Hyderabad based Hetero Drugs has approached the office of the Drugs Controller General of India (DCGI) seeking marketing approval for oseltamivir, the generic equivalent of Roche's patented Tamiflu drug. The company's move has come at a time when the Central Government has decided to stockpile the drug as precaution against any possible outbreak of avian influenza in the country.
According to highly placed DCGI sources, Hetero is the first generic manufacturer to submit an application for manufacturing and marketing the drug in the country. Companies like Ranbaxy Laboratories Ltd and Cipla Ltd had also let known their capabilities to manufacture the generic version of Tamiflu for both domestic as well as export purposes. However, none of them, other than Hetero, is really known to have gone ahead and applied for market approval. The DCGI is to process the Hetero application for a possible approval.
Sources informed Pharmabiz.com that the approval to the drug regulatory authority may be subject to the positive opinion from various ministries that deal with the intellectual property issues relating to the drug. It should be noted that there is a pending patent application filed by Roche on the drug and there are differences of opinion on the exact nature of market exclusivity that may be enjoyed by Roche. Hetero spokesperson could not be contacted for their view on the issue.
As Pharmabiz had reported earlier, Cipla Limited had recently announced its plans to produce its version of the drug soon. Ranbaxy had also said that they are gearing up for the commercial production of the drug.