The approvals, given by the health ministrys apex committee, come ahead of a September 24 hearing by the Supreme Court where the health ministry will present details of the new regulatory regime for clinical trials. The domestic clinical research organisation market was worth $485 million in 2011 and is set to cross the $1-billion mark by the turn of 2016, according to a Frost & Sullivan report.
A government-appointed panel chaired by Dr Ranjit Roy Choudhury is also ready with its recommendations on a new set of rules for clinical trials. These include guidelines on compensation for clinical trial patients, set-up of technical review committees and regulatory timeline for approval of a trial.
Pharma companies, CROs and doctors are optimistic that these regulatory initiatives are a step forward and would create a secure environment for conducting clinical trials in the country,.
On compensation, the Choudhury committee states that if any adverse effect occurs during a clinical trial, the sponsor investigator will be responsible for providing medical treatment and care to the patient at their cost till the resolution of the side effect. 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 panel proposes.
Compensation will also be paid to the trial participant if any drug-related anomaly is discerned at a later stage and accepted to be drug-related by a competent authority whether in India or abroad.
However, if the drug under trial fails to show the claimed therapeutic effect on the patient participating in the trial, there is no need to financially compensate her/him.
Clinical trials can only be carried out at centres which have been accredited for such purpose, said the Choudhury report. It has also done away with several sub-committees involved in approving clinical trial applications.
The 12-drug advisory committees which are functioning at present 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 panel proposed.
This is a positive development for the entire clinical research environemnt in India, said Suneela Thatte, president, Indian Society for Clinical Research, an industry body.
On banning drugs, the Choudhury report 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 that 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.