The Parliamentary Standing Committee on Chemicals and Fertilisers has recommended the manufacturing of Swine Flu medicine by a public sector undertaking considering it as life-saving drug, when the Department of Pharmaceuticals (DoP) has turned down the proposal saying that it is a patented drug.
“The Committee in their original recommendation had observed the efforts made by the Private Sector in producing/supplying medicines for the treatment of Swine Flu. They were, however, disappointed to find that there was no move on the part of the Government to produce the oseltamivir medicine through their PSUs on the plea of it being not economically viable,” according to a recent report by the panel headed by Gopinath Munde.
At present, six private pharma companies are engaged in the supply of Oseltamivir 75 mg capsules in the country. Four of these companies, viz. Hetero Drugs, Cipla, Ranbaxy and Strides Acrolab have facilities for indigenous production of oseltamivir from its raw material i.e. Shikimic Acid. Out of the remaining two companies, Roche has no local production in India and is supplying oseltamivir capsules by importing the same from their corporate set up. The other Company, viz. NATCO has only formulation capability of the capsules based on oseltamivir API.
“The Committee was not convinced by the Government’s logic since production of one specific thing which has been commercially/economically viable for one sector could not be otherwise for another sector, more so when the private Sector does not opt for anything that is economically unviable. In Committee’s view, cost alone could not be always the prime factor particularly when dealing with a pandemic situation like Swine Flu which had taken so many precious lives. Moreover, the Committee had dreaded a situation where the private sector, for some unforeseen circumstances, was not able to produce oseltamivir at all or curtail its production and the Government had no contingency plan in place to deal with the situation. Prudence, therefore, had required the Government to gear up their preparedness to ensure availability of oseltamivir medicine in any eventuality, notwithstanding the commercially viability factor. As it is life saving drug, the Department of Pharmaceuticals should have entrusted to one of its PSUs the job of production of oseltamivir despite the same being unviable. Such company should be compensated suitably, if necessary, through budgetary grant,” the report said.
In its reply, the DoP said that oseltamivir is a patented drug. “The pharma CPSUs do not have API manufacturing facilities to produce oseltamivir. As such, it is not being manufactured by pharma CPSUs. The CPSUs also do not have the generic composition to launch their own brand,” the Department said.
However, the panel has come down on this attitude. “The Committee is not convinced again with the reply of the Government that oseltamivir is a patented drug. The Committee would like to be apprised of the facts/ reasons when six private sector companies who volunteered for production and availability of oseltamivir API and capsules could develop, acquire and create API manufacturing facilities/ generic composition to produce and launch oseltamivir why CPSUs failed to respond positively and actively to fight the pandemic influenza and save their own countrymen by following the footsteps of these six companies, by overcoming the bottlenecks coming in the way to produce and make available life saving drug as a welfare measure and serving the cause of humanity for which the very same CPSUs were created and established in the country,” it said.