expresspharmaApril 12, 2021
Tag: COVID-19 , API , Remdesivir
In view of increased demand for remdesivir due to a surge in COVID-19 cases, the Centre said the export of the antiviral injection and its Active Pharmaceutical Ingredients (API) has been banned till the situation improves.
In addition, to ensure easy access of the drug, which is used in the treatment of coronavirus, to hospitals and patients, all domestic manufacturers of remdesivir have been advised to display on their website details of their stockists and distributors, the Union Health Ministry said.
Drugs inspectors and other officers have been directed to verify stocks, check malpractices and also take other effective actions to curb hoarding and black marketing. State health secretaries will review this along with drug inspectors of the respective states and UTs, it said.
Seven Indian companies are producing the injection under voluntary licensing agreement with Gilead Sciences, US. They have an installed capacity of about 38.80 lakh units per month, the ministry said.
“In light of the above, Government of India has prohibited the exports of remdesivir injection and remdesivir Active Pharmaceutical Ingredients (API) till the situation improves,” it said.
The Department of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the drug’s production, it added.
The government of India has also advised states that the extant ”National Clinical Management Protocol for COVID-19”, which is based on evidence, has been developed after many interactions by a committee of experts and it 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 contraindications mentioned in the detailed guidelines, the ministry said.
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, it added.
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