Regulatory Changes Due to Covid 19

Regulatory Changes Due to Covid 19

Total Count : 2088; Website updated as on 22nd January, 2021 | Displaying data for the month of January 2021

December 2020 November 2020 October 2020 September 2020 August 2020 July 2020 June 2020 May 2020 Apr 2020 Jan-Mar 2020

Central / StateDocument TitleDate IssuedSummaryMandatory or AdvisoryIndustry(ies) ImpactedValid TillDoes it Impact Komrisk Database?
CentralDGFT issues information regarding Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits and their components/laboratory reagents19-01-2021The Directorate General of Foreign Trade, Ministry of Commerce and Industry (“Ministry”) has in a Trade Notice dated 19th January, 2021 issued information regarding Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits and their components/laboratory reagents.

The quota for export of the following types of diagnostic kits has been fixed for the period from December, 2020 to February, 2021 as follows:

1. VTM Kits or its component elements [15 ml Falcom Tube or Cryovials, Swabs sterile synthetic fibre swabs (Nylon, polyester, Rayon or Dacron)] exported as part of a kit or individually-  660 Lakh

2. RNA Extraction Kits or its component elements (Silicone Columns, Poly AdenylicAcide or Carrier RNA, Proteinase K, Magnatic Stands, Beads) exported as part of a kit or individually- 400 Lakh

3. RT-PCR Kits( COVID/Non-COVID) or its component  elements (Probe Specific for Covid-19, Primers specific for Covid-19 Revers Transcriptasen Enzyme and Deoxy Nucleotide Triphosphate) exported as part of a kit or individually- 280 Lakh

The application procedure and criteria for export of above Diagnostic kits is outlined below:

i. Export of Diagnostic kits and their components/laboratory reagents as per above mentioned export quota is for the period till February, 2021.

ii. Exporters (Only Manufacturers) may apply online through DGFT's ECOM system for Export authorizations (Non-SCOMET Restricted items) ¬Please refer Trade Notice No. 50 dated 18.03.2019(enclosed). There is no need to send any hard copy of the application via mail or post.

iii. Exporters who have already filed an online application for export of these diagnostic kits need not apply again. However, they need to write a mail with the application file number and also submit the documents as described in this trade notice through email at export-dgft@nic.in mentioning the specific file number in the subject of the mail.

iv. Online applications for export of "Diagnostic Kits (VTM/RNA Extraction kits/RT-PCR Kits) or their components/laboratory reagents" for the above quantities may be applied from 21st to 31st January, 2021.

v.  the applications will be examined as per the Para 2.72 of Handbook of procedures.

vi. Validity of the export license will be for 3 months only.

vii. The following eligibility criteria will be applicable for consideration of applications:
a. Documentary proof of manufacturing "VTM/RNA Extraction kits/RT-PCR Kits.
b. Only 1 application per IEC may be considered during this period.
c. The documents to be submitted may include the following:
• Copy of Purchase order/Invoice
• Copy of IEC
• Undertaking duly signed by the authorized signatory in the company letter head to be submitted by the manufacturer certifying that as on date, all domestic commitments/orders have been fulfilled.

Please note that all the documents must be duly self-attested by the authorized person of the firm.

All the relevant documents as specified above must be submitted along with the application to verify the eligibility criteria. Incomplete applications will not be considered for any allocation. Any application received through email or submitted outside the timeline specified will not be considered.

Background:

Earlier through a Notification  the Ministry had restricted the export of Diagnostic Kits/Laboratory Reagents/Diagnostic Apparatus.

Now, the present export quota is being issued through this notification.
MandatoryEXPORTERS OF MEDICAL DEVICENO END DATE SPECIFIEDNA
CentralSEBI further extends relaxation granted for strict enforcement of SEBI (ICDR) Regulations, 2018 regarding Rights Issue upto 31st March, 202119-01-2021In a Circular dated 19th January, 2021, the Securities and Exchange Board of Indian (“SEBI”) has extended the earlier relaxations granted under the SEBI (Issue of Capital and Disclosure Requirements) Regulations, 2018 (“Regulations”).

