As the new patent regime is expected to be in place from January 2005, the concerns of Indian pharmaceutical industry over some of the critical changes in the new patent law are becoming increasingly urgent. The Group of Ministers which is to finally decide these changes under the Indian Patent Act proposed by the aggrieved Indian sector of the pharmaceutical industry and some of the public interest bodies, is to meet during this week and ready the draft to be submitted to the cabinet. And a cabinet clearance of the draft is expected towards the middle of this month. There is not much time left for the government to incorporate any last minute changes in the interest of the domestic pharma industry. What is bothering the domestic industry most in the patent bill are two key provisions: 1.Patentability criteria. 2. Pre grant opposition. These are the two areas where MNCs are also constantly putting pressure on the government to toe their line. It is possible that deletion of section 5 in the patent Act will create absolute product monopolies in drug and agrochemical industries. Therefore, it is to be ensured under the amended Act that the product patents are granted only for new molecules and process patents for genuinely invented technology processes. For this the government has to clearly define the patentability criteria and what is not patentable. Urgency of this need is to be understood in the background of 4792 patent applications already filed in the mailbox for drugs and pharmaceuticals during the last ten years. It is anybody's knowledge that the research laboratories of world pharmaceutical industry have not invented so many new molecules in such a short span. The number of new molecules cannot be more than 300 by any estimate. If that is the case, nearly 4500 applications in the mailbox could turn out to be frivolous or flimsy. The country's patent offices should not be accepting such huge number of bogus patent applications at least under the new patent regime. The pressure being put by MNCs to delete section 25 in the bill relating to calling for pre grant opposition before grant of patent is another area of concern. First of all, such a change is not required under TRIPS. Secondly, considering the present trend of filing patent applications, other stakeholders should have an opportunity to oppose in case their rights are threatened by wrong or false patent applications. This provision has been retained in the Patent Act by the Joint Parliamentary Committee in 2001 and is also being followed by a dozen developed and developing countries in the world today. Wrong grant of EMR to Novartis for Glivec last year by India's former Patent Controller underlines the need for such a legitimate caution in matters like this. Apart from these essential safeguards, adequate number of professionals in the patent offices and a competent judiciary are also critical for the effective implementation of this complex piece of legislation.