As part of its continued efforts to streamline operations through digitisation, the Central Drugs Standard Control Organisation (CDSCO) has transitioned from offline to online acceptance of clinical trial applications for cell and gene therapies products (CGTP).
The agency has also prepared a user manual and a video instruction for the online filing process, to assist units that may require assistance in applying for these clinical studies.
On July 9, the drug regulator issued a notice (https://cdsco.gov.in/opencms/resources/) announcing that the CDSCO will not accept offline submissions of CGTP clinical trial applications for processing after July 10, 2025.
This decision is about filing clinical trial applications for phase I, II, and III trials, and the regulator has urged the industry to do so through the Sugam online registration system.
“This provision is now made functional and the applicants seeking for such permission may now submit the clinical trial applications (phase I, II and III) through Sugam online portal system as per the checklist in the developed modules,” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) in a notice to the relevant stakeholders.
The user manual and video lesson for filing applications have been added to the CDSCO website’s Industry section. Some industry groups have requested that the pharmaceuticals regulator handhold the units linked to online application submission whenever the system is switched from offline to online mode.
To aid stakeholders in online form submission, the CDSCO has incorporated tooltips for legal forms in its e-governance platform Sugam and medical device web portals, which provide explicit guidance on expected inputs.
To improve the user experience and expedite data submission in the apps, tooltips for legal forms have been enabled on the Sugam and Medical Device online portals. The tooltips are intended to provide helpful information about the exact requirements for each field in the various application forms submitted to CDSCO for approval.
“By offering clear instructions on expected inputs, this feature aims to minimise errors and facilitates the quality of submissions,” said the DCGI while announcing the facilitation of tooltips.
He mentioned that the agency urges stakeholders to use this feature while filling out applications on both platforms. To access the tooltips, simply mouse over the information icon or help text next to each field.
The CDSCO has recently shifted many application forms to online format as part of its efforts to digitise and streamline the regulatory submission system.
It has also promoted the Online National Drugs Licensing System (ONDLS) portal, which is designed as a single-window platform for online processing of various applications submitted by stakeholders for the issuance of manufacturing and sales licenses, including blood banks, as well as certificates such as COPP, GMP, WHO-GMP, Market Standing certificate, and post-approval changes.
The system is expected to aid in the establishment of uniformity in the requirements for document submission for various types of applications as well as the issuance of licenses/permissions throughout India, as well as to support uniform administration of the Act’s and Rules’ provisions through the use of cutting-edge technology tools such as e-governance via the online portal for state/UT Drug Control Authorities.