In its previous Circular dated 6th May, 2020 SEBI had in view of the difficulties faced due to COVID-19 pandemic and the lockdown measures, and in order to ensure that all eligible shareholders are able to apply to rights issue during such times, informed that the issuer shall along with lead manager(s) to the issue, the registrar, and other recognized intermediaries [as deemed fit by issuer and lead manager(s)] institute an optional mechanism (non- cash mode only) to accept the applications of the shareholders subject to ensuring that no third party payments is allowed in respect of any application

This relaxation was granted from *Regulation 76 of the Regulations under which an application for a rights issue shall be made only through ASBA facility. The relaxation is now being further extended till 31st March, 2021 subject to the conditions that were specified earlier in Circular dated 6th May, 2020. The conditions require that the issuer along with Lead Manager(s) has to ensure the following:

i. The mechanism(s) will only be an additional option and not a replacement of the existing process. As far as possible, attempts will be made to adhere to the existing prescribed framework.

ii. The mechanism(s) must be transparent, robust and have adequate checks and balances. It should aim at facilitating subscription in an efficient manner without imposing any additional costs on investors. The issuer along with lead manager(s), and registrar has to satisfy themselves about the transparency, fairness and integrity of such mechanism.

iii. An FAQ, online dedicated investor helpdesk, and helpline must be created by the issuer company along with lead manager(s) to guide investors in gaining familiarity with the application process and resolve difficulties faced by investors on priority basis

iv. The issuer along with lead manager(s), registrar, and other recognized intermediaries (as incorporated in the mechanism) will be responsible for all investor complaints.


Background:

Earlier through Circular SEBI/HO/CFD/DIL2/CIR/P/2020/78 dated 6th May, 2020, SEBI had granted one time relaxations from strict enforcement of certain Regulations of SEBI (Issue of Capital and Disclosure Requirements) Regulations, 2018, pertaining to Rights Issue opening upto 31st July, 2020.

Subsequently, through another Circular the validity of the relaxation for or Rights Issues opening upto December 31, 2020.

Now, a further extension is being granted.

________________________________
*Regulation 76. - ASBA
The issuer shall provide the ASBA facility in the manner specified by the Board where not more than one payment option is provided. Provided that the applicants in a rights issue shall be eligible to make applications through ASBA facility only if such applicant:
(i) is holding equity shares in dematerialised mode;
(ii) has not renounced entitlement in part or in full; and
(iii) is not a renouncee. Provided further that payment made for application for any reserved portion outside the issue period can be through electronic banking modes.
MandatoryListed companies31-03-2021NA
CentralSEBI extends relaxations with regard to sending physical copies of annual report to shareholders and proxy requirement for general meetings held through electronic mode under the LODR Regulations till 31st December, 202118-01-2021Pursuant to the relaxations granted by the Ministry of Corporate Affairs (“MCA”), the Securities and Exchange Board of India (“SEBI”), through a Circular dated 15th January, 2021 has extended the time for sending physical copies of annual report to shareholders and requirement of proxy for general meetings held through electronic mode under the provisions of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 till 31st December, 2021.

Background:

Through a Circular dated 31st December, 2020 the Ministry of Corporate Affairs (“MCA”) has further extended relaxations to companies to conduct their Extraordinary General Meeting (EGM) through Video Conferencing (VC) or through other audio-visual means (OAVM) upto 30th June, 2021. Further, through another Circular dated January 13, 2021, MCA has also extended these relaxations to Annual General Meeting (AGMs) of companies due in the year 2021 (i.e. till 31st December, 2021).

