Ranjit Roy Chaudhary Committee Recommendations on Clinical trials

What were the key recommendations of Ranjit Roy Chowdhary committee on Clinical trials? What is current policy stance of the government on same?

With the objective of making more innovative medicines available to the patients with critical illnesses like hepatitis, tuberculosis and HIV the Health Ministry has planned to do away with clinical trials with respect to some drugs that have been approved by the developed markets like the US, Japan, European Union, Canada and Australia. The conclusions have been drawn from the recommendations of the Ranjit Roy Chowdhary Committee on Clinical Trials. Some of the major recommendations of this committee are as follows:

• Clinical trials must be carried out only in the accredited centres.
• The accreditation must be both of the principal investigator of trial and the ethics committee of the institute.
• A Central Accreditation Council must be set up which will look into the selection of assessors for accreditation and the experts who will review the new drug applications through a random procedure.
• There should not be any violation of the approved process which highly emphasizes on the informed consent of the participant. If found violating, the Principal Investigator shall be blacklisted for a period of minimum of 5 years. Audiovisual recording of this informed consent must be facilitated which shall be preserved while maintaining confidentiality.
• The 12 drug advisory committees must be replace by a single broad expertise based Technical Review Committee for quick clearance without any compromise on the rules and regulations.
• The responsibility for compensation in case of adverse or serious adverse effects during trial lies with the sponsor investigator. This must be given irrespective of whether the patient is in control group, placebo group, standard drug treatment group or test drug administered group.
• The drugs that have been in the market of well-regulated countries with a post-marketing surveillance of atleast four years.
• A special expert committee other than the Drug Technical Advisory Board must be set up which will review all the drug formulations in the market and identify potentially hazardous drugs.

While the health ministry has accepted the recommendations, the final implementation has not been possible owing to the objections raised by the Drug Technical Advisory Board. The fear is that the drugs which have been accepted in other countries may not be suited to the genetic structure of Indians. This point is being considered on a case to case basis with a view to ensure the efficacy and safety of the drug along with increasing quick availability of the drug.