The Supreme Court today directed that the secretary in the Union Health and Family Welfare Ministry should directly monitor clinical trials of drugs on humans to ensure that the statutory procedures are followed. The court expressed dissatisfaction with the monitoring by the Director General of Health Services (DGHS). Therefore, the secretary has been asked to vet all applications for trials from pharmaceutical companies.
A Bench headed by Justice RM Lodha was hearing a petition moved by 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 governments’ 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 the states, through their chief secretaries.
When the government counsel submitted that a committee is going into the issue, the judges said that 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 that there were only 80 deaths. The judges intervened to say that 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.
