Changes in Law introduced in 2020, that will impact your industry / business in 2021

admin

Handpicked Notifications Published in 2020

2020 surely took us to surprise with the spread of the COVID-19 Pandemic and the never seen nationwide lockdown. To help us all deal with this crisis the Government granted many reliefs to ease the compliance burden of businesses in India.

We have compiled some data on changes in the law brought during the year 2020 which has an impact in 2021 in the areas of Corporate Laws, Labour Laws, Environmental laws, Taxation laws, Healthcare Industry, Insurance Industry and the food Industry.

LS-2020-Highlights

With this, it’ll be easier for you to fully grasp the changes that can affect your business, and prepare for the new year.

All you need to know of changes brought in 2020 impacting 2021:
A. 20 SEBI Notification which will have an impact in 2020 on:

      1. Investors
      2. Listed companies and Promoters of listed companies 
      3. Alternative investment fund
      4. Investment advisors
      5. Portfolio managers

B. 7 major Company law amendments impacting the corporate sector in 2021:

      1. CSR
      2. Annual return disclosure
      3. NFRA filings
      4. Issue of Sweat equity share
      5. Takeover of company
      6. Company formation
C. 12 Tax law changes in 2020 which will attract compliance in 2021 covering:

      1. Income-tax Act and Rules
      2. GST
      3. Customs

D. 7 Labour Law changes in 2020 you need to know

E. 7 Healthcare Industry news

F. 3 Foreign Exchange Control law changes

G. 9 COVID-19 related notifications

 

SEBI:

1. Investors

  • SEBI Introduces ASBA as payment mechanism for IPO:

SEBI introduces Application Supported by Blocked Amount (ASBA) as the sole payment mechanism in the IPO and Rights issues for making subscription and/or payment of calls. 

Intermediaries including the issuer company and its RTA shall provide necessary guidance to the specified security holders in use of ASBA mechanism while making payment of calls

Effective Date: 8th December 2020  

Notification Date 8th December 2020

READ MORE

 

  • SEBI guidelines on processing of re-lodged transfer request

Operational guidelines for crediting the transferred shares into the respective demat  account of the investor following re-lodged transfer request.

 Subsequent to processing of re-lodged transfer request, the RTA shall intimate the investor (transferee) about the execution of transfer through a letter of confirmation. the investor would have to submit the demat request, within 90 days of issue of letter of confirmation, to depository participant along with the letter of confirmation who will then process the Demat Request

Effective Date: 2nd December 2020

Notification Date 2nd December 2020

READ MORE

 

  • Investors allowed to file online KYC form

SEBI has also allowed eSign mechanism for affixing cropped signature on the KYC form and on the copy of OVD of the investor and it has allowed the investor to complete the KYC process by filling the online KYC form.

Once all the information as required as per the online KYC form is filled up by the investor, the process can be completed and then the investor will need to take a printout of the completed form and after affixing their signature using eSign, Digilocker and electronic signature as permitted by the Government of India under the Information Technology Act, 2000, send the scanned copy of the same to the registered intermediary under eSign and the registered intermediary would forward the KYC completion intimation letter to the address of the investor.

Notification date: 29th April 2020

Effective date: 29th April 2020

READ MORE

 

  • Mobile Application for entering investor grievances

SEBI has launched a mobile application for assisting investors to enter grievances in SEBI Complaints Redress System (SCORES) portal, for furtherance of digital governance.

The investors shall lodge their complaints by using the internet medium. After mandatory registration on the application, Investors can not only file their grievances but also track the status of their complaint redressal using the application.aggrieved aggrieved 

Notification date: 5th March 2020

Effective date: 5th March 2020

READ MORE

2. Listed Companies and promoters of listed companies

  • Action for non disclosure by issuer of NCD, NCRPS etc

The Stock Exchanges are directed to take action against non-compliances with continuous disclosure requirements by  issuers of listed NCD Securities, NCRPS & Commercial Papers

The Stock Exchanges shall levy fine and take action in case of non-compliances with continuous disclosure requirements by issuers of listed Non-Convertible Debt Securities and/ or NCRPS and/ or Commercial Papers.

Effective Date: November 13, 2020

Notification Date:  November 13, 2020

READ MORE

 

  • Open ended debt schemes holding in liquid assets

All open-ended debt schemes shall hold at least 10% of their net assets in liquid assets. 

