Revolutionizing Regulatory Processes CDSCO

In an era marked by technological advancements and a paradigm shift towards digitization, government agencies worldwide are embracing digital platforms to streamline their operations and enhance public service delivery. The Central Drugs Standard Control Organization (CDSCO) has taken a significant leap in this direction with the launch of its forms on the Online Submission of Applications and Monitoring System (NSWS) portal.

The NSWS portal serves as a centralized hub for the submission of applications and monitoring of various regulatory processes. As the stakeholders are aware that the NSWS is established by the Central Government with the objective to build a genuine Single Window System which act 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/registrations/clearances as applicable.

In this regard, Invest India through TCS has developed NSWS portal has been developed for COSCO, which will be independent from the existing SUGAM portal or cdscomdonline portal. Initially following three activities under the Medical Devices Rules, 2017 have been developed and will be made 'Live' on NSWS portal w.e.f. 01.01 .2024:

  1. Application for grant of Certificate of Registration of a Notified Body-Form MD-01.
  2. Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training-Form MD-12.
  3. Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training -Form MD-16.

On 16.01.2024 the following additional Forms have also been developed and will be made 'Live' on NSWS:

  1. 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- CT-10.
  2. 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-CT-12.
  3. 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-CT-13.
  4. Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis -CT- 16.

Further Form 12 i.e. 'Application for licence to import drugs for purpose of examination, test or analysis' will also be made 'Live· on 24.01.2024.

In essence, the launch of forms on the NSWS portal signifies a pivotal moment in the modernization of regulatory processes, heralding a new era of efficiency, transparency, and agility in the pharmaceutical industry. As the NSWS portal continues to evolve, its impact on the regulatory landscape is poised to be transformative, providing a model for other sectors and countries to follow in the quest for a digitally empowered and streamlined regulatory future.

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