US cos seek speedy pharma reforms in India

Mumbai: `Big pharma' representatives have urged authorities in India to 'speed up' their act and clear the air on issues such as patents, data protection and compulsory licensing.

The scope of drug patents should be expanded from merely a new chemical entity to include salts etc; pre-grant opposition should not be used as a delaying tactic; and at least a five-year protection of data must be ensured to attract more investments from major drug companies, said Mr Brian Toohey, Managing Director (Federal Affairs and International Trade) with Phrma (Pharmaceutical Research and Manufacturers of America).

Pharma representatives are scheduled to meet officials from the Ministries of Commerce, Chemicals and Fertilisers, and Health, they told Business Line.

Compulsory licensing


The triggers are too low for compulsory licensing, Mr Toohey observed. Compulsory licensing legally allows drug companies to make copies of an innovative product, with a royalty payment to the original patent holder. And one of the conditions that allows for Governments to issue a compulsory licence is a health emergency.

Data protection


Authorities in neighbouring countries like Singapore are actively wooing the industry, Mr Ranjit Shahani, President of the Organisation of Pharmaceutical Producers of India (OPPI) pointed out. The Indian Government too must quickly address all patent-related issues, he said.

In the past, there were concerns over protection of intellectual property when clinical trials were done in India, pointed out Mr Nigel Thompson, Executive Director with Merck & Co Inc. That has changed to some extent with India protecting product patents through its new Patents Act, he said.

However, data protection still needs to be worked on, he added.

While the US gives a five-year protection on data, Europe gives 10 years of data protection, China gives six years and Jordan gives 15 years, Phrma's representatives pointed out.