Drugs, Medical Devices and Cosmetics Bill
Date: 8th July, 2022
F.No.X.11012/2/2021- DRS
Government of India
Ministry of Health and Family Welfare
(Department of Health & Family Welfare) (Drugs Regulation Section) *******
Nirman Bhawan, New Delhi Dated then 8th July, 2022
NOTICE Subject: Draft of New Drugs, Medical Devices and Cosmetics Bill, 2022 -regarding. 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.
2. 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.
4. 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 drugsdiv-mohfw@gov.in 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.
Encl: Draft Bill
Copy to: (Bik. R Mahato) Under Secretary to the Govt. of India Tele: 2306 1141
1. All concerned Central Government Department 2. All additional Chief Secretaries/principal Secretaries/Secretaries Health and family Welfare/Medical Education of all States/UTs 3. All NIPER
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SMTA/Public Notice 10th March 2022
Date: 10th March 2022
No. 31026/91/2015-PI-II
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
PUBLIC NOTICE
Subject:- Approach paper on Draft National Medical Devices Policy 2022 for consultation – reg
The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of medical conditions, diseases, illnesses, and disabilities. It forms an important pillar in the healthcare delivery system along with healthcare providers, pharmaceuticals and health insurance industry, thereby helping achieve the key values enshrined in the National Health Policy (NHP) 2017 in terms of provision of good quality, affordable, and comprehensive healthcare to all citizens.
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SMTA/Notification/3rd March, 2021
Date: 3rd March, 2021
MINISTRY OF CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 3rd March, 2021
G.S.R. 149(E).—In exercise of the powers conferred by sub-section (1) read with clauses (c), (f), (h), (i) and (s) of sub-section (2) of section 52 of the Legal Metrology Act 2009, (1 of 2010), the Central Government hereby makes the following rules further to amend the Legal Metrology (General) Rules, 2011, namely: –
1. (1) These rules may be called the Legal Metrology (General) (Amendment) Rules, 2021.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Legal Metrology (General) Rules, 2011 (hereinafter referred to as the said rules), in rule 27, –
(i) for sub-rule (1), the following sub-rule shall be substituted, namely:-
“(1) Every weight or measure used or intended to be used in any transaction or for protection of living beings or things in clause (k) of section 2 shall be verified and stamped by the legal metrology officer of the State of manufacture or import or at the place of installation as specified in clause (iv) of sub-rule (5) and be re-verified and stamped at periodical intervals by the legal metrology officer in the State in which such weight or measure is put to use.”;
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SMTA/Public Notice 1st February, 2022
No. 35026/176/2021-MD
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
Janpath Bhawan, New Delhi Dated 1st February, 2022
PUBLIC NOTICE
Subject:- Relaxation on Global Tender Enquiry (GTE) under rule 161(iv) of General Financial Rules (GFRs) 2017 for procurement of Medical Devices based on the requests of the procurement agencies on the grounds of non-availability of Class-I or Class-II suppliers — Confirmation of the the consolidated list of 391 Medical Devices, prior to sending the proposal to DoE through DoHFW – reg
Reference is taken to the DoP Public Notice dated 18.12.2021 vide which medical devices in two lists (493 Medical Devices viz, 128 in List-1 and 365 in List-2 of Annexure-I of the Public Notice) were published to seek the details of local manufacturers for the purpose of procurement under PPO (MII) Order, 2017. The exercise has been taken pursuant to the representations received from the procuring agencies under different Ministries of the Govt. of India such as CMSS, ESIC, AIIMS, Railway Board, DGAFMS, RITES, etc. with regard to non-availability of Class-I or Class-II suppliers for identified Medical Devices/Equipment.
