CDSCO centralises GMP issuance and verification with new online portal

The Central Drugs Standard Control Organisation (CDSCO) is set to launch an online portal aimed at streamlining the issuance and verification of WHO Good Manufacturing Practice (GMP) certificates. The new portal will also centralise the certificate issuance process for manufacturers, provide a uniform format, and include a barcode for instant authentication for pharmaceutical companies.

 

This initiative addresses long-standing concerns over inconsistent certificate formats and verification challenges across India’s 28 states. The new system, currently in the testing phase, is expected to go live next month.

 

At present, WHO GMP certificates are issued by state authorities, resulting in variations in format and difficulty in verifying the authenticity of certificates. Overseas regulators often struggle to confirm the validity of these documents, leading to delays in product registrations and exports. The new portal will centralise the issuance process, provide a uniform format, and include a barcode for instant authentication for pharmaceutical companies.

 

“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.

 

Additionally, it will house a database of authorised signatories to ensure transparency and efficiency.

 

In another move towards digitalisation, CDSCO is also developing an online registration system for clinical research organisations (CROs). The system, expected to launch by April, follows a newly amended rule requiring all CROs to be registered. Until now, CROs operated without mandatory registration, making regulatory oversight challenging.

 

With this new rule, CROs will need to register through the upcoming online portal, allowing CDSCO to better monitor data integrity and compliance. The move ensures that research data submitted to regulators meets stringent quality standards. “We want to ensure that CROs maintain high-quality standards, as their research data plays a crucial role in drug approval decisions,” Chandrashekar added.

 

This comes on the heels of yesterday’s announcement by the Drugs Controller General of India (DCGI) regarding a revamp of the process for granting no-objection certificates (NOCs) for exporting unapproved drugs. The revised process aims to simplify export procedures and enhance regulatory efficiency.