Banned: No more exports of Remdesivir out of India
Seven Indian companies are producing Injection Remdesivir under a voluntary licensing agreement with Gilead Sciences, USA
New Delhi: With a surge in COVID-19 cases, the Central Government has banned the export of Remdesivir injection and Remdesivir active pharmaceutical ingredients (API) till the pandemic situation in the country stabilises.
"India is witnessing a recent surge in COVID cases. As of 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 the treatment of COVID patients. There is a potential for further increase in this demand in the coming days," the government said in a statement.
Seven Indian companies are producing Injection Remdesivir under a voluntary licensing agreement with Gilead Sciences, USA. They have an installed capacity of about 38.80 lakh units per month.
In light of the above, the Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves.
In addition, the 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 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 the Committee of Experts, and is the guiding document for the 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 contraindications mentioned in the detailed guidelines.
The States and UTs have been advised that these steps should again be communicated to all hospitals, both in the public and private sector, and compliance monitored.