Usha Sharma – Mumbai
The Drug Controller General (India), in a recent order, seems to be expecting all State and Union Territory Drugs Control Authorities, to play a more vigilant role when it comes to approving clinical trial protocols and monitoring ongoing clinical trials in their jurisdiction.
All state regulators will be expected to accompany CDSCO officers on their regular activities related to monitoring clinical activities in their respective states, taking on a watchdog role.
Commenting on the CDSCO order dated December 12, Dr GN Singh, Drugs Controller General of India said, “Our mission is to protect human health safety and we are constantly working towards this goal. The order letter dated December 12 aims to ensure that clinical trials are conducted in accordance with the provision of Schedule Y of the Drugs and Cosmetic Rules. As we have issued copies of this letter to State and Union Territory Drugs Control Authorities as well, it is equally their responsibility to keep an eye on clinical trial activities in their territories.”
Commenting on this latest development, Dr Bharatesh Jagashetty, Drug Controller, Karnataka state said, “So far, we have not received any official communication from the DCGI’s office regarding this matter but if it is true, then we welcome this move as we were trying to do this for a long time.”
He also added, “We should be allowed to get involved in all matters related to clinical trials like inspecting investigator sites, granting approval (to conduct the trial) etc.”
In the order dated December 12, the DCGI has reiterated the responsibilites of Ethics Committees (ECs) under Schedule Y of the Drugs and Cosmetic Rules, and concludes with a reminder that sites of sponsors/clinical research organisations (CROs) as well as ECs need to remain open for inspection by inspectors/officials of CDSCO to ensure that the clinical trials are conducted strictly in accordance with Schedule Y.
The DCGI has indicated that representative officials of state regulators will be expected to accompany CDSCO officers on these inspections and other regular activities related to monitoring clinical activities in their respective states.
This order seems to be a follow up to the points discussed at the 44th meeting of the Drugs Consultative Committee (DCC) held on July 20. In the inaugural deliberations, Sanjay Prasad, Director, Ministry of Health and Family Welfare had stated that the drug regulatory frame work both at the Centre and the States is an important part of health care system.
He had opined that the large number of Court cases and RTI applications show that there is awareness in the public about the Drugs Control Departments and therefore the regulatory agencies are required to be transparent and accountable, with both the Centre as well as States required to work in tandem to ensure that there is strict control over the quality of drugs in the country.On the subject of Centre and State authorities working together, the minutes of the same DCC meeting go on to quote Dr V M Katoch, Secretary, Dept Of Health Research & Director General, ICMR, New Delhi, saying that the regulatory environment in the country is changing and as there are lot of expectations from the drug regulatory authorities, he opined that the system which is working with the nucleus organisations at Centre as well as State level is required to be made broad based to ensure that responsibilities are discharged more effectively.