The Government has made amendments in the export policy and restricted export of specified APIs (Active Pharmaceutical Ingredients) and formulations made from 13 APIs for safety purpose due to COVID-19 outbreak in India. A notification issued by Directorate General of Foreign Trade, Commerce and Industry says that the restrictions will come into immediate effect and until further orders.
The notification covers following APIs and formulations made from these APIs: Paracetamol, Tinidazole, Metronidazole, Acyclovir, Vitamin B1, Vitamin B6, Vitamin B12, Progesterone, Chloramphenicol, Erythromycin Salts, Neomycin, Clindamycin Salts and Ornidazole.
Department of Pharmaceuticals has constituted a committee under the chairmanship of Dr. Eshwara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organization (CDSCO) to address the issues of drug security in the country in the context of Novel Coronavirus outbreak in China.
The committee, in its report, has mentioned that the present stock-inhand of the APIs may be sufficient for 2 to 3 months to manufacture formulations and also given certain recommendations. The committee further mentioned that there is no need to panic so far as drug security is concerned.
Based on the recommendations of the Committee, the department has issued necessary instructions to National Pharmaceutical Pricing Authority (NPPA), Drugs Controller General of India (DCGI) and State Governments to ensure adequate supply of APIs and formulations at affordable prices in the market and to prevent black-marketing, illegal hoarding, creating artificial shortages in the country.
NPPA has also written to Chief Secretaries of States with copies to Principal Secretaries Health and State Drug Controllers requesting them to closely monitor the production and availability of APIs and formulations to prevent the black marketing and hoarding in their States and UTs as well as to ensure that there is no violation of provisions of Drugs (Prices Control) Order, 2013 with regard to compliance of ceiling prices/ permissible increase in prices of scheduled/ non-scheduled formulations respectively. In this regard, Department of Pharmaceuticals has written to DGFT to restrict exports of 13 API and formulations made using these APIs. These APIs are primarily made in Hubei province of China.
As per the latest available information, most of the Chinese companies manufacturing pharmaceutical ingredients (excluding those in Hubei province) have now resumed operations partially and expected to resume fully by end of March. There are no restrictions on the export of APIs from China. The Chinese companies are willing to export to India, however logistics sector has not yet resumed operations fully.
It is observed from Port offices of CDSCO that APIs are being imported from China. As per the information received from port offices of CDSCO, 56 consignments of APIs are imported during 26th and 27th Feb 2020. Out of 56, 40 consignments are from China and rest are from countries other than China.
