India speeds up national pharma policy

Sets up new Group of Ministers to decide on the National Pharmaceutical Policy

Indian government may soon take a decision on the National Pharmaceutical Policy which has been pending  since 2002.

As a measure to expedite the whole process, the central government has formed a new Group of Ministers (GoM) to decide the National Pharmaceutical Policy.

Sharad Pawar, Union minister for agriculture and consumer affairs will head the new GoM. Union health minister Ghulam Nabi Azad, law minister Veerappa Moily, commerce and industry minister Anand Sharma, chemicals and fertilisers minister M K Alagiri, deputy chairman planning commission Montek Singh Ahluwalia and science and technology minister Prithviraj Chavan are reportedly the other members of the GoM.

The previous GoM set up by the prime minister in January 2007 was also headed by Sharad Pawar. Even though  GoM held four meetings on April 10, 2007, September 12, 2007, January 30, 2008 and April 30, 2008, it failed to make any acceptable recommendations..

The new committee will examine the draft national pharmaceutical policy prepared by the previous regime under Ram Vilas Paswan.

The draft policy submitted to the Cabinet secretariat calls to bring over 354 drugs instead of existing 74 medicines under price control.

The proposal to include more drugs under essential medicines to bring them under price control net has attracted strong resistance the pharmaceutical industry.

The government of India is under tremendous pressure from international power groups and lobbyists to have a pharmaceutical policy which can give clarity on product patents and other IP related issues, it is learnt.

Recently, the government asked the Technical Expert Group (TEG) which formed under Dr Mashelkar to resubmit his report.

TEG on Patent Law Issues headed by Dr Mashelkar was supposed to make recommendations into two contentious issues – limiting patent to new innovations and the patentability of micro organisms.

TEG submitted the first report to the Government on December 29, 2006, which later recalled on March 7, 2007. Subsequent to the withdrawal of report, Dr Mashelkar expressed his desire to resign from the chairmanship of TEG. The government rejected the plea of chairman and requested the TEG to submit the report incorporating the changes.

The request was again made by the government in February and March and Dr Mashelkar agreed to accept his responsibility as the chairman again to submit the report, according to the revelation.

Following this, TEG subimitted its revised report. In the new report, Dr Mashelkar-led committea argued that  “it would not be TRIPS (Trade Related Aspects of Intellectual Property Rights agreement) compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a ‘statutory exclusion of a field of technology’”.

The report also suggested that restricting patentability to just NCEs, as being practised in India, would mean that most of the pharmaceutical product patents would be owned by MNCs.

TEG also re-asserted its earlier conclusion submitted in 2007 that excluding micro-organisms per se from patent protection would be considered as violation of TRIPS Agreement.

Another contentious issue being debated now is the Section 3 (d) of the Indian Ptent Act. The Section 3(d)  has gained international attention through the high profile lawsuit filed by Novartis questioning the rejection of a product patent for its anti-cancer drug Glivec in India.

TEG, under Dr Mashelkar, has not made its comment on the controversial question of the TRIPS compatibility of Section 3(d) of the Indian Patents Act or any other existing provision in the revised report, maintainaing that the group is not mandated to examine in the Act.

However, NGOs working on patent issues in the country have again come up asking the government to reject the recommendations of the Mashelkar Committee on the twin issues of ‘evergreening of patents’ and ‘excluding micro-organism from patentability’. Instead, the NGOs have asked the government to accept the recommendations of Department Related Parliamentary Standing Committee which has recommended that the patentable pharmaceutical product should be restricted only to ‘new drug molecules’.