The pharma war between Roche and Cipla over the manufacture of Oseltamivir, the generic version of the avian flu drug, has led the government to set up an expert panel as manufacture of the drug is illegal under the patent law.“A committee of experts headed by high-level officials in the Health Ministry is being constituted on October 17. We can answer the questions regarding the issue only after it submits its report,” Secretary, Health, P K Hota, said.The four-member panel comprises the Director-General Health Services, the Drug Controller-General of India and two officials from the Ministry of Chemical and Industrial Development.Generic manufacturers cannot legally manufacture patented drugs in India, but the World Trade Organisation’s TRIPS agreement allows the government to cancel patents and issue compulsory licensing during emergencies. This can force patent holders to licence out their formula to rival companies.“The problem is when can you declare emergency. In this case Roche can approach the Patent Disputes Counsel in Geneva. In case they win the case, the government and the manufacturer will have to compensate them hugely,” Dr C M Gulati, former WHO drug expert and editor of the medical journal MIMS India, said.Roche has sent an application for manufacturing the drug in India to the Union Health Ministry and said it wants to continue to be the only manufacturer of Tamiflu. Cipla, on the other hand, is firm on its decision to manufacture the generic form of the drug.Yusuf K Hamied, chairman of the Mumbai-based Cipla, said his company would approach the government soon. “We live by the law of the land and will abide by it,” said Hamied. He earlier said he was ready to fight it out in Indian courts with Roche which holds the patent.“We are supplying antiretroviral drugs to 90 countries. If there is no problem there why should be a problem for avian flu. We can’t wait for the outbreak to happen and then react,” Hamied added. He said it would not be a problem to produce bioequalents (copying the formula) as Cipla already has a system in place. “The government is in a complex problem as over 1 billion people are at risk. Although the strain is not present in India, what will happen if there is an epidemic — we will have no drugs,” Gulati said.
