Roche India has been issued a customs duty waiver for importing one million capsules of the swine flu drug oseltmavir by the government of India.Roche India, the Indian arm of the Swiss drug giant, will maintain the oseltamivir drug stock as a buffer to supply to the government in case of an emergency situation arising out of a swine flu out break.
The government order exempting customs and excise duty for the importation of one million tablets of Tamiflu 75 mg (oseltamivir phosphate) was issued by Central Board of Excise and Customs.
The one-million duty-free Tamiflu pills will be maintained only for government supply.
The customs duty exemption order has been issued on the recommendation of the Department of Health and Family Welfare.
The health ministry has been in the process of stockpiling the swine flu treatment oseltamivir, setting a target of around 10 million doses as a precaution against the pandemic spread by the deadly H1N1 strain of human influenza virus.
Roche India, the patent holder of Tamifllu drug, is the second drug-maker, approached by the health ministry of India for purchasing oseltamivir for the flu drug stockpile.
However, Roche does not hold a patent for the drug Tamiflu in India as the company’s claim for a patent for oseltamivir was denied by the Indian Patent Office, in April 2009, following a pre-grant opposition by the Indian generic firm Cipla.
Hetero Drugs Ltd, a Hyderabad-based drug-maker, was the first oseltamivir manufacturer to bag the million-dose oseltamivir order from the government of India.
The oseltamivir order placed by the Ministry of Health, Government of India, on Hetero is estimated to worth between Rs 35-36 crore.
Hetero is the only one Indian company that was licensed to produce oseltamivir generic by Roche to be supplied in India and other developing countries following a patent dispute with Cipla.
Cipla Ltd’s version of oseltamivir has recently been included in WHO’s pre-qualification list.
Besides Cipla, other companies including Ranbaxy, Natco, Strides etc also have developed capabilities to manufacture oseltamivir.
Incidence of swine flu cases has more than doubled in the past two weeks as the pig-derived virus became established in countries outside North America, where it was discovered about six weeks ago.
Forty-six countries have officially reported 12,954 cases, including 92 deaths, according to WHO.
The tally excludes 47 new cases in the U.K., 45 in Chile, 42 in Australia, 8 in South Korea, 2 in Ireland, and 1 in Singapore, that were announced subsequently.
Among Chile’s new cases, 19 resulted from community transmission in four regions.
However, WHO is yet to declare swine flu a global pandemic as the agency wants to see more evidence of widespread community transmission before declaring the first influenza pandemic since 1968.
“Countries are saying we want you to take a look at these criteria because if you apply them in the wrong way, they may not help us, in fact they may cause more difficulties,” stated Keiji Fukuda, WHO’s assistant director-general of health security and environment.
India confirmed the first case of swine flu infection in the country in mid-May 2009, in a 23-year-old man who arrived in Hyderabad from the US.