All open-ended debt schemes (except Overnight Fund, Liquid Fund, Gilt Fund, and Gilt Fund with 10-year constant duration) shall hold at least 10% of their net assets in liquid assets. 

Effective Date: 6th November 2020

Notification Date: 6th November 2020

READ MORE

 

  • Process for handling Scheme of arrangement filed with Stock Exchanges 

SEBI streamlines the processing of draft schemes filed with the stock exchanges, and on  Listed  Entities.

Draft schemes of arrangement of listed entities filed with the stock exchanges shall include a valuation report from a Registered Valuer and an Audit Committee report. Stock Exchanges shall provide the ‘No-Objection’ letter to SEBI on the draft scheme; in coordination with each other.  SEBI shall issue a Comment letter upon receipt of ‘‘No-Objection’ letter from Stock Exchanges

Effective Date: 3rd November 2020

Notification date: 3rd November 2020

READ MORE

 

  • SEBI clarification on Unfair trade practice 

The Securities and Exchange Board of India (Prohibition of Fraudulent and Unfair Trade Practices relating to Securities Market) (Second Amendment) Regulations, 2020 provides that manipulation of data of a listed company to influence prices is always an unfair trade practice

Any act of diversion, misutilisation or siphoning off of assets or earnings any concealment or manipulation of books of accounts or financial statement  of a listed company that would directly or indirectly manipulate the price of securities of that company shall be an unfair trade practice in the securities market

Effective date: 9th October 2020 

Notification date: 9th October 2020 

READ MORE

 

  • System driven disclosures on insider trading

SEBI implements the system driven disclosures for member(s) of promoter group and designated person(s) of company under Prohibition of Insider Trading (‘PIT) Regulations.

Depositories and Stock Exchanges shall make necessary arrangements such that the disclosures pertaining to PIT Regulations are disseminated on the websites of respective stock exchanges with effect from 1st October 2020.

Notification Date: 9th September 2020

Effective date: 1st October 2020.

READ MORE

 

  • Record date intimation where Stock Derivatives are listed

LODR Amendment mandates intimation of record date by listed entity to every stock exchange where stock derivatives are available 

in order to determine whether a shareholder is qualified for benefits on a particular date, a listed entity fixes a record date. A listed entity is required to intimate the record date not only where it is listed on the stock exchange but also where stock derivatives are available on the stock of the listed entity or where listed entity’s stock form part of an index on which derivatives are available.

Notification date: 5th August, 2020

Effective date: 5th August, 2020

READ MORE

 

  • Minimum Public Shareholding to be maintained within 3 years of 2020 Amendment

SEBI Mandates public listed companies to comply with minimum public shareholding requirements within 3 years

every listed company (other than public sector company) shall maintain public shareholding of at least 25%, Provided that any listed company which has public shareholding below 25%, on the commencement of the Securities Contracts (Regulation) (Amendment) Rules, 2020, shall increase its public shareholding to at least 25%, within a period of three years

Notification Date: 31st July 2020

Effective date: 31st July 2020

READ MORE

 

  • Structure digital database under Insider Trading Regulation

SEBI issues Prohibition of Insider Trading (Amendment) Regulations, 2020 provides for Communication or procurement of unpublished price sensitive information.

Every person required to handle unpublished price sensitive information shall ensure that a structured digital database is maintained containing the nature of unpublished price sensitive information and the names of such persons who have shared the information and also the names of such persons with whom information is shared under this regulation along with the Permanent Account Number

Notification date: 17th July 2020

Effective date: 17th July 2020

READ MORE

 

  • Preferential issue – exempt from open offer under SEBI Takeover code

Substantial Acquisition of Shares and Takeovers (2nd Amendment) Regulations, 2020 relaxes open offer requirements for preferential issue.

Any acquisition of shares or voting rights or control of the target company by way of the preferential issue in compliance with regulation 164A of the Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2018 shall be exempt from the obligation to make an open offer. 

Notification date: 22nd June 2020

Effective date: 22nd June 2020

READ MORE

 

  • QIP placements after ban

Issue of Capital and Disclosure Requirements (Amendment) Regulations, 2020 prescribes time limit for further qualified institutional placements.

A listed company cannot make any subsequent qualified institutions placement until the expiry of two weeks against the previous ban for six months from the date of the prior qualified institution’s placement made pursuant to one or more special resolutions.

