India might be shining for multinational drugmakers, but when it actually comes to introducing innovator drugs the $20 billion Indian pharma market is light years away.
The time gap between introduction of an innovator drug in the US market and its launch in India is widening.
A recent case in point is AIDS drug darunavir. It was approved by US FDA (US Food & Drug Administration) in June 2006, and in December 2008 its maker Tibotec Pharma (a part of US major Johnson & Johnson) signed a licence agreement with Pune-based Emcure Pharma for its distribution in India.However, J&J’s darunavir is still not available in India.
A J&J spokesperson says Emcure has received the marketing approval, site approval and import licence to launch darunavir in India, and the drug would be introduced in the first half of 2010.
J&J has several patent applications for various forms of darunavir in the Indian patent offices, of which one was rejected in 2009 for not meeting the patentability criteria laid down in the Indian Patent Act.
Had the patent been granted, no generic version could have been introduced, and with the innovator drug yet to hit Indian shores, patients would have to suffer.
According to Loon Gangte, president of Delhi Network of Positive People, which works with HIV/AIDS people, darunavir is an important second line treatment, especially when patients develop resistance to first line drugs.
According to Leena Menghaney, project manager-India at international aid organisation MSF (Access Campaign), for patients in developing countries, generic registration becomes crucial for availability of drugs.
Pharma experts say that usually MNCs don’t prefer quick launches of innovator drugs in developing countries.
Another example is the HIV drug tenofovir which was applied for registration in India by its US company Gilead Sciences only in 2006, despite getting a US FDA approval in 2001.
Menghaney, says that experience shows that MNCs do not prioritise access, and their marketing decisions target high income countries rather than those with a high burden of HIV/AIDS.
“It’s 5-6 years before an innovator drug is introduced in developing economies. The time gap has got nothing to do with regulatory approvals but is a commercial issue. If the drug is introduced at US price, there might not be a market in India,” says D G Shah, secretary general of Indian Pharmaceutical Alliance
Prezista is internationally priced at $9000 (Rs 420,000) per annum, whereas the generic darunavir by Cipla is for Rs 114,000 annually.Prezista had global sales of $592 million in 2009, a growth of 77% over 2008 numbers.
Ironically, darunavir was discovered by Arun K Ghosh (after whom it is named), a chemist at the public research University of Illinois at Chicago, and later developed by Tibotec Pharma, which was acquired by J&J in 2002.