**Executive Summary**
The 1st ICMR Annual Clinical Trial Meet was held on May 20, 2026, to advance India’s clinical research ecosystem and evidence-based integrative medicine. The event focused on launching new regulatory reports for Phase 1 trials, operational guidelines for ethics reviews, and presenting clinical evidence for Ayurvedic treatments. Key outcomes included strategies for streamlining approval processes and strengthening ethical governance in multicentre research.
**Key Points / Main Content**
**Integrative Medicine and Clinical Evidence**
* Presented results from a Phase III Randomized Controlled Trial (RCT) involving 4,000 non-pregnant women with moderate anaemia.
* The study confirmed that Ayurvedic formulations (*Punarnavadi Mandura* and *Drakshavaleha*) are therapeutically equivalent to standard Iron Folic Acid supplementation over a 90-day period.
* Emphasized the scientific validation of integrative healthcare to address public health challenges.
**Enhancing Early-Phase Clinical Trials**
* Launched the report “Advancing First-in-Human Phase 1 Clinical Trials in India,” developed via a Delphi study with 37 industry and academic experts.
* Identified critical bottlenecks in early-phase trials and recommended strengthening regulatory capacity and streamlining approval processes.
* Called for enhanced coordination among agencies to support innovation-driven research.
**Regulatory and Ethical Frameworks**
* Released the “Operational Guidelines for Single Ethics Review of Multicentre Research in India” to harmonize ethical review mechanisms nationwide.
* Held panel discussions on "Policy Uptake of Integrative Research Evidence" to facilitate the translation of scientific data into healthcare practice.
* Reaffirmed commitment to fostering collaboration and scientific excellence within the clinical research ecosystem.
**Impact Analysis**
**Regulatory Authorities**
**Impact**
Responsible for managing the identified bottlenecks in clinical trial approvals and oversight.
**Action Required**
Strengthen regulatory capacity, streamline approval processes, and implement the new operational guidelines for single ethics reviews in multicentre studies.
**Pharmaceutical Industry and Contract Research Organisations (CROs)**
**Impact**
Affected by the new pathways for First-in-Human Phase 1 clinical trials and the drive for innovation-driven research.
**Action Required**
Align early-phase trial protocols with the recommendations of the Delphi study and enhance coordination with national regulatory agencies.
**Scientists and Researchers**
**Impact**
Influenced by the shift toward evidence-based integrative medicine and harmonized ethical reviews.
**Action Required**
Utilize the new operational guidelines for multicentre research and focus on translating scientific evidence into public health policy and practice.
**Healthcare Practitioners and Policymakers**
**Impact**
Provided with validated evidence regarding the equivalence of Ayurvedic treatments for anaemia.
**Action Required**
Integrate scientifically validated Ayurvedic formulations into healthcare delivery mechanisms and public health policy where applicable.
Key Entities Referenced
Indian Council of Medical Research (ICMR): The apex body for biomedical research in India responsible for organizing the meet and launching initiatives to strengthen the clinical trial ecosystem.
Advancing First-in-Human Phase 1 Clinical Trials in India: A policy report launched to identify regulatory bottlenecks and streamline approval processes for early-phase clinical research.
Operational Guidelines for Single Ethics Review of Multicentre Research in India: A document released to harmonize and strengthen ethical review mechanisms for multicentre research studies nationwide.
Central Council for Research in Ayurvedic Sciences (CCRAS): A key research council that collaborated with ICMR on a multicentric Phase III trial evaluating integrative Ayurvedic treatments for Iron Deficiency Anaemia.
Ministry of Health and Family Welfare
1st ICMR Annual Clinical Trial Meet 2026
highlights India’s emerging leadership in
integrative medicine research
ICMR launches report to strengthen First-in-Human Phase 1
clinical trials in India
Operational guidelines for single ethics review of multicentre
research launched
Experts deliberate on strengthening India’s clinical research
and regulatory ecosystem
Posted On: 21 MAY 2026 11:35AM by PIB Delhi
The Indian Council of Medical Research successfully organised the “1st ICMR Annual Clinical Trial Meet
2026” on May 20, 2026, under the theme “International Clinical Trials Day: Focus on Integrative
Medicine Clinical Trials.” The national-level event served as a significant platform for deliberations on
strengthening India’s clinical trial ecosystem and advancing evidence-based integrative medicine research
in the country.
The meet brought together policymakers, scientists, clinicians, researchers, regulatory authorities and
experts from diverse fields to discuss emerging opportunities, ethical frameworks, regulatory pathways
and innovations in clinical research.
The programme was graced by Prof. (Dr.) V. K. Paul, Dr. Rajiv Bahl and Vaidya Rajesh Kotecha along
with eminent experts and stakeholders from the healthcare and scientific community.
Addressing the gathering, the dignitaries highlighted the need for robust clinical research systems, ethical
governance and scientific validation of integrative healthcare practices to address emerging public health
challenges and strengthen healthcare delivery mechanisms in the country.
One of the major highlights of the event was the presentation of findings from the ICMR-CCRAS
multicentric Phase III Randomized Controlled Trial (RCT) on Iron Deficiency Anaemia. The study
evaluated integrative approaches for managing anaemia, a major public health concern in India.
The clinical trial compared the efficacy of Punarnavadi Mandura alone and in combination with
Drakshavaleha against standard Iron Folic Acid supplementation. Conducted among nearly 4,000 non-
pregnant women aged 18–49 years with moderate anaemia, the study assessed haemoglobin levels and
clinical outcomes over a period of 90 days. The findings demonstrated that both Ayurvedic formulations
were therapeutically equivalent to standard iron-folic acid therapy.The event also witnessed the launch of the report titled “Advancing First-in-Human Phase 1 Clinical
Trials in India: A Delphi Study on Regulatory Pathways and Opportunities.” The report was developed
through a two-round consultation involving 37 experts from the pharmaceutical industry, Contract
Research Organisations (CROs), academia and national regulatory agencies.
The study identified major bottlenecks affecting the advancement of early-phase clinical trials in India and
recommended measures including strengthening regulatory capacity, streamlining approval processes and
enhancing coordination among agencies to support innovation-driven clinical research in the country.
Another important milestone during the event was the release of the “Operational Guidelines for Single
Ethics Review of Multicentre Research in India,” aimed at strengthening and harmonising ethical review
mechanisms for multicentre research studies nationwide.
A panel discussion on “Policy Uptake of Integrative Research Evidence” was also organised during the
programme. The discussion facilitated meaningful deliberations on translating scientific evidence into
public health policy and healthcare practice.
The Annual Clinical Trial Meet reaffirmed ICMR’s commitment towards fostering collaboration,
strengthening ethical and regulatory frameworks and promoting innovation and scientific excellence in
India’s clinical research ecosystem.***
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