In light of these extensions granted by MCA, SEBI has granted the present extension to listed companies in continuation to the earlier relaxations granted till 31st December, 2020 under Paras 3 to 6 of the
Circular No. SEBI/HO/CFD/CMD1/CIR/P/2020/79 dated 12th May, 2020. The extensions/ relaxations are with regard to sending physical copies of annual report to shareholders and  requirement of proxy for  general meetings held through electronic mode.
MandatoryListed companies31-12-2021YES
CentralOwing to the pandemic, the period from the 01.04.2020 to the 31.03.2021 will not be considered for the purpose of calculating the period of validity of Prior Environmental Clearances; says MOEFCC18-01-2021The Ministry of Environment, Forest, and Climate Change (“Ministry”) in a Notification dated 18th January, 2021 has issued the following amendments to the Environment Impact Assessment Notification dated 14th September, 2006 (“Principal Notification”) which mandated the requirement of prior environmental clearance from the concerned regulatory authority mandatory for all new projects or activities listed in the Schedule to the said notification, their expansion and modernisation and/or change in product mix, as the case may be, before any construction work or preparation of land by the project management except for securing the land

Implication-
1. Through the amendment, a new sub clause has been inserted basis which the period from the 1st April, 2020 to the 31st March, 2021 will not be considered  for the purpose of calculation of the period of validity of Terms of Reference granted under the provisions of this notification.

The said relaxation has been granted in light of the outbreak of the pandemic COVID 19 and the lockdowns declared to control its spread.

Please note that all activities undertaken during this period in respect of the said Terms of Reference shall be treated as valid.

2. Owing to the pandemic, the period from the 1st April, 2020 to the 31st March, 2021 will not be considered for the purpose of calculating the period of validity of Prior Environmental Clearances.

Please note that all activities undertaken during this period in respect of Environmental Clearance will be treated as valid.

Earlier, through an amendment, the validity of prior environmental clearances granted under the provisions of the Notification in respect of the projects or activities whose validity is expiring in the Financial Year 2020-2021 is deemed to be extended till the 31st March, 2021 or six months from the date of expiry of validity, whichever is later. (detailed in the trail mail)

Now, the said provision is being entirely substituted.

Background:
in view of the outbreak of Corona Virus (COVID-19) and subsequent lockdowns (total or partial) declared for its control, implementation of projects or activities in the field has been affected. The Ministry has received number of requests for extension of the validity of prior environmental clearances beyond the maximum period allowed in the said notification, as the COVID-19 pandemic has not yet come to an end.

In light of these, the present amendment has been issued.
MandatoryAllNo end date specifiedNO
RajasthanRajasthan Government issues guidelines to implement caution and strict surveillance in the State till 31st January, 2021; lockdown extended in Containment Zones upto 31st January, 202118-01-2021The Government of Rajasthan has notified guidelines to implement caution and strict surveillance in the State upto 31st January, 2021.

Ministry of Home Affairs (“MHA”), Government of India, had extended the surveillance, containment and caution Guidelines issued earlier on 25th November 2020. Taking into account the prevailing COVID outbreak scenario in the State, and the emergence of a new variant of the virus in the United Kingdom; the following measures have been prescribed to implement caution and strict surveillance in Rajasthan:

Key Highlights

1. Lockdown will remain in force in Containment Zones till 31st January, 2021;

2. Exhibition halls only for business to business (B2B) purposes is permitted with a maximum of 50% hall capacity and ceiling of 100 persons;

3. Organisation and businesses entities with 50 or more employees are encouraged to avail the Aarogya Setu Open API service in view to ensure safety in offices and workplaces; 

4. Containment Zones will follow strict containment measures as prescribed by MoHFW;

5. Employers to ensure on best effort basis that AarogyaSetu is installed by employees having compatible mobile phones;

6. Online / distance learning will continue to be permitted and will be encouraged. Schools / colleges / universities are open since 18th January, however, classes from 1st to 8th will remain closed till further orders;

7. Cinema halls / theatres / multiplexes, entertainment parks and similar places will remain closed for activities till 31st January, 2021.

8. Functions and other congregation are permitted in areas outside containment zones with prior information to the concerned Sub-divisional Magistrate (preferably on email) with following basic COVID-19 precautions.

a. Funeral / last rites related gatherings with proper COVID-19 precautions are allowed with maximum number of persons allowed not more than 20.

b. Social / political / sports / entertainment / academic / cultural / religious functions are allowed after prior permissions from District magistrate / Police Commissioner and with maximum number of guests at 100 and by occupying 50% hall capacity in closed spaces. In open spaces, 100 persons are allowed and each person to maintain a distance of 6 feet.

