the current regulatory environment in Goa?
I have been a part of the Goa Food and Drugs Administration for the last 21 years, engaged in regulating and controlling quality of food and drugs in this State. Our administration has been co-operative and responsive to the needs of both, industry and trade, yet, firm in implementation of the regulations like the Drugs and Cosmetics Act, Prevention of Food Adulteration Act and other legislations related to drugs. Considering fast changes in the global needs and requirements in respect of drugs, FDA Goa endeavours for upgradation of production, quality control facilities and improvement in quality standards of drugs, as needed.
Goa continues to be a sought-after destination for domestic companies to set up their manufacturing/ research activities. What, according to you, that makes Goa an unique location for domestic as well as overseas players ?
In Goa, pharmaceutical industry started as back as 1967 promoted by local entrepreneurs, who manufactured drugs in collaboration with foreign companies and industry had grown steadily. Consequent to income tax and sales tax exemptions granted to new units in Goa, there was a significant inflow of reputed Indian companies as well as multinational companies between 1994 and 2006, and about 4 large and medium scale companies were set up in Goa. Recently, some R&D units with formulation development and clinical research facilities are set up. Besides tax benefits, at present, Goa has good air and rail connectivity to major cities in India, clean and green environment, good educational facilities. Goa also has extensive network of roads, well organized industrial estates, communication facilities, decent life style and easily approachable bureaucracy and government. Skilled and disciplined manpower, educated labour force are additional advantages. Out of 108 odd pharma units, Goa has 28 units certified for WHO-GMP compliance with several approvals by other foreign regulatory agencies like USFDA, MCC, MHRA, PIC, TGA etc. Goa being famous internationally as tourist destination, also helps in attracting industries. My interaction with few manufacturers revealed that having a plant in Goa makes their business trips to be a pleasure trip as well.
Goa is said to be free from irrational combinations and spurious drugs for the past several years, when compared to other states. What are the ongoing special measures taken by the FDA to curb the occurrence and in-flow of spurious drugs in the state?
Goa has always been free from irrational combinations, misbranded and spurious drugs. The mindset and the attitude of local entrepreneurs, as well as of the other manufacturers, who started their operations coupled with the vigilant Food and Drugs Administration, could make this possible. The attitude and culture at Food and Drugs Administration and support of the government received by this office, helps to maintain this position. Verification of antecedents of the applicants, regular inspections, better public awareness and the measures taken by Food and Drugs Administration helped to prevent any inflow of spurious drugs in this state.
How proactive have been the policies taken by the government to attract more investments in pharmaceutical industry in the state ?
Besides other reasons cited earlier, tax benefits available were the catalysts for the major investments in pharma industry. However, discontinuation of tax benefits to new industry since 2002, and further, Central Excise duty exemption granted in 2005, to the units set up in some parts of the country, have been a setback for the pace of growth of pharma industry. Still the measures taken by Government of Goa, in providing ideal conditions and developed infrastructure for pharma manufacturing, Goa continues to attract companies for export oriented production, clinical research organizations and other research and development activities. Now, development of pharma SEZs is also being mooted.
The Drug Testing laboratory under FDA was undergoing modernization programme. What is its status at present ?
At present the Combined Food and Drugs Testing Laboratory equipped with modern equipment/instruments is working under this directorate. However, the new building for laboratories under the Capacity Building Project with assistance from the World Bank, at the cost of more than Rs. 2.00 crores, is near completion and expected to be operational shortly. This laboratory will be equipped for all types of chemical, instrumental and microbiological analysis of food and drug samples. FDA strives to upgrade this laboratory to comply with Good Laboratory Practices and make it suitable for NABL accreditation.
How successful has been Goa in the implementa-tion of Schedule M in manufacturing ?
Goa has a combination of manufacturing plants aiming for international regulatory compliance and some small units set up by entrepreneurs with positive mindset. Therefore, implementation of Schedule M has been highly successful with approximately 90% of the units being Schedule M compliant already. However, four to five manufacturing units are in final stage of upgradation and likely to comply Schedule M requirements in one to two months.
What are the issues that the FDA concentrating on, at present ?
As you said, Goa FDA and pharma industry has a reputation to maintain. Our effort is to develop a well-trained, motivated team of regulatory personnel to help the industry in regulatory compliance so as to promote export business as well as to produce quality drugs for domestic market at reasonable prices. With fast developments as an international tourist destination, Goa has a lurching danger of trade of medicines with potential for misuse and misbranded drugs. FDA has to be vigilant so as to frustrate the effort for ingress of such drugs in the state.
Do you think that there are certain issues that have to be addressed immediately by the Government to make the FDA machinery more effective?
Expansion of directorate with recruitment of more drug regulatory officers and laboratory scientists, is at the final stage. Food inspecting team is strengthened by appointment of seven food inspectors. Computerisation of records is in progress under e-governance scheme and Capacity Building Project under the World Bank assistance. Staff of the directorate are regularly been trained by deputing them to various related training programmes for food and drugs safety.
Could you give us a brief overview on the current developments in the pharmaceutical industry in the State?
Despite cessation of income tax and sales tax exemptions in the state, and the excise exemptions granted in other parts of the country, Goa continues to attract new industries. In the recent past, facilities for hypodermic disposable syringes, formulation development and clinical studies, are set up. Commercial testing laboratory and few manufacturing unit projects are under progress. Further, the development of a pharma SEZ is also in progress. There is continuous development and upgradation in existing facilities. Estimated pharma industry turnover is more than Rs. 3000 crores.