Efficiency Measures Implemented for Document Submission to CDSCO
These measures are designed to expedite the processing of documents within the CDSCO, reducing paperwork and enhancing the overall efficiency of regulatory affairs. The move towards digital documentation aligns with the broader global trend of modernizing administrative processes and promoting sustainable practices.
CDSCO permits applicants of Class C & D Medical Device Licences to continue Operations
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular clarifying that an existing manufacturer or importer of Class C or Class D medical devices can continue to import/ manufacture these devices till 12th April, 2024. This circular has been issued with the view to limit the disruption to business continuity.
CDSCO Grants Approval to Private Testing Laboratories to test Cough Syrups to be Exported
Central Drugs Standard Control Organisation (CDSCO) has granted approval to 3 NABL Accredited Private Testing Laboratories to test cough syrups to be exported by manufacturers and authorised persons of manufacturers/ exporters. This notice was issued on 13th September, 2023.
CDSCO issues alert on Falsified Versions of Adcetris Injection
Patients and healthcare professionals are urged to remain vigilant and cautious in their dealings with Adcetris Injections, seeking only authorized sources and promptly reporting any unusual reactions or suspicions regarding the medication. These measures will help ensure that patients receive genuine and effective treatments while safeguarding them from potentially harmful counterfeit drugs.
Alert Issued by DCGI on Abbott India’s Digene Gel
The Drugs Controller General of India (DCGI) has issued a precautionary alert concerning Abbott India’s antacid product, Digene gel, manufactured at its Goa facility. This action follows Abbott India’s disclosure that certain batches of the product have been subject to complaints regarding their color and taste, which deviated from the normal standards.
CDSCO revises its Drugs Alert List for June 2023
The Central Drugs Standard and Control Organisation (CDSCO) has added two more drugs to its Drugs Alert List for June 2023.
CDSCO publishes List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious for July 2023
A total of 1306 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 51 drugs, medical devices and cosmetics that are identified as being deficient.
CDSCO notifies COVID-19 vaccines approved for Manufacture for Sale or for Distribution
The CDSCO has approved COVISHIELD & COVAXIN vaccines for manufacture for sale or distribution in the country. It has also approved 15 more COVID-19 vaccines for Primary vaccination series for Restricted Use in Emergency Situation in the country.
CDSCO warns against Dispatch of Same Batch of Cough Syrups to Multiple Test Centres
CDSCO has stated that it has observed that cough syrup samples of same batch number, manufactured by the same manufacturer (for export purpose) is being received by two different laboratories for testing purposes. The CDSCO has emphasised that this is highly objectionable and not acceptable.
CDSCO issues FAQS on Implementation of the Drugs (Eighth Amendment) Rules, 2022
The CDSCO has now issued 8 FAQs on the aspects covering this amendment. The FAQs particularly deal with the bar code or QR code on the notified 300 brands.
