Free use, as with Tamiflu, risks virus mutation and resistance.
Cipla, the leading domestic drug maker which launched a substitute medicine earlier this month for oseltamivir to treat swine flu, will have to withdraw the stocks of this drug, zanamivir, from retail markets. The central government is to notify a ban on retail sale of this medicine, the only drug other than oseltamivir that is used worldwide to treat swine flu.
The notification is likely in a week’s time, said sources. However, the drug, a low cost version of multinational drug maker GlaxoSmithKline’s brand, Relenza, will be considered for government procurement in the near future, sources said.
Swiss multinational drug major Hoffmann-La Roche’s Tamiflu (oseltamivir) and Relenza are the only two recognised drugs to treat the pandemic swine flu, which has plagued over 1.7 lakh people worldwide and caused 41 deaths in India.
While the government had already restricted the sale of oseltamivir to select government outlets, a similar decision was lacking in the case of zanamivir. “This medicine was not available in the country until Cipla launched the product recently,” a health ministry official said. GSK, the company that markets Relenza globally, is yet to import the medicine for sale in India.
“We had launched the drug at the retail level, but I am not in a position to give further details on this product,” said Amar Lulla, joint managing director, Cipla. Lulla said he was not aware of the government move to restrict its sale at the retail level.
“I don’t know about this and will not comment”, he said, while replying to a query on whether Cipla would legally challenge the move.
Cipla had launched its version of zanamivir, an inhalation drug branded as ‘Virenza’ in the domestic drug market about 10 days ago, following the outbreak of the disease in various parts of the country. Relenza, a pre-1995 molecule, lacks patent protection in India and legally Cipla can manufacture and sell the drug.
The Indian government has not allowed retail sale of oseltamivir in India, arguing that unrestricted use of the drug can cause mutation of the virus, leading to drug resistance against the disease. So far, the Indian government uses only Tamiflu to treat the disease outbreak, imported by Roche and made in India by its licencee, Hetero Drugs.
Sources said the drug was currently available in many retail shops in swine flu-hit Maharashtra, New Delhi, Karnataka, Andhra Pradesh and Tamil Nadu. Cipla’s Virenza is priced at about Rs 800 for one course of five days, including the price for the inhalation device. Internationally, the drug is not prescribed for children below the age of six and those having chronic lung diseases, they said.
Hasit B Joshipura, managing director of GSK India, said the company has not started stockpiling Relenza in India. “We are yet to hear from the government on inclusion of Relenza in the drug procurement scheme,” he said.
Already domestic drug makers like Cipla, Ranbaxy, Strides Arcolab, Natco Pharma and Hetero Drugs have informed the government of their readiness to supply generics of Tamiflu. The government, which had earlier procured 10 million packs of Tamiflu, is planning to soon stockpile another 20 million packs.
