Apr 8, 2020

India’s Central Drugs Standard Control Organisation (CDSCO) has published several notices since mid-March in response 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.

Prioritization of COVID-19 IVD test kits

The CDSCO 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​.

Priority applications are to be processed within seven days. As part of the expedited approval process, data requirements (e.g., for clinical performance evaluations) may be condensed, deferred, or waived on a case-by-case basis.

A regulatory framework for rapid COVID-19 response

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 coronavirus unit to address inquiries on the development of these products.​​

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.

 

Learn how other device markets are responding to COVID-19.

 

New disease prevention policies for CDSCO employees

A last notice introduces workplace measures intended to limit the exposure of government staff to the SARS-CoV-2 virus. Companies dealing with the CDSCO are encouraged to make contact via telephone and e-mail whenever possible instead of entering its facilities. Staff members and visitors in CDSCO offices are encouraged to follow recommended​ practices for hand washing and hygiene, and to wear masks when necessary. Signage will be in place in CDSCO facilities outlining “dos and don’ts” for COVID-19 prevention. The CDSCO will distribute official documents​, such as approvals and clarification letters, via e-mail until further notice.

Learn more about Indian medical device regulations at Emergo by UL:

Author

  • Timothy Herr

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