Clinical trials should be for our benefit, not for MNCs: Court

NEW DELHI, OCT. 21:  

Clinical trials in the country must be to help the people and must not be allowed for the benefit of multinational companies, the Supreme Court said on Monday, while holding that the norms formulated by the Centre are “deficient” in protecting the people’s rights.

While allowing trials for five entities, the apex court said no trial of new drugs will be allowed till the consent of people being subjected to the trial is recorded in audio/visual form. The Court refused to pass an order on 157 drugs that were allowed by the Centre.

“The norms themselves are deficient and cannot ensure that untoward incidents do not take place. You (the Centre) should have a balanced approach and you cannot take a one-sided view. The regime must be fool-proof,” a bench headed by Justice R.M. Lodha said.

It ordered that clinical trials for the 157 drugs must be cleared by the technical and apex committees set up by the Centre for this purpose.

Not Guinea pigs

The court was hearing PILs filed by a doctor, Anand Rai, and an NGO, Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms using Indian citizens as guinea-pigs. The Bench directed the committees to evaluate applications for clinical trials of drugs and take decisions by assessing the risk and benefit aspects and the people’s medical needs.

“In light of the above, it is not possible to pass an order regarding the 157 drugs. It can be considered only after the reports of the technical and apex committees are submitted,” the Bench said, adding: “With regard to five cases the trial is permitted.”

Investigators

The Bench also said the government should appoint a panel of investigators to probe cases of clinical trials.

“How to ensure that the rights of people who are subjected to clinical trial are not jeopardised? What is the mechanism in place to protect their lives and avoid serious side-effects?” the Bench asked the Centre.

Additional Solicitor-General Siddharth Luthra submitted that the Centre is committed to putting in place a proper mechanism and the law has to be amended for the purpose; this is under consideration.