CDSCO to Launch Online Portal for WHO GMP Certificates and CRO Registration

New Delhi (The Uttam Hindu): The Central Drugs Standard Control Organisation (CDSCO) is set to launch an online portal to streamline the issuance and verification of WHO Good Manufacturing Practice (GMP) certificates. This initiative will centralise the certificate issuance process for pharmaceutical manufacturers, provide a uniform format, and incorporate a barcode for instant authentication. The portal, currently in the testing phase, is expected to go live next month.

At present, WHO GMP certificates are issued by state authorities, leading to inconsistent formats and challenges in verifying authenticity across India’s 28 states. This lack of uniformity has caused delays in product registrations and exports, as overseas regulators often face difficulties confirming the validity of these certificates. By centralising the issuance process, the new portal aims to address these issues and enhance transparency in India's pharmaceutical regulatory framework.

Ranga Chandrashekar, joint drugs controller of India, stated, “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.”

In addition to the WHO GMP certificate portal, CDSCO is developing an online registration system for clinical research organisations (CROs), expected to launch by April. This move comes after a newly amended rule requiring CROs to be registered. Until now, CROs operated without mandatory registration, making regulatory oversight challenging. With the new online portal, CROs will need to register, allowing CDSCO to better monitor data integrity and compliance.

“This system ensures that research data submitted to regulators meets stringent quality standards,” said Chandrashekar, emphasizing the importance of maintaining high-quality standards for data used in drug approval decisions.

This announcement follows a recent update from the Drugs Controller General of India (DCGI), which revealed a revamp of the process for granting no-objection certificates (NOCs) for exporting unapproved drugs. The revised process aims to simplify export procedures and improve regulatory efficiency.