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6 years ago

DGDA can issue NOC for Covid-19 drugs, devices

Ministry amends drug policy amid pandemic

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The Ministry of Health and Family Welfare has authorised the Directorate General of Drug Administration (DGDA) to issue emergency use authorisation (EUA) certificate for the drugs, used for detection, treatment and prevention of Covid-19 infection.

As a result, the DGDA will be able to issue no objection certificate (NOC) as licencing authority to the companies for manufacturing required medicines, investigational drugs (IND), and medical devices.

The ministry has issued a gazette on Sunday in a bid to ensure local production, supply and availability of these items to fight the ongoing pandemic.

In the gazette, the ministry has amended a provision of National Drug Policy 2016 for ensuring availability of the COVID-19-related drugs.

The amendment has been done to incorporate the name of new coronavirus along with Malaria, Nipah, SARS, Tuberculosis, AIDS, Dengue and other communicable diseases.

With the amendment, the drug administration has no legal bar on issuance of NOC or EUA to the pharmaceutical companies.

Talking to the FE on Monday, health ministry additional secretary Habibur Rahman said the amendment has been done to expedite production and supply of new generation drugs for fighting Covid-19 pandemic.

Pharmaceutical company insiders said the government has already sent letters to them, requesting making the drugs, required for Covid-19 treatment, available.

doulot_akter@yahoo.com

 

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