CROs Registration

Launching of registration of Clinical Research Organisation applications through SUGAM Portal

The Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024, wherein registration of Clinical Research Organisation (CRO) has been made mandatory with effective from 1st day of April, 2025.

In this regard, the online registration of Clinical Research Organisation (CRO) is now functional on SUGAM portal (www.cdscoonline.gov.in). Applications for registration shall be submitted through SUGAM portal only along with the prescribed checklist of documents for the registration.

Health Ministry notified Rules to register CROs under NDCTR (New Drugs and Clinical Trials Rules), 2019 and amendment to the Rules was introduced in September 2024 notifying the Chapter on CROs with related requirements to the Registration of CROs in the country. These amended rules shall come into force on and from the 1st day of April, 2025.

The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September 19, defines CROs as “the sponsor or a body, commercial or academic or of other category, owned by an individual or an organisation having status of legal entity by whatsoever name called, to which the sponsor may, delegate or transfer in writing, some or all of the tasks, duties or obligations regarding clinical trial or bioavailability or bioequivalence study.”

Amendment in NDCTR on CROs stipulates that no clinical research organisation shall conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects without registration granted by the Central Licencing Authority (CLA) under these rules.

Newly inducted Chapter VA addresses the following :

• Registration of Clinical Research Organisation
• Application for Registration of Clinical Research Organisation
• Grant of registration to Clinical Research Organisation
• Validity period and renewal of registration of Clinical Research Organisation
• Inspection of Clinical Research Organisation registered with Central Licencing Authority.
• Suspension or cancellation of registration of Clinical Research Organisation

Subsequent to this MoHFW has issued a notification of 4th Feb 2025 launching mandatory registration of CROs and applications for the same through Sugam Portal of CDSCO.

Sharing the notifications issued by MoHfW here for references :

Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024 – New Drugs and Clinical Trials (Amendment) Rules (NDCTAR), 2024.

STUDY ON CRO SECTOR IN INDIA CONDUCTED BY DEPARTMENT OF PHARMACEUTICALS MINISTRY OF CHEMICALS & FERTILIZERS GOVERNMENT OF INDIA AUGUST, 2023

Department of Pharmaceuticals has released a report of Clinical Research Organisations in the country in 2023 based on a study conducted.

The Pharmaceutical global contract outsourcing market has been picking up after the covid pandemic. During the years between 2022-30, the global contract research outsourcing market is expected to grow @ CAGR of 7 % and reach USD 90.4 Billion by 2030. Out of this about USD 61.2 Billion will be contributed only by the outsourcing done in the domain of clinical development. The CRO sector in India has been growing @ CAGR of 10.75 % and will reach USD 2.5 Billion by the year Hence, it is imperative to identify the emerging opportunities for the Indian CRO sector beforehand, draft and implement strategies which will help in promoting the Indian CRO business.

Under the PMPDS Scheme, the Department of Pharmaceutical, Government of India took an initiative to conduct an independent study on the CRO sector/ market in India to identify and understand the real issues faced by CROs operating in India and work out a proposed roadmap to resolve those issues and make the necessary policy revisions.

Report has detailed information on :

RESEARCH FRAMEWORK
Business Trends in CRO industry
MARKET DYNAMICS
INDIAN CRO MARKET, BY END USER
INDIA CROs CATEGORIZATION, BY SERVICE TYPE
CROs CATEGORIZATION BY THERAPEUTIC AREA
CROs CATEGORIZATION BY LOCATION
CROs CATEGORIZATION BY SIZE
PROFILES OF SOME PROMISING CROs OPERATING IN INDIA
INSIGHTS & RECOMMENDATION

Report can be downloaded here