In the last weeks, India has seen serious setbacks to its life sciences industry. The NIH recently announced that they were cancelling 40 clinical trials in India due to an ‘unstable regulatory environment’. Earlier, the UK Medicines and Healthcare products Regulatory Agency (MHRA) recalled 16 Indian drugs, citing deficiencies in manufacturing procedures.
These recent occurrences compound prior concerns over the patentability of medicines (here and here), and low drug innovation rates. Furthermore, in the recent issue of Scientific American Worldview I showed how the sum of India’s API production revenues were exceeded by the the top-selling patented drug. So, even having a focus on generic drugs is not generating substantial revenues for India.
These developments lead one to question — does India present a postive environment for biotechnology?