Mumbai, Feb 11
As a sequel to the Novel Coronavirus out break in China, the supply of actual pharmaceutical ingredients (APIs) has been severely affected and the Drug Controller of India (DCI) has directed the Food and Drug Administrations (FDAs) across the country to collect information of available stocks of 58 APIs, from drug manufacturers.
API is the part of any drug that produces the intended effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways. Production of APIs has traditionally been done by the pharmaceutical companies, in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs.
Nearly 75-85% ingredients are imported from China. Some 354 drugs and drug ingredients were imported from China in 2017 and the situation was same in the year that followed. But due to the coronavirus, import of APIs has come to a standstill. The Hubei province is considered as a hub of API manufacture. Since January, Hubei remains in a state of lockdown to limit the spread of the virus and imports of APIs from China have stopped. Prior to that, the supply was slow because of the Chinese New Year and holiday season during December.
A top official from Maharashtra FDA confirmed that the instructions to take stock of APIs have been received from DCI and the information is being collected from the 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.
Some of the APIs include: Cyclosporine, Clozapine, Clindamycin hydrochloride, Cyclophosphamide, Ciprofloxacin, Methotrexate, Carbamazepine, Lithium carbonate, Phenytoin, Phenytoin sodium, Lamivudine, Penicillamine, Thiabendazole, Efavirenz, Nevirapine, Rifampicin, Lopinavir, Ritonavir, Zidovudin, Aciclovir and Ampicillin.
Lopinavir and Ritonavir, are used for HIV/AIDS treatment and have been approved by the Indian Council of Medical Research (ICMR) for treatment of coronavirus infection. Amoxicillin, Cephalexine are used as common antibiotics to treat a bacterial infection, Rifampicin is used in tuberculosis regimen. Paracetamol, Doxycycline, Gentamycin, Prednisolone, Meropenam are commonly used APIs.
China remains a major supplier of not just antibiotics, but also Vitamin B12, B1, B6, and E to India. The manufacturers in India had faced a spurt in prices earlier and imports were stopped from China, for some time. For finished products we have a month’s stock right now. But if the situation continues, we need to do something, Indian Drug Manufacturers’ Association (IDMA) Secretary General Daara B Patel, said.
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 and even National health schemes can get affected.
The India pharma industry’s reliance on China for its bulk drugs and APIs and the risk this poses to India’s health security has been a subject of policy discussions for many years now, but with little follow-up action. The current situation is a “call for action” for India to shore up its strength when it comes to drug intermediates, since India imports over 60 per cent of its requirement from China, Secretary-General of the Indian Pharmaceutical Alliance Secretary-General Sudarshan Jain said.
Industry executives fear that if the situation does not improve soon, the cost of materials used to make medicines in India will rise regardless of therapeutic category. In the case of products that are under price control, the prices that customers pay should not be impacted. On earlier occasions, industry bodies had sought an increase in the maximum retail prices of these medicines, arguing that they were unable to recover the cost of manufacturing them.
In the meanwhile, ICMR stated that all the 654 samples from quarantine centres tested proved negative and they will be retested on the day 14 of the quarantine period. Out of 918 samples referred from suspected cases,, three confirmed laboratory positive for nCoV. In addition to ICMR, NIV, Pune, 13 Virus Research and Diagnostic Laboratories across the country and National Centre for Disease Control, New Delhi are performing testing.