Corona outbreak: Govt puts export restrictions on 26 pharma ingredients, medicines

By: Pharma Tips | Views: 1336 | Date: 03-Mar-2020

The government on Tuesday put export restrictions on 26 pharma ingredients and medicines, including paracetamol, vitamin B1 and B12, amid the coronavirus outbreak. With this, export of these active pharmaceutical ingredients (APIs) and formulations requires licence from the Directorate General of Foreign Trade (DGFT), an arm of the Commerce Ministry.



Exports of certain APIs, formulations put under restricted category amid coronavirus outbreak
The DoP had called the meeting on Wednesday to discuss long term solutions for improving domestic production of APIs, which are also known as bulk drugs
Another industry official concurred, saying that the ban was not supposed to take place as the government had assured them



The government on Tuesday put export restrictions on 26 pharma ingredients and medicines, including paracetamol, vitamin B1 and B12, amid the coronavirus outbreak. With this, export of these active pharmaceutical ingredients (APIs) and formulations requires licence from the Directorate General of Foreign Trade (DGFT), an arm of the Commerce Ministry.

Earlier, there were no restrictions on outbound shipments of these products. "Export of specified APIs and formulations made from these APIs ...is hereby restricted with immediate effect and till further orders," the DGFT said in the notification.

The Department of Pharmaceuticals (DoP) has asked the Directorate General of Foreign Trade (DGFT) to ban the export of 12 drugs and their key ingredients due to an outbreak of the novel coronavirus in China, from where these are almost entirely imported.

“The committee after examining the situation has recommended to impose restrictions on the export of following 12 APIs (active pharmaceutical ingredients) and formulations made by using these APIs till further orders" DoP deputy secretary M.K. Bhardwaj wrote to DGFT director general Amit Yadav in a letter on Tuesday. Mint has reviewed a copy of the letter.

The department has asked the trade regulator to ban the export of 12 drugs, including the antibiotics chloramphenicol, metronidazole, tinidazole, erythromycin and neomycin, as well as vitamins B1, B12 and B6. The department also asked for a ban on export of the hormone progesterone.

Bhardwaj in his letter wrote that DoP Secretary P.D. Vaghela has approved the proposal.

However, in a meeting with NITI Aayog and industry officials on Wednesday, Vaghela said that there was not going to be a ban on exports, according to two industry officials and one government official present at the meeting.

“The DoP Secretary had assured us that the government was not planning to ban the export of any drugs after we assured them that there was enough stock of APIs and formulations for a few months," an industry official told Mint, on condition of anonymity.

The industry official said there are two to three months of APIs in the inventory, with another couple of months worth of formulations, which are finished products, with the companies, and a stock of at least one month at distribution and retail level.

Another industry official concurred, saying that the ban was not supposed to take place as the government had assured them.

It is not clear whether the government changed its stance during the meeting, which happened a day after the letter was written.

Phone calls and messages sent to Vaghela seeking clarification on the letter and the subsequent meeting remained unanswered at the time of publishing.

The DoP had called the meeting on Wednesday to discuss long term solutions for improving domestic production of APIs, which are also known as bulk drugs.

“Fruitful, constructive & positive meeting with captains of industry in the pharmaceutical sector to discuss the options for domestic manufacturing of critical APIs on which India is import dependent. Consensus arrived at on a range of policy measures for creating an ecosystem in India," NITI Aayog chief executive officer Amitabh Kant said on Twitter on Wednesday.

Among the various suggestions discussed was setting up of common bulk drug parks and environmental clearance for changing product mix at an API manufacturing plant. The environment ministry said that the government would look into providing faster clearance for API plants, an industry official said.

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