The Supreme Court on Thursday asked the secretary in the Union health and family welfare ministry to directly monitor clinical trials of drugs on humans to ensure the statutory procedures are followed. The apex court, dissatisfied with the monitoring by the Directorate General of Health Services, has asked the secretary to vet all applications for trials from pharmaceutical companies.
A bench, headed by Justice R M Lodha, was hearing a petition moved by the Swasthya Adhikar Manch of Indore, alleging trials without the knowledge of the patients. The judges said unregulated clinical trials of new drugs were causing havoc in the country. The trials are conducted in state government hospitals, whose employees and doctors were under the control of the respective state governments.
The court sought a comprehensive reply from a high official in the central ministry within eight weeks. It issued notices to all states, through their chief secretaries.
When the government counsel submitted that a committee was going into the issue, the judges said appointment of committees and commissions was only to divert the attention from the main issue. “We gave opportunities after opportunities, but people are still dying, there has been no improvement,” the court observed.
While the petitioner organisation alleged that there were close to 12,000 trials, leading to 560 deaths, the government said there were only 80 deaths. The judges intervened to say it was not a question of numbers, but whether the experiments are necessary and whether the country benefited from such exercise. They said the government was shying away from its responsibility in a serious matter. Patients are being treated as guinea pigs.
According to the petition, moved by a public interest organisation with doctors as members, low costs, weak laws and inadequate enforcement have made this country an attractive destination for the tests.