An official expert committee has recommended major changes in the guidelines for approval of new drugs, clinical trials and banning of medicines.
It suggested setting up of a council to oversee the accreditation of institutions, clinical investigators and institute ethics committees for clinical trials in the country.
The six-member Prof. Ranjit Roy Chaudhury Expert Committee, set up in February this year, said clinical trials can only be carried out at accredited centres. Both the principal investigator of the trial, and the ethics committee of the institute should be accredited. Only those trials conducted at such centres should be accepted by the Drugs Controller General of India (DCGI), it said.
Seeking to set up a Central Accreditation Council, the panel said the selection of assessors for accreditation and of experts to review new drug applications and other purposes should be made by a random procedure from a Roster of Experts.
Focussing on the importance of informed consent from each participant for clinical trials, the panel said any departure or violation from the approved process should result in blacklisting of the Principal Investigator for at least up to 5 years.
In circumstances where special groups of people who have diminished capacity to protect their interests are involved, the guardian can give consent and this should be witnessed by an independent person who also has to sign the document. Audiovisual recording of the informed consent process should be undertaken and the documentation preserved, adhering to the principles of confidentiality, it said.
Appreciating the recommendations, S. Srinivasan of the All India Drug Action Network and Low Cost Standard Therapeutics (LOCOST), however, said not many institutions would be able to meet the criteria. He also told The Hindu that the report was silent on whether clinical trials should be covered under the Right to Information Act.
Further, it calls for replacing the existing 12 drug advisory committees by a single broad expertise-based Technical Review Committee to ensure speedy clearance of applications without compromising on quality of data and rules and regulations.
On compensation for adverse effects (AE) or serious adverse effects (SAE) during trial, the committee puts the onus of responsibility on the sponsor investigator for providing medical treatment and care to the patient at his/their cost till the resolution of the AE/SAE. This is to be given irrespective of whether the patient is in the control group, placebo group, standard drug treatment group or the test drug administered group.
However, it does not favour paying of compensation for injury or death due to totally proven unrelated causes. In all other cases of death or injury/disability, compensation should be paid to the participant or his legal heirs.
Terminal cases
In cases of clinical trials being carried out on patients suffering from terminal illnesses such as cancer, compensation may be payable if the ethics committee, after deliberation, is of the considered opinion that “there is an increase in the number of SAEs occurring in such a patient as compared to standard treatment, and which may be irreversible; or life expectancy has been severely curtailed.” The panel is of the view that Phase I to IV clinical trials of all new entities developed in and to be marketed in India would need to be carried out here.
Drugs, which have already been on the market in well-regulated countries with good post-marketing surveillance (PMS) for more than four years and which have a satisfactory report, may be granted marketing licence, subject to strict PMS for four to six years, it said.
It further said a Special Expert Committee should be set up independent of the Drug Technical Advisory Board to review all drug formulations in the market and identify drugs which are potentially hazardous and/or of doubtful therapeutic efficacy.
