The steady gains being made by India in clinical trials, as the global industry shifts to Asia, highlights the possibility of adding another lucrative business to the growing list of commercial activities in which the country can exercise a comparative advantage. Though India and China are in a neck-to-neck race for marketshare, India is ahead on the number of clinical trials being conducted by large multinational corporations. But, as pointed out in an FE report on Monday, keeping up the momentum would require a multi-pronged strategy that would involve strengthening and fine-tuning domestic regulatory mechanisms, stepping up the supply of skilled manpower, and providing permission for phase-1 trials, which typically include tests to evaluate the safety limits/dosage ranges and possible side-effects of new drug formulations. Broadly, if at one end the business suffers from lack of multinational faith in research data protection from theft and leakages, then at the other, human rights advocacy groups worry that lax regulations on trial safety combined with unethical practices could infringe human dignity in unacceptable ways. While due data protection can be assured by tighter intellectual property rules and time/cost overruns can be minimised by cutting red tape, the record on bio-ethics has been dismal. Eight of the 22 known cases of unethical clinical trails in 2006 were from India, sadly almost all involving collusion across borders by some of the best known names in the business. Even a top university stands accused of malpractice. None of these cases was indicative of systematic human abuses?and certainly nothing approaching Ishiguroesque horrors of body-part farming?but a country stricken by poverty and illiteracy has little option but to be extra vigilant.
It is bad enough that clinical trials all over the world are shrouded in secrecy. The Helsinki declaration of the code of ethics for medical research continues to be treated lightly. India has formulated guidelines for good clinical practices, setting up an ethics committee to monitor trials and building an online clinical trials registry, which makes researchers accountable through public disclosure of essential information. But there are still gaps in the enforcement network, as there are no provisions for mandatory compensation payments or deterrent penalties on errant companies. For success, we must close the lacunae.