New Delhi, Oct. 21: The Supreme today extended its ban on clinical trials of 162 new drugs till December 16 and directed the government to ensure a “foolproof” mechanism for regulating such experiments that use human beings as guinea pigs.
“You should ensure that a foolproof mechanism is in place and the drugs are not cleared for any extraneous considerations. Our apprehensions must be allayed,” Justices R.M. Lodha and Shiva Kirti Singh said.
The court, which on September 30 had stayed the trials for two weeks, agreed to hear the matter again on December 16 after additional solicitor-general Sidharth Luthra sought further time to place on record a proper regulatory mechanism and rules for such clinical trials.
Swastya Manch, an NGO, had first moved the court seeking a ban on the trials, saying Indians were being used as guinea pigs by several foreign pharmaceutical companies.
The bench said the government must keep in mind that the drugs are cleared after considering four parameters — the risks involved, benefit to India, their efficacy and unmet medical needs, which refer to the uniqueness of the drug sought to be introduced.
Luthra said the government was keen on coming out with new rules in tune with the recommendations of the Ranjit Roy Chowdhary panel, which had made a series of suggestions to ensure proper ethical standards for conducting trials.
The additional solicitor-general also informed the court that the technical committee of the Indian Council for Medical Research (ICMR) had approved five of the 162 drugs.
Luthra said the Chowdhary panel had, among other things, suggested that it was necessary to ensure that the consent of patients or guardians for drug trials was obtained in front of independent witnesses. He said the process would be video-graphed for which rules have to be amended.
“We are only concerned about the safety of the subjects. If the trials are conductedů it has to be ensured that lives are not put in jeopardy. You have to ensure both privacy and transparency. Presently, the norms are deficient and there are no proper rules,” Justice Lodha, who was heading the bench, observed.
Counsel Sanjay Parekh, who appeared for one of the NGOs that had moved the court seeking a ban on the trials, said “clinical investigators” appointed for the experiments were being paid by private companies and hence vulnerable to influence.
The bench then suggested that the government empanel the “clinical investigators” to eliminate the possibility of “extraneous” considerations.
Senior counsel Colin Gonzalves, who appeared for another NGO, said a standing committee of Parliament had given three damning reports, the latest on August 13, expressing concern over the trials that it wanted stopped unless a proper regulatory mechanism was in place.
On September 30, the apex court had banned for two weeks clinical trials of these 162 new drugs so that the Union government could place on record the report of the ICMR expert committee that had come out with specific guidelines.
A bench headed by Justice Lodha had wanted to pass a written order, but granted the government two weeks after Luthra gave an undertaking that he would place the guidelines on record. Till then, the court said, no clinical trials of these drugs could be conducted.
At an earlier hearing on January 3, the court had slammed the government for indiscriminate grant of permission to MNCs and pharma companies to conduct clinical trials.
It regretted that though a parliamentary committee had indicted the government and its authorities in July 2012 for permitting indiscriminate trials, no step had been taken to prevent the “racket involving MNCs and pharma companies” from exploiting Indians.