SC concerned over clinical trials of drugs, seeks details

The Supreme Court on Monday expressed concern over the lives of people who, without their knowledge, were subjected to drug clinical trials by pharma companies and sought details of the number of such trials and the deaths and adverse reactions caused by them over the last seven years.

“We are concerned with the lives of those who become subjects of clinical trials unknowingly and helplessly,” ta bench of Justices R M lodha and A R Dave said, seeking from the Centre details of clinical trials from June 1, 2005 till June 30 this year, across the country. The bench also wanted to know if any compensation was paid to the victims of such trials.

It was hearing a public interest litigation (PIL) filed by NGO Swasthya Adhikar Manch alleging large-scale illegal clinical trials without the knowledge and consent of people.
The bench issued notice to all state governments, except Madhya Pradesh, and all union territories to file an affidavit if any clinical trial was being conducted in their areas.

The judges had already issued a notice to Madhya Pradesh as the petition filed by Indore-based NGO had pointed out such illegal trials with new chemical entities which could not even be termed as drug.

Without passing any formal order, the court said, “all these malpractices which affect many people should stop forthwith. Why should not immediate steps be taken to stop the chemical trials,” the court asked.

The court asked Union Ministry of Health and Family Welfare and others, including Central Drugs Standard Control Organisation (CDSCO), to file their response in the matter.
Senior counsel Sanjay R Parikh, appearing for the NGO, submitted that new chemical entities were being tried on people by different pharmaceutical companies in collusion with the authorities. He alleged that such tests were conducted in Madhya Pradesh, Maharashtra and Andhra Pradesh, besides other places.

Role of DCGI

The court then asked Additional Solicitor General Siddharth Luthra, appearing for Ministry of Health, for details of the extent of power vested in the Drug Controller General of India (DCGI) and the role of central government and rules framed for the purpose of giving approval for clinical trials.

“Systems are put in place but not being adhered to. If there is true adherence, no petition would have been filed,” the court observed.

Senior advocate Dushyant Dave, appearing for MP, said the state authorities were not taken into confidence as the doctors employed by the state hospitals indulged in clinical trials at the instance of central authorities. He also claimed that the state government had taken action against the erring doctors.

The matter was posted for further hearing after eight weeks. According to the NGO, clinical trials, in particular after 2005 amendment to the Drugs and Cosmetic Rules 1945, have been conducted using India as a soft target and the citizens as guinea pigs.

“No record is maintained by Madhya Pradesh with regard to deaths which  have taken place from January 2005 to December 2006. As per available information, from 2007 to June 2012, 2,374 deaths have taken place due to  clinical trials, some as young as in their 30’s dying. Drug companies, investigators employed by drug companies and Ethics Committees have, however, claimed that only 37 died due to drug trials,” it said.