9. People to wear masks at all times in public places and to follow all SOPs issued by the Government of India.

10. Vulnerable persons are advised to stay at home and move out only for essential and health purposes only.

11. There is no restriction on any kind of movement of persons and goods. 
Mandatory AllNo end date specifiedNo
MeghalayaGovernment of Meghalaya extends night curfew in East Khasi Hills District in Meghalaya from 11:00 to 5:00 am on a daily basis; effective upto 24th January, 202117-01-2021The District Magistrate of East Khasi Hills District in Meghalaya has extended the night curfew in East Khasi Hills District with effect since 18th January, 2021 upto 24th January, 2021 between 11:00 pm to 5:00 am daily. This has been done with a view to contain and consequentially eliminate the pandemic of COVID-19. 

The exceptions to the curfew order has been detailed below-

1. The night curfew will not apply to:

i. press (print and electronic), Information and Public Relations Department;

ii. wholesale and retail pharmacies;

iii. medical teams and officials on COVID-19 duty,

iv. police, security and armed forces,

v. civil defence and home guard volunteers, wholesale and retail pharmacies, Fire and Emergency service, Information and Public Relations Department.

vi. fire and emergency service;

vii. MeECL, NEEPCO and Power Grid, FCI vehicles;

viii. officers and staff of corona care centres;

ix. National Highway and Infrastructure Development Corporation Ltd., and

x. Shillong Municipal Board and telecom service. .

2. Adherence to all the protocols and procedures including social distancing, is mandatory.

Note: The exemption from night curfew will also be applicable to movement of vehicles carrying essential goods, security forces, medical equipment and shops for repair of vehicles on highways. However, drivers and attendees of vehicles shall be subjected to medical screening as per the protocol.

Curfew passes for night curfew timings may be obtained via online application at eastkhasihills.gov.in.
MandatoryAll24-01-2021No
West BengalGovernment of West Bengal directs issuance of death certificate by the doctors attending the patient during his last illness15-01-2021During the COVID-19 pandemic, there has been a crisis of ICU/CCU beds with instances of patients expiring in the ambulance while being shifted from private hospitals to government designated COVID-19 hospitals.

Therefore, it has been directed that the medical practitioner who attended the patient during his/ her last illness must issue the Death Certificate without charging any fee for the same as prescribed under Section 10(3) of the Registration of Births and Deaths Act 1969.

The above-mentioned shall apply to all patients.

For a detailed read, please refer to the attached document.
MandatoryHealthcareNo end date specifiedNo
CentralMoHFW issues letter to all States and UTs with details on contraindications and special precautions while administering COVID-19 vaccines14-01-2021Ministry of Health and Family Welfare ("MoHFW") has in a letter addressed to the Additional Chief Secretary/ Principal Secretary/ Secretary and Health Department of States and Union Territories, released a detailed note on contraindications and special precautions that needs to be followed while administering COVID-19 vaccines:

Key highlights -

1. COVID-19 vaccine is to be administered to people who are 18 years of age and above;

2. COVID-19 vaccines and other vaccines to be separated by an interval of at least 14 days;

3. Interchangeability of COVID-19 vaccines is not permitted and the second dose of the COVID-19 vaccine should be the same as the first dose;

4. COVID-19 vaccine should not be used on -

a. People with history of anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine;

b. Pregnant and lactating women;

5. COVID-19 vaccines should be deferred for 4-8 weeks after recovery for the following:

a. Persons having active symptoms of SARS-CoV-2 infection;

b. SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma;

c. Acutely unwell and hospitalised (with or without intensive care) patients due to any illness;

6. Vaccines should be administered with caution to persons with history of any bleeding or coagulation disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder);

7. The document also provides comparative sheet for different COVID-19 vaccines under the Indian Government Supply.

For a detailed read, please refer to the attached document.
Advisory AllNo end date specifiedNo
CentralMCA clarifies that spending CSR funds on awareness campaigns/programmes or public outreach campaigns on COVID-19 Vaccination programme is eligible CSR activity13-01-2021The Ministry of Corporate Affairs (MCA) had earlier in a Circular dated March 23, 2020 issued a clarification stating that spending Corporate Social Responsibility (“CSR”) funds for COVID-19 is eligible CSR activity (detailed in trail).

