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 In order to streamline the regulatory submission procedures related to grant of license and loan license to manufacturers of recombinant DNA (r-DNA) products, the Central Drugs Standard Control Organisation (CDSCO) has announced that the applications for such approvals will now be available only through the online system.
The drug regulator has said that, "...the submission of applications for grant of license in Form 28-D/28-DA for r-DNA products is functional now through Online System of Online National Drugs Licensing System (ONDLS Portal)...".
All applicants seeking grant of license in these forms for r-DNA products shall apply through online portal as per the checklist in the module, it added.
Following this, the facility of offline submission of applications in hard copy has been discontinued for processing from March 10, 2026.
According to the Drugs Rules, Form 28-D is to apply for license to manufacture for sale or for distribution of large volume parenterals, sera and vaccines, and r-DNA derived drugs, specified in Schedules C and C(I) excluding those specified in Schedule X.
Form 28-DA is to apply for loan license for the same drugs, through submission to the drug regulators in the country.
The CDSCO has 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.
Recently, it 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, through Sugam portal.
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.
Online National Drugs Licensing System (ONDLS), developed by Centre for Development of Advanced Computing (CDAC) in collaboration with CDSCO, is a single window platform for the online processing of various applications submitted by the applicants for issuance of manufacturing and sales licenses, including blood banks and other certificates like COPP, GMP, WHO-GMP, market standing certificate etc., and post-approval changes.
It establishes uniformity in documentation and licensing processes, ensuring consistent administration and promoting e-governance across India.
It is to ensure uniformity in regulatory process across the country and envisages transparency, accountability, and consistency in the decision making of drug regulators across the country.
The CDSDCO and the Drugs Consultative Committee, the advisory committee formed by the Central government to advise the Central and state governments on matters that require uniform implementation across the country, has been recommending the State Licensing Authorities (SLAs) to ensure that applications are received and processed through Online National Drugs License System (ONDLS) portal only.
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