Health Min submits details of 'trastuzumab' to DIPP

Trastuzumab is among the three medicines being considered for possible issuance of a compulsory licence

The Health Ministry has submitted to the DIPP all the details of Swiss drug major Roche's anti-cancer drug trastuzumab, which is among the three medicines being considered for possible issuance of a compulsory licence.

"Out of the three anti-cancer drugs, the DIPP has received the details of 'trastuzumab' and the department is examining the proposal," a source said.

In January, the Health Ministry had approached the DIPP for issuance of compulsory licences (CLs) for three anti-cancer three drugs - trastuzumab, ixabepilone and dasatinib, which are very expensive.

Subsequently, the Department of Industrial Policy and Promotion (DIPP) had sought details from the Health Ministry.

"The department has received information, such as price of the drug in the domestic and international markets and also the number of cancer patients in India using trastuzumab," another source said.

The Health Ministry had expressed concerns over the exorbitant prices of these medicines.

While one vial (of 50 ml) of 40 mg trastuzumab costs Rs 1.24 lakh, 60 tablets of 20mg each of dasatinib priced at Rs 1.17 lakh. Similarly, one vial of 45 mg of ixabepilone costs Rs 66,430.

The sources, however, said a decision for CL of these three drugs, the patent for which are held by Swiss drug major Roche and US-based drug maker Bristol-Myers Squibb are unlikely to be taken in a hurry.

Under the Indian Patents Act, a CL can be issued for a drug if the medicine is deemed unaffordable by the government and grants permission to qualified generic drug makers to manufacture it.

As per the WTO agreement, a CL can be invoked by a national government allowing a company to produce a patented product without the consent of the patent owner in public interest.

So far India has issued only one CL -- that of kidney cancer treatment drug, Nexavar owned by Bayer Corporation in 2012 -- to Hyderabad-based Natco Pharma. On the other hand, more than 50 CLs have been issued worldwide by countries, including Brazil and  Canada.

Under Section 92 of the Indian Patents Act, the government can notify the need for issue of a CL on three grounds - circumstances of national emergency; circumstances of extreme urgency; and in case of public non-commercial use.