The Supreme Court has directed that until further orders all clinical trials on drugs will have to be conducted under the direct supervision of the Union Health Secretary to prevent illegal trials by pharmaceutical companies.
A Bench of Justices R.M. Lodha and Anil R. Dave expressed serious concern over the menace caused by uncontrolled clinical trial of drugs on humans by multinational companies and pulled up the Centre for failing in its duty to control this menace and putting in place an effective mechanism.
The Bench said the Central Drugs Standard Control Organisation under the Directorate General of Health Services (DGHS) failed to monitor the clinical trials and ensure that they were conducted ethically.
The DGHS should be kept away from monitoring the trials, it said.
Additional Solicitor General (ASG) Sidharth Luthra said the government was ready to entrust the responsibility with the Union Health Secretary.
The Bench was hearing a public interest litigation petition filed by Swasthya Adhikar Manch, an Indore-based NGO, contending that 560 of the 12,000 patients subjected to clinical trials died as a result of the side effects. Disputing this, the ASG put the casualties at 87.
Clarifying that the issue did not relate to just the number of casualties, the Bench wanted to know whether the trials were essential.
Rejecting an affidavit filed by a Deputy Director in DGHS in response to its notice on the PIL plea, the Bench made it clear that the Health Secretary or the DGHS Director General should have filed the document as directed by it. A fresh affidavit should be filed by the Secretary within four weeks.
When the ASG clarified that only patients suffering from serious ailments were being subjected to trials, the Bench said “every human life is precious” and the companies had no business to test their medicines even on sick people.
Justice Lodha drew the attention of the ASG to the report of a parliamentary standing committee submitted to Parliament in May last year and asked “what have you done in the last seven months.”
“The committee pointed out that several multinational companies are involved in the racket and children are being used as guinea pigs. This is something serious. You should have taken steps to stop these illegal trials. What have you done all these months? You have to protect the health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed. You have slipped into deep slumber. The Parliamentary Committee has said that the companies are running a racket and you are showing just draft rules. Uncontrolled clinical trial is creating havoc in country. There has to be some semblance of responsibility on your part.”
When the ASG submitted that the Government had formed a committee to look into the issue, Justice Lodha observed: “It is very easy to form a committee or a commission. It is done just to divert people’s attention on the issue. It is the best way to divert attention on important issues. Give us the performance of even one committee during the last 21 months. We gave you many opportunities. Your officials are not working in a manner they should work. If there is foolproof mechanism then we would not have interfered in the matter.”
The Bench then adjourned the matter for four weeks.