Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facility The Indian government is reportedly reconsidering its decision to act against pharmaceutical companies who are manufacturing nutraceuticals, health supplements and drugs in the same facility, due to objections raised by small scale manufacturers. The previous Good Manufacturing Practices (Schedule M) for drugs gave some concession to manufacturers of drugs to manufacture nutraceuticals and health supplements in the same facility. However, no such concession exists under revised Good Manufacturing Practices (Schedule M) published in December 2023. Source: bit.ly/3x59lQo
Exporters of Indian farm produce are facing phytosanitary challenges Indian agricultural exports, including fruits and vegetables, are reportedly finding it difficult to enter regions like Europe, Australia, and the US due to tough phytosanitary requirements and thresholds such as high pesticide content. In response, India’s Commerce Ministry is reportedly creating a data set on export consignments of agricultural exports that were refused by European countries and other nations on grounds of phytosanitary non-compliances, resulting in significant trade hurdles regardless of duty relaxations. A phytosanitary certificate is required for the export of agricultural products to ensure that the produce is pest-free, disease-free, and meets other health requirements such as traceability at the farm level. Source: bit.ly/4ctvxnB
Indian government has established Fact Check Units to check spread of fake news The Indian Ministry of Electronics and Information Technology has appointed the Press Information Bureau of the Ministry of Information and Broadcasting as Fact Check Unit to address fake and misleading news against Central Government. The fact check unit of the central government is expected to vet all the online content related to the business of the central government. Any content identified as fake by the unit will be taken down from the internet. Source: bit.ly/3Px3Yj8
The Centre gives more time to states to establish Allied Healthcare Councils India’s Ministry of Health and Family Welfare has extended the timeline for states to establish state allied and healthcare councils by six months. State Governments have to setup State Councils for Allied Healthcare by November 2024. The National Commission for Allied and Healthcare Professions Act 2021, which regulates quality of allied and other healthcare professionals in India, will be operationalized once the State Councils have been established. Sourve : bit.ly/3PxeZ4d
Integrated Veterinary Health Certificates (VHC) mandatory after 30th June,2024 for import of milk and milk products into India The Food Safety and Standards Authority of India (FSSAI) has extended the deadline for implementing its decision to require imported food consignment of milk and milk products to be supported by an integrated veterinary health certificate. The requirement will take effect on July 1, 2024. From that date, only those milk and milk products that are supported by integrated veterinary health certificates will be allowed importation into India. The Integrated Veterinary Health Certificate must demonstrate that imported milk and milk products meet both the FSSAI’s food safety standards and the Department of Animal Husbandry and Dairying’s (DAHD) sanitary criteria. Source: bit.ly/3TIh53F
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward. Source: bit.ly/3TEO74B
Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India. Source: bit.ly/3VsdCaQ
Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company. Source: bit.ly/3vu45VQ
Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided. In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity. Source: bit.ly/3vkn7hu
EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period. The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market. Source: bit.ly/3Vr9zeK
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Drinks or beverages should not be sold as “health drinks” for children: NCPCR The National Commission for Protection of Child Rights (NCPCR) in India has sent a recommendation to the Consumer Affairs Department that no drinks or beverages including a popular drink for children and other similar products should be sold under the category of health drinks in stores or shops. It has sent a recommendation to Ministry of Commerce and Industry to issue directions to all e-commerce entities to remove these drinks and beverages from the category of health drinks on their websites. Source: bit.ly/4aksQTe
Cookware, Utensils and Cans for foods and beverages will require Indian Standard Marks for sale in India The Department for Promotion and Industry and Internal Trade has published a Quality Control Order (QCO) which makes it mandatory for importers and manufacturers of Cookware, Utensils and Cans for foods and beverages to obtain an Indian Standard Mark (IS mark) from Bureau of Indian Standards (BIS) for sale of products in India. BIS grants rights to use IS mark after testing and inspection of products and manufacturing facilities, both in India and abroad, and charges a fee on the products sold. The QCO will take effect from September 1, 2024 for large scale manufacturers. Source: bit.ly/49WwzXf
