Regulatory Framework in India for Clinical Trials: Important Regulations and Compliance Overview

Introduction

The regulatory framework in India has evolved rapidly over the past decade, becoming more structured, transparent, and aligned with global standards. 

Dr. Deepa Arora, Founder, Director, and CEO of CLINEXEL explains, “Indian regulatory structure is akin to that of the USA. Like the USFDA, CDSCO is the single CLA in India responsible for clinical trial approvals across India.”

Through this article, we provide an overview of the key authorities, rules, ethics oversight, and practical tips to help pharma, biotech, and medical device companies navigate the regulatory framework in India with confidence.

Regulatory Authorities in India

The following entities collectively maintain a system that balances innovation with ethical and public safety imperatives.

The Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare (MoHFW), Government of India, is the National Regulatory Authority (NRA) of India. The headquarters is in New Delhi, and it has six zonal offices. CDSCO is also known as the Central Licensing Authority (CLA), which functions similarly to the USFDA. This single body is responsible for approving drugs, devices, and clinical trials across India in all states. The CDSCO continually strives to enhance transparency, accountability, and uniformity in its services, forming the backbone of the regulatory framework in India, to ensure the safety, efficacy, and quality of medical products manufactured, imported, and distributed across the country. 

State Licensing Authorities – There are State FDAs in each state that are responsible for approvals for manufacturing and distribution licenses

The Indian Council of Medical Research (ICMR) sets ethical guidelines for biomedical research, ensuring the protection of human participants. ICMR plays a diverse role in clinical trials, contributing significantly to the ethical dimension of the regulatory framework in India, spanning funding, infrastructure development, ethical oversight, policy formulation, and research promotion, each contributing to the advancement of biomedical research and the improvement of public health in India. It promotes adherence to Good Clinical Practices, which are essential for ensuring the quality and integrity of clinical trials. ICMR contributes significantly to the ethical dimension of the regulatory framework in India, ensuring trials protect participant rights.

“Research is conducted under conditions that no person becomes a mere means for the betterment of others and that participants are dealt with in a manner conducive to their dignity and well-being,” adds Dr. Arora, quoting the ICMR.

The registered Ethics Committees (ECs) monitor trials locally to ensure patient safety and adherence to regulations. The Institutional Review Boards (IRBs) are known as the ECs in India. For clinical trials, the jurisdiction of an ethics committee typically extends to the same city or within a 50-kilometer radius of the trial site, ensuring it can effectively oversee and remain accountable for the research conducted. 

• In multi-site research studies, it is common for multiple ethics committees to be involved, as each participating site typically has its own Institutional Ethics Committee (IEC). If a site does not have its IEC, an Independent Ethics Committee, or an ethics committee from a nearby site within a 50 km radius of the trial site can approve a trial and oversee the trial. This is necessary because each site may face unique ethical considerations or regulatory requirements that must be addressed locally.
• Considering the huge diversity in India, this structure ensures localized oversight, familiarity with site-specific challenges, and faster, context-sensitive decision-making. The impact on budget and efforts is minimal, considering the huge advantage that India offers in terms of cost and timelines.
• Both IECs and Ind-ECs review the scientific merit, ethical implications, and participant safety aspects of research proposals. While an IEC is generally embedded within a research institution, an Ind-EC operates independently without institutional affiliation. Regardless of type, all ethics committees function under standard operating procedures (SOPs) that align with national guidelines.

Legal Framework in Clinical Trials: Laws & Rules

India’s drug regulation system is a vital component of the broader regulatory framework anchored by the Drugs & Cosmetics Act, 1940, and the Drugs & Cosmetics Rules, 1945, which lay out requirements for manufacturing, importing, and selling pharmaceuticals. Additional frameworks like the New Drugs and Clinical Trials Rules (NDCTR) 2019, and the Medical Devices Rules (MDR), 2017, bring clarity to clinical trial requirements, approval timelines, and post-market obligations.

• The Drugs & Cosmetics Act, 1940, and the Drugs & Cosmetics Rules, 1945, are the foundation of drug and device regulation. They govern the import, manufacture, sale, and distribution of drugs and ensure they meet safety and quality standards.
• The New Drugs & Clinical Trials Rules (NDCTR) 2019, modernized clinical trial processes, setting clear definitions, timelines, and ethical benchmarks. The NDCTR 2019 broadened the regulatory scope and improved timelines. According to Rule 101 of NDCTR 2019, the Central Licensing Authority may specify for considering a waiver of local clinical trial for the approval of new drugs under Chapter X and for granting permission for conducting clinical trials under Chapter V. 
• The Medical Devices Rules (MDR), introduced in 2017, established a structured framework for device regulation by defining classification, licensing, Unique Device Identification (UDI), labeling, and post-market surveillance. As part of compliance, both pilot and pivotal studies are critical. Pilot studies generate preliminary data to support feasibility, while pivotal trials deliver the conclusive evidence required for regulatory approval and market access.

