SME Times News Bureau | 04 Jan, 2013
The Supreme Court
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 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 Peedith 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.