Restriction on package size of tablets or capsules relaxed in India India’s Ministry of Health and Family Welfare has issued an amendment in Drugs Rules, 1945 for the sale of multipacks (more than 10) of Tablets (coated or uncoated) or Capsules (hard or soft gelatin). From now onwards, packet of more that 10 tablets can be sold in the multiples of 5 or 7. Earlier, it could only be sold in the multiples of 5. Source: bit.ly/3VjpDPJ
Strict implementation of new Pharma and Medical Device Promotion Code 2024 on cards as government reaches out to industry. India’s Department of Pharmaceuticals will reportedly be holding a spree of meetings with the stakeholders from the pharma and medical device industry to ensure strict implementation of Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024. The UCPMP 2024 has replaced UCPMP 2015, and will govern interaction of pharma and medical device industry with doctors going forward. Source: bit.ly/3Tminjw
India’s Plastic Waste Management (PWM) Rules, 2016 have been overhauled India’s Indian Ministry of Environment Forest and Climate Change has introduced major amendments to the PWM Rules, 2016. A summary of the major amendments is described below:
Extension in date of filing of annual returns for FY 2022-2023: The Producers, Importers, Brand Owners (PIBO’s) and Recyclers of Plastic Packaging Waste will have to file the annual returns for the FY 2022-2023 by 31st March 2024. This extension is granted only for the FY 2022-2023.
Dates to file annual return by PIBO’s and recyclers: The annual return filing date for PIBO’s is 30th June and for Recyclers is 30th April of next financial year to which the return relates.
Definitions of Importer, Manufacturer and Producer has been amended: • “Importer” means a person who imports for commercial use, any plastic packaging or any commodity with plastic packaging or carry bags or plastic sheets or like material, or plastic raw material including in the form of resin or pellets, or intermediate material to be used for manufacturing plastic packaging such as films or preforms. • “Manufacturer” means and includes a person engaged in production of plastic raw material, including compostable plastics and biodegradable plastics. • “Producer” means a person engaged in manufacturing of plastic packaging; and, includes a person engaged in manufacture of intermediate material to be used for manufacturing plastic packaging, and also the person engaged in contract manufacturing of products using plastic packaging or through other similar arrangements for a brand owners. Source: bit.ly/4cnitjy
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Prior Government approval not necessary for using unreliable or untested artificial intelligence (AI) in India India’s Ministry of Electronics and Information Technology (MeitY) has revised its controversial advisory on use of AI, and has done away the requirement of permission from Indian Government prior to use of under-testing/unreliable AI products. However, the requirement to label under-testing/unreliable AI products prior to making them available to users, and to obtain informed consent prior to use of such products by users continues. Source: bit.ly/3VlHOUI
Indian Patent Rules have been amended significantly The Patent (Amendment) Rules, 2024 notified by India’s Ministry of Commerce and Industry have introduced several key changes to patent framework. The time-limits for foreign applications, notice of pre-grant oppositions and request for examinations has been revised. Additionally, the revised rules now require permit a patentee or a licensee to furnish a statement of working of patent only once every three years, as opposed to once every year. Source: bit.ly/49TDwZl
India’s Food Regulator confirms that there is no specific food standards for seeds of fruits and plants India’s Food regulator, Food Safety and Standards Authority of India (FSSAI), has confirmed that there are no specific food standards for edible dried seeds obtained from fruits and vegetables as of now. Importers and manufacturers can follow the current standards and obtain license under the parent category of dried fruits and dried vegetables till such time specific standard is notified by FSSAI. Source: bit.ly/3VnSNNI
India’s New Code on Interaction between Industry and Doctors may not be enforceable India’s Department of Pharmaceuticals (DoP) published Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024 to regulate the interaction between doctors and pharma and medical device companies. The DoP has not described UCPMP 2024 as voluntary, which it had done in for UCPMP 2015. This implies that the UCPMP may be mandatory. However, concerns are being raised by experts on the enforceability of UCPMP 2024 due to absence of statutory backing. Source: bit.ly/3vj0JoH
