Early last month, a three-day meeting of the state health ministers was concluded in Hyderabad to draw up a time bound action plan for creation of new posts of regulatory staff and upgradation of drug testing laboratories throughout the country. The meeting was presided over by the Union minister for Health, Gulab NabiAzad and was viewed as significant considering the fact that both at the Centre and in most of the states, there has been a huge shortfall of regulatory staff especially the post of drug inspectors. The issue of shortage of regulatory staff has to be seen in the background of spectacular growth of Indian pharmaceutical industry over the last 30 years. During the three decade period, the number of pharmaceutical units and trading establishments expanded in many states including certain new states like Himachal, Utterakand and Jammu & Kashmir. And almost 40 to 50 per cent of the country’s drug production has been shifted to these new states on account of the tax incentives offered by the governments there.
Now with the export oriented growth of Indian pharmaceutical industry, a need for bringing stricter regulatory provisions was felt by the Union health ministry over the years. Thus, some of the key provisions of the D&C Act such as Schedule K, Schedule M, Schedule Y, etc. have been amended and modified over the last ten years. Responsibility to enforce all the amended rules under the D&C Act is with the state health departments. But, the states have been usually lax in implementing these amended regulations and rules on account of inadequacy of funds and staff. However, some of the states like Gujarat, Maharashtra and Andhra Pradesh have taken steps to expand their inspection staff over the last two years. Poor implementation of the laws by most of the other states has been making a mockery of the Act and rules in the pharmaceutical sector. At the Centre, there is an urgent need for strengthening the regulatory staff at the office of CDSCO in Delhi and its regional offices. Now, having decided to have regular inspection of overseas manufacturing facilities before drug imports are allowed, there is a need for special team of drug inspectors directly under DCGI. In fact, a team of inspectors has been already finalized but the whole process is yet to commence months after the declaration of the intent. The concern of the Union health ministry over the inadequacy of regulatory staff in the country is understandable but the minister himself has to take the initiative and make his bureaucrats fasten the process.