Compulsory licensing required for Bristol-Myers Squibb Co.’s anti-cancer drug Dasatinib

An expert committee on compulsory licensing recommended to the DIPP to issue a compulsory licence for anti-cancer drug Dasatinib.

Sep 13, 2013 19:29 IST
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An expert committee on compulsory licensing recommended to the Department of Industrial Policy and Promotion (DIPP) to issue a compulsory licence for the manufacture of Bristol-Myers Squibb Co.’s anti-cancer drug Dasatinib. This drug is used in the treatment of chronic myeloid leukaemia.

Dasatinib became the second drug recommended by the DIPP for compulsory licence. In March 2012, India issued its first compulsory licence to Natco Pharma Ltd. for the manufacture of Bayer AG’s Nexavar anti-cancer drug.

The Health Ministry approached DIPP in January 2013 for compulsory licences of three anti cancer drugs namely Roche Holding AG’s breast cancer treatment  Herceptin (Trastuzumab) , Bristol mayers Squibb’s lekeamia medicine Sprycle (Dasatinib) and Ixempora (Ixabepilone).

The proposal was made by the health ministry to the DIPP to make the cancer drug cheaper. Now a month’s dose cost is 1.6 lakh rupees.  

According to Section 85 of the Indian Patents Act, 1970 a compulsory licence for manufacture of a patented pharmaceutical product can be issued, if the drug is considered unaffordable by the Government.

Role of Trade-Related Aspects of Intellectual Property Rights

Trade-Related Aspects of Intellectual Property Rights (TRIPS) of The World Trade Organization’s (WTO) agreement allows a country to issue a compulsory licence without the consent of the innovator, if it is in public interest.

About Dasatinib

It is anti cancer drug. This drug is manufactured by Bristol-Myers Squibb Co (BMS). If compulsory licence is issued on dasatinib, the cost of the drug comes down to 8000 rupees from 1.6 lakh rupees for one month dose.

About Chronic Myeloid Leukaemia

Chronic Myeloid Leukaemia (CML) is a type cancer that affects the blood and bone marrow. In CML the bone marrow produces too many white cells called Granulocytes. These cells sometimes called blasts or lekaemic blasts gradually crowd the bone marrow, interfering with normal blood cell production. They also spill out of the bone marrow and circulate around the body in the bloodstream. Because they are not fully mature, they are unable to work properly to fight infections. Over time, a shortage of red cells and platelets can cause anaemia, bleeding and/or bruising.

CML usually develops gradually, during the early stages of disease, and progresses slowly over weeks or months. It has three phases: the chronic phase, the accelerated phase   and the blast phase. These phases are distinguished by the number of blast cells (immature white cells) in the blood and bone marrow, and the severity of symptoms.

Department of Industrial Policy and Promotion

The Department of Industrial Policy and Promotion was established in 1995 and has been reconstituted in the year 2000 with the merger of the Department of Industrial Development. It comes under the Ministry of Commerce and Industry of Government of India.

The role and functions:

• Formulation and implementation of industrial policy and strategies for industrial development in conformity with the development needs and national objectives.
• Monitoring the industrial growth, in general, and performance of industries specifically assigned to it, in particular, including advice on all industrial and technical matters.
• Formulation of Foreign Direct Investment (FDI) Policy and promotion, approval and facilitation of FDI.
• Encouragement to foreign technology collaborations at enterprise level and formulating policy parameters for the same.
• Formulation of policies relating to Intellectual Property Rights in the fields of Patents, Trademarks, Industrial Designs and Geographical Indications of Goods and administration of regulations and rules .
• Administration of Industries (Development & Regulation) Act, 1951.
• Promoting industrial development of industrially backward areas and the North Eastern Region including International Co-operation for industrial partnerships.
• Promotion of productivity, quality and technical cooperation.

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