Thaindian News

New Delhi, Feb 6 (IANS) The Supreme Court Monday issued notice to the central government on a plea seeking investigation into illegal and unethical clinical trials of new drugs which are yet to be introduced in the country. The petition sought to describe it as a scam.

Notice has also been issued to health and family welfare ministry, the Drug Controller-General of India, the Central Drugs Standard Control Organisation, the Medical Council of India and the Madhya Pradesh government.

An apex court bench of Justice R.M. Lodha and Justice H.L. Gokhale issued notice on a plea by Madhya Pradesh-based NGO Swasthya Adhikar Manch alleging that in a large number of cases MNCs were using contract research organisations for carrying out clinical trials of their drugs which were yet to be introduced in the country.

The central government has been asked to respond to the notice within six weeks.

Senior counsel Sanjay Parekh, appearing for the NGO, alleged that as a consequence of these illegal clinical trials, 1,727 patients have died in four years between 2007-10.

“These organisations are created by MNCs and they outsource to these organisations the task of obtaining consent for conducting clinical trials,” Parikh told the court, adding that “all these MNCs operate through these committees”.

“Your grievance is inadequate statutory regime and you have objection to the implementation,” Justice Lodha said.

Parekh said “we don’t have rules and regulations” and “we have corruption”.

The petition said that the illegal and unethical clinical trials were being conducted on adults, children and even mentally ill people in India “because these trials are not allowed outside India or because such trials are cost prohibitive”.

“The poor, illiterate and vulnerable sections of society become subjects of these illegal clinical trials. In conducting these trials, the doctors, with the sole aim of making money, grossly compromise with ethical medical practices,” the petition said.

“These trials are conducted without regard to the consent of the subjects (patients), despite apparent conflicts of interest. The petitioners submit that the manner in which these trials are conducted is grossly illegal and violative of Article 21 of the Constitution,” the petition read.

The petition said: “The inaction of the government in not banning/restricting these clinical trials is violative of Article 14 of the constitution.”

Regretting the inaction of the government on “extremely important and sensitive issue”, the petition said: “There has been rampant compromise with human life and the entire episode demonstrates a sordid nexus, which is nothing but a scam.”

“That the world-over the subject of clinical trials is considered to be an important ethical issue as it not only touches animal life, but the welfare of human beings and their rights,” the petition said.