Medical Device Regulation: MDR, 2017

The MDR, 2017, introduced a structured classification system for medical devices into risk-based categories (A to D), with corresponding regulatory requirements. It has brought clarity and modern practices to device regulation.

The DCGI oversees high-risk categories (C and D), and the state bodies handle low- to moderate-risk (A and B) devices.

The MDR 2017 also covers labeling, shelf life, traceability through Unique Device Identification (UDI), and post-market surveillance, aligning India’s system with ISO and global safety standards.

Sugam Portal and Clinical Trial Approval

To improve efficiency and transparency in regulatory processes, the CDSCO launched the Sugam Portal, an online system that enables applicants to submit dossiers, track application queries, and receive notifications in real time. This digital platform streamlines communication between sponsors and regulators, ensuring faster turnaround and accountability in clinical trial applications.

1. Sponsor/Applicant Registration

• The sponsor, CRO, or investigator registers on the Sugam Portal.
• Basic organization details, contact information, and credentials are verified before access to submission modules is granted.

2. Application Submission in CTD Format

• The clinical trial application is prepared in the Common Technical Document (CTD) format, which standardizes data on quality, safety, efficacy, and trial protocols.
• Supporting documents such as the Investigator’s Brochure (IB), protocol, informed consent form (ICF), and insurance details are uploaded.

3. Ethics Committee Approval

• Before portal submission, the protocol must be reviewed and approved by a registered Institutional Ethics Committee (IEC) or Independent Ethics Committee (Ind-EC).
• Proof of EC approval is attached to the application.

4. Review by the CDSCO office

• The CDSCO reviews the CMC data as well as pre-clinical and clinical data for quality and completeness.
• If deficiencies are noted, queries are raised on the portal for the applicant to address.

5. Review of the Protocol by Subject Expert Committee (SEC)

• Applications are reviewed by the Subject Expert Committee (SEC) relevant to the therapeutic area (oncology, cardiology, neurology, etc.).
• The SEC evaluates:

1. 1. 1. Scientific design and merit of the study.
      2. Safety concerns for potential trial participants.
      3. Ethical considerations in line with ICMR guidelines.

6. Recommendations to DCGI

• Based on the SEC’s evaluation as well CDSCO review of the clinical trial application dossier, recommendations are forwarded to the Drug Controller General of India (DCGI).
• The DCGI makes the final decision: approval, conditional approval, or request for further data.

7. Notification of Approval

• Once approved, the applicant is notified via the Sugam Portal.
• The portal also allows real-time tracking of status, queries, and notifications throughout the process.

8. Post-Approval Compliance

• The sponsor must register the trial on the Clinical Trials Registry of India (CTRI) before enrolling participants.
• Continuous reporting of SAEs, submission of Clinical Study Reports (CSRs), and protocol amendments must be done through the portal.

Additionally, Shivani Nayak, Head of Regulatory Affairs at CLINEXEL, quotes “CDSCO has now made the online registration of CROs functional on the SUGAM portal, an important step toward enhancing transparency and oversight in India’s clinical research industry.”

Role of the Subject Expert Committee (SEC) in the Sugam Portal

Within the CLA-CTA framework, the Subject Expert Committees (SECs) play a pivotal role in ensuring that applications for clinical trials, new drugs, and medical devices undergo rigorous scientific and ethical evaluation before approval.

The SECs are panels of independent experts drawn from diverse therapeutic specialties such as oncology, cardiology, neurology, and infectious diseases. Their primary responsibility is to critically review trial protocols, preclinical and clinical data, and the evidence presented for the clinical trial application.

SEC plays a pivotal role in the clinical trial approval process in India. It provides an independent scientific and ethical review of trial applications Portal. Its responsibilities include assessing the scientific soundness of the study design, evaluating safety safeguards in the trial protocol, and reviewing efficacy and safety evidence presented in previous Clinical Study Reports (CSRs).

The committee also ensures that participant rights and welfare are protected in accordance with ICMR ethical guidelines, while confirming compliance with the regulatory frameworks of the New Drugs and Clinical Trials Rules (NDCTR), 2019, and the Medical Devices Rules (MDR), 2017. By offering expert recommendations to the Drug Controller General of India (DCGI), the SEC helps ensure that only trials meeting high standards of safety, ethics, and scientific merit receive approval.

Based on their review, SECs provide detailed recommendations to the Drug Controller General of India (DCGI), who makes the final decision on granting approvals or requesting further data. This collaborative mechanism enhances transparency and accountability in decision-making.

By integrating SEC evaluations into the Sugam Portal workflow, CDSCO ensures that expert opinion informs regulatory approvals, thereby strengthening public trust in the safety, efficacy, and ethical conduct of clinical trials in India.

