The inter-ministerial committee on data protection set up by the chemicals ministry is to meet here on September 6, to discuss the pending issues related to data protection in drugs and pharmaceuticals. The committee had, in its previous meeting, decided to give five-year data protection and non-reliability of test data clause for agrochemicals. However, it took no decision on pharmaceuticals as the members felt the matter needed more deliberation. The committee is hopeful of having more fruitful deliberations during the forthcoming session, official sources informed.

Interestingly, the participants of the last inter-ministerial meeting had by and large agreed to a model that offered limited data protection with sufficient safeguards. A compensatory model, as proposed by Dr R A Mashelkar of Council of Scientific and Industrial Research (CSIR), was known to have received maximum acceptance. The forthcoming meeting may attempt to build on the general consensus.

Data protection and thereby exclusivity rights on use of test data for regulatory approval for a fixed period of time is important for research based multinational pharmaceutical companies if they have to have some sort of market exclusivity in the Indian drugs market. With most of their research molecules coming out of patent protection due to the inbuilt clauses within Indian Patent Laws, the multinational pharmaceutical companies consider data protection as the last effective tool for market advantage.

For the same reason, the domestic industry continues to oppose the proposed non-reliability of test data clause. The domestic industry feels that such clauses may affect their capability to come out with cheaper versions of research molecules within short time.

The patient groups and health NGOs that procure medicines from Indian generic manufacturers are also concerned with the development. Given the sensitive nature of the issue, the committee would be very cautious not be seen as taking sides. Its attempt would be to come out with a balanced solution, sources said.