In November last year the Department of Pharmaceuticals had set up a Task Force on 'Enabling the Private Sector to lead the growth of Pharmaceutical Sector' headed by its secretary to provide a big thrust to the ailing pharmaceutical industry of the country. The other members of the task force are from Planning Commission, Department of Industrial Policy and Promotion, Department of science and technology, Department of biotechnology and various industry associations. After achieving a commendable growth for almost 25 years, Indian pharmaceutical industry has been facing tough times from 2010 on account of various internal and external factors. This was getting reflected in the overall sales and profitability of many top Indian companies since then. As the profit growth of most of the Indian companies depended on the exports to the developed countries and mainly to the US, repeated actions against Indian manufacturing facilities by the US FDA on regulatory issues have been affecting exports quite seriously. And it is a fact that the frequency of regulatory inspections of manufacturing facilities of Indian companies has been stepped up by the US FDA in recent years. Now the question remains whether Indian companies have been taking adequate care in maintaining good manufacturing practices in their facilities and the product quality or is it a deliberate attempt by the US authorities to check the steadily growing pharmaceutical export from India to the US.
The Task Force has considered the issue of poor export performance quite seriously and made some recommendations. It suggested that the government should streamline the process for grant of Certificate of Pharmaceutical Products (CoPP) so that exports are not affected due to non renewal of CoPP on time. Currently, the CoPP is granted for 2 years and extended up to 3 years. Ensuring adequate cold chain facilities at ports, providing better regulatory infrastructure and faster clearances of export cargo at the ports are some other suggestions. The main issue however is the periodical upgradation of manufacturing facilities for exports and product quality. This has to be addressed by the respective companies themselves. Another important area which needs serious attention is environmental clearances for API units. One of the reasons for the closure of several API units in the country is the stringent environmental policies followed by the state pollution control boards. The Task Force has asked the Centre to rationalise environmental clearances and also make it time bound. A company already having Pollution Control Board clearance should not be forced to apply again in case of change in product mix if the total effluent discharge remains the same. Clinical trial segment has been a major revenue earner for Indian pharmaceutical industry until a few years ago. For the last four years, the clearances for conducting trials in the country have become extremely slow. The Task Force has proposed to create a simplified and streamlined process with well defined time lines for approvals of clinical trials. Currently, there is a 3-tier structure for permitting clinical trial of a new drug with a chain of Expert Committee, Technical Committee and Apex Committee having overlapping mandates. Another suggestion is a review of the implementation of DPCO 2013. There are a few more recommendations made by the Task Force during the past few months. Now last month, the DoP constituted an Inter-Ministerial Coordination Committee for addressing recommendations of the Task Force. Coordination is certainly required between various central ministries, departments and also the state governments to resolve the complex issues faced by the pharmaceutical industry. But what is most important is the earnestness and speed of the Coordination Committee to sort out these matters so that Indian pharmaceutical sector may not turn into a sick industry.