SC stops approval of new clinical trials until regulatory outline is positioned


The Indian Supreme Court has prohibited clinical trials of new drugs until a proper monitoring mechanism is put in place. The court made the decision on 30 September in response to a petition filed by an Indore and Pune based health activist group, Swasthya Adhikar Manch. 


The group said that the court had given the government 10 weeks to “come out with the actual implementation of the suggestions given by state government, National Human Rights Commission, petitioner and NGOs to strengthen the regulatory framework of clinical trials in the country.” 


Amulya Nidhi, a representative at the Swasthya Adhikar Manch, told the BMJ, “Between 3 July 2013 and 31 August 2013, 162 applications regarding global clinical trials including new chemical entities and new molecular entities have been approved by the drug controller general of India.


“It is risky to approve such a large number of clinical trials in such a short period, and this speedy approval reflects that the Indian government is not pursuing proper norms to monitor clinical trials in this country.”


He added, “A bench in the Supreme Court headed by justice RM Lodha has asked the government to submit all data related to the approved 162 clinical trials to review in two weeks.”


Professionals and experts believe that the Supreme Court’s decision may protect Indian people from unethical drug and vaccine trials, and may adversely affect foreign pharmaceutical companies that have used India as a cost effective place for clinical trials. It follows a controversy in India over a trial of a vaccine for human papillomavirus (HPV).


Swapan Jana, secretary of the Kolkata based Society of Social Pharmacology, said that he thought the Supreme Court’s decision might stop incidences like the HPV vaccine trial in future. He added, “The unethical HPV vaccine trial on 14 091 girls in Khammam (Andhra Pradesh) and 10 686 girls in Vadodra (Gujarat) led to the death of seven girls in 2009-2010, and that trial involved Indian and international organisations, including two international pharmaceutical companies.”


Karan Thakkar, a specialist in clinical pharmacology and therapeutics at the Grant Medical College and Sir JJ Group of Hospitals in Mumbai, told the BMJ, “Even before the Supreme Court’s decision, with the recent state of events, such as the US FDA’s [Food and Drug Administration] action [telling some pharmaceutical firms about concerns noted during factory inspections] most foreign pharmaceutical companies must have been reconsidering conducting trials and setting up base in India, and the Supreme Court’s decision will further add to their concern until something positive comes out.


“However, with the Supreme Court’s decision, many Indian companies manufacturing generics and ‘me too’ drugs will be adversely affected in the short term; but in the long term there is much to gain in the form of better safety and a refined trustworthy approach to conducting trials.”


Although the Supreme Court’s ruling will not apply to drugs that have already been approved for use abroad, and for which companies now want approval in India, it appears that the ruling will put up the costs of trials because it is likely to lead to more stringent regulatory requirements.