16th June 2020

16th June 2020

READ MORE

3. Alternative Investment Fund

  • SEBI introduced a framework for processing applications for registrations of Alternative Investment Funds.

The applications wherein the investment committee proposed to be constituted to approve investment decisions of AIF include external members who are not ‘resident Indian citizens’, then those will be considered only after receiving clarification from the government and the Reserve Bank of India (RBI).

Effective date: 22nd October 2020

Notification date 22nd October 2020

READ MORE

 

  • Audit of Private Placement Memorandum Compliance – AIF

SEBI has introduced standard templates for Private Placement Memorandums(PPMs) and a mandatory procedure for performance bench-marking for Alternative Investment Funds (AIFs). 

It will be mandatory for AIFs to carry out an annual audit of Private Placement Memorandum compliance. The audit shall be carried out by either internal or external  auditor/legal professional and findings of the  audit and corrective steps shall be communicated to the management of the AIF and SEBI.

Notification date: February 05, 2020

Effective date: February 05, 2020

READ MORE

4. Investment Advisors

  • Investment Advisory to maintain client level segregation 

SEBI directs investment advisors to maintain records of compliance with client level segregation requirements.

The investment adviser shall maintain records of interactions with all clients and a record on annual certificate from an auditor confirming compliance with the client level segregation requirements as specified in Regulation 22 of amended IA Regulations. Such annual certificate shall be obtained within 6 months of the end of the financial year

Notification Date: 23rd September 2020

Effective date: 30 september 2020

READ MORE

 

  • Investment Advisors are allowed to provide implementation services

SEBI notifies Amendments to SEBI (Investment Advisers) Regulations, 2013 to allow Investment Advisers to provide implementation services (Execution) through direct schemes/ products in the securities market.

Investment Advisers are allowed to provide implementation services (Execution) through direct schemes/ products in the securities market. However, no consideration can be received directly or indirectly, at the investment adviser’s group or family level for these services. Further through this amendment, the individual will have the option to register as an investment adviser or provide distribution services as a distributor, while a non-individual investment adviser will have client-level segregation at group level for these services and maintain an arm’s length relationship between its activities by providing advisory services through a separately identifiable department or division.

Notification date: 3rd July 2020

Effective date: 3rd october 2020

READ MORE

5. Portfolio Managers

  • Guidelines for Portfolio Managers offering non-discretionary advisory services

SEBI has issued the Securities and Exchange Board of India (Portfolio Managers) Regulations, 2020 by setting out new norms for governing the portfolio management service.

The portfolio managers offering non-discretionary or advisory services to clients may invest or provide advice for investment up to 25% of the assets under management of such clients in unlisted securities. They shall also maintain net worth of Rs 5 crore, which shall be achieved within thirty-six months. 

Portfolio managers

16th January 2020 

16th January 2020 

READ MORE

Company Law:

  • Annual return to be placed on website of the Company

The provision of Company (Amendment) Act, 2017 amending the particulars to be contained in annual returns is given effect.

Every company is required to place a copy of the annual return on the website of the company. Further, the web-link of such annual return must be disclosed in the report of the Board of Directors.

Notification date: 28th August 2020

Effective date: 28th August 2020

READ MORE

 

  • Permissible activities for CSR contribution expanded

The Central Government expands the purview of CSR contributions on view of pandemic outbreak

Contributions to R&D projects, in the field of science, technology, engineering and medicine, funded by the Central/ State Government/ any agency thereof/ by PSUs, DBT, Ministry of AYUSH or the Department of Pharmaceutical and Central Armed Police Forces (CAPF) and Central Para Military Forces (CPMF) veterans & their dependents/ widows and Prime Minister’s Citizen Assistance and Relief in Emergency Situations Fund (PM CARES Fund) is included as a CSR activity 

Notification date: 24th August 2020

Effective date: 24th August 2020

READ MORE

 

  • Restrictions on issue of sweat equity shares

MCA notifies Companies (Share Capital and Debentures) Amendment Rules, 2020 to provide restriction on issue of sweat equity shares.

A company shall not issue sweat equity shares for more than fifteen percent of the existing paid-up equity share capital in a year or shares of the issue value of rupees five crores, whichever is higher.

