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India’s Most Critical Trade & Regulatory Compliance Digest

India’s Most Critical Trade & Regulatory Compliance Digest
DEPARTMENT OF CONSUMER AFFAIRS SETS UP A COMMITTEE TO CONSTRUCT THE RIGHT TO REPAIR FRAMEWORK IN INDIA

The Department of Consumer Affairs (“DCA”) has set up a committee (“R2R Committee”) to develop a frameworkon the Right to Repair (“R2R”) in India, under the LiFE (i.e. Lifestyle for Environment) Movement, with the aim of ‘developing sustainable consumption of products’, ‘reducing e-waste’ and harmonizing ‘trade between original equipment manufacturers and third party buyers and sellers’. The R2R Committee is chaired by the Additional Secretary of the DCA and includes members from the legal fraternity as well as stakeholders from various consumer organizations.

The R2R movement demands that manufacturers make spare parts of their products available to consumers and/ or third parties to allow consumers to repair the products purchased by them or choose their own service providers, instead of approaching the manufacturer or purchasing an authorized replacement.

The R2R Committee held its first meeting on 13th July 2022 and identified various sectors, including, (i) Farming Equipment, (ii) Mobile Phones/ Tablets, (iii) Consumer Durables, and (iv) Automobiles/Automobile Equipment, for the purposes of constructing the R2R framework.

The R2R Committee discussion included aspects like manufacturers’ proprietary control over spare parts and claim that such monopoly infringes consumers’ ‘right to choose’. Further, this committee also discussed the issue of ‘planned obsolescence’ and artificially limited life spans of products to encourage replacements. As per the committee, restricting the R2R forces consumers to deliberately make a choice to purchase a new model of their product. Further, the R2R Committee acknowledged that India has a vibrant repair service sector which includes inter alia third-party repairs. Accordingly, parts and tools should be made available to these third parties to repair minor glitches.

It was felt that tech companies should provide complete knowledge and access to manuals, schematics and software updates to these third party service centers and the software license should not limit the transparency of the product.

The R2R Committee considered the steps taken as well as practices adopted by other jurisdictions (the European Union, the United Kingdom, and the United States of America) towards R2R and how the same can be incorporated within the Indian framework.

THE FIRM’S TAKE

With the strengthening of consumer protection statutory framework in India, the R2R topic has now come centre-stage with the government actively considering a framework on this topic. While consumer interest indeed needs to be strengthened, the government will have to carefully assess the implications of the R2R framework/policy particularly from the perspective of cyber security issues in relation to high-tech products, any potential expropriation or nontreaty limitations of/exceptions to intellectual property rights and finally the aspect of quality as regards spare parts availability and how these will impact manufacturer warranties etc. Pertinently, access to the aftermarket allows manufacturers to ensure reliability of their products and eliminate malpractices pertaining to their products which may end up hurting their goodwill and the safety of their consumers. Presently, the discussions around introduction of R2R in India are at a nascent stage. Accordingly, the R2R Committee’s approach towards resolution of these issues in the Indian market would be crucial to the formal introduction and the scope of the R2R in India. A balanced approach will have to be taken to provide a consumer-friendly market while maintaining the rights of the manufacturers.

THE MINISTRY OF COMMUNICATION ISSUES A CONSULTATION PAPER ON THE “NEED FOR NEW LEGAL FRAMEWORK GOVERNING TELECOMMUNICATION IN INDIA” – A BRIEF REVIEW OF THE PROPOSED LEGAL FRAMEWORK

The Ministry of Communications (“MoC”) has issued a consultation paper on the “Need for a new legal framework governing Telecommunication in India”. While issuing the consultation paper, the MoC noted that the “India needs a new law which is clear, precise, and attuned to the realities of the sector for realizing the potential of telecommunication.” The MoC has sought suggestions from the public regarding the consultation paper until 25th August 2022.

Currently, the telecom sector is regulated by the Indian Telegraph Act, 1885, the Indian Wireless Telegraphy Act, 1933 and the Telegraph Wires (Unlawful Possession) Act, 1950. The Consultation paper recognises the fact that the technology and the nature of telecommunication have undergone a massive change since these laws came into effect. Hence, a new law on telecommunication is needed which aims at establishing and enabling a future ready framework for the development of telecommunication sector and deployment of new technologies. Such a law needs to consolidate the existing laws governing telecommunication sector, while taking into consideration global best practices.