India’s antitrust regulator to examine in-app billing practices of Google The Competition Commission of India (CCI) has initiated an investigation against Google for abusing its dominant position through its new user Choice Biling System. CCI has taken a prima facie view, based on information received by multiple stakeholders, that Google’s new policy skews and disrupts market competition in the downstream app markets and continues to favour Google’s apps while cementing its position in the payment processing market as well. Source: bit.ly/3THykCh
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Hospitals and pharma companies in India bought electoral bonds worth 9 billion Rupees Indian hospitals and pharma companies have reportedly bought electoral bonds for approximately Rs. 900 crore. Electoral bonds bought by businesses are later encashed by political parties, and until recently, the identity of businesses that bought electoral bonds was kept confidential. Source: bit.ly/43qtXyz
New portal for filing consumer complaints to be introduced India’s Central Consumer Protection Authority (CCPA) will reportedly launch a dedicated online complaint portal for consumers to file complaints against misleading advertisements and unfair trade practices. The timing of the launch of the portal is intended to coincide with World Consumer Rights Day (March 15). Source: bit.ly/3ViSKCP
New guidelines that will differentiate brand extension and surrogate advertisements to be notified soon India’s Central Consumer Protection Authority (CCPA) has reportedly formed a committee to deal with the issue of differentiation of genuine brand extensions from surrogate advertisements. Brand extensions are advertisements by companies that extend existing brands into new product categories. For example, advertisements by alcohol companies to sell music CDs, glasses, soda, etc. under the same brand name. However, if the products covered brand extensions are not available for sale in the open market, then such advertisements become surrogate advertisements. Source: bit.ly/3Tll3hn
EU may soon adopt a single compulsory license regime for medicines in crisis situations The European Union Parliament is reportedly going to consider a proposal to allow manufacturers of critical medicines to manufacture them for all member states without the consent of the patent holder in crisis situations. Under the current law, even if one State of the EU grants a compulsory license to a manufacturer to manufacture a critical medicine in a crisis situation, the medicine cannot be exported or sold in other EU states unless the concerned State also grants some kind of immunity against the import of such medicine into that State. Source: bit.ly/3Vp0Iud
Brand owners now responsible for collection of any plastic packaging waste The Ministry of Environment has amended the Plastic Waste Management (Amendment) Rules, 2024. All brand owners who use plastic packaging on the product package are obligated to collect plastic packaging waste. However, if the brand owners have met the Extended Producer Responsibility targets by contracting with a registered recycler, then physical collection of plastic packaging waste may not be required. Source: bit.ly/3PrvG0L
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: Government The Secretary, Department of Pharmaceuticals, has reportedly said that the government will appoint a panel of auditors who can undertake risk-based audits from time to time, to evaluate whether the promotional expenses, especially towards conferences and workshops, have been incurred in an ethical manner as per the Uniform Code for Pharmaceutical Marketing Practices 2024. Any discrepancy will be reported to the appropriate government agency or authority. Source: bit.ly/49SNs5f
Industry welcomes the new Uniform Code for Pharmaceutical Marketing Practices The pharmaceutical industry has reportedly welcomed the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP). According to news reports, the industry feels that the new code is a step ahead towards the advancement of the industry as it ensures ethical and healthy engagement between the pharmaceutical industry and medical professionals. Source: bit.ly/4a6SZWd
Nutraceutical and food supplement regulations are to be tightened further The Food Safety and Standards Authority of India (FSSAI) is in the process of tightening the regulations for nutraceuticals and health supplements. This move was prompted by the receipt of several complaints by the FSSAI about the presence of non-compliant health supplements on the market and the fact that the over-the-counter availability of nutraceuticals and health supplements is resulting in people consuming supplements along with drugs, which increases the risk of adverse effects. Source: bit.ly/3wXMsOU
