Ministry of Health and Family Welfare

Centre Prohibits Exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the COVID situation in the country improves

Centre takes Various Steps to ensure easy access of Remdesivir to Patients and Hospitals

Posted On: 11 APR 2021

India is witnessing a recent surge in COVID cases. As on 11.04.2021, there are 11.08 lakh active COVID cases and they are steadily increasing. This has led to a sudden spike in demand for Injection Remdesivir used in treatment of COVID patients. There is a potential of further increase in this demand in the coming days.

Seven Indian companies are producing Injection Remdesivir under voluntary licensing agreement with M/s. Gilead Sciences, USA. They have an installed capacity of about 38.80 lakh units per month.

In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves.

In addition, Government of India has taken the following steps to ensure easy access of hospital and patients to Remdesivir:

  1. All domestic manufactures of Remdesivir have been advised to display on their website, details of their stockists/distributors to facilitate access to the drug.
  2. Drugs inspectors and other officers have been directed to verify stocks and check their malpractices and also take other effective actions to curb hoarding and black marketing. The State Health Secretaries will review this with the Drug Inspectors of the respective States/UTs.
  3. The Department of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the production of Remdesivir.

The Government of India has also advised the States that the extant  “National Clinical Management Protocol for COVID-19″, which is based on evidence, has been developed after many interactions by Committee of Experts, and is the guiding document for treatment of Covid-19 patients.  In the Protocol, Remdesivir is listed as an Investigational Therapy, i.e. where informed and shared decision making is essential, besides taking note of contra indications  mentioned  in the  detailed guidelines.

The States and UTs have been advised that these steps should again be communicated to all hospitals, both in public and private sector, and compliance monitored.

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MINISTRY OF COMMERCE AND INDUSTRY
(Department of Commerce)
(DIRECTORATE GENERAL OF FOREIGN TRADE)
New Delhi

Notification No. 01/2015-2020 Dated: 11th April, 2021 

Subject : Amendment in Export Policy of Injection Remdesivir and Remdesivir API.

S.O. 1548(E).—In exercise of powers conferred by Section 3 of the Foreign Trade (Development & Regulation) Act, 1992 (No. 22 of 1992), as amended, read with Para 1.02 and 2.01 of the Foreign Trade Policy, 2015-20, the Central Government hereby makes the following amendment in Schedule 2 of the ITCHS Export policy related to export of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API):

S. No. ITC HS Codes Description Present Policy Revised Policy
Ex 293499 Injection Remdesivir and Remdesivir Free Prohibited
207AA Ex 300490 Active Pharmaceutical Ingredients(API)

2. The provision under Para 1.05 of the Foreign Trade Policy (FTP) 2015-20 regarding transitional arrangement is not applicable for this notification.

3. Effect of this Notification:

The export of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) falling under the ITCHS Codes specified above or falling under any other HS Code has been prohibited, with immediate effect.

[F. No. 01/91/180/24/AM-22/EC/E-27724]

AMIT YADAV, Director General of Foreign Trade

& Ex-Officio Addl. Secy.

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