Govt forms panel to look into irregularities in passing new drugs

New Delhi: Taking serious note of a Parliamentary Standing Committee report on functioning of Central Drugs Standard Control Organisation (CDSCO), Health and Family Welfare Minister Ghulam Nabi Azad on Friday constituted a panel of experts to look into irregularities in passing new drugs.

The three-member Committee of experts comprising Director General ICMR V M Katoch, President of National Brain Research Centre, Department of Biotechnology, Manesar P N Tandon and former Director of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, S S Aggarwal, has been asked to submit its report within two months.

The Committee has been asked to examine the validity of the scientific and statutory basis adopted for approval of new drugs without conducting clinical trials, outline appropriate measures to bring about systemic improvements in processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO.

The report has pointed out serious irregularities and serious lapses in clearing new drugs in the grant of approval to new drugs without conducting clinical trials in India.

It also pointed out to a collusive nexus between drug manufacturers, officials of Drugs Control Organisation and medical experts in granting approvals to new drugs and said drugs banned, discarded or withdrawn in developed countries are in circulation in India.

The Parliamentary Standing Committee Report has made recommendations and observations on various aspects such as organisational structure and strength of CDSCO, approval of new drugs, banning of drugs, approval of fixed dose combinations, pharmacovigilance and spurious/sub-standard drugs.

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 constituted to evaluate clinical trial proposals.

He said these committees consist of leading experts from central and state government medical institutions.

The Minister 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.

It also provides for a procedure for payment of financial compensation; enhancement of responsibilities of Ethics Committee (EC), sponsor & investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths and such information is provided to Drug Controller General of India (DCGI).

Azad said amendment of the format for obtaining informed consent of trial subjects to include their socio-economic status and see that in all clinical trials, permission for which have been granted by the office of DCG(I) on or after June 15, 2009, have to be mandatorily registered on the clinical trial registry of Indian Council of Medical Research (ICMR).

CDSCO has also issued guidelines for conducting inspection of clinical trial sites and Sponsor/Clinical Research Organisations (CROs), he said.