Clinical Trial Rules counter-productive: ASSOCHAM

Major industry chamber ASSOCHAM has expressed concern at the setback to clinical trials for new pharmaceutical drugs in the country and has called for several changes in the Drugs and Cosmetics Amendment Rules (DCAR) to meet industry concerns about these trials.

In its study on the Indian Pharmaceutical Industry (IPI) the chamber pointed out that few clinical trials have been approved in calendar year 2013 after the Supreme Court's interim order on this subject. As against 55 global clinical trials in 2012, only 17 were approved last year. With India having 16 per cent of the world population and 20 per cent of the global disease burden, only 1.5 per cent of the global clinical trials were being conducted in the country.

Allaying much of the myths against these trials, the chamber stressed the need to create awareness among various groups at all levels about the need and importance of clinical trials among the Indian population groups to enable foreign drug discoveries to be applied in our conditions. Clinical trials are NOT unsafe and are NOT conducted in India only because of cost effectiveness, patient vulnerability and lack of regulatory safeguards, ASSOCHAM pointed out. Testing drugs in the ethnic groups is of paramount importance before approving any drug of foreign origin, the study stressed.

Attacking what the study calls the myths created regarding clinical trials in India, the study also pointed out that patients/subjects across the globe take an informed decision to participate in clinical research after made fully aware of the potential benefits and risks involved and clinical research is carried out in a highly regulated environment.

About the regulatory environment in India, the chamber's study said that certain outstanding concerns of the industry remain to be addressed in the draft rules the Ministry of Health has published in this regard. These relate to criteria entitling a patient to compensation, broad definition of 'trial related to injury' and the strict and unreasonable reporting timelines required to be followed in case of serious adverse events. The draft Drugs and Cosmetics (Amendment) Rules 2014 published last April were addressing only some of the industry concerns and remain yet to be finalized.

ASSOCHAM study called for streamlining at the earliest published draft changes to the DAB along the lines of international best practices in order to establish a regulatory mechanism which is predictable, stable and transparent. The streamlining was needed on issues related to in cases of clinical trials, injuries or deaths, establishment of appellate authority in case of disputes on causality and compensation issues, bio-equivalence and bio-availability studies and timelines for approval process.

The study also revealed that the industry was committed to complying with the new regulations notified in 2013 to ensure the interest of patients like Rule 122 DAB of the Drugs and Cosmetics Amendment Rules 1945 (DCR) on compensation in case of injury or death of a clinical trial subject during such trials.

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