NEW DELHI: Pharmaceutical lobby groups have urged the government to lift restrictions on export of active pharmaceutical ingredients (APIs) and formulations, saying they have enough stock and there will be no shortage of these formulations in India amid the coronavirus outbreak.
The government had put a restriction on export of several antibiotics, hormones and vitamins, anticipating shortage of these medicines as the coronavirus infection spreads globally.
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.
“In case of any shortages developing unexpectedly, all production and sale of APIs and formulations will be restricted to domestic consumption only,” said the letter by IDMA.
According to the department of pharmaceuticals (DoP), it has asked an expert committee it had formed last month to review the stocks and inventory with the pharma firms. “We will review the situation in Hubei and the existing inventory and stocks available with these companies and then take an informed decision,” said a senior official.
As part of public health preparedness, in respect of APIs, intermediates and KSMs (key starting material), which are imported from China, the committee constituted by DoP had recommended restricting export of certain 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 others medicines.
Officials, however, said the demand of the pharma lobby groups is unreasonable, given the fact that there is no complete ban on exports. “The restriction is relaxed to much extent. The companies require NoC from the DGFT. We will have to review India’s situation before we take any further step,” said another official, on condition of anonymity. A technical committee under the Joint Drug controller is working on the matter.
The committee set up by the by DoP had earlier identified 58 significant APIs consisting of various antibiotics, vitamins and other essential medicines on which the dependence on China is upmost. These API are paracetamol, aspirin, azithromycin, amoxicillin, ofloxacin, metronidazole, vitamins such as B12, B1, B6, and E, female hormone progesterone, HIV drugs Lopinavir and Ritonavir, and blood pressure drug valsartan, among others.
According to the IDMA’s plea, “The finished dosage formulations of the affected APIs that are meant for export are manufactured and packed as per the specifications, standards, labelling…Hence, even if export is restricted, these products cannot be diverted to the Indian market and would be a colossal national loss and wastage of good quality medicines,” the letter says.
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