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After a Long Hiatus, Govt Now Mulling Deadline Extension to Medical Device Manufacturers

Written by : Aishwarya Sarthe

October 6, 2023

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This delay in licence issuance has prompted the government to consider allowing these companies to continue production for a limited duration.

The Indian government is considering allowing high-risk medical device manufacturers to continue production for a limited period. 

This potential extension is in response to delays in granting new licenses required to sustain production, reported the Economic Times.

This delay in license issuance has prompted the government to consider allowing these companies to continue production for a limited duration.

The Central Drugs Standard Organisation (CDSCO), responsible for approving such licenses, was expected to issue these licenses by October 1st but faced challenges meeting the deadline. 

As a result, companies that make ventilators, nebulisers, and x-ray machines among others, those have already applied for licences,  might receive an extension to sustain production, albeit temporarily. However, companies that have not initiated the licencing process will not benefit from this extension.

The primary motivation behind this approach is the government's intent to implement a regulation, starting October 1st, whereby all medical devices categorised as 'moderate' and 'high' risks ('class C' and 'class D') will fall under CDSCO's regulatory oversight. 

This step aims to ensure that locally manufactured and imported medical devices meet stringent quality standards before being available for sale within the country.

Previously, several manufacturers had reported applying for licences as early as July, expressing their concern about pending audits delaying the issuance of licenses.

Yesterday we reported that about 200 medical devices manufacturers, facing such issues, have ceased operations. Concerns and calls for swift resolution have emerged on social media platforms, highlighting the significance of resolving this issue for the industry and public health.


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