New Delhi: Acting on a Public Interest Litigation (PIL) filed against the illegal clinical trials of untested drugs on the people; the Supreme Court has issued a notice to the Central government and Medical Council of India to reply in six week’s time.

Appearing for the petitioners, advocate Sanjay Parekh said, “It is a critical matter, thousands of deaths have been recorded due to illegal clinical trials. But the matter has been ignored.”

A bench of justices RM Lodha and HL Gokhale after hearing the arguments issued a notice to the Central government, Health Ministry and Medical Council of India seeking their replies on the matter. The petition has been filed by a NGO Swasthya Adhikar Manch which sought appointment of a committee to monitor the clinical trials done by many MNCs in India.

While stressing the need for strict laws on clinical researches, Parekh said, “The multinational medicine companies carry out the research work on contract basis. During research the rules are not followed. These illegal clinical trials are carried out on poor people. So far 1727 people have died during illegal clinical trials throughout the country.”

Dismissing the appeal for the formation of a committee by the petitioner, the Bench said, “Only after the government’s reply on the petition, further orders will be released.”

Reacting on the Supreme Court’s order, Central Health Minister Ghulam Nabi Azad said, “Clinical trials should be done in the interest of the people.”

Concerns over illegal clinical trials raised in the past

The recent case filed is not the first time that issue of illegal clinical trials have been raised in India, time and again  different organisations and independent bodies have appealed for formation of strict laws and establishment of parameters which could control such trials.

In the last few years many cases have been recorded where poor patients have fall victims to illegal clinical trials. After the leniency in the clinical trial laws in the year 2005 in India, foreign companies showed great interest of carrying out their research here. But with the change in laws there was no formation of a structure which could monitor such trials.
The study done by the state government in Indore in June 2010 revealed that the illegal clinical trials conducted in Indore alone involved 3307 people of which 81 were reported dead. The study found that there has been a non-enforcement of the laws and directives of the trials were often violated. Many of the researchers who conducted trials were found to be the members of the ethical committee.

The laws of the clinical trials formed in 1945 were revised in January 2005. The revised law made the first and the second phase research easy therefore creating interest amongst the medicine and drug companies to invest in clinical research in India.