Announcement by MoHFW on CROs

Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022

Ministry of Health and Family Welfare issued a Notification regarding Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022 on 11th May 2023 to amend the New Drugs and Clinical Trials Rules, 2019. They shall come into force on the date of their final publication in the Official Gazette unless otherwise specified.

in rule 2, in sub-rule
(1), after clause (i), the following clause shall be inserted, namely:—
“(ia) ‘Clinical Research Organization’ means 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 some or all of the tasks, duties and/or obligations regarding clinical trial, such transfer or delegation of contractual transfers or obligations must be in writing.”

After Chapter V, the following Chapter shall be inserted, namely:— CHAPTER VA CLINICAL RESEARCH ORGANISATION

38A. Registration of Clinical Research Organisation

38B. Application for Registration of Clinical Research Organisation

38C. Grant of registration to Clinical research organisation

38D. Validity period and renewal of registration of Clinical Research Organisation

38E. Conditions of registration

38F. Inspection of Clinical Research Organisation registered with Central Licencing Authority

38G. Suspension or cancellation of registration of Clinical Research Organisation

In the Eighth Schedule, after Form CT-07A, following Forms shall be inserted, namely

Form CT-07B Application for Registration / Renewal of Clinical Research Organisation

Form CT- 07C Grant of Renewal of Registration of Clinical Research Organisation


Objections and suggestions which may be received from any person within 15 days from the date on which the copies of the Gazette of India containing these draft rules are made available to public;

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare,Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at

GCLP Workshop @ Chennai

Good Clinical Laboratory Practices (GCLP)Workshop on International Standards ISO 15189:2022 from 23rd – 25th March 2023

GCLP outline the basic principles and procedures to be followed by clinical/diagnostic laboratories involved in patient care or clinical research so as to provide highly reliable, reproducible and auditable results, which contribute to good patient care and promote a positive attitude from a patient’s perspective.

This GCLP workshop is designed to offer comprehensive guidance for those who are implementing GCLP/ISO 15189:2022 in their medical laboratories and a special session on Quality System and QA/QC in Molecularbiology Laboratory Testing included in this workshop

Only those from accredited (NABL/NABH) medical laboratories or preparing for accreditation or planning to take up a career in medical laboratory accreditation with ISO 15189:2012/2022 and Clinical Research Organization (CRO)’s laboratories (human clinical trials), are encouraged to participate in this workshop

Learning Objectives:

  • Basic principles of the GCLP and their relation to patient care services or clinical research.
  • Implementing GCLP essentials to establish a quality system and its maintenance.
  • Gaps between ISO 15189:2012 and ISO 15189:2022, and implementing new standards

Workshop Scope:

  • Overview and essentials of ISO 15189:2012.
  • Overview and essentials of new standard – ISO 15189:2022.
  • Overview and essentials of NABL-112 guidelines document.
  • Overview and essentials of ICMR-GCLP 2021 guidelines.
  • Special reference to the following key components:
    o Quality System Essentials (QSEs).
    o Establishment, management and monitoring of quality system.
    o Quality indicators and continual improvement.
    o Issues with EQAS/PT, Issues with facility operation.
    o Internal Quality Audit (IQA) – common NCs and its closures.
    o Lab accreditation associated challenges and overcoming the challenges.
    o Biosafety and infection control.
    o Quality system and basic requirements in Molecularbiology Laboratory Testing/Assays – International standard.
    Workshop activities include didactic lectures, interactive sessions, group discussions/exercises and case studies. The faculties from national and international settings will facilitate the program.

The participants can register for the program by paying Rs. 3,500/- and the payment can be done by scanning via net-banking or GooglePay to the following bank account: Account No. 1248135000009037, Account Name: SDC Microbiology CME, Bank: Karur Vysya Bank, IFSC Code: KVBL0001248, Branch: PH Road, Chennai-600077

The workshop is restricted to 60 slots and the registration will be done on “first come-first served basis”. For online registration, the following link has to be used: Out station participants need to book accommodation on their own

Venue: Decennial Hall, Saveetha Dental College and Hospitals Campus, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077.

Contact: Dr. Pachamuthu Balakrishnan, Department of Microbiology, Centre for Infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077. WhatsApp/Mobile: 7667444221, Email: