Contract research and contract manufacturing are going to be two critical areas of growth for Indian pharmaceutical industry in the post 2005 era. The trend is already visible in this industry with growing number of companies getting into these activities during the last two to three years. India offers a unique opportunity for conducting clinical trials with a large and diverse patient pool along with considerable low trial costs. The acceptability of Indian pharmaceutical industry as a reliable source for these services will, however, depend on the quality of services provided by the companies. And it is here the Indian pharmaceutical industry and the regulatory bodies have to be extremely vigilant. The recent decision of WHO to drop certain anti AIDS drugs of Ranbaxy and Cipla from its pre qualification list for certain anomalies in data handling and non compliance with good clinical and laboratory practices relating to bio-equivalence studies is a clear warning to Indian industry in this regard. Both the pharmaceutical companies have passed on the blame on contract research organizations that conducted the bio equivalence studies. And CROs have made counter allegations against the companies. There is no point in finding out who were actually at fault now. The damage has been done and the image of Indian CROs is primarily hit. WHO action on the two top Indian companies also cast a shadow on their reputation internationally.
Any compromise on quality of service directly hits the business prospects of individual companies and they have to be all the more careful in such matters. But, it is also important for the regulators to lay down certain specific rules and standards for these emerging sectors, particularly for CROs much before any adverse actions are taken by international bodies. The very purpose of amending the Schedule Y of the Drugs and Cosmetics Act was with this objective. The draft of Good Clinical Practices under Schedule Y was prepared and submitted to the Union health ministry several months ago. But, not many debates or interactions have taken place on this draft yet. It is no secret that clinical research administration is in a mess today. Lapses on the part of ethics committees do occur often but are rarely detected and action taken. There is neither a practice of evaluating the competence of these committee members nor a training programme for them. A highly competent machinery to implement the necessary provisions under Schedule Y is therefore necessary and urgent. If someone from the industry or from the regulatory system is articulating the need for a registration system in this segment, it is just because nothing is happening on this front and the health ministry and senior officials are not acting upon the GCP draft.