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Govt rolls back plan to ban export of APIs and essential drugs as API units resume production in China

Laxmi Yadav, Mumbai
Thursday, February 13, 2020, 08:00 Hrs  [IST]

The central government has now rolled back its plan to ban export of APIs and essential drugs as pharmaceutical companies in Chinese regions affected by coronavirus have resumed operation, except Wuhan region, the epicenter of coronavirus outbreak.

The Wuhan region accounts for 20 per cent of bulk drug supply to India. The country has alternate source of these supplies comprising of chlorofin, B-complex vitamins, female hormonal products-- progesterone etc. Hence they are not of much significance. The only concern area is key starting materials of antibiotics- azithromycin, amoxicillin, ofloxacin, gentamicin and metronidazole which are supplied from Wuhan to India but supplies can be sourced from units located in other regions, said a drug maker on condition of anonymity.

India imports APIs from Shandong, Zhejiang, Henan, Hubei, Hunan, Guangdong regions located 700km away from Wuhan. These regions have not much affected by coronavirus and production in the units located there resumed as per Indian embassy in China, he said.

In 2018-19, India imported bulk drugs and intermediates worth US$ 2.4 billion from China. In 2017-18 the import of bulk drugs and intermediates from China to India stood at US$ 2,055.94 million.

A panel set up by the government under chairmanship of Drugs Controller General of India (DCGI) last week to deal with repercussions of coronavirus outbreak on supply of Chinese APIs in India, has decided to closely monitor the situation after the Indian embassy in China informed it that several drugmakers there have resumed operations.

Said Nipun Jain, SME panel head, Pharmaceuticals Export Promotion Council (Pharmexcil), “We should wait and watch China situation closely and hopefully things will normalize within two weeks.”

The members of the committee include drug associations- Indian Drug Manufacturers' Association (IDMA), Indian Pharmaceutical Alliance (IPA) and Organisation of Pharmaceutical Producers of India (OPPI), Bulk Drug Manufacturers' Association (BDMA), the Directorate General of Foreign Trade (DGFT), the Indian Council of Medical Research (ICMR), the National Pharmaceutical Pricing Authority (NPPA) and Pharmexcil.

The drug makers have submitted a list of 57 essential APIs which may go out of stock if lockdown continues in China to the committee.

The list contained azithromycin, amoxicillin, ofloxacin, gentamicin and metronidazole, clavulanate potassium, metformin, paracetamol, vitamins--B12, B1, B6, E, hormonal therapy drugs, anti-cardiac arrest drug atorvastatin among others. Drug companies informed the committee that on an average, they keep API stock of two months.

Meanwhile, it is learned that there is shortage of certain APIs--paracetamol, azithromycin which has forced the government to consider slowing down the export rather than stopping it, so that there will be no shortage of bulk drugs in the country.

Since China has extended New Year holidays till mid February in the wake of coronavirus pandemic, the prices of certain APIs-  azithromycin, paracetamol, erythromycin and vitamins have gone up in India ranging from 10-50 per cent as traders started hoarding the stock.

Action should be taken against traders charging margin more than 15 per cent for APIs by DoP, said a manufacturer on condition of anonymity.

Said Dr Rajesh Gupta, All India Head-pharma Laghu Udyog Bharati, “ To curb the bulk drugs and excipients prices, they should be brought under price control as per formulations.”


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