Under the 12th five year Plan, a budgetary allocation of Rs.1750 crore is provided by the Union finance ministry for expanding the country’s entire drug control machinery. Out of this, a sum of Rs. 900 crore is earmarked for the strengthening the Central Drugs Standard Control Organisation, country’s apex drug regulatory body while the remaining Rs. 850 crore is expected to be spent for the development of the state regulatory bodies. The funds will be used to help the CDSCO and state drug control departments in their capacity building measures like construction of new drug testing laboratories, expansion of existing facilities and hiring of regulatory staff. Adequate regulatory infrastructure, qualified technical staff and proper coordination between the Centre and state governments are the key factors that determine the efficient functioning of a national drug control network. And that is what has been lacking in the country for several years despite India being a major producer and exporter of drugs and pharmaceuticals today. Testing laboratories in major drug producing states like Maharashtra, Gujarat, Andhra Pradesh, Karnataka and Himachal Pradesh are far from adequate. Primarily it is the responsibility of the respective state governments to allocate funds to set up sufficient number of drug testing laboratories to ensure only quality medicines are produced and sold in the territory of that state. By allocating Rs.850 crore in 12th Plan, the Centre is trying to help the state governments which are hesitant to set up testing labs and recruit necessary regulatory staff.

Perhaps the most critical factor in a drug regulatory framework is the adequacy of technically qualified staff for regular inspection of establishments and quality testing of drugs. To oversee the regulatory compliance of 10,000 pharmaceutical companies and 7 lakh retail chemists spread across the country, a large team of drug control staff is necessary. Currently, there are only 200 staff with CDSCO as against the sanctioned staff strength of 470. And there are just 1,200 drug inspectors for all the 29 states against the requirement of more than 3,200. Such inadequacy in staff numbers has been leading to huge work pressure on the existing staff both at the Centre and the states resulting in poor enforcement of drug laws in the country. The plan to recruit 5,500 new regulatory staff for both at the Centre and in states during the 12th Plan period, therefore, makes a lot of sense. CDSCO alone will have 2,500 drug control officials whereas states will get 3,000 additional staff for inspection and testing labs. Allocation of funds for advanced infrastructure and building up a strong regulatory machinery is indeed a first step in the right direction. What is more important is the timely and effective implementation of this reform process through better coordination between CDSCO and state regulatory departments. Absence of a uniform implementation of various central drug laws and directives by the state drug control departments is, perhaps, the biggest challenge Indian drug regulatory system is facing today and that needs to be addressed most urgently.