Amidst the chaos caused by serial bomb blats in Bangalore and Ahmedabad over the weekend along with the continuing onslaught of torrential rains in Mumbai, the lead story in Mint today completes the trinity of morose news here in India.
The headline reads ‘India fails to report drug side effects’ with the following summary – No adverse reactions to any drugs reported from 2005-07; govt concedes drug makers aren’t reporting either.
This may not come as a shock to those tracking the Indian Pharma story beyond the high profile deals and the ‘immense growth potential’ which most media and analyst reports harp about.
With a severe talent crunch affecting the so called booming Indian Pharma industry, knowledgeable gatekeepers of good policy are few and far between. The Indian judiciary system and policy makers must be credited with the fact that they have held up the independent nature of Indian Pharma Co’s at crucial junctures (the Glivec patent challenge is a case in point).
But, the fact remains that we have not invested enough in resources or infrastructure to ensure that all drug manufacturers adhere to what is known as ‘Good Clinical Practices’ in industry parlance.
But, isn’t it a reason more so for the governing bodies to protect its citizens from the most obvious harm. What we are talking about here is merely a side-effect to drugs not being categorically reported and documented. Such adverse reactions are believed to be the fourth largest cause of mortality and morbidity globally and that simple act, as the report suggest, could aid in saving millions of lives.
‘Drugs typically throw up newer side effects than were known during clinical trials once they begin to be administered across large groups of patients. Collecting this data is crucial for patient safety as well as fine-tuning medical research.’
It’s time that the DCGI takes cognizance of this fact and adequate measures, processes are put in place to correct such a gross oversight.