The three-day workshop on Theory and Practice of GCP held in Mumbai last week was a big draw. Such an encouraging response for the workshop clearly indicates the significance the pharma industry and CROs attach to this subject. There is no doubt that clinical research is emerging as a big business opportunity in India. Several independent CROs and some leading MNCs have already set up facilities for clinical research in India during the last two years recognising this possibility. India offers a unique opportunity for conducting clinical trials with a large and diverse patient pool along with considerable low per patient trial cost. This environment, therefore, calls for adequate regulatory provisions and an efficient enforcement machinery to check the possible excesses the MNCs and CROs often tempted to do for commercial purposes. Central Drugs Standard Control Organisation, in this regard, has already issued detailed GCP guidelines for some time now. But, not many debates or discussions have taken place with the regulatory officials so far. Such interactions, in fact, are indeed necessary between clinicians and regulatory officials before the guidelines are made into legislation. In fact, many more such interactions are called for to bring to light certain grey areas in the guidelines.
It is no secret that clinical research administration in India is in a total mess despite the existence of Schedule Y of the Drugs and Cosmetics Act. Lapses on the part of the institutional ethics committees do occur often but rarely come out and usually go unpunished. Informed consents are taken from patients without their understanding what drugs are tried on them and consequences of such exposures. A majority of subjects, undergoing trials, are either illiterate or semi literate. No adequate compensation or insurance cover against injuries during trials is offered by MNCs or CROs. Ethics committees are aware of all these. In short, the ethics committees do not function as they should and there is no system of regular monitoring of their functioning. Also, there is neither a practice of evaluating the competence of the ethics committee members nor a training programme for them. This highly unsatisfactory way of functioning of most ethics committees and their secretive nature of conducting clinical trials need to change for bringing certain amount of transparency and professionalism into clinical research programme. A responsible ethics committee and informed consent process are considered to be the two pillars of clinical research, as pointed out by one of the speakers at the Mumbai workshop. It is, therefore, important that the proposed legislation of GCP should activate these two departments of clinical research. An effective machinery to implement these provisions should also be part of the new legislation.