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CDSCO to switch PSUR submission on new drugs and others to online system
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Gireesh Babu, New Delhi
February 28 , 2024
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As part of the ongoing efforts to digitise and streamline the regulatory submission procedure, the Central Drugs Standard Control Organisation (CDSCO) has switched the submission of Period Safety Update Reports (PSUR) related to marketing authorisation of new drugs and others to online system. The offline mode of submission of these applications will be discontinued from March 11.
The drug regulator said that the system for submission of PSURs with regards to marketing authorisation of new drugs, subsequent new drugs, fixed dose combinations, biologicals and veterinary drugs is functional now through an online system of Sugam portal.
"All applicants submitting PSURs shall apply through an online portal as per checklist in the portal. The facility of offline submission of applications in hard copy or any other mode will not be available for processing from March 11, 2024," said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
The drug regulator has been in an effort to switch various application and approval processes related to its office to online mode in recent years, as part of implementation of an e-governance mechanism in the organisation.
Last November, the CDSCO directed all stakeholders to submit the applications for Post Approval Changes (PACs) with regard to marketing authorisation for human vaccines and antisera through online system of Sugam Portal under Post Approval Changes, as it is stopping the offline submission process from December 1, 2023.
In the beginning of 2023, CDSCO switched the procedure for submission of form for test license for veterinary vaccines and drugs to online, stopping the facility of offline submission of applications in hard copy following this. In 2021, it has switched the applications for registration of centres for Bioavailability and bioequivalence (BA/BE) studies and application for PACs in BA/BE studies online.
The CDSCO launched the National Single Window System (NSWS) portal on January 1, 2024, initially offering three activities for the medical devices industry, in an effort to improve the ease of doing business to the industry.
NSWS is established by the central government with the objective to build a Single Window System which acts as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The scope of NSWS includes all the approvals/licenses/clearances as acceptable.
The CDSCO has said that the portal for the drug regulator has been developed by Invest India through IT major Tata Consultancy Service (TCS) and this will be an independent portal from the existing SUGAM portal or the cdscomdonline portal, which is for the medical devices industry.
Initially, three activities under the Medical Devices Rules, 2017 have been developed and will be made ‘Live’ on the single window portal with effect from January 1, 2024.
These activities are the application for Certificate of Registration of a notified body under Form MD-01; application for license to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training, under Form MD-12; and application for licence to import medical devices for the purpose of clinical investigations or test or evaluation or demonstration or training, under Form MD-16.
The activities in this portal were expanded with five more forms added live on the NSWS portal with effect from January, 2024.
The forms added include form CT-10 application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis, and form CT-12 application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study.
The rest of the two forms include Form CT-13 application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study, and CT-16 application for grant of license to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis.
Further, form 12, that is application for license to import drugs for the purpose of examination, test or analysis will also be made live, it added in January.
The drug regulatory organisation has also, in November, 2023, initiated efforts to set up a Digital Drugs Regulatory System (DDRS) as a unified digital ecosystem as a single window, single sign on and unified portal for all regulatory activities.
The proposed DDRS is aimed at building trust and confidence in the quality of drugs, medical devices, cosmetics, etc., in the domestic and global market, transparency and accountability in the regulation of the quality, effective enforcement of quality, safety and efficacy at the field level, and ensuring compliance to Indian pharmacopoeia & standards, according to the CDSCO.
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