Planning Commission Demands Grant Of More Obligatory Licences To Make Sure Drug Safety

Planning Commission Demands Grant Of More Obligatory Licences To Make Sure Drug SafetyThe Planning Commission has called for getting more mandatory authorizations issued for patented and costly medications with a vision to increase drug safety in the nation.

As per the report of the Steering Committee of the Planning Commission, ahead of finalizing the Plan document, "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."

During the month of March, the Patent Office had allotted India's first compulsory authorization to Hyderabad-based drug manufacturer Natco, permitting it to manufacture and market in the country, a similar edition of Bayer's Nexavar, an innovative kidney cancer medication.

The necessary permission has been allotted by the Controller General of Patents, Designs and Trade Marks for the medication in which the compound is "Sorafenib Tosylate" (Patent No. 215758).

The copyright was allotted to Bayer Corporation, USA on 03.03.2008 by the Indian Patent Office, resulting to their filing a national stage application in the country.

Bayer formulated the medication under trade name "Nexavar" and bagged regulatory authorization for importing and selling the medicine in the Indian market and introduced it in the country in 2008.

The verdict had raked up sharp reactions from MNCs who stated that arbitrarily utilization of required licenses would weaken innovation in the segment.

But, domestic pharmaceutical biz largely welcomed it as a move, which would benefit the patients.

In the meantime, Minister of State for Chemicals and Fertilisers Srikant Kumar Jena stated that the administration had decided to annul the suppleness under the WTO deal on trade linked Intellectual Property Rights for required licensing of patented medications to make sure accessibility of patented drugs at reasonable rates.