Notification date: 5th June 2020

Effective date: 5th June 2020

READ MORE

 

  • Submission of Audit files to NFRA

Draft procedure which shall be followed by all entities regulated by NFRA for submission of Audit Files to NFRA.

The Audit File has to be submitted by all entities regulated by NFRA in an electronic format and the original formats should not be changed except as provided in this document. Wherever hard copies/physical files/records are maintained; the entity shall take measures to ensure the integrity of such records. The hard copies shall be serially numbered, dated and signed and sealed, wherever applicable.

Notification date: 28th April 2020

Effective date: 28th April 2020

READ MORE

 

  • Takeover of company by majority shareholders

MCA introduces procedure for takeover of any Company by majority shareholder and mandated application to tribunal before making the offer.

A member along with others holding not less than 3/4th of shares of the Company can make a takeover offer after making an application for arrangement along with report of a registered valuer disclosing the details of the valuation of the shares proposed to be acquired before the Tribunal for acquiring any part of the remaining shares of the company.

Notification date: 03 February 2020

Effective date: 03 February 2020

READ MORE

 

  • New Companies to get PF/ ESI and GST registration with SPICe+ Incorporation  

New Public& Private Limited Companies and One Person Company shall get registration number for EPFO & ESIC on MCA portal (www.mca.gov.in) through Spice + and AGILE-PRO eforms), right at the time of incorporation.

READ MORE

 

  • MCA suspends IBC proceedings due to COVID-19 defualts for further 3 months

The Ministry of Corporate Affairs has further extended the suspension of insolvency proceedings for any COVID-19 related default by a period of three months, effective from 25th December 2020.

The Centre had earlier suspended IBC proceedings for a period of six months with effect from March 25, 2020. 

Notification date: 22 December 2020

Effective date: 25 December 2020.

Taxation:

1. Income-tax

  • PAN not mandatory while making payment to certain non-residents

The Central Board of Direct Taxes (CBDT) issues the Income Tax (19th Amendment) Rules, 2020 which provide that the requirement to furnish PAN shall be dispensed in relation to payments made to a non-resident [other than a (foreign) company]. Provided, the non-resident person does not earn any income in India, other than the income from investment in the specified fund during the previous year and any income-tax due on the income of non-resident has been deducted at source and remitted to the Central Government by the specified fund at the rates specified.

Notification date: 10th August, 2020

Effective date: 10th August, 2020

READ MORE

 

  • Tax collection statement amended

CBDT notifies the Income-Tax (17th Amendment) Rules, 2020, which requires the assessee to furnish in the statement of tax collection particulars of the amount received or debited on which tax was not collected. 

Further, Credit for tax collected at source shall be given to the person from whose account tax is collected and paid to the Central Government.

Notification date: 24th July, 2020

Effective date: 1st of October, 2020

READ MORE

 

  • Annexure to Form 26Q and 27Q amended

The Central Board of Direct Taxes has issued the Income-tax (16th Amendment) Rules, 2020 on 3rd July, 2020.

The tax deductors while filing quarterly statements under Rule 31A to the Director General of Income-tax (Systems) shall,  from the 1st day of July, 2020, also furnish particulars of amount paid or credited on which tax was not deducted or deducted at lower rate

Notification date: 3rd day of July, 2020

Effective date: 1st day of July, 2020

READ MORE

 

  • Mutual Agreement procedure – Application Form 34F altered

Income-tax (8th Amendment) Rules, 2020 altered the Form for application and procedure for an assessee, resident in India to invoke mutual agreement procedure provided for in agreements with other countries 

Where an assessee, being a resident of India, is aggrieved by any action of the tax authorities of any country or specified territory outside India for the a reason that is not in accordance with the terms of agreement with such other country or specified territory, he may make an application to the Competent Authority in India seeking to invoke the mutual agreement procedure, if provided in such agreement, in Form No. 34F

Notification date: 6th May 2020 

Effective date: 6th May 2020 

READ MORE

 

  • Forms or modes of investment or deposits by a charitable or religious institutions

The Central Board of Direct Taxes has issued The Income-tax (7th Amendment) Rules, 2020 which provide a a new form of investment to the list under Rule 17C  which provide the Forms or modes of investment or deposits by a charitable or religious trust or institution which is granted tax exemption.

