DATE: 26th July 2021

Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi

Notice

File No. 29/Misc./0312020-DC (147) 

Subject: Classification of Medical Device pertaining to Dermatological & Plastic Surgery under the provisions of Medical Devices Rules, 2017- Reg.

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, sale and distribution, clinical investigation, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (F) dated 31.01.2017 which is already implemented from 01.01.2018

DATE: 26th July 2021

Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi

Notice

File No. 29/Misc./03/2020-DC (202)

Subject: Classification of Medical Device pertaining to Physical support under the provisions of Medical Devices Rules, 2017- Reg.

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, sale and distribution, clinical investigation, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (F) dated 31.01.2017 which is already implemented from 01.01.2018

DATE: 23rd July 2021

File No.-20(8)/43/2021/Div.VI/NPPA
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
National Pharmaceutical Pricing Authority

OFFICE MEMORANDUM

The Government vide Gazette Notification No. 2808 (E) dated 13′^h July 2021 has capped Trade Margin at Price to Distributor (PTD) at 70% for medical devices, namely, (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer. It was further notified that the prices are to be revised by the manufacturers / importers as per the formula prescribed in the aforesaid notification and the revised prices shall be effective from 20^th July 2021.

DATE: 14th July 2021

File No.-20(8)/43/2021/Div.VI/NPPA
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
National Pharmaceutical Pricing Authority

OFFICE MEMORANDUM

Sub: Submission of price related information in pursuance to the Trade Margin  Rationalization Notification dated I 3^rd July 2021 for (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v)  Glucometer -reg.

The Government vide Gazette Notification dated 13th July 2021 (copy enclosed) has capped Trade Margin at Price to Distributor (PTD) at 70% for (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer and directed manufacturers / importers of these products to submit revised MRP in the prescribed format (Annexure-I) based on the aforesaid Notification by 20th July 2021. Further, manufacturers / importers of these products have also been directed to issue a price list in Form—V as per Paragraph 25 of the DPCO, 2013 to State Drug Controller and Dealers with a copy to NPPA by 20th July, 2021.

DATE: 2nd July 2021

Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi

NOTICE
File No. 29/Misc.103/2020-DC (177)

Subject: Classification of medical devices pertaining to Anesthesiology under the provisions of Medical Devices Rules, 2017-Reg.

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices for their with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.1.2017 which are to be commence from 01.01.2018.

In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the undersigned is hereby classify the medical devices, Appendix A, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule.

List of medical devices placed at Appendix A is subjected to the followings:

1. General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
2. This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017

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

DATE: 13th July, 2021

(Published in Part II, Section 3, Sub Section (ii) of the Gazette of India Extraordinary)
Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
National Pharmaceuticals Pricing Authority
New Delhi, 13th July 2021

ORDER

S.O. _____ Whereas, the National Pharmaceutical Pricing Authority (NPPA) was established vide Resolution No. 33/7/97-PI.I dated 29th August 1997 of the Government of India in the Ministry of Chemicals and Fertilizers to regulate and monitor prices of drugs/formulations and oversee the implementation of the Drugs (Prices Control) Order (DPCO); and whereas the Government of India by S.O. 1394(E) dated 30th May 2013 and S.O. 1249(E) dated 6th April 2020 in exercise of the powers conferred by Section 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955) has delegated the powers in respect of various paragraphs including paragraph 19 of the DPCO, 2013 to the NPPA to exercise the functions of the Central Government;

DATE: 2nd July, 2021

No. 5/2(2)/2021-E/P & G/Policy (E-19025)

Government of India
Ministry of Micro, Small & Medium Enterprises
(Policy Division)

710, Nirman Bhawan, New Delhi

OFFICE MEMORANDUM

Subject:  Activities (NIC code) under MSMED Act, 2006 for Udyam Registration —Addition of Retail and Wholesale Trade- regarding

This Ministry’s O.M. No. UAM/MC/01/2017-SME dated 27.06.2017 on the subject ‘Activities (NIC codes) not covered under MSMED Act, 2006 for registration of Udyog Aadhaar Memorandum (UAM)’ excluded certain activities from registration on UAM Portal. This O.M. was further validated for Udyam Registration vide O.M. no. 5/2(1)/2020-P&G/Policy dated 17.07.2020. Certain changes were made vide 5/2(1)/2020/E-P&G/Policy dated 01.12.2020; where it was clarified that in Table. 1 of O.M. no. UAM/MC/01/2017-SME dated 27.06.2017, NIC codes 45, 46 and 47 and the activities mentioned against these NIC codes, are not permitted for registration in Udyam Registration Portal (https://udyamregistration.gov.in).

DATE: 4th July, 2021

GOVT. OF NCT OF DELHI
OFFICE OF THE DISTRICT MAGISTRATE (CENTRAL)
14, DARYA GANJ, NEW DELHI-110002.

No. SDM/KOT/COVID-19/2021/ 6942–6947

ORDER

Whereas, the Delhi Disaster Management Authority (DMA) is satisfied that the NCT of Delhi is threatened with the spread of Covid-19 epidemic, which has already been declared as a pandemic by the World Health Organization and has considered it necessary to take effective measures to prevent its spread in NCT of Delhi.

Arid whereas, Delhi Disaster Management Authority has Issued various orders/Instructions from time to time to all Authorities concerned to lake all required measures to appropriately deal with the situation.

DATE: 8th June, 2021

WM-10(22)/2020
Government of India
Ministry of Consumer Affairs, Food and Public Distribution
Department of Consumer Affairs
Legal Metrology Division

To,

The Controllers of Legal Metrology, All States/ UTs
Krishi Bhawan, New Delhi Dated: 08.06.2021

Subject: Extension of period up to 30.9.2021 for utilisation of the pre-printed packing material stock due to prevalent situation of COVID-19 – reg.

Sir,
The undersigned is directed to refer to the above mentioned subject and to state that due to prevalent condition of COVID-19, leading to the lockdown of the whole country the manufacturing activities have come to a grinding halt. Consequently, the inventory of packaging material / wrapper with pre-printed date of manufacturing is not expected to be exhausted within the time limit prescribed under Rules.

F.No.23/8/2021-HSMD
DATE: 10th June, 2021

Government of India
Ministry of Environment, Forest and Climate Change
(HSM Division)

OFFICE MEMORANDUM

Subject: Exemption for import of Used critical medical equipment for re-use (Basel No. B1110) under Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 – reg.