The Economist has joined the increasing number of publications covering the problems within India's pharmaceutical industry. Notably, the authors notably cite our research:
"India’s efficient manufacturing has made drugs available to millions who could not otherwise afford them. Many Indian medicines remain of the highest quality. But too many are not. Roger Bate, of the American Enterprise Institute and the author of “Phake: The Deadly World of Falsified and Substandard Medicines”, studied more than 6,000 drug samples across Asia and Africa. Of these, nearly half were made in India and many were either degraded or contained too little active ingredient. The best solution would be to improve oversight not just by American regulators, but Indian ones."
To this end, today my colleagues Dinesh Thakur, Amir Attaran and myself publish our sixth S4S working paper, on the interactions between India's drug industry, India's regulator and the US Food and Drug Administration and how these interactions could be improved.
Margaret Hamburg, the head of USFDA, has just finished a visit to India where she tried to negotiate improvements to the existing relationships between her agency and those of the Indian government, in order to increase safety of US patients. We discuss her proposals in our paper. Unfortunately she is not negotiating with like-minded regulatory colleagues. India does not treat regulatory standards seriously, and assumes any interference by FDA is an attempt to undermine Indian sovereignty and India's generics industry. As a result there seems little chance that India will entertain her honest attempts to improve safety.
Sooner or later, the US Government will realize it requires a better strategy to deal with India. Until that time, drug quality will not improve.