Pharma industry has called for further amendment to the Patents Act to strengthen the criteria of patent protection and constitution of a fresh technical expert committee on the scope of patentability of pharma products as the earlier panel headed by Dr R A Mashelkar has run into controversy yet again.

In a meeting called by the department of pharmaceuticals recently, the industry leaders noted that it was time for a re-look at the certain provisions of the Patent Act and the government should undertake an expert evaluation of patents granted on known substances to understand the limitations of the Act and the patent office.

"The purpose of the evaluation is to suggest amendments to the provisions on patentability criteria in the Act as mentioned in Section 2 and 3 and suggest further amendments to strengthen the criteria on patent protection," SME Pharma Industries Confederation suggested at the meeting, attended by the representatives of all major pharma bodies.

It was also suggested that the government should go for a new technical expert committee to examine whether the patentability on pharmaceutical substances can be limited to new chemical entities (NCEs). The pharma department has called the meeting to discuss in detail the issues related to IPR in the wake of recent developments across the world and garner the support of the industry. The industry across the board has urged the government to resist the attempts by the developed world to create trade barriers for the Indian generics and extend full support to the department.

The SPIC also urged the government to reconsider the patent examination manual in the patent office. "Presently, compulsory license chapter in the Patents Act is not a user-friendly tool. There are many issues including procedural delays, cooling period, lack of guidance on the royalty payment etc. Therefore, legal amendment is required to make the compulsory license really an effective tool," the association said.

The FTA negotiations with the European Union, Madrid protocol, attempts by the multinationals to get the definition of counterfeit drugs changed, and ongoing deliberations at the WIPO also came in for discussion at the meeting.