India is again in news for its policy on compulsory license. After being in news for issuing first of a compulsory license on Nexavar, Indian government has decided to issue compulsory license for three more drugs (Indian Express news) which are related to the treatment of cancer.

The three anticancer drugs that are the target now are:

1. Trastuzumab or Herceptin that is used at present for the treatment of breast cancer.

2. Ixabepilone which is being used for chemotherapy

3. Dasatinib that is used to treat leukemia.

Trastuzumab is a product of Roche and Ixabepilone and Dasatinib are the products of Bristol-Myers Squibb.

The new drugs that are brought under the compulsory license regime cost about 3 lakh. A CEO of Indian generic company which is engaged in dispute with MNCs, said on condition of anonymity, “These cancer drugs cost about 3 lakh per month. How many patients in India, where there is no public insurance facility is available, can afford these prices?” Unless MNCs will be ready to change the strategy for 1.2 billion people in India, issuing compulsory licenses will be the only option to make drugs affordable to Indian population, he added.

These will be the addition to the Nexavar drug that has already been issued a compulsory license. The Nexavar belonged to Bayer and the compulsory license was issued to Natco for the production of generic version of Nexavar and that has led to about 95% decrease in the price of the drug. Nexavar used to cost around 2.8 lakh rupees but the generic version of Nexavar cost only 8.8 thousand rupees.

Compulsory license is a part of the TRIPS that allows the government of a country to issue a license to a company for the manufacture of a patented drug and that too without the consent of the company owning the patent for the drug.

These drugs were brought under the scanner by the Health ministry of India.

The compulsory license is issued under Section 84 and 92 of the Patents Act, 1970. According to section 84 of the Indian Patents Act 1970, Compulsory licensing (CL) can be issued in India if the patented drug is unavailable, unaffordable, or not supplied properly whereas section 92 deals with the special provisions for the issuance of compulsory license on notification by the Central government.

Officials at the Department of Pharmaceuticals said it was too early to predict the post-CL price of these drugs. Dr Shyam Aggarwal, consultant oncologist at Sir Ganga Ram Hospital, said, “Even after the recent cut in the prices of Trastuzumab and Dasatinib, they are still way too expensive for the common man. It is a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European nations.”

The Cancer Patients Aid Association (CPAA) has welcomed the government move.

YK Sapru, founder chairman & CEO, CPAA said, “Giving compulsory license for a few more anti cancer drugs is a very good move, especially Herceptin which was required by a large number of breast cancer patients who were dying because the drug was not affordable.”


It is to be seen here that even the government is trying to decrease the prices of the drugs for the patients and most of the major hospitals and cancer associations are appreciating this move but the government is also making multi-national companies lurch. This will not affect the market of drugs for now but with time the MNCs that are hoping to be a part of India’s multi-billion dollar industry of drugs will move away and would not invest in India. Owing to decisions of compulsory license as well as using strict guidelines for FDI will result in the movement of MNCs out of the country and that will surely hamper the growth of India and will also result in economic losses.