The proposed and upcoming changes in regulatory authority promise a lot to global pharmaceutical companies. Current structure of regulation not only restricts global firms entering the market but also curb the opportunities for India in global market. Before proceeding further with the impact and benefits of Central Drug Authority (CDA) lets discuss the scenario and status of drug regulatory and pharmaceutical industry in India and globally.
Delving bit deep to the phase when we got independence the figures were not very impressive for pharma industry. But over the decades the trend in figure has witnessed huge growth in the pharmaceutical Industry. The number of units in pharmaceutical industry at the dawn of independence was 100. Over two decades it leaped to 2000 units in 1970.The figures further grew to 6000 in early 90's. Currently, if not equivalent to the share that major pharmaceutical industries hold, but still India occupy a prominent place in the global scenario with 10,000 units as in 2006.
Drug regulatory scene
Drug regulatory authority (DRA) not being an autonomous body immensely varies in their rules and law making in each state and at central level. The overall objective - ensuring medicinal products quality, safety and efficacy - remains the same but implementing the policy and measures taken tends to differ a lot in each state.
Whereas the manufacturing / sale and quality monitoring of drugs in the country is looked after by respective state governments, the making of legislation, laying down standards, monitoring imports and exports and clearance of new drugs come under the scrutiny of central government.
Besides these there stands, some responsibilities are performed jointly by both state and centre, especially approval of license for the manufacture of the certain drugs, including:
● Vaccine and sera
● Blood bank and blood products
● r- DNA
● Large volume parenternals
● Medical devices
● WHO-GMP approvals
The amalgamated responsibilities held differently have left the global companies between major haves and haves not. Juxtaposition of central and state government distinct statutory functions under the act in India, while other countries such as USA, Canada, China, South Africa, Malaysia, Australia, Thailand holds Centralized Drug Regulatory Authority (CDRA).
CDA formation - Breaking the major hiccup
Dispersed role and responsibility between state and central drug authorities is a major hiccup for global companies to try their hand in India for their business in spite of India's huge potential in pharmaceutical industry. Global companies often get baffled as different states in India hold different procedures when it comes to drug regulations. If a certain work takes 15 days in Bombay then the same work may take around 6 months in Jammu and vice versa.
With upcoming law on centralising the drug authority in India on the recommendation of health committee under the leadership of Dr Anbumani Ramadoss (Minister of Health and Family Welfare), India will see yet another scintillating face of scope for pharmaceutical and health care industry. The idea behind the CDA authority in India is making it as an autonomous body with all the comprehensive powers as per the Drug and Cosmetics (amendment) Bill, 2007.
The CDA will have a chairman with not more than five members but at least 3 members to be appointed by central government. The CDA office will be maintained at Delhi and all the existing power of CDSCO would be shifted to CDA. DCGI (Drug Controller General India) will then work under Chairman with additional DC (I) appointed separately for AYUSH and drugs.
Opportunities
With the proposed structure of Drug Regulatory Authority, a plethora of global opportunities will prop up. These opportunities will cover contractual manufacture (agreement for global manufacture of pharmaceutical products in compliance to the international standards), contractual research and development including formulation development, clinical research, collaborative clinical trials and customised synthesis, services like analytical method development and validation, clinical data management, ancillary equipment and material production and manufacturing of packaging material. India is a hub for contractual manufacturing process of pharmaceutical products due to its cheapest manufacturing cost across the globe.
Through the centralised licensing, vaccine manufacturing units in India will gain the most. Only 15 countries around the globe producing vaccines hold licensing of vaccines on global standards. India will get the cutting edge over others once CDA get formulated as India holds 14 units, which manufactures vaccines.
Formation of CDA is expected to support the Indian regulatory system in the present scenario of competition with Asian and East European countries. The foundation of CDA is laid with the view to introduce new technologies and new therapies along with added benefits of global participation and increasing business opportunities, capacity building, employment opportunities, production of cost effective drugs and economic acceleration through foreign exchange.
In the market, in terms of laissez faire structure, in pharmaceutical industry it gets bit ossifying to grasp all the issues related to the regulations and implement them in the right and best ways possible. The area seems beyond the comprehension of everyone. Here, it's a government call to employ some well educated person to perform the role and set up CDA. Government can look forward to current Health Minister, Dr. Anbumani Ramadoss or some strong bureaucrats for the Chairmanship of CDA.
Central Drug Authority will raise the expectations of global pharmaceutical companies to join hands with India for setting up their units or tie-ups with contract research organisations.
The fact is that the pharmaceutical market in India has a huge potential when compared to other emerging markets in Asia (China, Thailand, Malaysia etc) and East European countries.
Despite the optimism there are few speed breakers. Of which one of the major factors is proceeding of centralisation of drug authority at very slow pace. This may partially explain the aggression among the global pharmaceutical industry to expand the market in other less potential countries. At the same time, there are others who see the value in making India one of their global hubs.
The implementation of current amendment on the lines of recommendations by Hathi and Mashelkar Committees, National Drug Policy (1986-1994-2000) tends to bridge the major gap and will give India its due share in global pharmaceutical industry.
(Khalid Khan is MD of Fermish Clinical Technologies Pvt. Ltd., while Iram is content writer with the same company)