SALIENT FEATURES
  • Spectrum Management: The consultation paper affirms the principle of spectrum allocation that it must be assigned to best serve the common good and enable widespread access to telecommunication services. Additionally, there needs to be a provision for re-farming and harmonization of frequency range.
  • Right of Way (“RoW”): The consultation paper suggests that a framework is required to be put in place to obtain RoW in a uniform, non-discriminatory manner for establishment of telecommunication infrastructure and to also set up a dispute resolution mechanism for the same. Such a framework should include establishing common ducts and cable corridors in infrastructure projects. • Insolvency: The consultation paper states that there is a need to ensure that insolvency proceedings do not lead to suspension or termination of the license. Such license should be operative if: (a) telecommunication services continue to be provided and (b) there is no default in payment of dues in relation to the telecom license/ use of spectrum.
  • Universal Service Obligation Fund (“USOF”): The consultation paper suggests the overhauling the existing USOF into a “Telecommunication Development Fund”. Such a fund could also address issues regarding research and development in the telecommunication sector in addition to ensuring delivery of telecommunication services to underserved areas.
  • Penalties: The consultation paper suggests that penalties need to be made proportionate to offences.
  • Equipment Standards and National Security: The consultation paper states that the new law should have enabling provisions for taking measures in the interest of national security. Additionally, the law should also enable the Government of India to prescribe specific standards for telecommunication equipment.
THE FIRM’S TAKE

The MoC has taken a welcome step in recognising the archaic legal framework governing the telecommunication sector in India. With the advent of next generation technologies like AI, 5G, M2M, ML, etc., this initiative by the MoC is noteworthy since it may potentially remove any legal lacunae delaying the deployment of such technologies.

The Consultation Paper dwells upon the need to have a framework for RoW without analysing the problems affecting the extant RoW regulations issued in 2016. A Judicious approach could be to first issue a white paper outlining the lacunae in the existing RoW regulations and thereafter ameliorate the RoW framework.

Similarly, the extension of the ambit of USOF for research and development purposes is laudable. However, it is equally important to continue to resolve the problem of underutilisation of the existing funds under USOF for deployment of telecommunication facilities in underserved areas.

The move to make penalties proportionate to the offence committed is in line with the ease of doing business approach of the Government of India and is certainly much needed and commendable. A detailed consultation process with the industry and relevant stakeholders is highly recommended to ensure balancing of interests.

Lastly, the provision to mandate telecommunication equipment standards should be accompanied by detailed consultation process as well as an exercise rationalizing the extant standards mandated under the Mandatory Testing & Certification of Telecommunication Equipment and the National Security Directive on Telecommunication Sector. Overlapping mandates for equipment certification militates against a light touch regulatory approach and ease of doing business initiative adopted by the Government of India.

DEPARTMENT OF CONSUMER AFFAIRS NOTIFIES THE LEGAL METROLOGY (PACKAGED COMMODITIES) (SECOND AMENDMENT) RULES, 2022

On 14th July, 2022, the Department of Consumer Affairs notified, with immediate effect, the Legal Metrology (Packaged Commodities) (Second Amendment) Rules, 2022 (“Second Amendment Rules”). The Second Amendment Rules allow certain mandatory declarations (that are otherwise required to be made on the label on a packaged commodity) to be made through a QR Code on product packaging of electronic products for a period of one year (on a trial basis), if not declared on the package itself.

Presently, the Legal Metrology (Packaged Commodities) Rules, 2011 (“LMPC Rules”) under Rule 6 (1) require specific declarations to be mandatorily made on product packaging. This mandatory requirement, for limited declarations and subject to underlying conditions specified vide the Second Amendment Rules, stands temporarily eased for a period of one year, i.e., till the 15th July, 2023, only for electronic products. It is worth noting that the LMPC Rules accommodate QR Code placement on product packaging irrespective of the category of products under Rule 6 (4A), however the same can be placed by a manufacturer, packer or importer only in addition to the aforementioned mandatory declarations under Rule 6 (1) and not in place of them.

