Given its population size, India is a huge market for pharmaceutical giants. Hence, it is imperative that any new drug to be marketed in India and undergoing global human trials should have Indian patients to test its efficacy.

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The decision of the technical committee of Drugs Controller General of India (DCGI) — empowered under Supreme Court guidelines — to make it mandatory is a welcome move that protects the interests of consumers. Since most such drugs are manufactured outside the country, pharma giants may not factor in their impact on Indians. 

However, a transparent system of conducting trials, replete with checks and balance, is immensely helpful in India’s resource-challenged healthcare environment. Clinical trials form the basis of evidence-based medicine. For both national and international researchers, India’s population and easy access to an impressive array of treatment of native diseases make it an ideal platform for holding clinical experiments. At the same time, lax regulations were being exploited by pharma giants whose trials led to the death of 2,800 patients between 2005 and 2012. 

The 2009 HPV vaccination controversy had brought to the fore the need for a better compensation structure for trial subjects. Thanks to the public outcry for transparency, a few renowned organisations, including Indian Council of Medical Research (ICMR), UK Medical Research Council and international organisations like PATH and Bill and Melinda Gates Foundation, have decided to make the results of all clinical trials funded and supported by them, public.

The government needs to safeguard the interests of its citizens, especially the poor and those who are least aware of their rights. Big companies rarely display accountability, since for them, profits, and not human lives, are of paramount importance.