The Prof Ranjit Roy Chaudhury expert committee, constituted by the Union health ministry to formulate policy, guidelines and SOPs for approval of new drugs including biologicals, clinical trials and banning of drugs, has recommended sweeping changes in all these sectors and recommended that a Central Accreditation Council should be set up to oversee the accreditation of institutes, clinical investigators and institute ethics committees for clinical trials in the country.

In its 99-page long report, the panel has recommended that the clinical trials can only be carried out at centres which have been accredited for such purpose. The principal investigator of the trial should be an accredited clinical investigator. The ethics committee of the institute must also have been accredited. Only those trials conducted at centres meeting these stipulations will be accepted by the Drugs Controller General of India (DCGI), the report said.

The panel further recommends that the 12 drug advisory committees which are functioning at present for new drug approvals will be replaced by one broad expertise-based Technical Review Committee to ensure speedy clearance of applications without compromising on quality of data and rules and regulations. The Committee would be assisted as required by appropriate subject experts selected from the Roster of Experts.

On any adverse effect (AE) or serious adverse effect (SAE) occurs during a clinical trial, the panel in its report recommended that the sponsor investigator will be responsible 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.
The committee further recommended that a Special Expert Committee should be set up independent of the Drug Technical Advisory Board (DTAB) to review all drug formulations in the market and identify drugs which are potentially hazardous and/or of doubtful therapeutic efficacy.   A mechanism should be put in place to remove these drugs from the market by the CDSCO at the earliest.

Dr V. P. Kamboj, Dr BT Kaul, Dr Vasantha Muthuswamy, Dr Mira Shiva
and Dr Uma Tekur are the other members of the committee which was announced by the ministry on February 6, 2013.