Investment made by a person, authorised under section 4 of the Payment and Settlement Systems Act, 2007, in the equity share capital or bonds or debentures of a company — (A) which is engaged in operations of retail payments system or digital payments settlement or similar activities in India and abroad and is approved by the Reserve Bank of India for this purpose; and (B) in which at least fifty-one percent of equity shares are held by National Payments Corporation of India is granted tax exemption.

Notification date: 5th March, 2020 

Effective date: 5th March, 2020 

READ MORE

 

  • Ecommerce operators to pay equalisation levy

Equalisation levy (Amendment) Rules, 2020 provides the new manner to pay the levy and filing of the Statement of specified services or e-commerce supply or service.

The assessee or e-commerce operator, as the case may be, who are required to deduct and pay equalisation levy, shall pay the amount of such levy, by remitting it into the Reserve Bank of India or in any branch of the State Bank of India or of any authorised Bank accompanied by an equalisation levy challan. Statement of specified services or e-commerce supply or services” in Form No. 1,  may be furnished by the assessee or e-commerce operator, as the case may be, in the following manner, namely:- (i) electronically under digital signature; or (ii) electronically through electronic verification code.

Notification date: 28th October 

Effective date: 28th October 

READ MORE

 

  • TDS liability on E Commerce operators 

The Central Board of Direct Taxes (CBDT) issued Guidelines for Tax Deduction at Source (TDS) by e-commerce operators and TCS by sellers of goods where the sale consideration exceeds INR 50 lakh.

e-commerce operators must deduct TDS at the rate of 1% of the gross amount of the sale of goods or provision of services. Sellers of goods whose value exceeds INR 50 lakh also have to collect TCS from the buyer at the rate of 0.1% of the sale consideration

Notification date: 29th September 2020.

Effective date: 1st October 2020.

READ MORE

 

  • Banking company and insurance company

Income-tax (21st Amendment) Rules, 2020 has made the procedure for application by a banking company for receipt of interest and other sums without deduction of tax applicable to insurers as well.

22nd September, 2020

22nd September, 2020

READ MORE

2. GST

  • CBIC introduces new return

CBIC has introduced new return for registered tax payers by commencing the operation of section 39 of Central Goods and Services Tax Act, 2017

Every registered person, other than an Input Service Distributor or a non-resident taxable person shall, for every calendar month or part thereof, furnish, a return, electronically, of inward and outward supplies of goods or services or both, input tax credit availed, tax payable, tax paid and such other particulars, in such form and manner, and within such time, as may be prescribed.Further every registered person who is required to furnish a return, shall pay to the Government the tax due as per such return not later than the last date on which he is required to furnish such return.

Notification date: 10th November 2020

Effective Date: 10th November 2020

READ MORE

 

  • Registration of Corporate debtors by Insolvency professional on GST portal

The Goods and Service Tax portal has come up with the facility for registration of insolvency resolution professionals/resolution professionals in the GST portal.

The Insolvency Resolution Professionals/ Resolution Professionals appointed to undertake corporate insolvency resolution proceedings for Corporate Debtors, shall apply for a new registration on GST Portal, on behalf of the Corporate Debtors, where the corporate debtor was registered earlier within 30 days of their appointment as IRP/RP

Notification date: 27/05/2020

Effective date: 27/05/2020

READ MORE

 

  • Aadhar authentication for GST Registration

Central Board of Indirect Taxes and Customs vide notification dated 23rd March 2020 has mandated aadhar authentication for GST registration and has determined the class of persons, other than individuals who shall undergo authentication of Aadhaar number in order to be eligible for GST registration.

The Applicant shall while submitting the application for registration after 1st April 2020 shall undergo authentication of Aadhaar number for grant of registration.

Individual, Authorized signatory of all types, Managing and Authorized partner, Karta of an Hindu undivided family are exempted from requirement to undergo authentication of Aadhaar number in order to be eligible for GST registration. 

Notification date: 23rd March 2020

Effective date: 1 April 2020

READ MORE

3. Customs

  • Turant Custom seva introduced for quick customs clearance

The Central Board of Indirect Taxes & Customs has issued new measures under the flagship of  ‘Turant Customs’ program with a view to further prepare the ground for applying the reforms pan-India.

Importers / exporters are advised to register on ICEGATE and conduct their Customs clearances through electronic interface through the link.