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SMTA/Notification 9th February, 2022
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 9th February, 2022
G.S.R. 104(E).—The following draft of certain rules further to amend Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from
the date on which copies of the Gazette of India containing these draft rules are made available to public;
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Registration Certificate for Sellers & Distributors of Medical Devices
REGISTRATION CERTIFICATE FOR SELLERS & DISTRIBUTORS OF MEDICAL DEVICES
This is to bring to the notice of all members – with reference to the Ministry of Health & Family Welfare’s notification no. G.S.R 104(E) containing Draft Rules for amendments to the Medical Devices Rules dated 9th Feb 2022 – A series of amendments have been proposed through which a ‘Registration Certificate to sell, stock, exhibit or of offer for sale or distribute a medical device including in vitro diagnostic medical device’ has been introduced. This will come into effect at least after 45 days from the date of the notification and through further announcements by the Ministry. In a nutshell, this Registration Certificate will replace the Drug License requirement for Dealers and Distributors of Medical Devices. The Registration Certificates will have to be applied for, and will be issued by the state licensing authorities. It is indeed a moment of pride for all SMTA members that our association’s consistent efforts and representations to various departments and the Ministry have paid off. Following our submissions to the departments regarding ‘Drug Licensing’ for traders through our letters and subsequent meetings with the various authorities – our
suggestions have been taken into consideration and these changes have been implemented.
We are confident that this in the interest of traders and will benefit all SMTA members as well as all the sellers and distributors of Medical Devices in India, bringing ease to the process and eliminating the need for drug licenses. We request you to go through the notification and for any queries please contact the SMTA Office Bearers. We will be further communicating the objections & suggestions of our members to simplify the registration process further, as we feel it can be improved. Our efforts will focus on including these suggestions before the notification comes into effect.
Thanking You,
Regards,
Pradeep Chawla
President
The Surgical Manufacturers & Traders Association
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Public Notice: Relaxation on Global Tender Enquiry for procurement of Medical Devices
No. 35026/176/2021-MD
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
Janpath Bhawan, New Delhi
Dated 1st February, 2022
PUBLIC NOTICE
Subject:- Relaxation on Global Tender Enquiry (GTE) under rule 161(iv) of General Financial Rules (GFRs) 2017 for procurement of Medical Devices based on the requests of the procurement agencies on the grounds of non-availability of Class-I or Class-II suppliers — Confirmation of the the consolidated list of 391 Medical Devices, prior to sending the proposal to DoE through DoHFW – reg
Reference is taken to the DoP Public Notice dated 18.12.2021 vide which medical devices in two lists (493 Medical Devices viz, 128 in List-1 and 365 in List-2 of Annexure-I of the Public Notice) were published to seek the details of local manufacturers for the purpose of procurement under PPO (MII) Order, 2017. The exercise has been taken pursuant to the representations received from the procuring agencies under different Ministries of the Govt. of India such as CMSS, ESIC, AIIMS, Railway Board, DGAFMS, RITES, etc. with regard to non-availability of Class-I or Class-II suppliers for identified Medical Devices/Equipment.
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List of available standards of Bureau of Indian Standards for Medical Devices
Public Notice: No. 31026/83/2021-MD
Dated 1st February 2022
Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
Public Notice dated 01.02.2022
Subject: List of available standards of Bureau of Indian Standards for Medical Devices — regarding
I am directed to refer to Rule 7 of Medical Device Rules, 2017 as under, which stipulates the requirement of Product Standards for medical devices :-
“Product standards for medical device —
- The medical device shall conform to the standards laid down by the Bureau of Indian Standards established wider section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
- Where no relevant Standard of any medical device has been laid clown under sub-rule (1), such device shall conform to the standard laid down by the International Organisation far Standardisation (1S0) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia!
- In case of the standards which have not been specified under sub-rule (I) and sub-rule (2), the device shall conform to the validated manufacturer’s “
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SMTA/ORDER/31st-January-2022
THE GAZETTE OF INDIA : EXTRAORDINARY
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 31st January, 2022
S.O. 401(E).—The National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India vide S.O. 2808(E) dated 13th July, 2021 issued notification under Para 19 of the DPCO, 2013 regarding capping the trade margin of five medical devices, namely, (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer at first point of sale of the product through Trade Margin Rationalization Approach. In continuation to the above notification, capping the trade margin of five medical devices, namely, (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer at first point of sale upto 31′ January, 2022 is further extended upto 31st July, 2022.
- The Notes (b) to (m) of the Notification S.O. 2808 (E) dated 13rh July, 2021shall remain in force dining the currency of this order.
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SMTA/Jan-23/1st Executive Body Meeting
Ref: SMTA/Jan.2022/EBM/Min-01
Dated 23-01-2022
MINUTES
Pursuant to the Agenda Notice dt 18/01/2022 the 1st Executive Body Meeting of The Surgical Manufacturers & Traders Association was held on Sunday, 23 Jan 2022 online via Zoom meetings.
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