Now, in a recent Circular dated January 13, 2021, the MCA has further clarified that spending of CSR funds for carrying out awareness campaigns/ programmes or public outreach campaigns on COVID-19 Vaccination programme is also an eligible CSR activity under item nos. (i), (ii) and (xii)* of Schedule VII of the Companies Act, 2013 relating to promotion of healthcare, including preventive health care and sanitization, promoting education and disaster management respectively.

Accordingly, companies may undertake such activities subject to meeting other criteria as specified under the Companies (Corporate Social Responsibility) Policy Rules, 2014 and other directions issued by the MCA in this regard.


*(i) Eradicating hunger, poverty and malnutrition, promoting health care including preventive health care and sanitation including contribution to the Swach Bharat Kosh set-up by the Central Government for the promotion of sanitation and making available safe drinking water.
(ii) promoting education, including special education and employment enhancing vocation skills especially among children, women, elderly and the differently abled and livelihood enhancement projects.
……..
(xii) disaster management, including relief, rehabilitation and reconstruction activities
MandatoryAllNo end date specifiedYes
CentralIRDAI issues letter to general and health insurers on settling cashless health insurance claims for Covid-19 treatment; emphasizes on ‘Reference rates for COVID-19 treatment’ issued by General Insurance Council for guidance13-01-2021The Insurance Regulatory and Development Authority of India (“IRDAI”) has in a letter addressed to all General and Health insurers (except ECGC and AIC) advised that “Cashless Claims” under a health insurance policy, be settled as per the tariff decided by the parties in compliance with provisions of Regulation 31 of IRDAI (Health Insurance) Regulations, 2016.

Insurers have also been advised to have agreement with health providers on rates for treatment of Covid-19 like other diseases (for which rate agreements are in place). Also, while entering into such agreements, insurers have been advised to refer to the ‘Reference rates for COVID-19 treatment’ issued by General Insurance Council for guidance along with the rates fixed by State Governments and Union Territory Administration, as relevant.

Further, all insurers have been directed to ensure that the “Reimbursement claims” under a health insurance policy are settled as per the terms and conditions of the respective policy contract and honor all the health insurance claims as per the terms and conditions of the policy contract. Insurers have been advised to issue suitable guidelines on this to all TPAs.
MandatoryInsurersNo end date specifiedNA
CentralMCA allows companies whose AGMs were due in the year 2020 to conduct their AGMs on or before 31.12.202113-01-2021The Ministry of Corporate Affairs (MCA) had earlier in a circular dated May 5, 2020 stated that companies will be allowed to conduct their Annual General Meeting (AGM) through video conferencing (VC) or other audio visual means (OAVM), during the calendar year 2020, subject to the fulfilment of specific requirements which were also listed out in the said circular.   Now, in a recent circular dated January 13, 2020, the MCA has decided to allow companies whose AGMs were due to be held in the year 2020, or become due in the year 2021, to conduct their AGMs on or before 31st December, 2021 in accordance with the circular dated May 5, 2020.   MCA has further clarified that companies which fail to adhere to the relevant timelines will be exposed to legal action under the Companies Act, 2013. MandatoryAll31-12-2021Yes
DelhiDDMA extends order mandating  self-paid RT-PCR test on arrival at the airport for travellers returning from the UK; effective till 31st January, 202112-01-2021The Delhi Disaster Management Authority (“DMMA”) has informed that the Order No. 347 dated 08.01.2021 will remain in force 31st January, 2021 till further orders.

