A comatose regulator, GEAC kills Indian biotech


The biotech industry leaders are calling this extraordinary state of inaction of the biotech regulatory agency GEAC as the "Jayanthi whiplash" which sent its 16 members into a near coma state for more than 24 months. The shadow Prime Minister of the leading Bharatiya Janata Party (BJP), Mr Narendra Modi, called the status of environment ministry's inaction as "Jayanthi Tax" on industry. The reference is to the former minister, Ms Jayanthi Natarajan, who until recently lorded over the ministry as its head, for 30 months, from July 2011-to-December 2013 until she was replaced by Mr M Veerappa Moily in a surprise cabinet reshuffle.

The facts about the regulatory inaction during Ms Natarajan's stewardship of Environment Ministry which handles GEAC is stark. The regulatory body used to meet once a month, on every second Wednesday, since 2005 to clear biotechnology products which are required to get a compulsory approval for its environmental impact from this regulatory agency.

GEAC has met only six times during the 30-month tenure of Ms Natarajan. More devastatingly, the last two meetings have taken place after a gap of a year each, which has literally choked the growth of biotech industry that was growing at over 18 percent every year since 2006.

As a result, close to 100 important biotech products, many of them life-saving and cost-effective substitutes for imported high-priced medicines, are pending clearances. Millions of India's patients are keenly awaiting the release of these products to prolong their lives impacted by various dreaded diseases.

Data compiled by BioSpectrum throws some startling facts. After Ms Natarajan took over as the minister in July 2011, the GEAC met five times-September, October, and December 2011, February 2012 and April 2012.The next meeting was 14 months later on April 11, 2013. The meeting took some decisions. But the minutes of the meeting have not been made public nearly 11 months later. This meeting was the first one of the reconstituted committee which had 16 members.


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