The Second Amendment Rules are purported to be a pilot project aimed at familiarizing the average consumer with the option of accessing information through a QR Code. The Second Amendment Rules therefore require a declaration to be made on the product packaging to inform the consumers to scan the QR code for other related information in case such information is declared through the QR Code and not declared on the package itself.

The temporary allowance (for a period of one year from 15th July 2022) providing the option to use QR Codes under the Second Amendment Rules is limited to;

  • The address of the manufacturer/ packer/importer • The common or generic name of the commodity and where such package contains more than one product, then for the name and number or quantity of each product
  • Size and dimension of the commodity • Name and address of the person/ office that can be contacted in case of consumer complaints
THE FIRM’S TAKE

While the allowances introduced under the Second Amendment Rules appear to be a pilot project attempting to understand the ability of a consumer to access mandatory declarations on a label through the use of QR Codes, the temporary nature of the allowances may pose to be an inconvenience on manufacturers, importers or packers to implement changes on the product label that will entail serious production and packaging related effort and costs. It remains to be seen whether relevant stakeholders will be willing to make the effort and put in the required costs to carry out these packaging related changes on their labels for an allowance that may be temporary in nature and may not be renewed after a period of one year. While declarations made through QR Codes enable relevant stakeholders to effectively and in a compact manner declare important information, a temporary allowance that has the potential to be withdrawn after a period of one year may pose to be a deterrent. Given that the world is moving towards technology driven solutions and that consumers have become increasingly technologically savvy, it would be useful to implement the QR Code allowances on a permanent basis for the purposes of pushing the Government of India’s initiative of enabling ease of doing business in India.

THE MINISTRY OF HEALTH AND FAMILY WELFARE SEEKS COMMENTS ON THE DRAFT DRUGS, MEDICAL DEVICES AND COSMETICS BILL 2022 – A BRIEF REVIEW ON PROPOSED MEDICAL DEVICES RELATED IMPLICATIONS

The Ministry of Health and Family Welfare (“MoHFW”) has issued the Draft “Drugs, Medical Devices and Cosmetics Bill, 2022” (“ DMDC Bill”) which specifically regulates medical devices apart from Drugs and Cosmetics. While issuing the draft DMDC Bill, the MoHFW noted that the “Drugs and Cosmetics Act, 1940 is a pre-independence legislation enacted by the Central Legislative Assembly. Review of obsolete laws and updating of the existing laws is a continuing process to accommodate changed requirements and adaptation of new technology.” The MoHFW has initiated a public consultation process seeking suggestions regarding the DMDC Bill till 21st August 2022.

Currently, medical devices in India are regulated as under the broad category of ‘Drugs’ under the Medical Devices Rules, 2017 (“MDR”), which in turn comes within the Drugs & Cosmetics Act, 1940 (“DCA”). However, the DMDC Bill appears to have brought medical devices outside the purview of drugs to be regulated and recognised as a separate category altogether.

SALIENT FEATURES
  • Definition of a Medical Device: The definition of a medical device has been adopted verbatim from the erstwhile Medical Device Rules 2017 and the notification dated 11th February 2020 which expanded the definition of medical devices.
  • Medical Devices Technical Advisory Board: An expert body has been proposed to advise the Central and State Government on technical matters pertaining to medical devices. The Board will be headed by DG Health Services, MoHFW with representatives from various ministries and experts from relevant sectors.
  • Central and State Medical Devices Testing Centre: For testing and evaluation of medical devices and carrying out other assigned functions testing centres have been proposed.
  • Appointment of a Medical Device Officer: A designated Medical Device Officer has been proposed who will be authorised to inspect any premises where medical devices are stored, offered for sale, etc. and has powers relating to search and seizure.
  • Regulation of Medical Devices: The medical devices shall have risk- based classification for conformity assessment and regulation in such manner as may be prescribed. An importer/ manufacturer has to submit the adverse event reports and periodic safety update reports in respect of its medical devices.
  • Prohibition of import or manufacture and sale of medical devices:
  • The following conditions have been proposed for prohibition of import/ manufacture/sale of medical devices –

    – non-conformity with prescribed standards of quality, safety and performance

    – misbranded, adulterated or spurious

    – does not display such details as may be prescribed in respect of accompanying software, part, component or instrument;

