The Planning Commission has called for getting more compulsory licences issued for patented and expensive drugs with a view to build up drug security in the country.
“In consultation with concerned Ministries, local production of bulk drugs and vaccines should be encouraged to build “drug security” in the country. The Ministry of Health and Family Welfare should identify and get compulsory license issued for patented expensive drugs required for public health programmes, and encourage their manufacture in the country,” according to the report of the Steering Committee of the Planning Commission, ahead of finalising the Plan document.
In March, the Patent Office had granted the country’s first compulsory licence to Hyderabad-based drug-maker Natco, allowing it to make and sell in India, a similar version of Bayer's Nexavar, an advanced kidney cancer drug.
The compulsory license has been granted by the Controller General of Patents, Designs and Trade Marks for the drug in which the compound is “Sorafenib Tosylate” (Patent No. 215758). The patent was granted to Bayer Corporation, USA on 03.03.2008 by the Indian Patent Office, consequent to their filing a national phase application in India. Bayer developed the drug under trade name “Nexavar” and received regulatory approval for importing and marketing the drug in India and launched it in India in the year 2008.
The decision had raked up sharp reactions from the multinational companies who claimed that arbitrarily using of compulsory licenses would undermine innovation in the sector. However, domestic pharma industry largely welcomed it as a move that would benefit the patients.
Meanwhile, Minister of State for Chemicals and Fertilisers Srikant Kumar Jena said in the Parliament recently that the Government had decided to invoke the flexibility under the World Trade Organisation (WTO) agreement on trade related Intellectual Property Rights for compulsory licensing of patented drugs to ensure availability of patented drugs at affordable prices.