Question : DRUG LICENSE



(a) whether the Government proposes to make certain drugs license-free in the country;

(b) if so, the details thereof;

(c) whether the Government has received applications from the domestic drug companies for grant of compulsory license in the country;

(d) if so, the details thereof along with the action taken/proposed by the Government thereon; and

(e) the number of applications still pending with the Government along with the reasons for their pendency?

Answer given by the minister



THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)

(a)&(b): There is no such proposal to make certain drugs license-free in the country.

(c) to (e): Yes. The Office of Controller General of Patents, Designs and Trade Marks (CGPDTM) has received two applications for grant of Compulsory License in the country from the domestic drug companies after 1.1.2005 i.e. after the introduction of the product patent regime in India. The details of the applications are as under:-

(i)M/s NATCO Pharma Limited had applied under Section 84(1) of the Patents Act, 1970 for a compulsory license against the Patent No. 215758 which was granted to M/s. Bayer Corporation for the cancer drug ‘Sorafenib’/‘Tosylate’. The CGPDTM granted Compulsory License to M/s. NATCO Pharma Limited on 09.03.2012.

(ii) M/s BDR Pharmaceuticals International Limited had applied under Section 84 (1) of the Patents Act, 1970 for a compulsory license against the Patent No. 203937 which was granted to M/s. Bristol-Myers Squibb for the drug ‘Sprycel’ covered under the said patent. The said application is required to be adjudicated under the provisions of the Patents Act, 1970.