Government lifts curbs on stocking of Tami Flu

New Delhi: In a significant move, the government has decided to lift restrictions on stocking and selling of Osteltamivir or Tami Flu (antiviral medicine for treatment of flu/swine flu) and Zanamivir, a medication used to treat and prevent influenza caused by influenza A and B viruses, allowing lakhs of chemists across the country to sell the drug instead of a few limited ones. In a recent Drug Technical Advisory Board (DTAB) meeting, the government’s chief advisory body on drugs, it was decided to shift both drugs from Schedule X to Schedule H1, enabling the chemists to sell the drug on prescription.

Earlier, the drugs were sold under Schedule X, which means to stock these medicines the chemists would have to procure a special licence besides maintaining records of every unit sold for two years.

However, the DTAB in their recent meeting, proposed amendments in Drugs and Cosmetics rules, 1945 for the inclusion of both the drugs under the appropriate schedule other than schedule X subject to the condition that “details of the manufacture and sale of the drugs should be submitted by the manufacturers to the DCGI at regular intervals and the DCGI should direct his enforcement officials to keep a strong vigil on manufacture, sale of these drugs,” pointed the DTAB.

Antivirus Tamiflu is a restricted medicine is not recommended for general use due to concerns that widespread use will encourage resistance development. To ensure that the drug is used wisely, the drugs will not be available over the counter.

The decision was taken after the pharma companies proposed to the government to repeal the notification of 2009 which led to the restriction on sale of these drugs as specified under Schedule 10.

The Gazette notification issued in 2009 under the Drugs and Cosmetics Act had imposed restrictions for stock and sale of oseltamivir phosphate and zanamivir formulations as a Schedule X Drug. “This had impacted the sale and distribution of drug as only a few chemists could sell the drug. Lifting this restiction will allow over 4 lakh chemists all over the country to sell these drugs. The recommendation to amend the act for its inclusion has already been sent to the government,” sources said.