Office Memorandum Dated 23rd July 2021
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 20th July 2021.
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Office Memorandum in pursuance to TMR Notification
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 3rd 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.
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Classification of medical devices pertaining to Anesthesiology
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:
- 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.
- 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)
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Trade Margin Rationalisation (TMR) of 5 Medical Devices
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;
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Activities under MSMED Act, 2006 for Udyam Registration
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).
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Effective measures to prevent Covid-19 spread in NCT of Delhi
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.
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Extension of period for utilisation of the pre-printed packing material stock
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.
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Exemption for import of Used critical medical equipment for re-use
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.
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SMTA/June.2021/EBM/Rate Notification COVID
DATE: 14th June, 2021
MINISTRY OF FINANCE
(Department Of Revenue)
NOTIFICATION
New Delhi, the 14th June, 2021
No. 33/2021-Customs
G.S.R. 401(E).—In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act, 1962 (52 of 1962) and section 3 of the Customs Tariff Act, 1975 (51 of 1975), the Central
Government, on being satisfied that it is necessary in the public interest so to do, hereby rescinds the notification of the Government of India in the Ministry of Finance (Department of Revenue) No. 30/2021- Customs, dated the 1st May, 2021 published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 313(E), dated the 1st May, 2021, except as respects things done or omitted to be done before such rescission.
[F. No. CBIC-190354/63/2021-TO(TRU-I)-CBEC]
RAJEEV RANJAN, Under Secy
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SMTA/June.2021/GST Updates
SMTA/June.2021/GST Updates
12th June 2021
GST Updates
Good morning.
To give effect to the decision taken at 43rd GST Council meeting, GST department has issued few notifications on 1st June 2021.
1. Notification no 16/2021 ( payment of interest on delayed filing of GSTR 3B)
Section 50 of CGST Act which governs payment of interest has been amended w.e.f 1st July 2017. Registered person will now be required to pay interest on tax paid through electronic cash ledger. No interest to be paid on tax paid through ITC.
2. Notification number 17/ 2021
The last date for filing GSTR-1 return for May 2021 has been extended till 26th June 2021.
3. Notification no 18/2021
Interest payment for delay in filing GSTR-3b –
A Registered person having turnover of more than Rs 5cr in preceding year – 9% interest p.a. for first 15days after due date of filing of GSTR 3B and 18% interest p.a. thereafter for the month of March, April and May.
B. Registered person having aggregate turnover upto Rs 5cr in last year –
For March 2021 – No interest for first 15 days after the due date of filing of GST 3B, 9% pa for next 45 days and 18% pa thereafter.
For April 2021 – Nil interest for first 15 days from the due date of filing GSTR-3B, 9% pa for the next 30 days and 18% pa thereafter.
For May 2021 – Nil interest for first 15 days from the due date of filing GSTR- 3b, 9% pa for next 15 days and 18% pa thereafter.
C. Registered person filing GSTR – 3b on a quarterly basis – No interest for the first 15 days from the due date of filing GSTR- 3b for quarter March 2021, 9% pa for the next 45 days and 18% pa thereafter.
4. Notification no 19/2021 ( waiver of late fees for GSTR 3B for March, April and May 2021)
a. Registered person having aggregate turnover of more than Rs 5cr in last year –
No late fees for the first 15 days from the due date.
b. Registered person having aggregate turnover upto Rs 5cr –
For March 2021- No late fees upto 60 days from the due date.
For April 2021- No late fees upto 45 days from the due date.
For May 2021- No late fees upto 30 days from the due date.
c. Registered person filing quarterly GSTR- 3b – No late fees upto 60 days from the due date of filing return for March 2021 quarter.
d. Amnesty scheme-
Those who have not filed their GSTR- 3b for any month or quarter from July 2017 till April 2021 can file the return before 31st August 2001 with the late fee of Rs 1000 per return.
If the tax payable in any return is Nil, then the late fees shall be Rs 500 per such return.
e. Maximum late fees for delay in filing GSTR-3b from June 2021 onwards-
If tax payable is Nil then maximum late fees shall be Rs 500 per return
If turnover in the last year is upto Rs 1.50 crore, then maximum late fees shall be Rs 2000 per return.
If turnover in last year is is up to Rs 5 crore, then the maximum late fees shall be Rs 5000.
5. Notification no 20/2021
Maximum late fees for delay in filing GSTR-1 from June 2021 onwards-
If there is no outward supplies during the month/ quarter, then maximum late fees shall be Rs 500.
If the turnover during last year is upto Rs 1.5 crore, then maximum late fees shall be Rs 2,000.
If turnover during last year is upto Rs 5 crore, then maximum late fees shall be Rs 5000.
6. Notification 26/2021 ( Filing of Job Work return)
All Registered person can file ITC 04 for Jan – March 2021 till 30th June 2021.
7. Notification 27/2021 (Availment of ITC and filing of IFF for April 2021)
a. Registered person can claim ITC for April and May 2021 as per their books without following GSTR 2A. However, while filing GSTR 3B for June 2021, it need to ensure that it has availed ITC for April, May and June, put together , as per GSTR 2A plus 5%.
b. Registered person filling quarterly GSTR 1 can file outward supply details in IFF for May 2021 from 1st June till 28th June 2021. Earlier the due date was till 13th June 2021.
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