SEBI has adopted new guidelines for governing the investment advisers and amended Investment Advisers Regulations by setting a tone for reformation which might change the business dynamics for various entities in India. It states that from October 1, 2020, the Individual Advisers can either distribute the investment products or advise on them. It further, restricts the advisers from performing both the investment activities simultaneously. 

As per the SEBI Regulations, any person who advises the clients on sale, purchase, investment or portfolio management in securities for a consideration is known as an ‘investment adviser’. However, a person might be restricted from providing such services unless he obtains a certificate license from the regulator. The amendment, further, aims to strengthen the already existing regulatory framework by making it mandatory for other non-individual investment advisors to introduce their client-level segregation between the advisory and distribution activities. It shall also introduce a revised net-worth criteria for various individuals and corporate persons.

The key changes being introduced by SEBI includes the segregation of services, implementation services, agreement between adviser and client, fees, eligibility criteria and corporatization of investment activities by advisors. As per the new framework prescribed by SEBI, the same client shall not be offered the same kind of services through a non-individual adviser and non-individual advisers must maintain an arm-length relationship with the advisory and distribution functions as rendered by a separate department or division. Further, in order to provide a standard for investment advisory business and improve the quality, SEBI has introduced a mandatory corporatization for individual advisors after they have crossed a threshold of 150 clients. 

Client fees shall also be charged by investment advisers as specified by SEBI, which has not yet been specified by SEBI. This has been capped at 2.5 percent of the assets under advice or a fixed fee of Rs. 75,000 per year across all products and services being provided. SEBI has prohibited usage of terms like ‘wealth adviser’ or ‘independent financial adviser’ by various non-registered investment advisers. Moreover, the individual investment advisers of a corporate investment advisor are now required to have a post-graduate qualification and at least 5 years of advisory work experience. Even employees of a corporate advisory firm are required to have an experience of at least 2 years and a postgraduate qualification.

With regard to the guidelines, SEBI issued a consultation paper in January 2020 on the review of Regulatory Framework for Investment Advisers and had sought comments from the public for the proposal.

Medical Devices Amendment Rules

Indian medical device market is growing and it is expected to reach a valuation of INR 794.29 billion by 2023. Key growth factors for the development of medical device market in India are combined efforts of the Government and private sectors to improvise healthcare industries and change in India’s Foreign Direct Investment policy. There were no medical device regulations in India prior to 2005. However, today the Government regulates certain medical devices under the Medical Device Rules. 

On February 11, 2020 Central Government notified that all medical devices will be treated as ‘drugs’. This notification will be effective from April 1, 2020.  The quality and safety standards of all medical devices are regulated under ‘Drugs and Cosmetics Act’. The Government notified the Medical Device (Amendement) Rules, 2020 and new definition of medical devices under it is reproduced below:

“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception”

The Medical Device Rules (hereinafter ‘The Rules’) have been framed under the Drugs and Cosmetics Act, 1940 (hereinafter ‘The Act’). Until February 11, 2020 only 37 notified medical devices were regulated by the Government. However, after the notification  on February 11, 2020 all the medical devices described by the above definition, will be regulated under the Act. The Government has moved a step forward in the direction of implementing quality standards requirement. All the medical devices imported or manufactured in India should be compliant with ISO 13485 standards and registration for these devices has to be obtained from Central Drugs Standard Control Organisation (CDSCO) through a dedicated online portal ‘Online Systems for Medical Devices’. ISO 13485 is a standard laid down by International Organization for Standardization for companies or organizations which are engaged in design, installation, production and servicing of medical devices However, the 37 categories of already regulated medical devices are exempted from obtaining the registration. Even though the 37 categories of notified medical devices are exempted from registration the importers, manufacturers, distributors, whole sellers and retailers will have to obtain licenses from appropriate licensing authority.

