Stung by the Supreme Court and hit by the flak from the parliamentary panel, the Union Health Ministry has finally woken up to the flaws and challenges being faced by the clinical trials sector in India. In the recent past, the Central Drug Standard Control Organisation (CDSCO) has taken a number of measures to streamline the sector and the moves have started showing some results.
Apart from specifying norms on determining the quantum of compensation to the victims of trials, the DCGI had also set up three independent expert committees for examining the reports of serious adverse events of deaths during the clinical trials, among many things that initiated.
The Drugs & Cosmetics Rules have also been amended to include several pro-active measures in the sector. The norms for giving permission to the clinical trials, steps to ensure approved protocols and Schedule Y requirements, mandatory approval by the ethics committees, registration of trials with Clinical Trials Registry of India, filing of annual status report, report of adverse reactions, compensation for injury and death, etc. were in detail specified by amending the laws.
One of the key measures was to allow the authorities to conduct surprise checks in the sites of clinical trials and check all records, as deemed require, including in the offices of the employees, sponsors, agents, contractors, investigators etc. The present order asking the zonal offices of CDSCO to set up expert panels is a follow-up to this.
In another welcome move, the DCGI has asked all the zonal offices of CDSCO to set up expert committees to mount regular inspections at the trial sites.
“It has been decided that the zonal offices of CDSCO should keep the records of the details of names, qualifications of investigators and clinical trial sites falling under their jurisdiction and also constitute expert committees to conduct clinical trial inspections,” DCGI Dr G N Singh instructed the zonal offices.
The expert committee along with drug inspectors shall visit the clinical trial sites at least once in a year to verify the compliance with Schedule Y, GCP guidelines and other applicable regulatory requirements, the DCGI said in a notice.
For examining the reports of serious adverse events (SAEs) of deaths occurred during the clinical trials in the country, Dr GN Singh has constituted three independent expert committees. Dr Arun Agarwal, Professor of ENT & dean, Maulana Azad Medical College, New Delhi is the chairman of all the three committees.
The committee will examine the reports of SAEs of deaths, to determine the cause of death. If the cause of the death is considered as clinical trial related death, the committee will give its recommendation to the DCGI. In case of clinical trial related death, the committee will also recommend the quantum of compensation to be paid by the sponsor or his representative to DCGI.
The committee will examine whether the death has been occurred due to adverse effect of investigational products; violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator; failure of investigational product to provide intended therapeutic effect; use of placebo in a placebo-controlled trial; adverse effects due to concomitant medication excluding standard care necessitated as part of approved protocol; for injury to a child in-utero because of the participation of parent in clinical trial; or any clinical trial procedures involved in the study.
The committee will examine each report of death within a time period of 30 days of receiving the reports from the respective ethics committee. The chairman of the committee can invite subject and other outside experts if considered necessary. The chairman of the expert committee will receive reports of serious adverse events of deaths from investigators, sponsors or his representatives whosoever had obtained permission from the DCGI for conducting the clinical trial and ethics committees.
These independent expert committees will function under the provisions as specified in Appendix XI1 of Schedule Y of Drugs & Cosmetics (D&C) Rules.
Apart from the three seven-member committees, the DCGI has also announced a 48-member panel of experts for constituting independent Expert Committee to examine the SAE (death) occurring during the clinical trials.
Over 200 ethics committees secured registration after CDSCO issued orders to make it mandatory for the clinical trial organisations to register the committees. The Government had issued the notification on February 8 this year to make it mandatory the registration of ECs and so far, the DCGI has given registration to 214 panels it is learnt.
Leading hospitals both from the public and private sectors, from all across the country, were among those applied and got the institutional ethics committees registered for trials as the Government had recently tightened the norms for trials through various steps.