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The Central Drugs Standard Control Organisation (CDSCO) has switched the process of Post Approval Changes (PAC) with regard to marketing authorisation for recombinant DNA (r-DNA) products to online mode from early March, as a latest step in its efforts to digitise the application and approval processes related to drugs and medical devices.
In line with the process, the facility of online submission of applications in hard copy will not be available for processing from March 5, 2026, informed Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
"In order to streamline the regulatory submission procedure, the submission of applications for Post Approval Changes (PAC) with regard to Marketing Authorisation or r-DNA products is functional now through Online System of SUGAM Portal...," said the drug regulator.
The link to filing the applications will be available under 'Post Approval Changes - MA', in the Sugam portal. The regulator directed that all applicants seeking the PAC shall apply through the online portal, as per the checklist in the module.
The CDSCO has been working on aligning the regulatory practices in the country with the international guidelines including that of World Health Organisation (WHO) and current international practices by various regulatory agencies.
It has also been in the process of digitising various application processes related to drugs and medical devices, in order to streamline the regulatory submission procedure and enhance ease of doing business for the industry.
It has in the recent past, announced switching of applications for clinical trial site addition and change of Principal Investigator, to online mode. Similar applications for clinical trials for biological products were also moved to online mode later.
Prior to that, it has switched various applications including the submission of Period Safety Update Reports (PSUR) related to marketing authorisation of new drugs and others to online systems. The veterinary division of the drug regulatory office has announced that it is switching submission of Form 44 for grant of permission to import or manufacture a new drug from offline to online mode.
In November, 2023, 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 has also 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.
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