In an effort to streamline the regulatory submission procedure with the Central Drugs and Standard Control Organisation (CDSCO), 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.
The facility of offline submission of application in Form 44, Form 45A/46A, Form 45/46 and Field Trial Permission for veterinary purpose only in hard copy or through e-office may not be available for processing, said the veterinary division of CDSCO.
"In order to streamline the regulator submission procedure, the submission of application for issuance of new drug permission of vaccines/drugs for bulk (API) in Form-45A/46A and finished formulation in Form-45/46 and field trial permission is now functional on online system of Sugam Portal," it added.
The applicants seeking such certificate, approval or permission shall apply through online portal as per the checklist in the developed modules.
According to the Drugs and Cosmetics Act and Rules, Form 45 and 46 are for permission to import finished formulation of a new drug, and permission or approval for manufacture of new drug formulation, respectively. Form 45A is for permission to import raw material (new bulk drug substance), while Form 46A is for permission or approval for manufacture of raw material (new bulk drug substance).
It may be noted that the CDSCO, as part of its efforts to digitise and streamline the regulatory submission procedure, has earlier this year switched the submission of Period Safety Update Reports (PSUR) related to marketing authorisation of new drugs and others to online system.
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.
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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