The CDSCO responds to COVID-19(CDSCO) has granted approval for the emergency use of ‘remdesivir’ to treat novel Coronavirus disease (COVID-19) patients. However, the Union Ministry of Health and Family Welfare (MoHFW), in a conference on June 2, 2020, could not share details of the evidence on the basis of which this authorization was granted.
The CDSCO responds to COVID-19 and also announced that it will prioritize COVID-19 IVD test kits for expedited approval. Manufacturers who already have approval for an IVD in another market are encouraged to contact the Drugs Controller General of India (DCGI) to discuss fast-track approval. Additionally, manufacturers pursuing the development of new IVDs may contact the DCGI directly to solicit guidance on the applicable regulatory pathway.
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India’s Central Drugs Standard Control Organization (CDSCO) has published several notices since mid-March of CDSCO responds to COVID-19 to the ongoing pandemic. These address new measures to expedite access to devices intended to prevent or treat COVID-19, to safeguard supply of other critical IVDs, and to reduce the exposure of CDSCO staff to the SARS-CoV-2 virus.
As part of its rapid response regulatory framework for handling COVID-19 vaccines, the Central Drugs Standard Control Organization (CDSCO) of India says that it is open to considering data generated outside of the country and to otherwise truncating development to cut the time it takes to access a vaccine.
According to rules, the import of such drugs may be permitted after taking an undertaking from the importers by the port officers of CDSCO that the drug will be utilized or consumed before the expiry date and no part of it will be available for sale and distribution after its expiry, informed a circular issued to all port offices of CDSCO.
In the light of the present situation due to the COVID-19 outbreak, the health ministry has instructed to take various steps in order to ensure availability of a sufficient quantity of drugs in the domestic retail market, besides ensuring that the product conforms to be of the prescribed specification. One of the steps is issuing immediate approvals to applications for registration, manufacture and import of pharma,” said the Drug Controller General of India (DCGI).
The CDSCO responds to COVID-19 and has also announced that it will prioritize COVID-19 IVD test kits for expedited approval. Manufacturers who already have approval for an IVD in another market are encouraged to contact the Drugs Controller General of India (DCGI) to discuss fast-track approval. Additionally, manufacturers pursuing the development of new IVDs may contact the DCGI directly to solicit guidance on the applicable regulatory pathway.
CDSCO responds to COVID-19 and Release of critical imported IVDs
The CDSCO issued temporary modified release procedures for other critical imported IVDs (e.g., HIV and HBsAG test kits) to be followed throughout the course of the COVID-19 pandemic, which has caused typical sampling and testing processes to be disrupted. Port offices holding consignments of these IVDs may release them based on a review of documents, protocol, the manufacturer’s batch release certification, and the history of compliance.
However, importers are required to retain a \”sufficient quantity” of IVDs for future analysis and to make a commitment to recall products that fail future laboratory tests. The Central Drugs Standard Control Organization (CDSCO) has allowed import of drugs with less than 60 per cent residual shelf life on the condition that importers give an undertaking that the drug would be utilized or consumed before the expiry date.
A regulatory framework for rapid CDSCO responds to COVID-19
Another notice published by the CDSCO details the decision to fast-track the regulatory approval process for vaccines, diagnostics, prophylactics, and therapeutics designed to prevent or treat COVID-19.
As part of this initiative, the CDSCO is creating a dedicated corona virus unit to address inquiries on the development of these products.
According to rules, the import of drugs may be permitted after taking an undertaking from the importers by the port officers of CDSCO responds to COVID-19 that the drug will be utilized or consumed before the expiry date and no part of it will be available for sale and distribution after its expiry, informed a circular issued to all port offices of CDSCO.
In the light of the present situation due to the COVID-19 outbreak, the health ministry has instructed to take various steps in order to ensure availability of a sufficient quantity of drugs in the domestic retail market, besides ensuring that the product conforms to be of the prescribed specification. One of the steps is issuing immediate approvals to applications for registration, manufacture and import of pharma, said the Drug Controller General of India (DCGI).
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