New Delhi, Apr 21 (PTI) The Supreme Court asked an NGO on Tuesday to file composite documents detailing alleged shortcomings in the 2024 rules that were framed to streamline the approval process for clinical trials of vaccines and new medicines in the country.
A bench of Justices P S Narasimha and Alok Aradhe was hearing a public interest litigation (PIL) matter filed by NGO Swasthya Adhikar Manch in 2012, alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms.
Citing inadequate safety provisions, the PIL has alleged that poor citizens are still being used as “guinea pigs” and not paid adequate compensation.
Senior advocate Sanjay Parikh, appearing in the court for the NGO, said there is a lack of a proper procedure for the “enrolment of subjects” for clinical trials of drugs.
The senior lawyer said almost 8,000 deaths have taken place during clinical trials and several dependents of the victims have not got adequate compensation.
Parikh said he is not challenging the New Drugs and Clinical Trials (Amendment) Rules. But there are several gaps in those that need to be addressed, he added.
The bench asked Parikh and other lawyers to file composite documents about the steps taken so far and the shortcomings in the rules, and fixed the plea for consideration on April 27.
Earlier, the court had said clinical trials of medicines and vaccines are often carried out in poor countries.
The Centre had said the rules for new drugs and clinical trials were framed in 2019 and notified in 2024.
It had said the rules were intended to streamline the approval process for clinical trials and new drugs and aimed at improving patient-safety protocols and ensuring compliance with global standards.
The Centre had said the PIL became infructuous as the rules and amendments were notified in 2019 and 2024 respectively, and nothing remained to be dealt with.
The court had said that clinical trials in India must be for the help of the people of the country and not be allowed for the benefits of multinational companies.
It said norms formulated by the Centre in 2013 were “deficient” to protect the rights of the subjects, following which the new rules were introduced.
The PIL has alleged that clinical drug trials conducted by various pharmaceutical firms take place indiscriminately across states and use poor citizens as guinea pigs. PTI SJK RC
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