With uncertainty looming over the fate of global clinical trials in India, the government has informed the Supreme Court that it has approved 76 clinical trials after re-examining them under the new regulatory regime and complying with the court orders on the issues of safety of the subjects and their benefits to India.
Out of these 76 cases of global clinical trials involving new pharmaceutical compounds, 64 trials are ongoing while 12 are yet to begin. The Technical Committee and the Apex Committee, entrusted with evaluation of clinical trials, have however suspended two other clinical trials, relating to patients with advanced HIV diseases. These two cases failed the test of assessment of risk versus benefit to the patients.
Clinical trial permissions have been in lurch for months after the court last stalled the authorities’ nod for 157 global clinical trials. Besides these 76 approved cases, others are either suspended, withdrawn or already completed.
A bench led by Chief Justice of India R M Lodha had earlier ruled for an additional triple-test for all global clinical trials and especially for cases involving new chemical entities. It had directed the government to ensure that three parameters — “assessment of risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical need in the country” — are followed before approval for any global clinical trial.
“To obviate any controversy in future in this regard, we direct that henceforth in the format seeking information from the applicants, three specific columns regarding the above parameters shall be inserted for the purpose of New Clinical Entities/Global Clinical Trials,” it had added.
The court order had come in the wake of its concerns over authorities’ seriousness in abiding with the stringent safety norms in clinical trial cases. The Centre had earlier disclosed that at least 80 people died due to clinical trials in the last seven years. The PIL, filed by NGO Swasthya Adhikar Manch, comes up for hearing on Monday.