DCGI warns chemists shops against selling swine flu drug oseltamivir

Oseltamivir will be supplied free through the government healthcare network in case of emergency to avoid drug resistance. India’s top drug regulator has heightened its vigil against selling anti-flu drug oseltamivir through retail drug stores warning strong action.

The Drug Control General of India (DCGI), Dr. Surinder Singh issued a directive to all regional drug regulatory offices in the country to step up the vigil on the import of the flu drug oseltamivir and to ensure that no such products ordered through internet are imported by courier or speed post and delivered to consumers for personal use.

DCGI’s action comes following reports that, oseltamivir the only known anti-viral drug for treatment of the Influenza A (H1N1) virus, was easily available in stores across the country.

Oseltamivir was being sold across the counters in several medical stores in Bangalore and other parts of the country.

Some retail drug stores in Vijaynagar were even ready to sell it without a prescription from the doctor, according to a news report.

A strip of 10 capsules manufactured by Roche, the first company that was issued a licence to manufacture the drug in India in October 2005, costs Rs. 1,700.

The retail drug stores supplied oseltamivir refused to give purchase receipts claiming that the drug was imported.

The Union Health Ministry recently issued a directive prohibiting chemists in India from selling oseltamivir phosphate in retail outlets.

The government of India has adequate stock of this drug that shall be distributed free through the Public Health Network in case of an emegency.

Oseltamivir, the only treatment that India stockpiles for the H1N1 influenza (swine flu), if used indiscriminately could result in the virus developing resistance, making the drug ineffective.

“It is illegal to sell the drug in retail following the advisory as the virus could develop resistance to the drug if it is used indiscriminately. Apart from swine flu, this drug is also used as an anti-viral medicine for several other infections such avian flu (H5N1 virus) and also for poultry,” the DCGI Surinder Singh was quoted as saying.

As there is no provision under the Drugs and Cosmetics Act as on date to restrict the sale of any drug, the advisory has been issued under the Essential Commodities Act.

If the stores were found selling it, they would be raided and punished, he warned.

Not only in Bangalore, but retail chemists from other regions too are found to be selling oseltamivir at very high prices taking advantage of the panic situation arising out of swine flu.

Obviously, “there is a possibility that some of the importers may be procuring this product through internet/courier/speed post from outside India,” noted the DCGI in his latest circular to zonal offices.

The state drug regulators are directed to ensure that the drug is not sold through retail stores.

The health ministry of India has ramped up its preventive measures to safeguard the country against a possible outbreak of  swine flu in the country as the first case of swine flu infection got confirmed in the country, last week.

India has set its stockpile of the antiviral oseltamivir target to 10 million doses from about three million currently, as it joins a host of Asian nations in stepping up surveillance to check the spread of the H1N1 flu in the region.

The National Pharmaceutical Pricing Authority (NPPA) has already asked drug makers in India to give periodic report pertaining to the stock of the common anti-flu drug situations.

The leading oseltamivir producers including Cipla, Ranbaxy, Roche, Hetero, Strides and Natco have been asked to give details on the stocks of the drug everyday by 4.30 p.m. to NPPA.

NPPA’s latest step is to ensure the oseltamivir selling prices are not moving up in the retail market in case of an emergency, besides keeping a close vigil on the availability of uninterrupted supply of drug in an outbreak like situation.