Agrochemicals get 5-yr data exclusivity rights

International pesticide majors have got a shot in the arm. With the Committee on Data Protection, headed by Satwant Reddy, deciding to grant five-year data exclusivity to agrochemicals, multinational pesticides and agrochemicals makers like Bayer, DuPont and Syngenta would stand to benefit.

The committee is also planning similar protection for the pharmaceutical sector, a move that would give multinational pharma firms the edge over Indian drug makers.

"Initially, a protection period of 3 years had been decided upon for agrochemicals, but that was found too short in today's discussions. The royalty model (where the generic company would pay royalty to the first applicant) has been cast aside," a government official said.

'Data protection' entails generic companies cannot have access to innovators' data from the office of the drug regulator, while 'Data exclusivity' "" a demand of the multinational pharma lobby and bitterly opposed by Indian players at large "" is a stricter condition implying non-reliance of the regulator on innovator's data.

In effect, it requires every generic company seeking approval for an existing drug to reproduce all data from scratch, an exercise that could cost millions.

Expanding its purview, the committee is also looking at providing data protection to herbal drugs, a demand of the department of AYUSH (ayurveda, yoga, unani, siddha, and homoeopathy) and the CII.

In the pharma sector, while one section of the committee felt that no protection was required for another 4-5 years until the entire impact of the new product patent system becomes evident, the other section felt the industry is mature enough and needs such protection to promote research.

The committee, including officials from the ministries of health and family welfare and agriculture, has not reached a final decision yet. It will, however, send a report to the commerce ministry by the end of this month representing the two divergent schools of thought.

Ever since India turned trade-related aspects of intellectual property rights (TRIPS) compliant and implemented the product patent system on January 1, 2005, it has been under an obligation to protect confidential data submitted by pharma companies to drug regulators, under Section 39 (3) of TRIPS.

Both AYUSH and CII had urged the committee to consider herbal drugs for data protection as their market is on the rise and such steps would spur companies to undertake extensive research for developing newer medicines.

Interestingly, even as Indian industry has opposed protection for pharmaceuticals, it has supported the cause vehemently for their stronghold, herbal drugs.