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

Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

The Ministry of Health and Family Welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.

A draft rule has been notified by the Ministry, under which it has proposed to insert a new sub-rule to the Rule 19, that the state government may, by notification, establish state medical devices testing laboratory for the purpose of testing and evaluation of medical devices or to carry out any other functions as may be specifically assigned to it.

The State Government may also designate any laboratory having facility for carrying out and evaluation of medical devices as state medical devices testing laboratory for the purpose, with a condition that the laboratory should be accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).

It has also added a definition to the state medical devices testing laboratory, stating that it means a laboratory established or designated by the state government under the Rule 19(3), which is the freshly proposed sub-rule. While the Rule 19 was specifically for Central medical devices testing laboratory, it has been proposed for amendment by omitting the word ‘Centre’, this emphasising that the laboratories could be established either by the Central or the state government. The draft amendment is expected to be taken into consideration in seven days from the date of making the draft available to the public.


CDSCO Notification

Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022 – Regulator’s Notification

MoHFW has released a recent notification on Sep 30th 2022 about the Registration / Licensing norms for Medical Device Manufacturers, Importers for Class A and B Devices .

Content of the notification is shared below for information purposes :

  • The Ministry of Health & Family Welfare (MoHFW) has published notification vide S.O. 648 (E) dated 11.02.2020 specifying all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 01.04 2020.
  • In order to regulate all the medical devices, MoHFW has published G.S.R. 102 (E) dated 11.02.2020 for regulation of such devices in phase wise manner. As per the said notification the Class A & B medical devices will be under licensing regime from 01.10.2022.
  • In the meantime, representations from various Associations and Stakeholders have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. 01.10.2022 for Class A & B medical devices.
  • In view of the above, it has been decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.

Notification can be downloaded from here

Source –

What the notification means ?

Manufacturers and importers of non notified devices (which are not regulated already) of Class A and B Categories were given time for 18 months timeframe – from April 2020 to Sep 30, 2021, to Voluntarily register their businesses and products sold by them in the market. This registration helps businesses to establish business identity with Regulator. Subsequent to this, thereafter, from October, 2021, Class A & B Medical Devices were brought under compulsory registration scheme up to 30th September- 2022. Regulator gave call of action to manufacturers and importers, to complete the mandatory registration process before 30th Sep 2022 as Licensing regime starts from Oct 1st 2022.

In the interim period, a draft notification was released by MoHFW inviting public comments about exempting Class A – non sterile and non measurement devices from Licensing . It was only a draft and no further announcement was made about the same. Members of the sector have assumed that this category of products was exempted . This interim notification has caused some confusion at the market place.

However, as per the recent notification, the status quo is clear where MoHFW has clarified that existing manufacturers, importers who were already manufacturing, importing Class A , B Devices in the market and who have already applied to CLA/SLA for License, after applying for voluntary or mandatory registration, can continue to operate in the market as their application for license will be deemed valid. They can continue to manufacture or import Class A, B devices for the next 6 months time from the date of this order or till the time the CLA/SLA takes a decision on the application whichever is earlier.

There are players who have not filed application under Voluntary & Mandatory registration process due to lack of awareness or various other business challenges and they are seeking clarification and guidance on how to apply now. They would like to know if they have to apply for Registration or Licensing now and if they are permitted to apply for Registration hereafter.

Some clarity and guidance from the Ministry on these concerns would certainly help the players/industry.



The Drugs and Cosmetics Act, 1940 is a pre-independence legislation enacted by the Central Legislative Assembly. Review of obsolete laws and updating of the existing laws is a continuing process to accommodate changed requirements and adaptation of new technology.

The Government has time and again emphasized the need to review obsolete laws and to periodically repeal and amend laws, for which Bill are being brought before the Parliament.

The work of review and updating of Drugs and Cosmetics Rules, 1945 was vigorously taken up from the year 2016.

In light of recommendations of the Central Government and the felt need to have comprehensive legislation, a committee was constituted for framing the New Drugs, Cosmetics and Medical Devices Bill. As per recommendations of the Committee. Ministry of Health and Family Welfare, Government of India proposes a draft New Drugs, Medical Devices and Cosmetics Bill, 2022 in order to keep pace with changing needs, times, technology. In this regard, a draft bill has been prepared, a copy of which is enclosed.

It has been decided to solicit suggestions/comments/objections from the public/ stakeholders with regard to the said draft Bill.

The suggestions/comments/objections may be forwarded within 45 days from the date of issue of this Notice by email to or by post to Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Room No. 434, C Wing, Nirman Bhawan, New Delhi – 110011.

The suggestions/comments/objections received on the above email/address within the period of 45 days from the date of issue of the Notice, shall be taken into consideration for finalization of the notification.

A detailed Notice is available in the following link.

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