Conclusion

The regulatory landscape for clinical trials in India has transformed into a more structured, transparent, and globally harmonized framework. With the establishment of the New Drugs and Clinical Trials Rules (NDCTR) 2019, the Medical Devices Rules (MDR), 2017, and the adoption of digital platforms such as the Sugam Portal, India has strengthened its position as a significant hub for ethical and scientifically sound clinical research.

Regulatory authorities like the CDSCO, ethical oversight by ICMR guidelines, and the involvement of SECs collectively ensure that clinical trials are conducted with the highest standards of safety, efficacy, and accountability. By emphasizing participant protection, streamlined processes, and faster yet rigorous approvals, the system is designed to balance innovation with public health priorities.

As India continues to align with international norms while addressing local healthcare needs, the country’s regulatory framework is not only fostering trust among global sponsors but also promoting the responsible growth of clinical research. For stakeholders, understanding and adapting to this evolving environment is key to unlocking opportunities in one of the world’s fastest-growing life sciences markets.

Why Partner with CLINEXEL

Successfully navigating India’s complex regulatory system requires deep expertise and local insights. This is where CLINEXEL, a trusted CRO, makes the difference.

With a strong foundation in regulatory strategy, clinical operations, and medical writing, CLINEXEL helps sponsors streamline submissions, engage with ethics committees, and ensure compliance with CDSCO, NDCTR 2019, and MDR requirements. Our team brings hands-on experience with the Sugam Portal, SAE reporting, Clinical Study Reports (CSRs), and Subject Expert Committee reviews, enabling seamless trial execution across India.

At CLINEXEL, we turn regulatory challenges into opportunities, helping you accelerate approvals, conduct high-quality trials, and bring innovative therapies to Indian patients faster and more efficiently.

Contact us at info@clinexel.com to schedule a consultation.

References:

1. Central Drugs Standard Control Organization. SUGAM portal. Online applications for CDSCO services. 
2. Central Drugs Standard Control Organization. Medical Devices Rules, 2017. Guidance documents. 
3. Indian Council of Medical Research. (2017). National ethical guidelines for biomedical and health research involving human participants. 
4. Ministry of Health and Family Welfare. (1940). The Drugs and Cosmetics Act, 1940. Gazette of India.
5. Ministry of Health and Family Welfare. (2019). New Drugs and Clinical Trials Rules, 2019. Gazette of India.

Authors:

Dr. Deepa Arora- CEO- CLINEXEL ( https://www.linkedin.com/in/deepaarora2019/ )

Dr Deepa is a physician with 25+ years of industry experience in leadership positions with pharma in Clinical Development, Medical Research, and Drug Safety departments.

Dr. Deepa led an industry consortium for the implementation of additional risk minimization measures in Europe. Her experience includes the development and execution of clinical development strategy and conducting clinical trials for NCEs, biosimilars, vaccines, complex generics, and repurposed drugs. 

Deepa has experience in interacting with various regulators- USFDA, EMA, MHRA, MEB, Health Canada, WHO, TGA for scientific advice, pre-IND meetings, end of phase meetings to discuss clinical development path, clinical trial designs, and post-marketing commitments, including PMS/ Phase IV studies and paediatric investigation plan (PIP). 

Dr. Mukesh Kumar– Chief Scientific Officer- CLINEXEL (https://www.linkedin.com/in/dr-mukesh-kumar-m-d-6223457/)

A Physician (MD) with over 25 years of deep expertise in clinical R&D, Dr Kumar’s career is a testament to innovation and excellence in clinical trials, clinical pharmacology, translational research, biopharmaceutics, and clinical development. His contributions have driven global product registrations across regulatory landscapes, including the USFDA, EMA, India, PMDA, and ROW regions.

Dr. Kumar’s illustrious career includes clinical R&D leadership roles at global pharmaceutical giants (Sanofi and Daiichi Sankyo) and large Indian pharma companies (CIPLA, DRL, and LUPIN), where he supported early and late phase clinical trials of innovative products, including repurposed drugs via 505(b)(2) path, complex generics, and biosimilars. He has played a key role in transforming the R&D business through clinical risk mitigation strategies and high-quality clinical trial executions. With a proven track record of significant contributions in clinical development of over 100 successful product registrations in the U.S. and Europe, he has redefined efficiencies in clinical strategies by implementing cost-effective, innovative clinical trials and pharmacology studies.

As CLINEXEL’s CSO, Dr. Kumar oversees clinical trial operations (Phases I-IV) and clinical program management. His value-added support is available for CLINEXEL-managed clinical trials in optimizing clinical strategies, global clinical development, and driving impactful scientific negotiations for innovative therapies, biosimilars, and complex generics