The past few weeks have seen an increase in the number of people infected by swine flu in the country. There is presently no vaccine for the flu and the popular antiviral drug which is being supplied by the government of India is oseltamivir. Oseltamivir (Tamiflu is the patented brand name) is patented by Gilead and exclusively licensed for the purpose of manufacture and sale to Roche. Gilead’s attempt to patent the drug in India was rejected by the Patent Office in March, 2009. This means that Indian generic cannot be prevented from manufacturing cheaper generic versions of the antiviral drug.
As has been pointed out in this news item, the central government is giving rise to an artificial monopoly to the Swiss multinational Roche and its Indian licensee Hetero Drugs by controlling the supply of the antiviral. The Indian generic manufacturers have not begun producing the drug in a large scale as the government is sourcing the drugs mainly from Roche and its Indian licensee, Hyderabad based Hetero Drugs. The government has disallowed retail sale of oseltamivir and is supplying the drugs to hospitals which are authorized to treat swine flu. Although it is legal (in the absence of a patent on oseltamivir), it does not make economic sense for domestic companies to go ahead with the manufacture of generic versions of Tamiflu until the government places orders or allows retail sales of the drug. Generic versions in the market will not only serve to increase the availability of the drug and also bring in competitive prices.
According to Cipla, the Government has been collecting data on the inventory and raw material stock of oseltamivir from manufacturers of the drug, but has not placed any orders. The news item rightly points out that this will adversely affect the speed at which the antiviral reaches the market in the event of a widespread outbreak as Roche India and Hetero Drugs do not have a large scale nationwide retail network compared to other generic manufacturers like Ranbaxy or Cipla.
In light of the growing number of infections, the government is likely to lift the ban on retail sales of the drug soon. This could lead to manufacture of the drug by domestic generic manufacturers. It however remains to be seen if the government will impose conditions in relation to prices of the drugs. Cipla has states that its generic version of Tamiflu, Antiflu will be priced at Rs. 1000 for 10 capsules.
The government has also failed to stockpile Zanamivir, another antiviral which has been globally used to contain the spread of swine flu. The drug is not under patent protection and many Indian generic manufacturers are willing to manufacture the drug. The drug was innovated by Glaxo Smith Kline and is branded as Relenza.
