The Hindu Business Line : Domestic producers of herbal products seek data-exclusivity

What it means
Data exclusivity ensures protection of the information submitted by companies seeking a marketing approval in the country.
The information is submitted to the domestic regulatory authority and the data exclusivity sought is not connected to whether the same product is patent-protected in the country or not.
Local producers of herbal products have sought data exclusivity for five years.

Mumbai , Sept. 12

Herbal products have added a fresh dimension to the on-going debate on data exclusivity. Domestic producers of herbal products have asked for data exclusivity on herbal products, notwithstanding the Centre's call on granting the same for the pharmaceutical sector.

Data exclusivity ensures protection of the information submitted by companies seeking a marketing approval in the country. The information is submitted to the domestic regulatory authority and the data exclusivity sought is not connected to whether the same product is patent-protected in the country or not.

Contrary to the position taken by domestic drug-makers who do not want data exclusivity on allopathic medicines, local producers of herbal products have sought data exclusivity for five years, an official with the Union Chemicals and Fertilizers (C&F) Ministry told Business Line.

The C&F Ministry has subsequently asked the Union Health Ministry's Ayush Department for its views on herbals and the gamut of traditional medicines. The Ayush Department handles traditional systems of medicines including Ayurveda, Siddha, etc.

A meeting is scheduled after a fortnight with the industry and the Ministries of Health, C&F, the Council of Scientific and Industrial Research (CSIR) and the Indian Council of Medical Research (ICMR).

Stressing the need for data exclusivity on herbal products, specifically phyto-products (developed from plant extracts) is Ranbaxy's spokesperson, Mr Ramesh L. Adige. Plants are used traditionally for specific purposes, but scientists further research this to develop innovative products that are checked for safety and efficacy, he explained.

These products are, however, not patentable under the existing product-patent regime, as the plants are used traditionally. But the additional research going into innovation and standardisation of products needs to be protected, he added. Otherwise, copies would be made of the innovative phyto-products even as they hit the market and that would act as a disincentive to companies, he said.

Herbal products have a $70-billion export potential. And domestic players such as Ranbaxy, Himalaya Drug Company, Dabur, Nicholas Piramal and Lupin are either already entrenched in the segment or have plans for it.

Standardisation of herbal medicines would also help bolster the image of the herbal industry overseas, which has, in the recent past, been tarnished by adverse reports in markets such as Canada, US, Europe and Singapore, said an industry representative.

Currently, a decision is pending with the Central Government on whether the pharmaceutical sector would be granted data exclusivity. A consensus has, however, emerged on granting the same for agro-chem.

The pharmaceutical industry is spilt through the middle along domestic and multinational lines, with the former largely not inclined to data exclusivity.

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