Pharmabiz
 

Hetero commits steady supplies of Oseltamivir to govt to control bird flu

Y V Phani Raj, HyderabadWednesday, February 22, 2006, 08:00 Hrs  [IST]

The Central Government has started preparing for the bird flu outbreak by making all out arrangements to procure drugs. The Hyderabad-based Hetero Drugs has already supplied five lakh capsules of Oseltamivir to the Cetntral Government and will be supplying another two lakh capsules by February 22. As a company policy, Hetero will keep ready another one million capsules in stock to meet any contingency, a senior official at Hetero Drugs told Pharmabiz. Swiss pharmaceutical company Roche has recently granted Hetero Drugs a sub-license for the production and marketing of Oseltamivir (generic Tamiflu). Under the sub-licensing agreement, agreed on December 21, 2005, Roche authorized Hetero to manufacture and market both the active pharmaceutical ingredient (API) and finished product of Oseltamivir, for supply to India, least developed countries and developing countries. Avian influenza has become a potential global health threat, and Oseltamivir is currently the most effective drug for the treatment of avian influenza in humans. The sub-licensing agreement between Roche and Hetero aims to increase available supplies of Tamiflu for pandemic use by Governments in developing and least developed countries. The source added, India is better equipped with necessary labs and work force to control any possible pandemic. Maharashtra and Gujarat have been affected at present and other States are acting cautious. Karnataka and Tamil Nadu have restricted supply of poultry from Maharashtra. Andhra Pradesh being a neighbour is also monitoring the situation. The chief minister, Dr YS Rajasekhara Reddy, has met the top officials from poultry and health departments and took account of the current situation. At the national level, the National Institute of Communicable Diseases [NICD], Delhi has been identified as the nodal agency to investigate any suspected cases / outbreak. National Institute of Virology [NIV], Pune has also been identified for laboratory support. Rapid response teams (RRTs) have been constituted and kept in readiness. Indian Council of Medical Research (ICMR) has strengthened Influenza surveillance network with 5 other institutions viz AIIMS; Entero Viral Unit, Kolkata; RMRC, Dibrugarh; King Institute, Chennai; and NIV, Pune. A Task Force under the chairmanship of Secretary (H&FW) was constituted to ensure availability of drugs and vaccines for management of Avian Influenza in the country. This task force decided to procure one-lakh courses of Oseltamivir (Tamiflu). 50,000 courses of Oseltamavir and 10,000 personal protective equipments have already been stockpiled. A contingency plan to manage human cases of Avian Influenza has been prepared and circulated to all States. A model State action plan has also been prepared and discussed with state health secretaries. Dr Anbumani Ramadoss, Union Minister for Health and Family Welfare stated in Lok Sabha on Monday, "As on date there is no confirmed case of human Avian Influenza. I would like to assure the house that the situation is being closely monitored and under control." Industry sources said, the Government and the poultry industry should present the facts, without any scope for distortion. There are few companies in India that are producing anti-virals for the birds and there needs some development in this direction, they pointed. The current outbreaks of highly pathogenic avian influenza (HPAI), which began in South-East Asia in mid 2003 are the largest and most severe on record. The causative agent, H5N1 virus, has proved to be more tenacious. The virus is endemic in many parts of Indonesia and Vietnam and some parts of Cambodia, China and Thailand. Vietnam is on of the most affected countries with estimated 22 deaths, whereas 19 deaths have been reported from Indonesia so far. So far, laboratory-confirmed human cases have been reported in four countries including Cambodia, Indonesia, Thailand and Vietnam. Since 2003, about 120 people have come down with the avian flu, half of whom have died, according to a recent study by the Hyderabad-based Cygnus Business Consulting & Research. Although a vaccine against the H5N1 virus is under development in several countries, no vaccine is ready for commercial production. Two drugs in the neuraminidase class, Oseltamivir (commercially known as Tamiflu) and Zanamivir (commercially known as Relenza) can reduce the severity and duration of illness caused by seasonal influenza. The other older drugs like Amantadine and Rimantidine can also be used. It is estimated that it takes about six months to develop a vaccine for a specific super flu strain from the date on which it appears. The super flu strain is known to undergo mutation. Therefore vaccines have to be renewed on a continuous basis. Although Roche has increased production of Tamiflu eightfold in the past two years, it will take US $ 16 billion and 10 years to make enough of the drug for 20 per cent of the world's population, the Cygnus study stated.

 
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