Union Health Minister Ghulam Nabi Azad on Wednesday admitted that the recent Supreme Court ruling on, and stringent regulations for, clinical trials had set drugs research back in India. But he was hopeful that the sector would gather pace again.
“We received a setback because not many pharmaceutical companies are coming forward for clinical trials now. There has been a 50 per cent drop in clinical trials after stringent regulations were put in place, but we are hopeful that they will pick up in the coming days,” he told The Hindu .
The changes were meant to protect the national interest and to do justice to those who participated in the trials, he said.
The Ministry has laid down tough rules to make companies liable for the death of, or injury to, any drug trial subject. Even permission for such trials is given after a rigorous process. Simultaneously, the Supreme Court suspended 157 previously approved trials pending review by new committees. This slowed down new trials, especially those by foreign companies or those being lined up with foreign collaboration.
The Supreme Court’s order came in response to a public interest litigation petition by a health rights group, Swasthya Adhikar Manch, which said trials in India had exploited poor patients, who were not even aware that the drugs were still being tested.
India made sweeping changes to the rules of the Drugs and Cosmetics Act, 1940, which governs clinical trials, making it mandatory for the principal investigator of the pharmaceutical company to reveal the contract between the subject and the company to the Drugs Controller-General of India. “Earlier, the informed consent of the persons on which the trials had been conducted was often manipulated by the companies to the disadvantage of the subjects,” Mr. Azad said.
Videography of the process of informed consent, with the full knowledge of the participant, had been made mandatory, and any death during a trial would have to be reported to the DCGI within 24 hours, he said.
The Drug Testing Advisory Board was the only body for granting permission for trials.
