Govt may not provide five-yr data protection to traditional medicines

The government may take back its earlier plan to provide five-year data protection to traditional systems of medicine.

The change has been triggered by the Department of Ayurveda, Yoga, Unani, Siddha and Homoeopathy (AYUSH) taking the view that such a protection will lead to similar demands from the allopathic segment.

While the government has been supporting the move to introduce data protection for traditional medicines, it has been reluctant to offer similar protection to the pharmaceutical sector in general due to the concerns of the domestic drug industry.

Domestic manufacturers say "data protection", which results in "non-reliance" of data generated by the patent-holding company, will increase the cost of drug production and delay the entry of generic drugs into the domestic market.

Incidentally, it was the Department of AYUSH that initially proposed such a protection to encourage generation of data for scientific validation of traditional medicines.

The government's plans for data protection began after a high-level inter-ministerial committee, set up by the Department of Chemicals and Petrochemicals in 2004, favoured such protection for traditional medicines and agro-chemicals.

Though the committee's mandate was to examine whether the current laws of the country were adequate to meet the obligations for "data protection" under the TRIPS Agreement of the WTO, the issue of providing data protection for traditional or herbal products, as distinct from other pharmaceuticals, came up before the committee through a submission by the Department of AYUSH in September 2006.

After considering the Department of AYUSH's submission, the committee, in its report submitted in May 2007, recommended that irrespective of the nature or the period of data protection granted to pharmaceuticals in general, a five-year data protection should be provided for traditional medicines.

It also wanted the health ministry to make amendments to the Drugs and Cosmetics Rules, 1945, to effect the change.

The chemicals ministry has now found that the Department of AYUSH has sought a review of the decision as it may have led to demand for data protection for pharmaceutical products in general.

"There are serious concerns relating to the ever-greening of patents under the guise of data protection and the need for providing affordable drugs to people," it had reasoned.

Data protection to pharmaceuticals has been one of the most debated issues due to the strong reservations expressed by the domestic drug industry against such a move.

On the other hand, multinational drug majors have been saying that data protection is a prerequisite for foreign investments in drug research in India.

While the committee recommended a five-year data protection for traditional medicines, it refrained from making such a recommendation for other pharmaceutical products.