In a PIL raising the issue of multinational pharmaceutical companies picking up poor people in India as “guinea pigs” for clinical drug trials, the Union informed the Supreme Court today that the Drugs and Clinical Trial Rules, 2019 substantially address the concerns of the petitioners and the matter has become infructuous.
The matter was before a bench of Justices Hrishikesh Roy and SVN Bhatti which, in view of Senior Advocate Sanjay Parikh’s (for petitioners) request for time to file submissions regarding the developments by way of notification of the 2019 Rules, listed the matter after 4 weeks.
At the outset of the hearing, Additional Solicitor General Archana Pathak Dave submitted that the PIL was filed way back in 2012 as there was a vacuum at the time in the clinical drugs trial process. However, since then, the 2019 Rules have been notified, which address the petitioners’ concerns and as such, the matter has become infructuous. The ASG further stated that public objections to the 2019 Rules were duly invited, following which the petitioners also gave gave suggestions and the same were taken into account. She informed that an amendment to the 2019 Rules was also made in 2024.
Parikh, on the other hand, contended that despite the 2019 Rules, a number of issues survive, including those related to investigators, compensation in the case of death or injury, picking up of poor persons as subjects for the trials, etc. It was alleged that in over 40,000 cases of serious injury, no compensation has been paid.
Senior Advocate Karuna Nundy also appeared in the matter, representing 5 organizations of victims of the Bhopal Gas Tragedy. Urging that submissions have been filed regarding clinical trials done by multinational companies on the victims of the disaster, she said, “there have been number of deaths and no investigation”. The senior counsel requested that the matter be listed for arguments on one of the prayers in the application(s).
In response, Justice Roy said, “we expect the response to come to us, and not in piecemeal manner that the matter be placed for arguments…in reality, clinical trials are conducted in poorer countries…if you also have a response to be made, you can do so or join Mr Parikh…”.
At this point, Parikh, who is also representing 2 organizations of victims of Bhopal Gas Tragedy, said that he would be making submissions with regard to the Bhopal Gas Tragedy victims as well as the Bivalent Human PapillomaVirus (HPV) vaccine trials in Andhra Pradesh.
Background
The PIL was filed in 2012 by NGO Swasthya Adhikar Manch (Indore) alleging that clinical trials by several pharmaceutical companies were going on indiscriminately in various states.
In 2013, a bench of Justices RM Lodha and SK Singh said that no trial of new drugs were to be allowed until consent of people subjected to the trial was recorded in audio/visual medium.
Observing that the clinical trials in the country ought to be for the help of people in India and not for the benefit of multinational companies, the Court allowed trial for five entities but refused to pass order on 157 drugs which were allowed by the Centre. Further, it was ordered that the technical and apex committees set up by the Centre must clear clinical trials for the 157 drugs with amendments to the Drugs and Cosmetics Act after earlier directions of the Court. Directions were also issued to the government to appoint a panel of investigators for investigating the cases of clinical trials.
In addition to the above, the bench expressed immense discontent against multinational companies conducting trials in India by not following the spirit of the law and criticized the Centre for not able to curb such practices which caused deaths. Observing these loopholes, the court ordered that all drug trials shall take place under the supervision of the Union Health Secretary. It further ordered that the technical and apex committees shall keep in view all relevant aspects of clinical trials and efficacy data, assessment of risk, benefits to patients, existing therapeutic options, and medical needs of the country.
In 2019, the Union government notified the Drugs and Clinical Trial Rules, 2019 under the aegis of the Drugs and Cosmetics Act, 1940. These rules provide inter-alia for an Ethics Committee, Compensation (in case of death or injury during a clinical trial/bioavailability or bioequivalence studies), etc.
