From Economics Times
That the government is concerned about abuses in drug trials on humans and wants to better regulate them is good news. This, however, may not suffice unless enforcement is improved. For, it’s not so much lack of regulation than the inability to enforce the existing provisions, which appears to have encouraged unethical research in India. Schedule Y of the Drugs and Cosmetics Act, enforced by the Drugs Controller General, lays down the framework for conducting clinical research in India and, inter alia, requires compliance with the ethical guidelines for biomedical research on human subjects issued by the Indian Council of Medical Research (ICMR) in 2000.

This has been further bolstered by the Medical Council of India’s (MCI’s) 2002 ‘Code of ethics regulations’, which reiterated that ‘clinical drug trials of other research involving patients or volunteers’ in India should follow the ICMR guidelines. The MCI itself has sufficient powers to prosecute ‘misconduct’. Clearly, want of regulations is not the primary reason for the rampant unethical research in India.

The problem is the lack of capacity to enforce existing provisions. Once the Drug Controller gives its permission for a particular trial, little is known thereafter of the outcome or the process. It appears to have little knowledge of or oversight over the activities of private labs that have mushroomed of late, nothing to speak of trials done without the regulator’s sanction. The latter are almost always organisations driven solely by the profit motive and would, therefore, be more than willing to cut corners while getting research done.

Indeed, while the low cost of research in India is certainly an attraction, the near absence of any accountability could actually be more the reason why clinical research is increasingly being outsourced to India. A poor, ignorant population, which has little recourse to grievance redress is ideal for research that cannot possibly receive sanction in more advanced countries. Therefore, any regulatory overhaul must focus on enforcement through appropriate monitoring and prescribe severe deterrent punishment. India has benefited from research done elsewhere and should contribute its bit in further developments but only under acceptable safeguards.