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.