Notification date: 6th of July, 2020 

Effective date: 6th of July, 2020 

READ MORE

 

Labour Law:

  • ESI allows online submission of documents on treatment procedures

The Employee State Insurance Corporation has directed the competent authorities to issue approval for the extension of stay, addition/modification in the treatment procedure to provide the same through an online platform.

Any application for the extension of stay, addition/modification in the treatment procedure to ESIC shall be submitted online. 

Norification date: 25th November 2020

Effective date: 25th November 2020

READ MORE

 

  • Pension contribution can be made using virtual id

The Pension Fund Regulatory and Development Authority of India has launched the facility under which NPS subscribers will be able to directly remit voluntary contributions using Virtual-Id.

NPS subscribers can generate Virtual Id linked to Permanent Retirement Account Number through the CRA System which can be used to directly remit voluntary contributions using Virtual-Id.

Notification date: 01 October 2020

Effective date: 01 October 2020

READ MORE

 

  • Atal Beemit Kalyan Yojana – Pandemic Relief

Atal Beemit Kalyan Yojana has been extended till 30th June 2021. It has also been decided to enhance the rate of unemployment relief under the scheme to 50% of wages from an earlier rate of 25% along with the relaxation of eligibility conditions for insured workers who have lost their employment due to COVID-19 pandemic and related lockdown.

Insured workers who have lost their employment due to COVID-19 pandemic and related lockdown can apply for unemployment relief. To avail the benefits, Insured Person should have been in insurable employment for a minimum period of two years immediately before his/ her unemployment and should have contributed for not less than 78 days in the contribution period immediately preceding the unemployment and minimum 78 days in one of the remaining three contribution periods in two years prior to unemployment and the claim shall be due 30 days after the date of unemployment.

Notification date: 17th September 2020

Effective date: 17th September 2020

READ MORE

 

  • Mobile number mandatory for Registering new person under ESIC 

While registering a new insured person, under ESIC the mobile number should be mandatorily filled. It should be available in the ESIC database. The number should be unique or it should be accessed through OTP.  The Bank details of existing insured persons shall be filled by the employer by logging into employer portal accessing “Update particulars of existing persons” link and the cash benefits will be settled only if the correct bank account details are available in the system.

Notification date: 29th June 2020

Effective date: 1st July 2020

READ MORE

 

  • EPF and ESI compliance for newly incorporated companies through SPICe+ 

New companies incorporated through SPICe+ which have obtained EPFO/ESI numbers are required to file statutory returns under Employees Provident Fund (EPF) and Employees State Insurance (ESI) only when they cross thresholds prescribed under the Employees’ Provident Funds and Miscellaneous Provident Act, 1952 and the Employees State Insurance Act, 1948.

Notification date: 4th March 2020

Effective date: 15.02.2020

READ MORE

 

  • ESIC direction to carry on inspection only in certain cases

ESIC directs the authorized officers not to ask for any records beyond 5 years from the employer for inspection. The authorities are also informed that there is no need to make  inspection visits in all cases of late registration of employees by employers.  Inspection needs to be undertaken only in case of super specialty treatment/Death/Accident where the RO/SRO has sufficient cause to believe that the delay was not for obtaining any undue benefits.

The time limit of five years must be strictly followed in determining the contributions and issue of speaking orders by the authorized officers.

Notification date: 28th January 2020

Effective date: 28th January 2020

READ MORE

READ MORE

 

  • Eligibility to provident fund – Supreme Court

The Supreme Court of India in its recent judgment has held that the employees who draw wages or salaries directly or indirectly from a company are entitled to provident fund benefits under the Employees’ Provident Funds and Miscellaneous Provisions Act 1952.

Contractual employees shall also be eligible for provident fund benefits

READ MORE

 

Healthcare:

  • Medical Oxygen fillers, manufacturers to submit stock information to NPPA

The National Pharmaceutical Pricing Authority has directed the manufactures and re-fillers of medical oxygen to submit the information relating to the oxygen type, the opening and closing stock, details relating to the consumption, and dispatch to the control room for monitoring the situation of availability, distribution, and demand of the medical oxygen 

Notification date: 24th September 2020

Effective date: 24th September 2020

READ MORE

 

  • Importers of drugs to furnish license information, labels etc to port office

The Central Drugs Standards Control Organization has directed importers of drugs to furnish labels of respective consignment, certificate of analysis of release of batch, and import license/permission along with bill entry and other documents to the port office

Notification date: 17th September 2020

Effective date: 17th September 2020

READ MORE

 

  • For Export of Medical devices free sale certificate to be applied through online

Medical device manufacturers in India who are having valid manufacturing license and intent to obtain Free Sale Certificate for export of Class A, B and Class C, D medical devices shall make application for issuance of free sale certificate, market standing certificate and non-conviction certificate of notified medical devices shall be submitted only through through online portal of Central Drugs Standards Control Organisation.