A major e-commerce entity was fined Rs 25 lakh due to its inaction to remove counterfeit products from the marketplace A State Consumer Commission in India has imposed a fine of Rs. 25 lakhs on a major e-commerce entity on the grounds that the e-commerce entity failed to correct the listing of a product, which it was aware was a counterfeit product. By failing to remove the listing, the Commission held that the e-commerce entity had engaged in dark patterns and unjust enrichment. Source: bit.ly/3IBUsaH
EU to extend regulatory data protection for innovator drugs to 7.5 years The European Union is set to extend regulatory data protection for innovator drugs to 7.5 years, with one extra year of incentives if the drug meets an unmet medical need and clinical trials are conducted in the EU. There is a proposal to grant an additional 3 years of protection from generics, taking the total protection to a maximum of 11.5 years. Source: bit.ly/3IxEIWl
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
New marketing code for pharmaceutical companies notified; Pharmaceutical Associations to set up dedicated portal for handling complaints of violations The Department of Pharmaceuticals has notified Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. In order to ensure strict compliance with UCPMP, all pharmaceutical associations are required to establish an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) and set up a dedicated UCPMP portal on their websites. Unlike the previous iteration of the code, the 2024 iteration has explicitly permitted pharma and medical device companies to provide brand reminders up to Rs. 1000 per item, and has also allowed another informational and educational items to be included in the category of brand reminders. Source: bit.ly/3IClT44
New law for regulation of prices of Drugs and Medical Devices soon; Indian Government constitutes a high level committee India’s Department of Pharmaceuticals has constituted a committee which has been tasked to draft a new Drugs and Medical Devices (Control) Order. The committee will also examine pricing regulation for drugs and medical devices with focus on balancing price availability for essential medicines and price moderation for medical devices without hindering growth of industry. Source: bit.ly/3v8Nff5
Government can give precedence to quality over price in tenders of life saving medical devices: High Court The High Court of Jharkhand in India, while deciding on the validity of decision rendered by Tender Committee for medical devices, has stressed that pricing cannot be the sole criteria for awarding tender, and the Tender Committee was within its right to consider quality of the medical devices in addition to pricing. The Court observed that judgments made by expert committees must not be subject to scrutiny by courts and in cases involving tenders, the focus should solely be on the decision-making process rather than the perceived validity of the decision itself. Source: bit.ly/3ICmNOi
Export of human blood and human blood components samples will require NOC from Drugs Regulator or Indian Council of Medical Research India’s Ministry of Commerce has amended its export policy put restrictions on export of samples of human blood and biologicals such as anti-sera made from human blood. If the purpose of export of sample relates to its use in development of a drug, then a NOC from Central Drugs Control Organization (CDSCO) will be required. In all other cases, a NOC from Indian Council of Medical Research (ICMR) will be required. Source: bit.ly/3VbtuhG
Anti-trust Committee recommends law to regulate conduct of large digital enterprises The Committee of Digital Competition Law has recommended that the Indian Government should proactively regulate behaviour of large digital enterprises, and that the Competition Commission of India (CCI) should intervene before instances of anti-competitive conduct transpire. At present, CCI has powers to intervene after anti-competitive conduct has been committed. Large digital enterprises are enterprises which have significant presence and financial strength, and provide core digital services. Source: bit.ly/3PokH8j
The Government of India notified the Medical Textiles (Quality Control) Order, 2023 (the “Order”) on 27 September 2023. This Order, drafted by the Ministry of Textiles in consultation with the Bureau of Indian Standards (BIS) mandates that certain medical textile products adhere to specified Indian Standards (IS) and bear the Standard Mark. Medical textiles are mainly used for protection from infections in hospital environment, personnel hygiene, wound treatments, wound closure, replacement surgery or as a mechanical organ. In this article, we have covered the implications with focus on personal hygiene category which is largely unregulated. The Order applies to all manufacturers, wholesalers, retailers, and importers of finished products for sale and marketing in India.
