Date: 18th August, 2022

File No. 31026/19/2020-MD
Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
Dated: 18th August, 2022

Guidelines for the Production Linked Incentive (PLI) Scheme for Promoting: Domestic Manufacturing of Medical Devices
1. Background
1.1. The Medical Device sector in India suffers from a considerable cost of manufacturing disability vis-a-vis competing economies, inter alia, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of power, limited design capabilities and low focus on research and development (R&D) and skill development etc. Thus, a need was felt for a mechanism to compensate for this manufacturing disability in order to ensure a level playing field for the domestic manufacturers of medical devices. To compensate for the manufacturing disability in selected segments of medical devices, the Government of India has come out with a scheme called ‘Production Linked Incentive Scheme (PLI) for promoting domestic manufacturing of Medical Devices’ (hereinafter referred to as ‘Scheme’) which has been notified vide Gazette Notification no. 31026/08/2020-MD, dated -21/07/2020.

Date: 25th August, 2022

Government of India, Ministry of Micro, Small and Medium Enterprises
Schemes implemented by M/o MSME & its organizations

• The scheme aims to provide financial assistance to set up self-employment ventures and generate sustainable employment opportunities in rural as well as urban areas.
• To generate sustainable and continuous employment opportunities to rural and unemployed youth as well as prospective traditional artisans and thereby halt occupational migration.

Apply on: https://www.kviconline.gov.in/pmegpeportal/pmegphome

Date: 24th August, 2022

No.31026/19/2020-MD
Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals
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Shastri Bhawan, New Delhi Dated the 24th August 2022

NOTICE

Subject:- Invitation of Applications from eligible Category B Applicants under the revised guidelines of Production Link Incentive (PM) Scheme for Promoting Domestic Manufacturing of Medical Devices dated 18.8.2022 from 1st September 2022 to 31st October 2022 – reg.
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Department of Pharmaceuticals issued Notification guidelines of the PLI Scheme for Medical Devices on 21.07.2020, which got revised on 29.10.2020 and as per this, so far, 21 applicants were selected based on the applications received under two rounds of inviting applications.

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)