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-in hand 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, the 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 the 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, the 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 the rest are from countries other than China.
Department of Pharmaceuticals, M/o Chemicals & Fertilizers Government of India
New Delhi: 03 March 2020
