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India’s clinical trial framework needs proper implementation

comment Updated: Apr 23, 2014 12:05 IST
Hindustan Times
clinical trials

The controversy regarding clinical trials in India is far from over. A new chapter was added to the saga on Monday when the Supreme Court pulled up the Union government for not ensuring that foreign pharmaceutical majors compensate those who suffer adverse effects during trials.

The court was hearing a public interest litigation filed by a Pune-based NGO, Swasthya Adhikar Manch, which alleged that many patients in India have been used by pharma giants as “guinea pigs” for clinical trials of new pharmaceutical compounds with not enough emphasis on the safety of patients and whether the compounds being tested on volunteers are needed by India. While the Union health ministry’s lawyer conceded that the ministry had not looked into this aspect and sought time to revert to the apex court with explanations from the ministry, the advocate appearing on behalf of one of the complainants observed that rules had been in place since 2005, mandating payment of compensation to those seriously affected by such trials.

Foreign companies want to conduct clinical trials in India because the country has certain advantages: First, India has a ‘drug naive’ population; second, the costs of doing such an exercise are low and third; there is adequate genetic variation in the population. Activists add a fourth dimension to these arguments: The State’s weakness when it comes to implementing the laws. This allows many companies to quietly do their business without adhering to the norms. Multinationals usually outsource the clinical trial processes to contract research organisations (CROs), which locate volunteers, mediate with them and medical institutions, basically they guide the entire exercise. And herein lies the catch: Many a time, these organisations don’t follow the framework and cut corners, leading to compensation issues and other problems. However, MNCs cannot hide behind the shield provided by the CROs. It is as much as their responsibility as that of the CROs to ensure that the entire process is transparent and the patient does not lose out on anything.

This is an emotive issue but again blaming all drug companies or CROs is not the solution. India’s clinical trial framework is robust and what we need is proper implementation and enough manpower to ensure that the people are not shortchanged.