The central government's decision to continue controlling supply of the swine flu drug, oseltamivir, will help the drug innovator, Swiss multinational Hoffmann-La Roche, and its Indian licencee, Hetero Drugs, maintain their effective monopoly in the country, even as the drug lacks patent protection in India, fear domestic industry circles.
Currently, domestic manufacturers are not focussed on making the drug, due to the effective monopoly and the government's direct procurement from select players, said a generic drug manufacturer. "Unless there is retail sale, manufacturing oseltamivir makes no business sense. If that (retail permission) happens, more companies will come forward to supply the medicine. It will not only increase the availability, but also bring down the price," he said.
At present, the government has disallowed retail sale of oseltamivir, and is directly procuring and supplying the drug to hospitals it has authorised to treat swine flu. Roche does not hold a patent for Tamiflu (oseltamivir is the generic name) in India, as its application for this was rejected by the India patent office in March. Any Indian company can legally manufacture the generic version.
Cipla joint managing director Amar Lulla said the Government has been collecting data on inventory and raw material stock of oseltamivir from all manufacturers of the drug on a day to day basis, but was yet to place any orders.
"Cipla is ready to supply any amount of the drug at cheaper rates, but where are the orders?" he asked.
The government's move could also cramp the speed at which the drug reaches the retail level quickly in case of a large-scale outbreak of the disease, as both Roche India and Hetero Drugs lack the nation-wide retail marketing muscle compared to other generic manufacturers of the drug such as Ranbaxy or Cipla, said sources.
They also questioned the government claim that a possible mass use of the drug may lead to resistance against the virus. "Nowhere in the world are anti-viral drugs sold as restricted items like narcotics," they said.
So far, the government has distributed 7.5 million capsules, out of its stock of 10 million, and has asked companies such as Cipla, Natco Pharma, Ranbaxy Laboratories, Strides Arcolab, Hetero Drugs and Roche India to be prepared to supply another 20 million capsules at short notice.
"All companies capable of supplying oseltamivir capsules can participate in the procurement programme. We have approached all those firms and are in the process of getting the orders finalised", ministry officials said.
They denied any preference to any company in sourcing the medicines.
The government had scrapped customs duty on the import of one million Tamiflu capsules for the government procurement programme in May, despite the fact that domestic manufacturers such as Cipla, Ranbaxy, Natco Pharma and Strides Arcolab were ready to supply the drug at much cheaper rates, said sources.
Sources also complained that the government has not stockpiled Zanamivir, the only other anti-viral drug globally used in effectively controlling the H1N1 virus infection. Innnovated by GlaxoSmithKline and branded as Relenza, the Drug Controller-General of India had 'fast-tracked' its approval process in India two years earlier, when bird flu was spreading in India. The drug lacks patent protection and many Indian manufacturers, including Cipla, are ready to manufacture the drug.
"So far, the government has not asked us to stockpile Relenza. If the government requires, we can supply it at short notice," said Hasit Joshipura, managing director of GSK India, who added that their parent company was planning to launch a vaccine for swine flu by October this year.
Roche India decided on Thursday to immediately donate half of its entire stock of Tamiflu - 500,000 capsules worth Rs 10 crore to the Maharashtra government, following discussions with the Union health ministry.
Tamiflu is the patented brand name of oseltamivir, the medicine for swine flu. Roche has been disallowed patent protection in India.
"In this situation, Roche India is concerned more on how quickly we can control swine flu epidemic and we are not looking at the cost involved in it. Our licencee, Hetero Drugs, is prepared to supply adequate quantities and if required, we can also import and supply," said a senior Roche India official.
