Supreme Court wants more clarity on clinical trials

Business Standard: New Delhi: Tuesday, April 22, 2014.

The Supreme Court on Monday directed the Union health ministry to make drug companies that  want to experiment with new formulations answer three queries in a format to be prepared by the technical committee.

The pharmaceutical companies must specify whether the risk involved in testing the new formulations on human beings is justified by the benefits expected from the exercise, whether there are unmet needs for the drug in this country necessitating the innovation and whether safer are methods available.

The court stated that by demanding responses on these three parameters, a lot of confusion can be obviated. The Bench headed by Justice R M Lodha gave two months’ time to the government to follow the order.

The order was passed in the public interest petition moved by Swasthya Adhikar Manch alleging deaths and injuries to poor people in Madhya Pradesh, where unmonitored experiments were allegedly organised on without getting informed consent from the subjects.

Counsel Sanjay Parikh mentioned a news report in which it was alleged that 254 persons died in 15 years in US-funded clinical trials conducted on a control group without screening.

While the government objected to mentions of news reports, the court allowed Parikh to file an application including the report, which will be considered in the next hearing.

When Parikh alleged that neither the government nor the sponsors gave compensation for the deaths and permanent injuries, the judges suggested that the compensation could be paid first by the government and it could be recovered from the companies. Victims could be informed about compensation rights through ads or opening an office where they can record their claims.

Parikh argued that in the past few years, there were 125 deaths resulting from experiments with one chemical alone and compensation was given only for five deaths. Adequate information regarding compensation to the death and injury cases was not coming forth and there were inconsistencies in what the government stated in the court and what was available from right to information queries.

Additional Solicitor- General Siddharth Luthra said committees have been constituted to look into the claims for compensation. When it was pointed out that years have gone by without any decision, the counsel explained that the government had to see whether the victims have already availed of insurance benefits and assess the actual degree of damage suffered in each case.

He said those who suffered injuries are given treatment. The judges observed that sometimes deaths would be preferred then continue with the suffering.