Notification date: 3rd September 2020

Effective date: 30th September 2020

READ MORE

 

  • Exemption from six month training under PNDT Rules

Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) (Six Months Training) Amendment Rules, 2020 has provided exemption to training requirement.

Registered medical practitioners, who are conducting ultrasound procedures in a Genetic Clinic or Ultrasound Clinic or Imaging Centre on the basis of one year experience or six months training are exempted from undertaking the said training provided they are able to qualify the competency-based assessment

Notification date: 26th June 2020

Effective date: 26th June 2020

READ MORE

 

  • Telemedicine guidelines introduced

Medical Council of India on 12th May 2020 has published the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2020” which seeks to provide Telemedicine guidelines.

The telemedicine guidelines deals with the specifications for hardware or software, infrastructure building & maintenance,  Data management systems involved, standards and interoperability, Use of digital technology to conduct surgical or invasive procedures remotely, and  Other aspects of telehealth such as research and evaluation and continuing education of health-care workers

Notification date: 12th May 2020

Effective date: 25th March 2020

READ MORE

 

  • New Consumer Protection Act and Rules for e commerce entity

The Consumer Protection Act, 2019 is brought into force. It provides for the constitution of the Central Consumer Protection Authority and Consumer Disputes Redressal Commission.

Every e-commerce entity is required to provide information relating to return, refund, exchange, warranty and guarantee, delivery and shipment, modes of payment, grievance redressal mechanism, payment methods, security of payment methods, charge-back options, etc. including country of origin which are necessary for enabling the consumer to make an informed decision at the pre-purchase stage on its platform.

Notification date: July 20, 2020

Effective date: July 20, 2020

READ MORE

READ MORE

 

Foreign Exchange Control Laws:

  • International financial services center allowed to conduct business in INR

RBI amended the Foreign Exchange Management (International Financial Services Centre) Regulations, 2015 to permit the financial institutions or a branch of a financial institution to, with express permission of RBI, conduct such business in Indian Rupee with such persons whether resident or otherwise as it may determine.

Notification date: 7th January 2020

Effective date: 7th January 2020

READ MORE

 

  • FDI from countries sharing land borders with India to obtain prior approval

The Foreign Exchange Management (Non-debt Instruments) Amendment Rules, 2020 in which it has made it mandatory that foreign investments from countries that share a land border with India to obtain prior approval from the government to prevent opportunistic takeover of domestic firms amid COVID-19 pandemic.

Notification date: 22nd April 2020 

Effective date: 22nd April 2020 

READ MORE

 

  • Import or export of Indian currency can be done with permission of RBI

Foreign Exchange Management (Export and Import of Currency) (Amendment) Regulations, 2020 provides that RBI can grant permissions to take/ send out of India to any country or bring into India from any country currency notes of the Government of India and /or of the Reserve Bank of India. This is subject to terms and conditions specified by the RBI. Furthermore, the RBI must determine that such import or export of Indian currency is necessary. 

Notification date: 11th August 2020

Effective date: 18th August 2020

READ MORE

 

COVID-19 reliefs:

  • Guidelines for preventing spread of COVID-19 in workplace

The Ministry of Home Affairs has published guidelines outlining preventive measures to contain the spread of COVID-19 in workplace settings.

Employees shall maintain physical distancing of at least one meter, use of face covers/masks. Any staff reportedly suffering from a flu-like illness should not attend office and seek medical advice from local health authorities. If there are one or two cases reported, the disinfection procedure will be limited to places/areas visited by  the patient in the past 48 hrs. There is no need to close the entire office building/halt work in other areas of the office and work can be resumed.

