New Delhi, Jan. 3: The Supreme Court today pulled up the government for letting multinational companies conduct clinical drug trials using Indian citizens as “guinea pigs”, saying such indiscriminate tests that had led to several deaths were creating havoc.
The two-judge bench also questioned the need for trials that were of “no use” to the country as it brushed aside the Centre’s claims that ongoing trials were being scrutinised by ethics committees, saying such panels were mostly a ploy to “divert attention” from the real issue.
Justices R.M. Lodha and A.R. Dave regretted that no step had been taken to prevent the “racket involving MNCs and pharma companies”, although a parliamentary committee had in July 2012 indicted the government for permitting such “uncontrolled” trials.
The bench wanted to stay all drug trials but relented after additional solicitor-general Siddharth Luthra gave an undertaking that the secretary in the ministry of health and family welfare would personally monitor them.
“It appears the Drug Control Authority is only a misnomer…. We do not want trials which are of no use to the country. Particularly when people are dying,” the bench said.
The Telegraph had in November carried a report where an Indian pharmacology expert had questioned a decision to approve an MNC-managed trial of a blood-thinner, saying it showed the country’s lax regulatory watchdogs were allowing foreign companies to use Indians as guinea pigs.
The rap on the government’s knuckles today came as the court resumed hearing on a public interest petition by the NGO Swasthya Adhikar Manch, which had sought a stay on all clinical trials of new “chemical entities” on the ground that they were being tested for export to different parts of the world.
Luthra’s admission that 87 people had died irked the court further. “You say only 87 people have died. As if their lives are not important,” the bench rasped.
Another earful followed when the law officer claimed trials are conducted under the supervision of specially constituted ethics panels. “We don’t believe in these committees. They are set up just to divert the attention…” the court said.
“You are treating this petition as an adversarial litigation when unfortunately people are dying. We want to know why the government is shying away from the responsibility (of stopping the racket).”
The court said the government had scant respect for even the findings of the parliamentary committee, which had described the procedure adopted for the trials as “highly deficient” and stated that 90 per cent of the regulatory mechanism did not meet the requirements.
“The committee had clearly stated that the authorities had been ‘persistently insolent’. You have not taken any action,” the bench said.
“The parliamentary committee had given its report in July 2012. Tell us what have you have done on the report. You have slipped into a deep slumber,” the bench said.
“…It really pains us. The parliamentary committee has said that the people are being used as guinea pigs.”
The court asked the health secretary to file within four weeks an affidavit on different aspects concerning clinical trials of new chemical entities and issued notices to all states and Union territories to submit status reports on ongoing trials.