ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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On Trial and Found Wanting

The government must act effectively, not hastily, to regulate the clinical trial industry.

India has steadily become a popular destination for clinical trials of drugs by multinational pharmaceutical companies even as health activists have warned of poor and ignorant patients being taken for granted by many middlemen and contract research organisations (CROs – local entities conducting the research on behalf of the companies). Not only that, the controversies over the actual number of deaths from the trials along with cases of serious adverse events, the use of cervical-cancer vaccines on tribal girls in Andhra Pradesh and Gujarat, and trials on mentally-ill patients have created an atmosphere of distrust and non-transparency. The Indian clinical trials industry is estimated to be worth $400 million and trends suggest it will only grow from there. Considering all these factors, the government had ample time and reason to fashion a strong regulatory mechanism to protect its citizens who are the subject patients and ensure that all norms were followed stringently by the CROs and the pharma industry.

As usual, the government has been found wanting and in its absence the Supreme Court (SC), in response to a public interest litigation (PIL) filed by the Swasthya Adhikar Manch, has banned all clinical trials for new drugs on humans until a monitoring mechanism is set up. This means that the central government will have to withdraw permission already granted for clinical trials of 162 drugs. A great deal now depends on how soon the government acts and most importantly, how effectively the monitoring is implemented. As is well known, it is this last factor that is pivotal in this country in almost all sectors.

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