Update in Standards
The Ministry of Textiles has introduced the updated standards with the Medical Textiles (Quality Control) Order, 2023. To comply with the Order, the manufacturer/producers of these products will have to get license from the BIS to use the Standard Mark on these products/their packaging to signify that the products meet with specified IS standards.
Reusable Sanitary, Pad Sanitary, Napkin Period Panties
IS 17514:2021
Reusable Sanitary Pad/Sanitary Napkin/ Period Panties – Specification
4.
Shoe Covers
IS 17349:2020
Medical textiles – Shoe Covers – Specification
5.
Dental Bib/Napkins
IS 17354:2020
Medical Textiles – Dental Bib or Napkins – Specification
6.
Bedsheet and Pillow Cover
IS 17630:2021
Medical Textiles – Bed Sheet and Pillow Cover – Specification
The standards in the Order do not apply to the goods or article meant for export or those that are manufactured by Self Help Groups. For others, these standards are slated to become effective from 01 April 2024 (the “Effective Date”), except for Small and Micro Enterprises (SMEs). The effective date for SMEs is 01 October 2024. Consequently, the industry will transition from the previous framework of standards to the updated framework commencing from the Effective Date. This transitional period provides the industry with approximately five months to make requisite preparations for the shift in compliance standards.
Impact on the Industry
Mandatory Licensing and Certification: Manufacturers need to be aware that compliance with the Medical Textiles (Quality Control) Order, 2023 requires obtaining a license and adhering to an elaborate certification process. The process is guided by Scheme I of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (the “Conformity Assessment Regulations”). This makes it a mandatory certification for using BIS mark on medical textiles products. All manufacturers of these products will require to initiate the licensing process promptly, recognizing that it is not optional but an essential compliance step.
The licensing process entails scrutiny of the production process by the Bureau of Indian Standards. This involves factory visits, review, and adherence to precise labelling and marking requirements. Manufacturers will have to allocate resources and manpower for the continuous compliance checks that accompany the licensing process. Furthermore, it is vital to establish protocols for maintaining compliance and documentation for potential audits and renewals.
Certification for Foreign Manufacturers: Foreign manufacturers are also required to comply with the standards for the products covered under the Order. For such foreign manufacturers, the BIS operates the Foreign Manufacturer Certification Scheme (FMCS), which is covered under the Scheme I of the Conformity Assessment Regulations. The FMCS is a scheme under which the manufacturers who have their factory location outside India can apply to get BIS licence in accordance with the BIS Act, 2016 and Conformity Assessment Regulations. The BIS license under the FMCS scheme ensures that the product of the foreign manufacturer sold in India conform to the applicable Indian Standards. Considering that there is approximately only five (5) months’ time before the updated standards become effective, foreign manufacturers may have to work on war footing to meet the timeline and be prepared with the updated products in time. However, as per the Frequently Asked Questions (FAQs) hosted on the BIS website, the average time taken for grant of licence is generally six (6) months from the date of receipt of complete application and its recording. It may further vary for reasons like delay in response to queries raised, organizing inspection(s), transportation of samples and remittance of dues, etc. Thus, it is of high importance for foreign manufacturers to initiate the licensing process from their end at the earliest to introduce compliant products in Indian market by the Effective Date.
Limited Time for Transition: With the updated standards slated to come into effect from April 2024, the industry has a finite window of approximately five months to prepare for compliance. Similar to foreign manufacturers, for entities lacking the requisite licenses, this timeframe becomes a pressing concern. It is crucial to understand that the certification and licensing process for domestic manufacturers, encompassing document preparation, verification, on- site inspections, and reviews, typically spans between four to six months (as per the FAQs on the BIS website). Consequently, early initiation of the process is important to meet the compliance deadline. After 01 April 2024, products that do not possess the BIS license for conforming to the updated standards will not be permitted to be sold in India, highlighting the urgency of proactive compliance.
