Monday, October 17, 2011

Government frees sale of Tamiflu, only drug effective against swine flu and bird flu


India's six lakh chemist shops can now stock and sell Oseltamivir Phosphate or Tamilfu - the only known drug effective against both the deadly influenza strains H1N1 swine flu and H5N1 bird flu.

India has decided to lift "restricted sale" of the drug and make it available through all chemist shops against a doctor's prescription. Till now, oseltamivir was the only drug available for treatment of H1N1 swine flu virus humans and indiscriminate and unregulated use access to this drug would have made it ineffective.

That's why the drug was kept under Schedule X of the Drugs and Cosmetics Rules, 1945 which meant it could only be sold by 480 select chemists who had permission to sell Schedule X drugs. The drug had to be kept under lock and key and in premises only responsible people had access to. Record of sales of this drug had to be maintained for a period of two years.




However, the Drug Technical Advisory Board (DTAB) on October 10 decided to bring the drug under Schedule H which means it can be stocked by chemists but sold only against prescription of a registered medical practitioner.

"Till now, limited access was permitted to make these formulations available to the needy patient only and avoid its indiscriminate use. Once the notification is made that oseltamivir phosphate and zanamivir formulations have been brought under Schedule H, as decided in the DTAB meeting on October 10, all chemists in India will be allowed to stock and sell it. However, over the counter sale of these formulations won't be allowed. Chemists will have to sell it against prescription," a health ministry official said.

Tamiflu is a class of medications called neuraminidase inhibitors. These drugs work by stopping the spread of the influenza (flu) virus in the body. It helps shorten the time you have flu symptoms such as a stuffy or runny nose, sore throat, cough, muscle or joint aches, tiredness, headache, fever and chills. Companies that make this drug include Cipla, Metco, Hetero, Strides and Roche.


This drug is presently being used as the first line of treatment in the US, Europe and Japan for cure of seasonal influenza.

DTAB said, "India now has an indigenous swine flu vaccine developed in 2010. Three vaccine manufacturers have already been granted permission to manufacture and market H1N1 vaccine - Serum Institute in Pune, Cadila Healthcare in Ahmedabad and Bharat Biotech in Hyderabad. In view of the fact that incidence of swine flu has come down, it would be suitable to include the drugs under schedule H."

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