Drug administration has turned into a hard task to the regulatory authorities in the country with the growth of the pharmaceutical industry and with the incorporation of various amendments to the Drugs & Cosmetics Act and other statutes over the years. This job has become more challenging for the drug control machinery especially after India emerged as a major supplier of generic drugs to the world markets. Absence of a uniform implementation of various drug laws and directives by the state drug control departments is, perhaps, the key issue Indian drug regulatory system is facing today and that needs to be addressed urgently. For meeting this challenge, there is a need for regular upgradation of regulatory manpower and infrastructure across the country. The Central government has, of late, started acting on this front. The plan to appoint 147 drug inspectors by the Central Drug Standards Control Organization towards the end of 2015 is a step in this direction. Another 1195 posts for the drug inspectors have been sanctioned for upgradation of manpower and labs under the 12th five year Plan. The Centre has already allocated Rs. 900 crore for enhancing manpower and capacities of minilabs at port offices and mobile labs at CDSCO level. CDSCO expects to double the manpower and enhance the lab infrastructure at the Centre and States by the end of 2017. CDSCO has also conducted 17 training programmes to train drug inspectors for carrying out GMP inspections.
Perhaps the most critical factor in a drug regulatory framework is the availability of technically qualified staff for regular inspection of establishments and quality testing of drugs. For this, regular training of officials of the drug control machinery and updating them with the latest knowledge in the field of drugs and policy matters are necessary on a continuous basis. The proposal of Kerala Institute of Drugs Studies, in this regard, to set up a Training and Research Academy for the benefit of Central and state regulatory agencies is noteworthy. KIDS suggested that a Training and Research Academy should be set up in each state jointly by Central and state governments for holding basic training, continuous education programmes, skill development and knowledge upgradation of drug control officials. KIDS also mooted the need for having a strong drug safety infrastructure in each state by way of establishing pharmacovigilance centres, computerized drug registry, R&D wing, etc with competent and qualified personnel. It will be only appropriate if the Department of Pharmaceuticals takes a serious look at the feasibility of the KIDS’ proposal in the interest of patient safety and overall public good.