India issues new requirements for clinical trial approval

BMJ 2014; 349 doi: (Published 15 September 2014) Cite this as: BMJ 2014;349:g5648
  1. Sanjeet Bagcchi
  1. 1Kolkata

The Indian government has issued an order with “immediate effect” to researchers, medical institutions, and drug companies about the criteria they must follow to win approval for clinical trials of new drugs.

The order from the drug controller general of India (DCGI), which was issued on 5 September,1 aimed to improve the regulation of clinical trials in the country. It stated that, for new trials to be approved, they must include information on an assessment of the drug’s risks versus benefits to patients, its innovation in relation to existing therapies, and how it fulfils unmet medical needs in India.

The approval criteria were issued as a result of an order by the Supreme Court made in October 2013. The court was responding to a case filed by Swasthya Adhikar Manch, an Indore and Pune based health activist group that has been campaigning to end unethical clinical trials. It filed a petition in 2012 to the Supreme Court, seeking directions on the regulation of clinical trials that involve new drugs and chemical entities. The group also wants to see better monitoring of deaths and of serious and adverse events during clinical trials in India.

Amulya Nidhi, a representative of Swasthya Adhikar Manch, told The BMJ, “The DCGI’s order has come after the order passed by India’s Supreme Court on 21 October 2013, and we demand that this order should be implemented retrospectively from 2005, as most of the deaths and serious adverse events due to clinical trials took place in that period.”

Nidhi also called for the DCGI to make it mandatory for clinical trial applicants to submit all relevant data justifying the approval criteria and to store the data for future inspection. “It is also required that the government should keep strict vigilance on the stakeholders to determine whether they adhere to the three parameters, as specified by the DGCI,” he added.

However, Gopal Dabade, president of Drug Action Forum Karnataka, a non-profit organisation that campaigns for rational drug policies, commented, “While some of these changes are welcome, one needs to have a larger picture as to how relevant [they are] to the needs of this country or to the needs of any developing countries. Are the clinical trials addressing the public health needs of this country?”


Cite this as: BMJ 2014;349:g5648


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