Drugs Manufacturing License and Other State FDA application

Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has come up with a national portal for filing of applications for licenses/ certificates for manufacturing, marketing and sales for Drugs and Cosmetics.
This was the need of the hour to bring uniformity, traceability and accountability in evaluation and disposal procedure of such application for issuance of licenses/certificates across the country for the benefit of all the stakeholders.
With the launch of this portal, India will have uniform online drug licensure procedure.
The Online National Drug Licensing System portal has been developed by CDAC in coordination with CDSCO & States.
It has been made functional for testing with effect from 31st March, 2021 for validation of the system which can be accessed through https://statedrugs.gov.in. The system will be shifted from validation mode to operational for all purposes w.e.f. from 15th April, 2021.
Our team of experts who are well versed with the application process shall help in portal registration, preparation and filing of the applications, answering the queries etc.
We follow up the application till the grant of license.

API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.