The Central Drugs Standard Control Organization (CDSCO) has established a new unit — the “Coordination Division” — as India broadens the mandate of its drug regulatory authority beyond just quality testing.

With multiple tasks ranging from approval and regulation of drugs, vaccines, cosmetics, and medical devices, CDSCO is running risk-based inspections and audits across the country at pharmaceutical firms, medical device-making units, contract research organisations, and private and public laboratories. The cdsco registration process and cdsco approval process in india remain important aspects of CDSCO’s responsibilities, ensuring that medical devices meet safety and regulatory standards before entering the market.

The health ministry has also asked CDSCO to wipe out the concerns of counterfeit medicines from the Indian market while pushing small and micro pharmaceutical manufacturers to upgrade their units on par with global standards. In addition, the cdsco medical device registration has become a significant area of focus, with CDSCO ensuring that imported medical devices meet Indian regulatory requirements before they are allowed into the market.

“Amid the ongoing changes at the CDSCO, the industry is experiencing delays of at least one to two months in the processing of requests and applications. Given the limited manpower and an expanding list of responsibilities, this new arm has been introduced to free up key personnel, allowing them to focus on handling priority areas.

List of tasks:

The document further details the work responsibilities shifting from other departments to the new coordination division such as:

• Submission of monthly summary to Cabinet (earlier handled by DTAB and DCC division)
• Monitoring coordination requirements in CDSCO that are not specifically allocated to other sections
• Collating achievement of CDSCO objectives as directed by the ministry from time to time
• Monitoring circulation of general circulars
• Monitoring circulation of training circulars and vacancy circulars (earlier done by the administration division)
• Collecting and collating sample data related to the SSDRS scheme (transferred from GCT & Ethics Committee)

Conclusion

The new Coordination Division will help CDSCO streamline the CDSCO registration process and the CDSCO approval process in India, and CDSCO medical device registration, improving efficiency and supporting India’s growing healthcare regulatory needs.