Hetero bags India’s one-million-dose oseltamivir order even as Strides joins fray

Leading oseltamivir makers like Cipla or Ranbaxy are yet to get the health ministry’s call.

Hetero Drugs Ltd, a Hyderabad-based drug maker has bagged the million-dose oseltamivir order from the government of India, winning over other leading suppliers of the generic version of Tamiflu including Cipla and Ranbaxy.

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 which was licensed to produce oseltamivir generic by Roche to be supplied in India and other developing countries following a patent dispute with Cipla.

Cipla had, earlier, sought to disallow a patent for Tamiflu (oseltamivir) through a pre-grand opposition. Very recently, the Indian Patent Office has rejected Roche’s claim for a patent for oseltamivir and allowed a level playing field for all the oseltamivir producers in India.

Almost all oseltamivir makers in India had bidden for the government order, which aimed to stockpile about 10 million doses of oseltamivir as a reserve to prevent a swine flu outbreak threat in the country.

Hetero supplies oseltamivir to the government at a subsidised rate, about 30 per cent less than the price at which it exports.

“This we do it as part of our social responsibility,” said M Srinivas Reddy, director (marketing), Hetero Drugs.

Apart from India, Hetero Drugs got similar inquiries from other countries, as well.

“Now an additional 25 countries are seeking supply of Tamiflu, though in small quantities,” Reddy said. Hetero is having the licence to market the drug in 100 countries.

But Hetero plans to give priority to the Union health ministry’s order, Mr Reddy said.

According to Mr Reddy, Hetero had the stock ready and the company was only waiting for confirmation from the ministry. The confirmation was expected in a couple of days.

Hetero had supplied nearly one million capsules of oseltamivir Government of India, earlier too. Hetero, which claims to have reached a monthly production capacity of about 80 million doses of oseltamivir within weeks, can still boost the production of the antiviral drug oseltamivir, if needed, the company said.

The Centre is now estimated to be having a stock of over 2 million doses of Tamiflu supplied earlier. Unlike many other drugs, Tamiflu has a shelf life of five years.

The other leading Indian generic makers, who have developed capabilities to produce oseltmaivir, such as Cipla, Ranbaxy and Natco are yet to receive orders from the Indian health ministry.

However, prepared with adequate capacities to meet any demand, they are expecting similar orders from other parts of the world.

“Cipla has the capability to supply 1.5 million dosages of the drug within four to six weeks,” the Mumbai-based company’s chief executive and joint managing director, Amar Lulla, stated

Cipla Ltd has the capacity to supply upto 1.5 million doses generic oseltamivir (Tamiflu) drug to prevent and treat global swine flu outbreak, the company said in a statement.

Cipla has already received proposals from people on behalf of countries in Latin America, Mexico and Israel. However, no approach had yet been made by either the World Health Organisation (WHO) or the Indian government, he added.

Ranbaxy Laboratories, India’s biggest drug maker, is also able to begin supplies of the anti-influenza vaccine at short notice, should it get any orders.

“We produce oseltamavir API and formulations and can start supplies at fairly short notice to meet urgent requirements of countries, to tide over the crisis emerging from outbreak of swine flu,” stated Ramesh Adige, president, Ranbaxy.

Strides Arcolabs starts supplying oseltamivir capsules

Meanwhile, Strides Arcolab from Bangalore also joined the fray announcing that it commercially started supplying  oseltamivir capsules. In a filing to the Bombay Stock Exchange, Strides Arcolab said it has commenced commercial supplies of oseltamivir capsules to various countries.

“We are particularly well equipped to handle such emergencies as we specialise in manufacture and supply of products that are used to treat similar disease epidemics,” Strides Business Development India Operations Aloka Sengupta said.

Strides generic oseltamivir is made in US Food and Drug Administration (FDA) approved and World Health Organisation pre-qualified oral dosage forms. It is prepared in the company’s manufacturing facility in Bangalore, the company claimed.

Oseltamivir is an antiviral drug that is used in the treatment and prophylaxis of both Influenza virus A and Influenza virus B.