Medical devices are classified under for categories as mentioned below:

  • Class A – Low Risk (For e.g.: Stethoscope)
  • Class B – Low-moderate Risk (for e.g.  Hypodermic needles)
  • Class C – Moderate-high risk (For e.g.: Bone fixation)
  • Class D – High Risk (For e.g.: Stents)

Government has laid down different deadlines for compliance with the licensing and registration requirements for different classes of medical devices, the deadlines are as follows:

  • All unregulated medical devices must be registered by the respective importers or manufacturers before October 1, 2021. 
  • All stakeholders involved in import, production, distribution, and sale of presently unregulated Class A and Class B medical devices must obtain a license from appropriate licensing authority before August 11, 2022.
  • All stakeholders involved in import, production, distribution, and sale of presently unregulated Class C and Class D medical devices must obtain a license from appropriate licensing authority before August 11, 2023.

The Government has provided the above mentioned window so that the manufacturers and importers get enough time to get their facilities certified as compliant with ISO-13485. 

It is important to note the difference between obtaining a registration and obtaining a license. Notified medical devices are exempted from obtaining a registration; however they are not exempted from obtaining a license. Importers, manufacturers, distributors, whole sellers and retailers of presently unregulated Class A (low-risk) and Class B (medium-risk) medical devices sold in India will have to compulsorily obtain a license from appropriate licensing authority. A registration of medical device is done by the Central Drugs Standard Control Organisation (CDSCO) whereas a license is issued by state licensing authority or central licensing authority depending upon the class of medical device for which license is sought. In order to obtain a registration the medical device should be ISO 13485 compliant. Licenses are to be obtained for sale of notified medical devices. However, as per latest guidelines supply chain of registered (ISO 13485 compliant) medical devices will not need licenses.

Regulating medical devices under the Drugs and Cosmetics Act is being criticised by many stakeholders. However, in our view it is an effective step towards ensuring quality and safety medical devices being used in the industry. Further, the Government has provided appropriate time to all the stakeholders to adapt to new regulations. Compliance to ISO 13485 standards will ensure supply and production of good quality medical devices. 

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Suspension of limitation period during COVID-19

Following the World Health Organization (WHO) directive that classified the Coronovirus outbreak (‘COVID-19’) outbreak as a global pandemic, a lot of anxiety and concern stirred across the globe leading governments to take measures to “flatten the curve” and ensure utmost protection to its citizens. This period reflects a point in history when the entire world economies are grappling to stand upright and tackle this menace of COVID-19 that has consumed both lives and resources while governments and state machineries are working hand in hand to contain the pandemic and show light to its citizens. The Indian Government and its state machineries are no exception to this.

In view of these unprecedented circumstances the Indian Government declared a complete lockdown for 21 days on March 24, 2020 which severely curtailed the mobility of its citizens and adversely affected the functioning off the state machineries, including the various courts and tribunals.

In light of these circumstances, on March 23, 2020 Supreme Court of India directed the suspension of the limitation period under both general and special laws with effect from March 15, 2020. This was done in furtherance of their plenary powers under Article 142 read with Article 141 the Indian Constitution. The bench comprised of Chief Justice S A Bobde and Justices L N Rao and Surya Kant who stated that the Court had taken sou motu cognizance of the current situation which had made it difficult for litigants and lawyers to approach the respective courts and complete the filings within the period of limitation. In this regard, the order passed by the three- Judge Bench reads,

“To obviate such difficulties and to ensure that lawyers/litigants do not have to come physically to file such proceedings in respective Courts/Tribunals across the country including this Court, it is hereby ordered that a period of limitation in all such proceedings, irrespective of the limitation prescribed under the general law or Special Laws whether condonable or not shall stand extended w.e.f. 15th March 2020 till further order/s to be passed by this Court in present proceedings.”

The Supreme Court further notified that this order was to be brought to the attention of all the High Courts, subordinate Courts and Tribunal. The decision by the Supreme Court is noteworthy and laudable and is bound to assure its citizens that justice is not uncertain at point of time where the entire country is battling this global pandemic.