Public interest groups working on intellectual property rights in India have criticised the recent report of an inter-ministerial committee headed by Union Chemicals and Petrochemicals Secretary, Satwant Reddy, on the issue of data exclusivity for drugs and agro-chemicals.

The groups describe the report by the Satwant Reddy panel as a “unilateral initiative” by the chemicals ministry that appeases industrialist groups without substantiating recommendations, and going beyond the terms of reference.

The Satwant Reddy Committee rejects the demand for five-year data exclusivity and suggests “a calibrated approach with a transitional period”.

During this period, it recommends, the drug regulator should continue with the existing practice of approving new drugs, according to the Drugs and Cosmetics Act.

The Delhi-based Centre for Trade and Development (Centad), which has been pursuing the case closely, observes that the committee has exceeded its terms of reference by examining whether data exclusivity benefits Indian industry or not. The report also lacks clear reasons for its recommendations including data exclusivity for pharmaceutical test data.

Further, the report contradicts its own reasoning by recommending data exclusivity for agro-chemicals and traditional medicine, says a Centad note.

Data exclusivity for traditional medicine will create a monopoly in the market and affect 67% of India’s population that does not have access to modern medicine, the note states.

“Exclusive rights on data would affect access to traditional medicine. Further, this recommendation will subvert the policy of putting traditional knowledge in the public domain. It also encourages migration of traditional methods of production of traditional medicine into a modern scientific process and results in the extinction of traditional small players,” adds the note.  

With reference to negative impacts, “the report brushes aside the important issue of access to medicines. In other words, the report proposes to introduce an unwarranted form of monopoly in the pharmaceuticals market and then provide safeguards (13 of them) to overcome the negative effects”.

Centad states that although the report acknowledges the contributions of some of the independent experts of an earlier (2004) committee, it contains only the authors’ signatures. “Hence the present report cannot be termed as a committee report and reflects the views of authors’ own department.”

This is important because the nodal ministry for the administration and management of test data is the Ministry of Health and Family Welfare, not the Ministry of Chemicals and Petrochemicals.

June 19, 2007