India says companies can make generic bird flu drug
An Indian health ministry official on Wednesday said local firms could make a generic version of Swiss-based Roche’s Tamiflu as an emergency measure for an outbreak of avian flu.
“India could go in for manufacturing of the medicine [Tamiflu] under compulsory licensing if there is a national emergency,” the senior health ministry official, who declined to be named, told reporters in New Delhi.
“But at the moment there are no cases of bird flu in India, so there is no national emergency,” he said.
He said India had not yet granted a “product patent” to Roche for Tamiflu, though a spokesperson for the Swiss firm, Martina Rupp, said on Wednesday the company had filed for a patent application in India.
Rupp noted, for Roche “the problem isn’t the patent, but rather the capacity to produce Tamiflu.”
She was responding to a report in the Times of India on Wednesday by Indian health secretary P Hota who said it was possible for Indian generic drug makers Ranbaxy and Cipla to make the drug now because Roche had not applied for a patent in India.
At a later press conference, Hota said the companies had approached the government about permission to make a generic version of Tamiflu, the antiviral thought to be the best defence against bird flu.
“Ranbaxy and Cipla have approached the government seeking assistance for procuring raw materials, sorting out licensing issues and selling the drug in the market,” he said, adding New Delhi would discuss similar issues with officials of Roche soon.
In March, India’s Parliament passed a patent Bill that prohibits domestic firms from making low-cost generic versions of most patented drugs as part of an effort to extend intellectual property rights under World Trade Organisation agreements.
The law replaced legislation allowing the copy of patented products using a different manufacturing process.
But public health officials worldwide are under growing pressure to allow other companies to make the drug, which is in short supply, in the face of warnings by the World Health Organisation of a possible pandemic of the fatal H5N1 bird-flu virus.
The spread of the human H5N1 strain of avian flu in birds migrating from Asia to Europe in recent weeks has prompted a rush for the drug, which treats symptoms, worldwide.
Roche on Wednesday said it was evaluating several proposals to collaborate on Tamiflu production after announcing last week it would consider license deals for other companies to make the drug.
“Since that announcement we have received numerous offers which we are in the process of examining,” said Rupp, declining to give further details.
Last week, Cipla, which was the first to make cheap generic HIV/Aids drugs, said it would try the same move with a cut-rate version of Tamiflu.
“We are doing generic drugs for treating bird flu,” Amar Lula, joint managing director of Cipla, told Agence France Presse last week. “We have no deal with Roche on the product, but could explore a tie-up.”
India is the fourth-largest producer of medicines, mainly generic, and is a key supplier for poor countries, according to Médécins Sans FrontiÃ¨res.
So far, it appears that all human cases of bird flu contracted the disease from poultry, and not from other people. Cases of people infected by the virus have occurred in China, Cambodia, Indonesia, Thailand and Vietnam.
Earlier on Wednesday, Indian Health Minister Anbumani Ramadoss told reporters there were “no cases of bird flu in India today”.
But India planned to stockpile “one-million doses [of unspecified medicines] to begin with” to deal with an epidemic and was prepared to buy drugs from any willing supplier, he said.
India had no reserves of Tamiflu at the moment but could get about 15 000 to 20 000 doses from World Health Organisation within hours of an outbreak if needed, he said.