Background:

With a view to curb the spread of the new variant of SARS-CoV-2 originating from the United Kingdom, the Delhi Disaster Management Authority ("DDMA") has directed that mandatory self-paid RT-PCR test for all travellers coming from United Kingdom (UK) to India, on arrival at the airport.  The travellers who test positive will be isolated in an institutional isolation facility in a separate (isolation) unit as per existing protocol. The travellers found negative will be kept in compulsory institutional quarantine for a period of 7 days followed by 7 days of home quarantine.  The above-mentioned is applicable on trial basis till 14.01.2021. 

Now, the said Order is being extended till 31st January,2021.
MandatoryAll31-01-2021NO
DelhiDDMA mandates self-paid RT-PCR test on arrival at the airport for travellers returning from the UK; effective till 14th January, 202108-01-2021With a view to curb the spread of the new variant of SARS-CoV-2 originating from the United Kingdom, the Delhi Disaster Management Authority ("DDMA") has directed that mandatory self-paid RT-PCR test for all travellers coming from United Kingdom (UK) to India, on arrival at the airport.

The travellers who test positive will be isolated in an institutional isolation facility in a separate (isolation) unit as per existing protocol. The travellers found negative will be kept in compulsory institutional quarantine for a period of 7 days followed by 7 days of home quarantine.

The above-mentioned is applicable on trial basis till 14.01.2021.

For a detailed read, please refer to the attached document.
MandatoryAll14-01-2021No
Tamil Nadu Tamil Nadu Government allows cinemas to operate with 50% seating capacity08-01-2021The Government of Tamil Nadu has in a Press Release dated 8th January, 2021 informed that theatres are allowed to operate in the State but with only 50% seating capacity.

The management of such theatres along with general public has been directed to follow basic COVID-19 precautionary measures like wearing face masks, use of sanitizers etc.

Please note that the press release is in vernacular and we have translated it to the best of our understanding.
Mandatory Multiplexes, cinemas, theatresNo end date specifiedNo
DelhiDDMA directs complaince with SOP issued by the MOHFW for Epidemiological Surveillance and Response in the context of new variant of SARS-CoV-2 virus detected in UK in the context of regulated resumption of limited flights originating from the UK to India from 08-Jan-2021 08-01-2021In the light of the new variant of SARS-CoV-2 originating from the United Kingdom, the Ministry of Health and Family Welfare ("MOHFW") had issed a Standard Operating Procedure ("SOP") for Epidemiological Surveillance and Response in the context of new variant of SARS-CoV-2 virus detected in United Kingdom on 01.01.2021.

Now, in view of the regulated resumption of flights from UK to India till 08.01.2021,  the Delhi Disaster Management Authority ("DDMA") has directed that the Chairperson, GNCTD, District DMA and all the other compliances to ensure strict compliance of the annexed SOP issued by MOHFW. 
MandatoryAll08-01-2021No
Andhra PradeshAndhra Pradesh Health Department revises rates for Rapid Antigen Testing to be charged by the private laboratories in the State06-01-2021Owing to the increased availability of kits in the market and competition as more firms started manufacturing Rapid Antigen kits and in the decrease in cost of kits, the Health Medical & Family Welfare (B2) Department, Government of Andhra Pradesh (“Department”) has,  in an Order dated 6th January, 2021 revised the rate for Rapid Antigen Testing to be charged by the private laboratories as mentioned below-

1. Rapid Antigen Test Kit - Rs. 230/- Including all charges (Test cost + VTM +PPE)

Please note that testing can be done only in the ICMR approved Laboratories and all other conditions laid down by the ICMR and the State Government will apply. 
All the Private NABL & ICMR approved Labs are instructed to follow the above guidelines and all the Hospitals/Institutes/Labs are must ensure to display the rates in the visible manner. 

Background:

Through a previous Order dated 27th July, 2020  the Department had fixed the rates for Rapid Antigen testing for Private samples, in the ICMR approved Private NABH/NAB Labs, which was not more than  Rs. 750/- per test (includes rapid kit cost, PPE’s, manpower cost) for the patients who approach them for getting tested.

Now the said rates are being revised
MandatoryPrivate Laboratoriesno end date specifiedNO