Updated on 8 July 2013
ASSOCHAM officials believed that the gazette notification issued by the department of Health, Ministry of Health & Family Welfare has put a ‘full stop' to the research and development (R&D) in India, triggering serious concerns amid entire pharma industry.
ASSOCHAM has further written to the Indian Prime Minister regarding the issue. "This notification is not in line with the established international standards and is likely to have a cascading effect on the future of clinical trials in India as the flaws in the gazette could negatively impact the future growth of R&D as well as development of low cost high quality medicines in the country," ASSOCHAM wrote on behalf of India's pharma majors.
ASSOCHAM claimed that the controversial gazette notification prescribed stringent laws that are not in line with the established regulations, making it almost impossible for the R&D based industry to comprehend it and provides compensation for investigational new drug studies (IND), even if a patient is taking (placebo) sugar pills, or other concomitant medication. The gazette also makes it mandatory for a study drug to be efficacious - a condition that is nearly impossible to meet since most drugs approved globally are not 100% efficacious every time a patient takes them.
The Health Ministry too has been approached by ASSOCHAM through a letter to immediately take action to prevent slowdown of clinical R&D in India while adding that global trials have almost come to a grinding halt in India over the past six months, consequently denying patients suffering from life threatening conditions access to brand new drugs.