Date: 29th July, 2022

MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 29th July, 2022

S.O. 3534(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 2021and and S.O. 401(E) dated 31st Jan 2022 issued notifications 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 (price to distributor) for fixation of Maximum Retail Price of these products. In continuation to the above notifications, 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 (price to distributor) upto 31st July 2022 is further extended upto 31st December 2022 or till further order, whichever is earlier. It has also been decided that the same shall be monitored as per the provisions of Paragraph 20(1) of the DPCO, 2013 subject to maintenance of trade margin stipulated in Para 11 of the notification vide S.O. 2808(E) dated 13 th July 2021.
2. The Notes (b) to (m) of the Notification S.O. 2808 (E) dated 13th July 2021 shall remain in force during the currency of this order.

Date: 18th July, 2022

Dear SMTA Members,
WE wish to inform you that FIEO – Federation of Indian Export Organization is planning to organize Participation in PharmaTech East Africa as per the following schedule:
Dates : 30th August – 1st September (Tuesday – Thursday)

We are pleased to inform that FIEO is planning to organize Participation in PharmaTech East Africa as per the following schedule:
Dates : 30th August – 1st September (Tuesday – Thursday)
Time : 1000 Hrs – 1800 Hrs
Venue : Diamond Jubilee Hall, Dar-es-salam, Tanzania

Tanzania is the most linguistic diverse country in East Africa. Around 16% of Tanzania’s GDP is formed by the export and import of goods and services. In 2017, Tanzania’s PharmaTech market was valued at USD 600 million. Forecast shows that it would reach USD 830 million by 2023. The vast majority of pharma, medical and healthcare imports in Tanzania in the private sector supply chain are dominated by imports from India, Switzerland, Egypt, USA and South Africa and the Tanzanian authorities have reportedly been seeking collaborations with international pharmaceutical companies to promote the local development of medicines and technology.

Date: 14th July, 2022

MINISTRY OF CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, 14th July, 2022

G.S.R. 577(E).—In exercise of the powers conferred by sub-section (1), read with clauses (j) and (q) 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 (Packaged Commodities) Rules, 2011, namely:-
1. (1) These rules may be called the Legal Metrology (Packaged Commodities) (Second Amendment) Rules, 2022.
(2) They shall come into force on the date of their publication in the Official Gazette.

Date: 11th July, 2022

File No.29/Misc/03/2022- DC (94) Government of India
Director General of Health Services Central Drugs Standard Control Organisation
NOTICE

In pursuance of notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices of Class A & Class B categories are scheduled to enter licensing regime with effect from 01.10.2022

A transition period of 30 months had been provided for Class A & Class B medical devices from date of implementation of G.S.R. 102(E) i.e., 01.04.2020 for the transition to licensing regime. During that period the manufacturers were required to register their products on the portal ( ) established for the purpose by CDSCO and to affix the registration number on the label of such registered medical devices.

Of late, it has come to the notice of this office that some other entities are issuing quality certificates to the manufacturers at their own level, which is becoming a source of confusion for manufacturers vis-a-vis the prescribed regulatory pathway for obtaining the licensure for such medical devices under Medical Devices Rules (MDR), 2017. In this regard, it is hereby clarified that such quality certificates issued by other entities shall not be a replacement of licensure to be granted under MDR, 2017 by the competent Licensing Authority. All manufacturers shall have to comply with the licensing requirement and obtain the license as per MDR, 2017, as the said rules do not recognize any such certificates which are not mentioned in it or part of it.

Further, it is again advised that all manufacturers shall apply for obtaining manufacturing license for Class A & Class B medical devices through CDSCO’s on-line portal so that the manufacturing license can be granted by respective State Licensing Authorities after review of the applications and audit (as the case may be) as per stipulated time specified in MDR, 2017 in order to avoid further delay.

In this regard this office has proactively taken up the issue vide notice No. 29/Misc/03/2022- DC (94) dated 25.04.2022, requesting all State Licensing Authorities (SLAs) to dispose of the applications received by them as per MDR, 2017 in time to avoid the disruption of the supply of such devices to the patients.
To, 1. All SLAB 2. All Associations 3. CDSCO Website 4. Quality Council of India 5. Department of Pharmaceuticals

(Dr. V. G. Somani) Drugs Controller General (India)

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

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.

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.”;

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.

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;