India’s clinical trial/research market worth over $500 million is finally going to be regulated by the government. I must say, this is a much sought out relief for the thousands of people enrolled in clinical trials across the nation. However, it took 2,242 clinical trial deaths in the recent five years, for the government to have taken cognizance of the fact and plan to regulate the sector by changing drug laws – make lapses by pharma MNCs punishable, increase compensation, lay down new guidelines for pharma companies, among others.
It came as a surprise that a country that boasts of being the largest democracy in the world did not, until now, have any rules governing or regulating the clinical drug trials sector! The judiciary to the rescue again… slamming the government for its callousness and nonchalant way of handling the ‘racket’ that has killed people, the Supreme Court has ordered all drug trials to be conducted under the supervision of the Union Health Secretary.
Of course, in a country where majority of the population pays from the pocket for healthcare and with 35% living below poverty line, India’s poor do stand to gain by the trials but the issue is that many clinical trials aren’t conducted ethically. The compensation meted out for deaths during trials have been as low as $900! There are serious lapses in the ethical committees required by law for each trial and regulations to govern contract research organizations (CROs) are almost non-existent.
The new rules are aimed at regulating the clinical trial sector by putting specific responsibility on investigators and sponsors of drug trials and making them accountable under the law. There would also be provisions for prescribing higher compensations in cases of serious adverse events like deaths. With the intervention of the Supreme Court, the Health Ministry has been forced to get its act together. Government is planning setting up independent ethics committees under medical institutes to monitor ongoing drug trials in India.
The introduction of patent protection laws in India in 2005, coupled with the US Food and Drug Administrations’ (FDA) relaxation of regulations allowing drug companies to submit results of foreign trials in applications for new drugs to be marketed in the US, were the two important factors that made India a global hub for clinical trials.
India was not any other middle-income country…it had a large diverse genetic pool, highly trained clinicians, high-quality hospitals, English-speaking staff and low costs – an attractive destination for pharma firms looking for conducting clinical trials. According to the Central Drug Standard Control Organization (CDSCO), an estimated 150,000 people are enrolled in clinical trials in India and a 2011 report of the Associated Chambers of Commerce and Industry of India (Assocham) claim that the over 100 domestic and multinational pharmaceutical companies conduct clinical trials in the country and the business is worth $ 500 million.
Pharmas like Bayer, Bristol Myers, Pfizer, Sanofi, Merck, Quintiles, Wyeth conduct plenty of drug trials in India would now have to shell out more and adhere to the new rules and regulations for continuing trials here.