The Department of Chemicals and Petrochemicals is toying with the idea of setting up a committee to deliberate the pros and cons of introducing data exclusivity (DE) in India.
While multinational companies operating in India are strongly in favour of introduction of DE, indigenous companies are strongly opposing granting of protection for data generated in clinical trials.
"The issue is under the administrative turf of the Health Ministry. However, since pharmaceutical companies, which are the concern of the Department of Chemicals and Petrochemicals are affected, we are willing to offer to mediate on the issue," said senior government officials.
At an interactive consultation held by the department with representatives of industry and of various associations of the chemical, petrochemical and pharmaceutical sectors, the issue of data exclusivity was one of the most hotly debated topics.
The Organisation of Pharmaceutical Producers of India, a grouping of MNC pharma companies argued that introduction of DE would result in India getting more clinical trial work.
The organisation said that the issue should be delinked from whether it is required under the Trips agreement or not.
Indian manufacturers however argued that the fact that the US was willing to offer significant concessions in return for DE, itself indicated that it would lead to a greater degree of protection for drugs.
The US has offered India concessions on 740 tariff lines in exchange for DE and is also willing to reconsider visas to IT professionals if DE is provided to it's pharma companies, pharma association representatives claimed.
The department's view seems to be that the overall picture would have to be kept in mind. "The important thing is what would benefit the country the most in the overall sense," said officials.
At the meeting, Vinay Kohli, Secretary, Department of Chemicals and Petrochemicals said that countries would enter into Free Trade Agreements with India with an eye on the Indian market and that it would be up to the industry to exploit the opportunity.
The comment was in response to the industry's' view that the proposed FTA with Singapore was tilted in it's favour as it does not have a huge consumer base like India.
They said major multinationals had set up bases in Singapore owing to its attractive fiscal regime and with little value addition they will be able to dump their products at lower tariffs.
The government needs to introduce stringent safeguards and rules of origin mechanism in order to safeguard Indian industry, they said.
Among the demands of the industry voiced today were the need to provide small and medium enterprises with loans on easy terms in order for them to meet the quality and good manufacturing practice norms as laid down in Schedule M of the Drugs and Cosmetics Act.
The revised schedule is expected to come into effect from 1 January, 2004.
Protection for pharma sector
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MNCs operating in India are strongly in favour of introduction of data exclusivity in India.
- Indigenous companies are strongly opposing granting of protection for data generated in clinical trials.
- The US has offered India concessions on 740 tariff lines in exchange for data exclusivity.
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