With the novel coronavirus outbreak in China stalling import of crucial Active Pharmaceutical Ingredients (APIs), the government has asked all state Food and Drug Administrations (FDAs) to reach out to drug manufacturers and understand how much stock each has of 58 crucial APIs.
APIs are a raw material used to make a pharmaceutical drug. India relies on China for 65-70 per cent of its annual API requirement. Stocks may last another two months, several domestic drug manufacturers said.
The list of 58 APIs includes Lopinavir and Ritonavir, both used for HIV/AIDS treatment and recently approved by the Indian Council of Medical Research (ICMR) for treatment of coronavirus infection. Amoxicillin, Cephalexine used as common antibiotics to treat a bacterial infection, Rifampicin used in tuberculosis regimen, and commonly used APIs like Paracetamol, Doxycycline, Gentamycin, Prednisolone, Meropenam are also on the list.
The province of Hubei, where novel coronavirus was first reported in December, is a major hub of API manufacturers, apart from two other provinces in China. Since January, Hubei remains in a state of lockdown to limit the spread of the virus.
Since a fortnight, domestic manufacturers said, imports of APIs from China have stopped. Prior to that too the supply was slow because of the Chinese New Year and holiday season during December.
“We received directions from the DCGI (Drug Controller General of India) on Thursday to inform about the quantity of APIs available with each local manufacturer. The process to reach out to manufacturers has begun,” a Maharashtra FDA official said. Maharashtra has 885 drug manufacturers.
The government is also collecting data on overseas manufacturers of APIs, the quantity imported since 2018, as well as the production capacities of domestic manufactures in case a scale-up is needed.
Imports from other countries would escalate cost by 20-30 per cent for Indian manufacturers. “We will need government support, they would have to reduce import duty,” Daara B Patel, secretary general, Indian Drug Manufacturers’ Association (IDMA), said.
An official of a multinational pharmaceutical company pointed out that it was not easy to immediately scale up API manufacturing units in India.
China remains a major supplier of not just antibiotics but also Vitamin B12, B1, B6, and E to India. “Even in the past we had faced a spurt in prices, and for some time imports were stopped from China. For finished products we have a month’s stock right now. But if the situation continues, we need to do something,” said Patel.
According to Sakthivel Selvaraj, Director, Health Economics, Financing and Policy Unit, Public Health Foundation of India, India was self-sufficient both in terms of APIs and drug formulations till the Nineties, but the cheaper rates offered by China pushed several to import APIs over the last 15 years.
“Coronavirus and its impact in India will be a worrisome factor. If domestic production, that accounts for 30 per cent of APIs, is unable to cope up, key medicine supply for malaria, tuberculosis, HIV, cancer and even diabetes may get hampered. National health schemes can get affected,” Selvaraj said.
Pharmaceutical company Cipla Limited said there were reports of price rise of specific APIs after the coronavirus outbreak. “But we have sufficient store of necessary ingredients for the next couple of months. We are hopeful of the situation getting better and supplies evening out. The industry might have to prepare alternatives otherwise. As of now, the industry is yet to fully feel any major impact,” Kedar Upadhye, Global CFO, Cipla Ltd, said.
Until Saturday, coronavirus had led to more than 700 deaths globally, almost all in China. Dr Sarada Devi, Head of the Microbiology Department in Government Medical College, Thiruvananthapuram, said currently for their stable patients, like the only three who have tested positive for coronavirus in the country, only symptomatic treatment is being offered. “But we will need anti-retroviral drugs, mainly Ritonavir and Lopinavir, if patients develop chest infection. That is the recommendation from the ICMR,” she said.
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