Clinical trial rules detrimental: ASSOCHAM study 10/09/2014

Clinical trial rules detrimental: ASSOCHAM study
10/09/2014 17:01
The apex industry body Assocham has urged for changes in the Drugs and Cosmetics Amendment Rules (DCAR) for clinical trials of new pharmaceutical drugs in the country to meet industry concerns. 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, the report said. 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. 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 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.