MNCs might have been waiting for this. After issuance of first compulsory license by Indian Patent Office to Natco from Bayer’s for their drug Gleevac which is an anticancer drug, these MNC companies were already tensed that when some new generic company will rise up to the situation and file for compulsory license to the drugs (belonging to these MNCs) that are available in the market at high costs.
As I have already reported in older blogs that Indian government was already eyeing to grant compulsory license to three drugs which were related to cancer. Here I present to you a news that BDR Pharma who is also known as ‘Software Pharmaceutical’ has filed an application with the Indian Patent Office to grant them the same for manufacturing of generic version of dasatinib which is marketed by Bristol-Myers Squibb (BMS) under the trade name of Sprycel and is very effective in chronic myeloid leukemia. This is the country’s second compulsory license application and more could follow.
Mumbai based BDR Pharma filed an application for compulsory license with the IPO on 4th March, 2013. They aere trying to get the approval to manufacture and market the generic version of Sprycel on two grounds which were:
- Non availability of drug
- High price of the product
BDR Pharma in its application has offered to provide the generic version of dasatinib at Rs 8100 for a month’s treatment. This was further confirmed when BDR Pharma founder and CMD Dharmesh Shah was quoted in a statement to Times of India; “We are waiting for the reply of the patent authorities on our application of compulsory license.”
According to the TRIPs Agreement a government of a country can allow a company to manufacture a patented drug under the provision of compulsory license which is a legal provision for overcoming barriers in accessing affordable medicines. In India Section 84, 91 and 92A deals with the compulsory license.
The first grant of compulsory license to Natco has brought down the cost of Bayer’s anticancer drug Gleevac by 97%. After that BDR sought a voluntary license from BMS in February 2012. BMS had raised certain queries which were not valid and after this the pharmaceutical company BDR decided to apply for the compulsory license from the patent office.
Incidentally, dasatinib is one of the three cancer drugs on which the government was planning to issue a compulsory license. A committee established by the health ministry had recommended that the government considered issuing compulsory licenses on three other cancer drugs — trastuzumab, ixabepilone and dasatinib.
BDR Pharma is also in the news as it is planning to launch the generic version of sunitinib in the country at an affordable price. The drug is marketed by Pfizer as Sutent at Rs 61,000 for 50 mg tablets (seven tablets) and Rs 31,500 for 25 mg tablets (seven tablets).
With this we can hope for more compulsory licenses being applied by the Indian generic companies as there are many drugs in the market which are not affordable by majority of the people living in India. So we can hope to see more of compulsory licenses in the coming future.