In a bid to regulate the booming clinical trial industry in India, government has set up four committees that will monitor and ensure accountability during such tests that have seen 2,242 deaths in the past five years in the country.
So far, there were no procedures in place to ensure accountability of this hitherto unregulated sector which is worth USD 500 million in India.
An Apex Committee under the Chairmanship of Secretary, Health and Family Welfare, has been formed to recommend new approvals for clinical trials and assist the technical committee to supervise and monitor the conduct of such trials in the country.
The competent authority in granting new licences and for monitoring clinical trials under the Drugs and Cosmetics Act is the Drug Controller General of India (DCGI), who will act on the recommendations of the Apex Committee.
The Apex Committee has Secretary, Department of Health Research and Director General ICMR, V M Katoch and Director General of Health Services Jagdish Prasad as its members and Joint Secretary in the Ministry of Health and Family Welfare A K Panda as its member secretary.
Government has also set up another 15-member technical committee under the chairmanship of DG Health Services Jagdish Prasad, It will comprise of experts that will give its inputs relating to clinical trials to the Apex Committee.
Two separate expert committees will formulate policy guidelines and Standard Operating Practices for approval of new drugs, clinical trials and banning of drugs as recommended by the Parliamentary Standing Committee on Health.
With the mechanism in place, pharma firms conducting clinical trial of drugs in India will no longer be able to get away with meagre and arbitrary payment of compensation in case of injury or death of subjects participating in such trials.
According to Health Ministry data, there have been 2,242 deaths during clinical trials in the past five years in the country.
The Ministry's moves come in the wake of recent Supreme Court's rap where it directed the Health Secretary to monitor all clinical trials saying the Government was in "deep slumber".
Government has already notified rules for grant of compensation in case of Serious Adverse Events (SAEs) like death and injuries on account of participation in clinical trial of drugs.
The other members of the Technical Committee are former member of MCI Board of Governors Ranjit Roy Chaudhury, Medical Superintendent of JIPMER Puducherry Ashok Kumar Das, Vinod Raina of AIIMS in Delhi, Sanjay Tyagi of GB Pant Hospital in Delhi, Jaspal Sharma of PGIMER in Chandigarh, Nikhil Tandon of AIIMS Delhi and Kamlakar Tripathi of Institute of Medical Sciences BHU Varanasi.
Shashank V Parulekar of Seth GS Medical College and KEM Hospital, Mumbai, Debasis Basu of Kolkata Medical College, P K Dalal of CSMU Medical College, Lucknow, Rajutitus Chacko of CMC Vellore, S N Gaur of VP Chest Institute Delhi, P L Sherwal of LHMC and Associated Hospitals Delhi and Nandini Kumar of National Institute of Epidemiology, ICMR Chennai are also members of this Committee.
While the seven-member Expert Committee to formulate policy guidelines and SOPs for approval of new drugs, clinical trials and banning of drugs, will be headed by Ranjit Roy Chaudhury, national professor of Pharmacology and advisor in the Department of Health and Family Welfare, Delhi Government.
The Committee will also monitor the functions of various ethics committees of organisations where clinical trials are held and grant accreditation of clinical trial sites. It will also conduct clinical trial inspections and monitor clinical trials.
The other five-member expert committee under the Chairmanship of C K Kokate, vice chancellor of KLE University, Belgaum, will formulate policy guidelines and procedures for approval of fixed-dose combinations, with special emphasis on requirement of clinical trials on Indian population and its type, besides assessing the safety of fixed dose combinations.
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