CDSCO Launches Online Registration for Clinical Research Organizations

The registration process will be conducted through the Sugam portal, enabling new and existing users to apply online with the required documents.

The Central Drugs Standard Control Organization (CDSCO) has launched an online registration facility for clinical research organizations (CROs) ahead of the April 1, 2025, deadline that mandates their registration under the New Drugs and Clinical Trials (NDCTR) Rules, 2019. 

The registration process will be conducted through the Sugam portal, enabling new and existing users to apply online with the required documents.

The Ministry of Health and Family Welfare (MoHFW) notified amendments to the NDCTR rules in September 2024. 

The new provisions make it compulsory for CROs to register with the Central Licensing Authority (CLA) before conducting clinical trials or bioavailability/bioequivalence (BA/BE) studies. The new provisions aim to streamline clinical research operations in India.

Online Registration Process & Key Requirements

The CDSCO has provided a detailed user manual to guide applicants through the online registration. New users can sign up on the Sugam portal, select ‘Clinical Research Organisation’ as their registration purpose, and submit the required forms. Existing users can request an additional role under their user profile.

As per the revised regulations, CROs must submit a registration fee of INR 5 lakh and necessary documents. Once submitted, the CLA is required to process applications within 45 working days. If deficiencies are identified, applicants will be notified for rectification within the same timeframe. In case of rejection, organizations can seek reconsideration within 60 days by paying an INR 1 lakh fee. Further appeals can be made to the Central government within 45 days.

The revised rules allow CLA-authorised officers to inspect CRO premises, records, and investigational products. 

Failure to comply with regulatory requirements can lead to warnings, rejection of study results, suspension or cancellation of registration, or a complete ban on conducting clinical trials in the future.

Regulatory Amendments & Compliance Measures

The New Drugs and Clinical Trials (Amendment) Rules, 2024, introduced a new Chapter VA, defining CROs as organizations that conduct clinical trials or BA/BE studies on behalf of sponsors. 

The amended rules' Ninth Schedule specifies that CROs must have adequate infrastructure, qualified personnel, and well-documented standard operating procedures (SOPs) for quality assurance and monitoring.

The amended Sixth Schedule outlines the registration and renewal application process. CROs must maintain comprehensive documentation of all trials for at least five years after study completion or two years post-expiry of the investigational drug batch, whichever is later.

The MoHFW had initially released a draft notification on May 11, 2023, inviting public comments. The final notification confirms that stakeholder feedback was considered before finalizing the amendments.