Covid-19: Govt lifts restrictions on 24 active pharmaceutical ingredients

The Government of India lifts restrictions on 24 active pharmaceutical ingredients (API) and formulations made from them. These APIs are now allowed to export.

by Sabiya

Updated: Apr 07, 2020 11:38 IST

Tags: India Corona
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API’s Export restrictions

Pharmaceutical groups urged the Government to raise restrictions on the export of active pharmaceutical ingredients (APIs) and formulations. They have enough stock, and there is no shortage of these formulations in India amid the coronavirus outbreak.The Government had put a restriction on the exportation of several antibiotics, hormones, and vitamins, expecting a shortage of these medicines as the coronavirus plague spreads globally.

The Indian Pharmaceutical Alliance (IPA), which describes the country's biggest drugmakers, and the Indian Drugs Manufacturers Association (IDMA) have written to the Government exploring withdrawal of that notification as, according to them, they have surplus to meet the global demand. Such a restriction would adversely affect their image. In case of any Shortages growing unexpectedly, all production and sale of APIs and formulations restrain to domestic consumption only.

According to the department of pharmaceuticals (DOP), It asked an expert committee, It had appeared last month to review the stocks and inventory with the pharma firms. A senior official said that we review the position in Hubei and the current inventory and stocks available with these companies and then make an informed decision.  As part of public health preparation, in respect of APIs, intermediates, and critical starting material, which imported from China, the committee constituted by DOP had recommended restricting. The export of specific APIs and formulation following, which the Directorate General of Foreign Trade (DGFT) in a notification put a restriction to exports of certain antibiotics, hormones, and vitamins, among other medicines.

Officials said the demand of the pharma antechamber groups is unreasonable, given the fact that there is no complete ban on exports. The restriction is carefree to much extent. The companies need NOC from the DGFT. We have to review India's situation before taking any further steps. On condition of anonymity, a technical committee under the Joint Drug controller is working on the material. DOP had earlier identified 58 vital APIs consisting of various antibiotics, vitamins, and other essential medicines, on which the necessity of China is upmost. Certain APIs are paracetamol, aspirin, azithromycin, amoxicillin, ofloxacin, metronidazole. Vitamins like 812, 81, 86, and E, are Female hormone progesterone, HIV drugs Lopinavir and Ritonavir, and blood pressure drug valsartan, amid others. According to the DMA's appeal, The completed dosage formulations of the theatrical APIs suggested for export are manufactured and packed as per the terms, patterns, labeling. Even if the export is restricted, these products cannot be sidetracked to the Indian market and would be an enormous national loss and wastage of high-grade quality medicines. Protection Status