NEW DELHI: Acting swiftly on the stinging criticism by a Parliamentary panel on the way new drugs are approved in the country without clinical trials, health and family welfare minister Ghulam Nabi Azad on Friday set up a three-member expert panel to probe the allegations and to recommend ways to improve the drug regulator’s functioning.
The panel comprises director General of ICMR VM Katoch, president of the National Brain Research Centre, department of Biotechnology, Manesar, PN Tandon and former director of Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow, SS Aggarwal. The panel has been given two months to report its findings.
The expert panel has been told to study the validity of the scientific and statutory basis adopted for approval of new drugs without conducting clinical trials. Indian drug authorities have been clearing new drugs, which are approved in the West, relying on the judgment and the expertise of the regulators in developed countries like theUS.
The Parliamentary panel alleged serious irregularities and lapses in clearing new drugs without conducting clinical trials in India. The parliamentary report alleged collusion between officials of the Central Drugs Standard Control Organisation (CDSCO), which oversees the licensing, marketing and trials of new drugs in India, and pharmaceutical firms. It also said the agency was chronically understaffed and lacked both expertise and high-tech laboratories to fulfill its growing responsibilities.
In reply to a written question in Lok Sabha on strengthening regulation and monitoring of clinical trials, Azad said 12 new Drug Advisory Committees (NDACs) and six Medical Device Advisory Committees (MDACs) have been set up to evaluate clinical trial proposals.
Azad also said a draft notification has been issued for incorporation of a new rule in the Drugs & Cosmetics Rules, 1945, which provides for medical treatment and financial compensation to trial subjects in case of trial related injury or death.
Terms of reference
* The panel told to examine the validity of the scientific and statutory basis adopted for approval of new drugs without conducting clinical trials
* The committee will also outline appropriate measures to bring about systemic improvements in processing and grant of statutory approvals
* The committee will finally suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO
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