Although no evidence of the avian flu virus has been found in India so far, with global fears growing of the possible spread of an epidemic, the Union Health Ministry has received an application from Swiss pharma giant Roche for permission to sell its anti-influenza drug, Tamiflu, in India.
The flu’s deadly H5N1 virus is resistant to Amantadine and Rimantadine, two commonly used influenza drugs available in India. Tamiflu is the only one considered to be effective so far.
While the government says it’s ‘‘processing the application on fast track,’’ in view of the threat, Indian drug firm Cipla has now announced that it’s ready to make a cheaper version of the drug.
The New York Times reported today that Cipla announced it would start making a generic version of Tamiflu, which is in critically short supply in the face of a possible epidemic.
‘‘Right or wrong, we are going to commercialise and make Oseltamivir,’’ Yusuf K. Hamied, chairman of Mumbai-based Cipla, told The New York Times. Oseltamivir is the drug’s generic name. He acknowledged he might face a legal challenge in the Indian courts from Roche that holds the patent. He told the newspaper that Cipla’s scientists had finished ‘‘reverse-engineering the drug’’ two weeks ago and could have small commercial quantities available as early as January 2006.
Speaking to The Indian Express from Marbello in Spain, Hameid said: ‘‘My effort is a wake-up call for the people and the government. If the bird flu spreads, people should be prepared…I don’t know about retaliation measures (by Roche)…but my effort is a humanitarian measure.’’
‘‘We’re in the process of making the generic version of this anti-influenza drug to treat bird flu. We have already started production…now the process of commercialisation is going on,’’ said the CEO who first attracted global attention by selling anti-AIDS drugs at rock-bottom prices. ‘‘My market is open, including India. Nobody can predict the spread of bird flu epidemic…it can reach anywhere, including India.’’
Confirming the Roche application, Drug Controller General of India, Ashwani Kumar said: ‘‘We are processing the application on a fast track as avian flu is proving to be a potential threat.’’
If the application clears all norms set by the Health Ministry, officials said, the medicine would be stockpiled as migratory birds pose a risk of bringing the disease to the country. This strain of influenza struck bar-headed geese in Quinghai, China. Most of the birds from the lake migrate to India and Myanmar.
India so far has not reported the virus in any form—in human or birds.
‘‘We are going to keep stocks for emergency. We have asked for advice from the WHO’s technical committees,’’ said P K Hota, Health Secretary.
The H5N1 virus has so far resulted in the death of millions of birds and has infected about 100 persons across the world. It has the potential of jumping from animals to humans. Though no reports of jumping from humans to humans have come so far, experts fear the virus can be deadly if transmission from one person to another is reported.
The fear is not unwarranted as reconstruction of the 1918 Spanish flu vaccine, carried by international journals, showed that it was the avian strain that mutated enough to infect humans directly and easily. The strain killed millions of people in the US alone.
The H5N1 virus has not been found in India so far. The High Security Animal Disease Laboratory in Bhopal, the apex laboratory for testing diseases among animals, says not a single strain of the deadly H5N1 virus has been found in India in the last five years. ‘‘The only flu strain found so far is H9N2 which is a non-pathogenic strain and has not caused any disease in animals,’’ said H K Pradhan, the lab’s joint director.
The laboratory has tested 22,000 samples and only a negligible percentage have shown the H9N2 strain. In the last three months, the laboratory has tested 3207 samples and none of them tested positive for the virus.
The government is monitoring 50 bird sanctuaries across the country. A team of experts from the lab will visit bird sanctuaries, including Bharatpur, next week to check migratory birds for the deadly H5N1 avian flu strain.
‘‘The birds have already started coming and testing needs to be done before the birds start mixing with the local poultry,’’ said Pradhan.