The Central Drugs Standard Control Organization (CDSCO) has launched an online registration facility for clinical research organizations (CROs). The initiative comes ahead of the April 1, 2025, deadline, which mandates CRO registration under the New Drugs and Clinical Trials (NDCTR) Rules, 2019.
Streamlining Registration Through the Sugam Portal
CDSCO has integrated the registration process into the Sugam portal, allowing new and existing users to apply online by submitting the necessary documents.
The Ministry of Health and Family Welfare (MoHFW) amended the NDCTR rules in September 2024, making it compulsory for CROs to register with the Central Licensing Authority (CLA) before conducting clinical trials or bioavailability/bioequivalence (BA/BE) studies. These new provisions aim to enhance regulatory oversight and improve clinical research standards in India.
Step-by-Step Online Registration Process
CDSCO has provided a detailed user manual to guide applicants through the registration process.
New users can sign up on the Sugam portal, select ‘Clinical Research Organisation’ as their registration category, and submit the required forms.
Existing users can request an additional role under their user profile.
To complete registration, CROs must pay a fee of INR 5 lakh and submit all necessary documents. The CLA will review applications within 45 working days. If deficiencies are found, applicants will have the same timeframe to address them.
Appeals and Compliance Inspections
If a registration application is rejected, 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.
Additionally, CLA-authorized officers will inspect CRO premises, review records, and examine investigational products. Non-compliance with regulatory requirements could lead to warnings, study result rejections, suspension or cancellation of registration, or even a complete ban on conducting clinical trials.
Regulatory Amendments and Compliance Measures
The New Drugs and Clinical Trials (Amendment) Rules, 2024 introduce a new Chapter VA, defining CROs as organizations conducting clinical trials or BA/BE studies on behalf of sponsors.
The Ninth Schedule outlines key requirements, including adequate infrastructure, qualified personnel, and well-documented standard operating procedures (SOPs) for quality assurance and monitoring.
The Sixth Schedule details the registration and renewal process. CROs must maintain trial documentation for at least five years after study completion or two years after the investigational drug batch expires, whichever is later.
Stakeholder Engagement in Regulatory Changes
MoHFW initially released a draft notification on May 11, 2023, inviting public comments. The final notification confirms that the government considered stakeholder feedback before finalizing the amendments.
As reported by digitalhealthnews.com, by implementing these measures, CDSCO aims to strengthen the clinical research ecosystem, ensuring transparency, efficiency, and regulatory compliance.