Import of the Products: Importers of medical textile products also face a compliance challenge under the Medical Textiles (Quality Control) Order, 2023. These importers (not being the foreign manufacturer) must ensure that the products they bring into India meet the specific Indian Standards and carry the requisite Standard Mark. This means that from the Effective Date the imported products must adhere to the same quality and safety benchmarks as those produced within India. To meet this end, importers will need to establish close collaboration with their international suppliers (foreign manufacturers) to ensure that these products are in
line with the standards outlined in the Order and are licensed under the FMCS when they reach the Indian custom barrier.
Additional Compliances: The conformity to one BIS Standard may also require conformity to other BIS Standards. Manufacturers should recognize that compliance with the new standards goes beyond the finished product; it extends to the raw materials, manufacturing process, testing capabilities as well. For instance, the BIS standard for sanitary napkins (IS 5405:2019) mandates that if cotton gauze is used as a raw material, it must conform to IS 758. Further, the testing of the products (by the testing facilities of the manufacturer) also requires adherence to various IS Standards; for instance, the test to ascertain the pH value of the products must adhere to IS 1390, which will require equipment and facilities that can correctly and accurately test products as per IS 1390. These additional compliance implications may translate to increased time and costs for the manufacturers.
Balancing Inventory: Managing existing inventory compliant with older standards also presents a challenge. Manufacturers must strike a balance between maintaining a consistent supply in the market until they secure the necessary licenses and utilizing the existing inventory. It is advisable to develop a phased inventory management plan, ensuring that obsolete stock does not remain on the market after the Effective Date. This may involve strategically phasing out non-compliant items till the Effective Date or till the license is obtained.
Implications for Hospitals: The implications of the Medical Textiles (Quality Control) Order, 2023 reach into the healthcare sector, presenting a significant challenge for hospitals. With the Order mandating specified standards for medical textiles, including bed sheets, pillow covers, shoe covers, and dental bibs, hospitals will face the task of sourcing compliant products during the transition phase. This challenge is compounded by the short timeline. As the licensing process itself spans four to six months, and the effective date is just five months away, a shortage of compliant products may emerge. This scarcity could lead to unavailability of these products, affecting public health as hospitals grapple with maintaining essential inventory that adheres to the updated standards while the industry transitions.
Quality Standards in Public Interest
The issuance of the Medical Textiles (Quality Control) Order, 2023, also carries a broader societal impact. It serves the purpose of upholding stringent quality standards, particularly in contexts where these products play a pivotal role. A notable instance can be found in the welfare initiatives implemented by various state governments in India, where sanitary pads are distributed to schoolgirls as part of their welfare schemes. Historically, the procurement of these products sometimes involved the selection of agencies that imported substandard, low- quality items from foreign countries, often at significantly reduced rates. Such practices occasionally led to the circulation of products that circumvented established quality norms.
However, the enforcement of the BIS-mandated Standard Mark now provides an unequivocal assurance that even products disbursed through welfare programs strictly adhere to meticulously defined quality criteria. This safeguard upholds the health and well-being of the beneficiaries and aligns with the overarching objective of elevating the overall quality of life.
Conclusion
The Medical Textiles (Quality Control) Order, 2023, combined with the BIS Act and Conformity Assessment Regulations, marks a significant stride towards ensuring the safety and quality of medical textiles in India. By making the BIS license mandatory, the Order raises the bar for manufacturers and importers of the medical textile products and reassures the consumers.
The Ministry of Electronic & Information Technology (MeitY) has recently issued an advisory which has the potential to regulate businesses that are using Artificial Intelligence (“AI”) models developed by them or third parties. In this article, we have analysed the scope of advisory, specifically to evaluate what compliance burden does it cast on businesses, and more importantly – which businesses are impacted, and which aren’t.
Brief background
All intermediaries in India must remain compliant with Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021 (“IT Rules) if they don’t want to risk the loss of statutory immunity (read safe harbour protection) granted to them. If an intermediary loses safe harbour, it may be made responsible for any and all illegal activities that takes place on its platform. MeitY has the powers to make and amend the IT Rules, and it is in relation to exercise of such powers, that it has issued the current advisory.
