The government, with immediate effect, has lifted the restrictions on export of 24 API pharma ingredients including Tinidazole, Metronidazole, Acyclovir, Vitamin B1, B6 and B12, Progesterone, Chloramphenicol, Ornidazole, formulations made of Vitamin B1.1


On March 06, the Union Minister of State for Shipping, and Chemical and Fertilizers, had said that the government has imposed short term restrictions on some active pharmaceutical ingredients (API) with regards to coronavirus preparedness. The ease on curbs on export 24 APIs assumed significance as some pharma companies had raised concerns over these restrictions. The total number of COVID-19 positive cases in India has reached 10k+ according to the latest government estimates. However, export restriction on paracetamol, a common fever and pain reliever, and its formulations would remain, as per the resource information.

Note: Earlier, there were no restrictions on outbound shipments of these products. APIs are raw material for pharmaceuticals. India has exported APIs worth approx. USD 225 million last year. The country's API imports stood at around USD 3.5 billion per year. Out of this, about USD 2.5 billion is from China. Besides Vitamin B1, B6 and B12, the other APIs and formulations over which the export restrictions have been eased include tinidazole, metronidazole, acyclovir, progesterone, chloramphenicol, ornidazole, formulations made of chloramphenicol, formulations made of clindamycin salts, and formulations made of neomycin. The restricted APIs and formulations included common antibiotics and vitamins.


Due to continuous request form pharmaceutical sector to remove the ban on the expot of API, central government has finally lifted the ban on assuraane given by the companies that they have enough stock and there will be no shortage of these formulations in India amid the coronavirus outbreak. The Indian Pharmaceutical Alliance (IPA), which represents the country's biggest drug makers, and the Indian Drugs' Manufacturer's Association (IDMA) have written to the government seeking withdrawal of that notification as, according to them, they have surplus to meet the global demand and such a restriction would adversely affect their image.



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