New Delhi: The growing demand for the antiviral oseltamivir, or Tamiflu, used to combat swine flu (now renamed A/H1N1 influenza), has led the Indian government to take steps to protect its own stock.
On Monday, the National Pharmaceutical Pricing Authority (NPPA) issued an order to all companies making oseltamivir asking them to provide details of the raw materials and finished formulation.
“The idea behind the move is to make sure that it is not sold to the public and that we also maintain adequate stock of the drug in the country. We are also trying to put a restriction on the export of oseltamivir from India by putting it under the restricted list,” an NPPA official said on Monday on condition of anonymity after the discussions.
India is one of few countries where generic drug makers can provide low cost versions of oseltamivir, making it the preferred supplier of the drug. But with the influenza spreading each day, governments are moving to increase their stock of the drug.
According to the World Health Organization, till 11 May, 30 countries have reported 4,694 cases of A/H1N1 influenza infection and 53 deaths. India has so far not reported a single case of swine flu infection or death.
NPPA’s order was sent to Cipla Ltd, Ranbaxy Laboratories Ltd, Roche Ltd, Hetero Drugs Ltd, Strides Acrolab Ltd and Natco Pharma Ltd, and was copied to the department of pharmaceuticals as well as the directorate general of foreign trade.
It requires each company to state on a daily basis its opening stock, purchase and manufacturing details, sales and closing stock of the ingredients and the finished formulation.
The Indian government had previously announced it would maintain a stock of 10 million doses of oseltamivir as a precautionary measure. The government had till week secured about seven million doses of oseltamivir.
But increasing worry over a possible shortage of shikimic acid, the key ingredient in oseltamivir, has forced Hyderabad-based drug maker Hetero, which has orders to supply nine million doses of the drug to the Indian government, to stop taking further orders.
As on date, Hetero has confirmed orders for supplying 20 million doses of oseltamivir. Its stock of shikimic acid was sufficient for making 25 million doses, according to a company executive.
Roche, which holds the global marketing rights for oseltamivir, has licensed Hetero to manufacture the antiviral in India.
“We stopped taking any more orders because we want to preserve headroom of five million doses, in case the government of India needs more,” said Srinivas Reddy, director (marketing) at Hetero, which is already committed to supplying 9 million doses to the government.
“We have alerted Roche to help with procurement of shikimic acid, through their suppliers,” he said.
Reddy said Hetero is negotiating with Chinese suppliers of shikimic acid, a natural extract from a herb called star anise, to procure 12-13 tonnes of the ingredient. The ingredient can be extracted from other trees as well but only in small, unviable quantities. The herb, on the other hand, is a rich source of shikimic acid, but is mostly found in China.
Cipla faces a similar problem. “We have enough material (shikimic acid) for 1.5 million doses. There is a shortage of shikimic acid, which is why prices have gone up. So, if we want to procure beyond 1.5 million then we will have to pay more,” said Amar Lulla, joint managing director, Cipla. He added that the Chinese government was putting restrictions on the supply of shikimic acid.
Last week, Guilin Layn Natural Ingredients Corp., a Chinese supplier of shikimic acid, said the Chinese government has issued orders requiring them to take prior approval before releasing any information regarding the natural extract’s stock position to public.
To date, China already has confirmed one case of swine flu.