Indian Swine flu drug makers want sell oseltamivir through drug stores; Govt says ‘no’

The Indian Government currently sells oseltamivir only through hospitals and health centres.

Oseltamivir makers in India have asked the government to permit them to sell their low-cost generic versions of the anti-flu drug through pharmacies and drug stores as a measure to improve accessibility of the drug in a case of a swine-flu out break in India.

“Everyone has the right to access medication. If the drug is sold only in government hospitals, then patients in private hospitals will not have easy access to it.” — YK Hamied, chairman, Cipla.

Currently, the Indian government allows the distribution of anti-flu drug oseltamivir only through hospitals and other healthcare outlets. And the pharma companies are restricted from selling the drug directly through retail outlets or through drug stores and pharmacies which are part of a private hospital.

In short, the drug firms can supply oseltamivir only directly to the government or to government hospitals. Selling the drug to the government itself is a cumbersome process. The drug makers have to go through a tender process. And even submitting the tenders doesn’t give them the assurance that the companies bid will be accepted. All these formalities can, in a way, only delay the accessibility of these crucial medicine in an emergency, oseltamivir makers feel.

“Everyone has the right to access medication. If the drug is sold only in government hospitals, then patients in private hospitals will not have easy access to it,” YK Hamied, chairman, Cipla quoted as saying.

Cipla, one of the leading generic oseltamivir producers from India, has recently announced that it can supply 1.5 million doses of oseltamivir within 4-6 weeks after the drug has been ordered for.

The health authorities, meanwhile argue that supplying oseltmivir through medical stores and retail shops can lead to excessive piling up of the drug and subsequent misuse.

But the industry refutes the rationale saying that such a situation would not arise in the case of swine flu (H1N1 influenza A). Although there is a possibility of “panic buying” even by people who do not need it, that is unlikely in the current scenario, they argue.

In other words, the delay in accessing the medicine can only contribute worsening the situation. Since oseltamivir is an antiviral drug that is used in the treatment of both Influenza virus A and Influenza virus B, it is import that the drug to be administered within the first 48 hours of infection to ensure its efficacy.

Oseltamivir is a neuraminidase inhibitor and acts as a transition-state analogue inhibitor of influenza neuraminidase, preventing progeny virions from emerging from infected cells.

However, the government seems to be quite adamant in its position of supplying the drug only through government hospitals.

The drugs would continue to be supplied through government hospitals and health centres and will not be available in retail market, Health ministry joint secretary Vineet Choudhary stated.

Oseltamivir is a patented drug by the Swiss drug maker Roche. However, Roche’s application to obtain a patent for oseltamivir in India was rejected by the Indian Patent Office (IPO) last week, following a pre-grant opposition filed by Cipla and a few NGOs.

In fact, Cipla has been supplying oseltamivir in India after obtaining a marketing approval from the Drug Controller General of India since January 2006. To curtail this, Roche signed technology license agreement with the Hyderabad based Hetero Drugs for manufacturing and selling of Tamiflu in several developing countries, including India.

Now, as part of the programme to stockpile the flu drugs, the government had invited bids from the local oseltamivir makers in India. Though several oseltamivir producers including Cipla and Ranbaxy submitted bids the health ministry gave the order to Hetero Drugs, the licensed manufactures of Roche’s Tamiflu in India.

However, with IPO rejecting the patent claim for oseltamivir, it doesn’t have much difference to be a licensed manufacturer anymore, as the market is now open for all generic players equally, industry observers point out.