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pharmaceutical industry: Govt frees exports of all APIs, formulations except paracetamol

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WorldIndiaConfirmed4,281Deaths111Confirmed1,345,048Deaths74,565NEW DELHI: India on Monday removed the export restrictions on 24 active pharmaceutical ingredients (API) and formulations, a month after imposing them in the wake of the Covid-19 outbreak. However, the outbound shipments of paracetamol and its formulations continue to remain restricted or need a license from the government to get exported.

The Directorate General of Foreign Trade (DGFT) amended the export policy for APIs such as vitamins B1, B6 and B12, tinidazole, metronidazole, acyclovir, progesterone and chloramphenicol, among others to ‘free’ from ‘restricted’ in a notification dated April 6.

DGFT had restricted the exports of 26 bulk drugs and their formulations on March 3 to ensure there is no shortage of drugs in India due to the lockdown in China’s Hubei’s province, a major source for these raw materials that has also been the epicentre of the coronavirus outbreak.

The government had restricted the exports of paracetamol and vitamins B1, B6 and B12, tinidazole, metronidazole, acyclovir, progesterone, chloramphenicol, erythromycin salts, neomycin, clindamycin salts and ornidazole amid the ongoing coronavirus pandemic.

ET had reported on Monday that the government is considering relaxing export restrictions on these APIs.

Due to the restrictions, exporters had complained that besides blacklisting of the companies by the procurement agencies abroad and imposition of penalties, non-supply of even one item could result in the cancellation of the order for all products.

Moreover, formulations manufactured for exports as per specific country requirements (pharmacopoeia specifications/labels/printing material used) cannot be diverted or utilised in the domestic market.

Almost 30% of India’s pharma exports are to North America, 16% to Europe and 17% to Africa.

Exporters had lined up applications seeking licence to ship restricted bulk drugs.

The relaxation comes in the wake of the the government likely to allow the export of Hydroxychloroquine used for Covid-19 treatment on a case-by-case basis. India, on March 4, imposed a blanket ban on the export of Hydroxychloroquine and its formulations, days after it culled out exceptions for some categories.

Drug and pharma exports from India rose 11.7% on year to $19.15 billion in the 11 months through February 2020.


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