It’s a classic case of the left hand now knowing what the right one is doing.
While Drug Controller General of India (DGCI) Surinder Singh says restricted retail sale of oseltamivir, the anti-viral drug used to treat H1N1, will be allowed in 10 days, ministry officials handling H1N1 containment deny it.
Currently, oseltamivir (or tamiflu) is only given on prescription by designated government hospitals because its misuse leads to resistance to H1N1, lowering its effectiveness to treat the infection.
“A notification allowing the retail sale of oseltamivir is expected in the next 10 days,” Singh said at the CII Life Sciences Conclave.
“I don’t know how he (Singh) said it. There is no change in the government position,” said Vineet Chawdhry, joint secretary, ministry of health, who is heading the H1N1 containment team.
“We had asked the DGCI to explore the option of allowing restricted sale of oseltamivir used to treat H1N1 but it was purely an exploratory exercise,” he said.
Singh had said the drug will be sold in the retail market under Schedule X norms that allow restricted sale of the drug.
Schedule X norms cover the sale of drugs containing psychotropic, narcotic substances. There are around 350 chemist shops in the country that are licensed to sell Schedule X drugs.
Under the Schedule X
norms, the patient will have to produce two copies of the prescription, of which one will remain with the chemist for two years. Besides, the contact details of the doctor will have to be mentioned on the prescription.
“This will help the government to track an indiscriminate use of the drug,” said Singh.
Once a notification is issued, six companies are likely to get government nod to sell the drugs through retail pharmacies said Singh.
Till now, six companies Ranbaxy, Cipla, Metco, Hetero, Strides and Roche have been granted licence for the manufacture and distribution of the drug.
“I repeat, the Centre currently has no plan to allow retail sale of oseltamivir and no such indication has been given to the DGCI or the pharmaceutical industry,” Chawdhry said.