New Delhi: The Supreme Court on Thursday frowned on the government’s failure to halt unethical clinical trials by multinational drug companies on Indian patients who were used as “guinea pigs”.
Referring to a May 2012 report of the Parliamentary Standing Committee on health and family welfare, judges R M Lodha and Anil R Dave said “it really pains us that illiterate people and children of India are being used as guinea pigs by the multinational drug companies.
“We want to know why the government of India is shying away from its responsibility?” the court asked.
“We want you to arrest this trend. It appears that the drug controller is a misnomer. If it can’t do it, who will do it?”
The court was hearing a public interest litigation (PIL) by a Madhya Pradesh-based NGO Swasthya Adhikar Manch, which alleged that clinical trials were being conducted in the state without the knowledge of the patients.
Slamming the casualness with which the Central Drugs Standard Control Organisation (CDSCO) was discharging its responsibilities, the court directed that until further orders, all clinical trials would be conducted “strictly in accordance with the procedure under the direct supervision of secretary, ministry of health and family welfare”.
Justice Lodha said the question was the “implementation and enforcement of the law”.
The court said this when Additional Solicitor General Sidharth Luthra sought to persuade the court that the CDSCO was carrying out its mandate in regulating the clinical trials of the chemical entities by the drug manufacturers.
The court asked Luthra what steps had been taken by the CDSCO after its indictment by the Parliamentary Standing Committee.
Taking note of the parliamentary panel saying that the CDSCO was highly deficient in its working, the court said: “We have to change the mindset.”
“You have slipped into deep slumber and did nothing for the last seven months (since the May 2012 Standing Committee report).
“You have no respect for the parliamentary committee. Do you need court’s orders to frame draft rules?” asked Justice Lodha.
As the court was told that there were ethics committees overseeing the field trials, senior counsel Colin Gonsalves, appearing for the petitioner, told the court that these committees were manned by government doctors and their colleagues were engaged in clinical trials.
The court also issued notice to the central government and the Madhya Pradesh government on an application by NGO Bhopal Gas Peedit seeking “full details” of the clinical trials conducted by the Bhopal Memorial Hospital and Research Centre on victims of the Bhopal gas tragedy.
The application mentioned by senior counsel Sanjay Parikh sought initiation of civil and criminal proceedings against all those involved in the clinical trials and payment of compensation to the victims. [Source: IANS]