NPPA unable to regulate Remdesivir as it’s not notified as a ‘drug’

The NPPA can only control prices of devices and products that are defined as drugs under the Drugs and Cosmetics Act

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Medicine Injection Doctor
picture: Pixabay

NEW DELHI: India has not set a price for anti-viral remdesivir because it has been approved only as an experimental therapy for Covid-19, leaving the field open for black marketers, who are said to be selling the drug for as much as 10 times the actual price.

The Drug Controller General of India said in June that remdesivir could be included in the clinical management protocol for Covid-19 as an experimental therapy for restricted emergency use on patients.

According to the National Pharmaceutical Pricing Authority, remdesivir has not been notified as a drug and hence it cannot regulate the price of one of the most expensive Covid-19 treatments in India.

Also read: HM to DCGI: To ensure equitable distribution of ‘investigational therapy’ drugs…

The NPPA can only control prices of devices and products that are defined as drugs under the Drugs and Cosmetics Act. A product or device that is not notified as a drug goes out of the NPPA’s purview, people aware of the matter told ET.

In the case of stents and orthopaedic implants too, the government had to notify them as drugs to bring them under price regulation. The DCGI said remdesivir cannot be brought within the ambit of a drug as yet.

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