    – false statement, design or accessory accompanying it or by any other means, purports or claims to cure any disease or ailment,

    – unlicensed import or manufacture for sale, stock, distribution of medical devices

  • Misbranded medical device: As per the DMDC Bill a medical device will be deemed to be misbranded if –
  • – it is configured so as to conceal any damage/ or made to appear of greater functional value or made to appear of lesser risk than it really is; or

    – it is not labelled or packed in the prescribed manner; or

    – it bears label, container, statement, design or device which makes any false claim; or

    – it contains colours not expressly permitted in the license or permission issued by the authorities

  • Adulterated medical device: As per the DMDC Bill a medical device will be deemed to be adulterated if –
  • – consists of rusted or corroded or filthy or putrid or decomposed substance; or

    – is prepared, packed or stored under insanitary conditions whereby it may have been rendered injurious to health; or

    – contains any harmful or toxic substance or component or software or parts thereof which may render it dangerous to use or injurious to health; or

    – is having any substance/component/ software or part thereof mixed/added/ substituted/removed there from so as to reduce its quality or performance or safety which may render it dangerous to use or injurious to health; or

    – is having a pack or container composed of any deleterious substance which may render it dangerous to use or injurious to health

  • Spurious medical device: As per the DMDC Bill a medical device will be deemed to be ‘spurious’ if it –
  • – is having the label/pack/container bearing the name of a fictitious/incorrect individual or firm or company purporting to be the manufacturer of the device or

    – purports to be the product of a manufacturer who is actually not the manufacturer of the product.

  • Initiation of Prosecution: As per the proposed regulations prosecution for violations can be initiated only on complaints by –
  • – Medical Devices officer

    – Authorised gazetted officer of the Central/State Government

    – Aggrieved Person

    – Recognised consumer association

THE FIRM’S TAKE

The MoHFW has taken a welcome step in recognising and regulating medical devices separately rather than considering it as ‘Drug’ under the DCA in order to regulate it. However, it remains to be seen if the comprehensive and sweeping risk-based classification of medical devices for conformity assessment and regulation as per the current notifications issued by the Drugs Controller General (India) under the MDR will continue to apply mutatis mutandis to the DMDC Bill. Additionally, in the interest of transparency the MoHFW should also consider mandating the Medical Devices Technical Advisory Boards to compulsorily engage in a public consultation while issuing any order/guideline/ notification under the DMDC Bill.

About Author

Ameet Datta

Ameet Datta is a Partner at Saikrishna & Associates. He is an IP litigator and TMT lawyer with over 22 years of experience and wide ranging expertise across IP Law, Technology law, privacy and data protection law, white collar crime cases around data breaches, and, media & entertainment law specifically in relation to licensing, content aggregation & acquisition, film & music production, distribution/ licensing, format rights, defamation and right of publicity. Ameet has extensive experience with the creative sector in terms of multiple litigations including licensing disputes before the Courts & the Copyright Board. Ameet is closely involved with Copyright laws, Technology regulations and policy matters. In 2010, Ameet appeared as an expert witness before the Indian Parliamentary Standing Committee overseeing amendments to the Copyright Act, 1957. Ameet has been highly ranked as a recommended lawyer for IP Litigation, and, telecoms, media & entertainment by Chambers & Partners (Asia Pacific), WTR1000; as a recommended lawyer for IP litigation by Legal 500, and recommended as an IP Star by MIP

Suvarna Mandal

Suvarna Mandal is a Partner at Saikrishna & Associates. She has nearly a decade of experience in providing trade & regulatory compliance advice to domestic and international clients for understanding and complying with a wide range of national, state as well as sector-specific legislations and regulations in the spheres of telecommunications, technology law, consumer law, environmental law, product compliance and safety regulations (including packaging standards, labels and safety standards), data protection and privacy, media law, advertising regulations, etc. She provides end-to-end compliance counselling to clients across various industries and sectors such as software services, consumer electronics, technology, telecom, media, intermediaries, e-commerce, online value-added services sectors, consumer goods and medical devices. Suvarna also works closely with clients’ Government Affairs team to prepare strategic policy documents, representations and formal communications towards policy development and policy reform efforts with the Government.