Notification date: 18th May 2020 

Effective date: 18th May 2020 

READ MORE

 

  • Insurance providers to intimate policyholders about cashless treatment facility 

General and health insurance companies may offer policies providing cashless services to the policyholders. The Insurance regulatory authority of India has directed insurance companies to ensure that the policyholders are notified about the availability of such cashless facility at the empanelled network provider

Notification date: 14th July 2020

Effective date: 14th July 2020

READ MORE

 

  • Corona Kavach policy to be mandatorily offered by insurance companies

The Insurance Regulatory and Development Authority of India has mandated general and health insurers to offer the indemnity based Individual COVID Standard Health Policy called “Corona Kavach”

The Corona Kavach policy will be available for three and half months (3 ½ months), six and half months (6 ½ months), nine and half months (9 ½ months) including the waiting period of 15 days.  The Policy can be availed by persons between the age of 18 to 65 years.

Notification date: 10th July 2020 

Effective date: 10th July 2020 

READ MORE

 

  • COVID-19 Bio-medical waste tracking app

The Central Pollution Control Board has launched a Mobile Application called the COVID 19 Biomedical Waste Tracking App (COVID19BWM App) and has issued a User Manual for the same.

The application can be used by waste generators, waste handlers, waste treatment facilities and pollution control boards for waste tracking. All Biomedical waste generator entities are mandated to register using the Application.

Notification date: 28 June 2020

Effective date: 28 June 2020

READ MORE

 

  • Guideline for validation and testing of COVID-19 diagnostic kits

The Ministry of Health and Family Welfare, has published the Guidelines for Validation and Batch Testing of Covid-19 Diagnostic Kits.  The guideline is a recommendatory. 

The manufacturers and suppliers of US Food and Drug Administration (USFDA) approved RT-PCR kits, RNA extraction kits and viral transport medium (VTM), rapid antibody test, ELISA and CLIA kits can directly apply for DCGI approval; and will not be required to get validation from ICMR. The firm will be required to provide the batch testing certificate while delivering the consignment. 

Notification date: June 4, 2020

Effective date: June 4, 2020

READ MORE

 

  • BA-BE Study of New drugs in human subject for export

The CDSCO has clarified that the BA-BE study of New drugs in human subjects for export shall strictly comply with guidelines and procedures laid down irrespective of any difficulty in compliance arising out of the COVID 19 outbreak.

If there arises an unavoidable situation where it is necessary to make amendments in protocol or modifications in the procedures, then the sponsor and BA-BE centre are advised to make assessments regarding the impact and to take decisions in consultation with the investigator and the ethics committee.

Notification date: June 9, 2020,

Effective date: June 9, 2020

READ MORE

 

  • Guideline for containing COVID-19 spread in hotels and hospitality

The Ministry of Health and Family Welfare has released SOPs on preventive measures to be taken in hotels and hospitality units to contain the spread of COVID-19.

Hotels shall mandatorily have hand hygiene and thermal screening provisions at the entrance and shall have a separate entry and exits for guests, staff and goods/supplies. The hotel staff at the receptions are to be well versed in hand hygiene, respiratory hygiene and protocols to be followed if a guest develops symptoms. They should also be trained to handle guests with symptoms and shall be provided with personal protective equipment.

Notification date: 4th June 2020 

Effective date: 4th June 2020  

READ MORE

 

  • Manufacturers of PPE coveralls to register with CDSCO medical device portal

The manufacturer of medical devices including PPE coveralls to get themselves registered voluntarily on the CDSCO medical device online portal and to secure a registration number from CDSCO which shall be a benchmark for their quality management system.

Notification date: 22 May, 2020

Effective date: 22 May, 2020

READ MORE

 

  • Guidelines on Safe Ophthalmology Practices to contain COVID-19 spread released

Guidelines on Safe Ophthalmology Practices aimed to minimize the spread of Covid-19 infection among Ophthalmologist, Ophthalmic assistants/technicians, nurses, support staff, patients and their attendants has been released by the Ministry of Health and family welfare.

Notification date: 28th December 2020

Effective date: 28th December 2020.

READ MORE

Fill in the form


Labour LawsEnvironment, Health and SafetyDirect Tax lawsIndirect tax laws (GST/ Customs / VAT)Corporate Laws (Company Law, SEBI & FEMA)Food Safety LawsFinancial Service sectorInsurance SectorHealthcare SectorOther ancillary laws

Do you want GST Refund ?


Get In Touch

Get Bulk Subscription