CDSCO Launches Online Portal for GMP Certificate Issuance & Verification
New system to standardize certification, improve transparency, and streamline international registrations
The Central Drugs Standard Control Organization (CDSCO) is set to launch an online portal for issuing and verifying WHO Good Manufacturing Practice (GMP) certificates.
The move aims to eliminate inconsistencies in certificate formats and authentication challenges across India’s 28 states. The portal, currently in the testing phase, is expected to go live next month.
Currently, WHO GMP certificates are issued by state authorities, leading to variations in formats and difficulties in verifying authenticity; overseas regulators often face challenges in confirming the validity of these documents, causing delays in product registrations and exports.
The new portal will provide a centralized certification system with a uniform format and a barcode for instant authentication.
“This initiative will reduce the time required for manufacturers to register their products internationally, making the process authentic and enhancing trust in India’s regulatory framework,” said Ranga Chandrashekar, Joint Drugs Controller of India.
The system will also include a database of authorized signatories, ensuring transparency and efficiency in the certification process.
Digitalization Efforts
As part of its broader digitalization drive, CDSCO is also developing an online registration system for clinical research organizations (CROs). The system is expected to be launched by April, following a newly amended rule mandating registration for all CROs.
Until now, CROs operated without mandatory registration, making regulatory oversight challenging. The upcoming portal will enable CDSCO to monitor data integrity and compliance more effectively.
“We want to ensure that CROs maintain high-quality standards, as their research data plays a crucial role in drug approval decisions,” Chandrashekar stated.
Regulatory Changes for Drug Exports
In a related development, the Drugs Controller General of India (DCGI) has announced changes in granting no-objection certificates (NOCs) for exporting unapproved drugs. The revised process aims to simplify export procedures and enhance regulatory efficiency.
The CDSCO’s latest measures indicate a shift towards a more transparent, standardized, and digital regulatory framework to strengthen India's position in global pharmaceutical markets.
