The recent US FDA decision to issue an emergency use authorisation (EUA) for Tamiflu (generic Oseltamivir) as a drug for the swine flu virus outbreak has come as a further boost to Indian generics companies Cipla and Hetero Drugs, firms that manufacture Oseltamivir in India. Tamiflu and GSK?s Relenza (Zanamivir) are the only available options for pandemic flu management. Globally, Tamiflu sales stood at $564 million in 2008, much lower than 2007 sales of $1.7 billion, owing to the bird flu outbreak.
With swine flu deaths rising to 159 in Mexico and the first confirmed death outside that country reported in the US on Wednesday, there is a global alert against the disease. Indian health authorities, for instance, have already said they will double the stock pile of Tamiflu to counter any emergency that might arise.
Prior to the US FDA notification, published on Monday, there was a lack of clarity on the use of Oseltamivir, an avian influenza drug, for diseases such as swine flu. Cipla, which is capable of supplying 1.5 million tablets of the drug, claims to sell the drug at a rate of $1 per capsule against the rate of $6 per capsule at which MNCs are selling the drug. Amar Lulla, CEO, Cipla, told FE, ?We are yet to explore the possibilities of US FDA authorisation for the use of Tamiflu. The decision is significant for us as we have received enquiries from companies based in the US, New Zealand, Mexico, Israel and Latin America.? Earlier this month, the Delhi patent office had rejected the patent application for Tamiflu filed by Gilead Sciences while considering the pre-grant opposition of Cipla.
Srinivas Reddy, director, marketing, Hetero Drugs, told FE, ?We have a high hand over any other generics company in India as we are the licensee of Roche. The efficacy of the drug we are supplying is clinically proved. We are maintaining a minimum quantity of Oseltamivir for emergency requirement irrespective of the orders we receive. We can supply a quantity of 40 million capsules in a span of 3-4 weeks. Also, we have a monthly capacity of 80 million capsules.? However, he refused to disclose the price of the drug due to confidentiality. Hetero has received enquiries from Latin America and African countries. It was in December 2005, Roche Holding AG had given a sub-license to Hetero Drugs to make Tamiflu.
The EUA authority allows the FDA to authorise the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency.
Booster dose
• Prior to the US FDA notification, there was a lack of clarity on the use of Oseltamivir, an avian influenza drug, for diseases such as swine flu
• Cipla claims to sell the drug at a rate of $1 per capsule against the rate of $6 per capsule at which MNCs are selling