An intermediary, for the purposes of IT Rules, is essentially any person or entity that receives, stores, or transmits particular electronic records on behalf of another, or provides any services in relation to the particular electronic record.
Due to the wide nature of the above definition, all internet service providers, telecommunication service providers, web hosting service providers, data centres, search engines, online marketplaces etc. are regulated as intermediaries in India.
Scope of the advisory – What compliances does it prescribe?
The advisory essentially introduces three new compliances in relation to AI models, Large Language Models(“LLMs”), generative AI, software(s) and algorithm(s) (together “AI”): (a) AI should not exhibit any inherent bias or discrimination; (b) if the AI is under-tested or unreliable, then its availability to Indian users can take place only with an explicit permission of the Government of India, along with a declaration which indicates that the output may be unreliable; and (c) if the AI is capable of generating information, audio and/or video, which may be potentially used as misinformation or deepfakes, then a permanent label, metadata or identifier should be embedded in the output which identifies the computer resource from which such misinformation or deepfake was created or originated, as well as any other computer resource that modified or played a part in the misinformation or deepfake.
Scope of the advisory – Who does the advisory apply to?
Since the advisory has been issued in relation to IT Rules which apply to intermediaries, there is no doubt that the advisory is binding on the intermediaries.
Interestingly, the IT Rules do not regulate businesses who are using or leveraging AI in order to provide goods and services to end consumers. So, the real question is, does the advisory apply to any and all business that are developing or using AI capabilities?
From a plain reading of the advisory, it appears that the advisory does not directly apply to any and all businesses, if the businesses do not qualify as an intermediary. Most businesses developing or leveraging AI would not fall under the definition of an intermediary.
Unfortunately, the language of the advisory leaves room for other interpretations as well. One interpretation is that the advisory directs intermediaries, in their capacity as gatekeepers of information that is exchanged between businesses and consumers, to ensure that AI developed or leveraged by businesses is of a ‘standard’ quality (as defined in the advisory). Since internet service providers, search engines and web hosting service providers are all intermediaries under Indian law, the advisory may be viewed as an attempt by Government of India to indirectly control businesses that are developing or leveraging AI.
The Minister of IT, however, has clarified that the advisory is applicable to significant platforms only and not to start-ups. Unfortunately, there is no definition of significant platforms. Until further clarification is received, it may be safely assumed that only large platforms will be required to take explicit permission for using under-tested and unreliable AI whereas startups will not.
What changes now for businesses?
All intermediaries operating in India have to submit Action Taken-cum-Status Report (“ATS Report”) to the Ministry. It appears that all intermediaries have taken a conservative view of the advisory and are interpreting the advisory such that it applies only to intermediaries such as platforms (e.g. social media platforms). There is no clarity on the permission process from Government of India as of now.
We expect further clarity to be received in the coming days, once MeitY has reviewed the ATS Reports. Until then, it should be business as usual for most businesses other than those who qualify as intermediary under the IT Rules.
The most important thing for businesses to do as of now, is to evaluate whether the business qualifies as intermediary under IT Rules or not. If it qualifies as an intermediary, all the compliance burden associated with the advisory (described above) will immediately shift on the business.
All pragmatic businesses may consider starting preparations to introduce a permanent label, metadata or identifier in the output, as described above.
From a policy perspective, the advisory appears to be a clear declaration of intent by the Indian Government, that it is looking to regulate AI given its disruptive powers.
Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
𝐃𝐨𝐜𝐭𝐨𝐫 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐯𝐢𝐜𝐚𝐫𝐢𝐨𝐮𝐬𝐥𝐲 𝐥𝐢𝐚𝐛𝐥𝐞 𝐭𝐨 𝐩𝐚𝐲 𝐜𝐨𝐦𝐩𝐞𝐧𝐬𝐚𝐭𝐢𝐨𝐧 𝐞𝐯𝐞𝐧 𝐢𝐟 𝐡𝐢𝐬 𝐚𝐝𝐯𝐢𝐜𝐞 𝐰𝐚𝐬 𝐩𝐫𝐨𝐩𝐞𝐫 𝐛𝐮𝐭 𝐰𝐚𝐬 𝐧𝐨𝐭 𝐟𝐨𝐥𝐥𝐨𝐰𝐞𝐝 𝐛𝐲 𝐡𝐨𝐬𝐩𝐢𝐭𝐚𝐥 𝐬𝐭𝐚𝐟𝐟: 𝐍𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐬𝐮𝐦𝐞𝐫 𝐂𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧 India’s apex consumer forum, the National Consumer Disputes Redressal Commission (NCDRC), has imposed a compensation of Rs. 30 Lakhs on a hospital and its doctors for deficiency in providing post operative care to patient. The NCDRC observed that failure to intubate the patient by hospital staff, including anaesthetist, despite the written advice of reintubation by the surgeon who had performed the surgery on the patient, amounted to medical negligence which left the patient in permanent vegetative state. The commission held that the surgeon was vicariously liable for the negligent actions of the hospital staff, along with the hospital. Source: bit.ly/3THv6id
𝐁𝐫𝐢𝐜𝐤 𝐚𝐧𝐝 𝐦𝐨𝐫𝐭𝐚𝐥 𝐫𝐞𝐭𝐚𝐢𝐥 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐢𝐞𝐬 𝐚𝐫𝐞 𝐩𝐫𝐨𝐩𝐨𝐬𝐢𝐧𝐠 𝐭𝐨 𝐜𝐫𝐞𝐚𝐭𝐞 𝐬𝐢𝐧𝐠𝐥𝐞 𝐩𝐫𝐨𝐜𝐮𝐫𝐞𝐦𝐞𝐧𝐭 𝐞𝐧𝐭𝐢𝐭𝐲 𝐚𝐭 𝐝𝐢𝐬𝐭𝐫𝐢𝐜𝐭-𝐥𝐞𝐯𝐞𝐥 𝐢𝐧 𝐞𝐚𝐜𝐡 𝐒𝐭𝐚𝐭𝐞 𝐭𝐨 𝐛𝐞 𝐚𝐛𝐥𝐞 𝐭𝐨 𝐩𝐚𝐬𝐬 𝐝𝐢𝐬𝐜𝐨𝐮𝐧𝐭𝐬 𝐭𝐨 𝐜𝐮𝐬𝐭𝐨𝐦𝐞𝐫𝐬, 𝐚𝐧𝐝 𝐜𝐨𝐮𝐧𝐭𝐞𝐫 𝐞-𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐢𝐞𝐬: 𝐑𝐞𝐩𝐨𝐫𝐭 India’s biggest association of brick and mortal retail pharmacies, The All India Organization of Chemists and Druggists (AIOCD), has reportedly proposed that it will guide its state branches to form a single entity, ‘distribution entity’ at every district or taluka level. AIOCD believes that having a single procurement and distribution entity will result in reduction of operational expenses, multiple licensing and tax payments for the unorganized distributors and chemists. It should also result in ability of retailers to pass more discounts to end consumers to ward-off the threat of e-pharmacies. Source: bit.ly/43uy3G9
𝐄-𝐰𝐚𝐬𝐭𝐞 𝐄𝐏𝐑 𝐪𝐮𝐚𝐫𝐭𝐞𝐫𝐥𝐲 𝐚𝐧𝐝 𝐚𝐧𝐧𝐮𝐚𝐥 𝐫𝐞𝐭𝐮𝐫𝐧 𝐟𝐢𝐥𝐢𝐧𝐠 𝐭𝐢𝐦𝐞𝐥𝐢𝐧𝐞𝐬 𝐦𝐚𝐲 𝐛𝐞 𝐫𝐞𝐥𝐚𝐱𝐞𝐝 India’s Ministry of Environment has notified the E-Waste (Management) Amendment Rules, 2024. The amendment has given the Ministry the power to relax the timelines for the filing of returns and reports by the manufacturer, producer, refurbisher or recycler, up to a period of nine months. As of now, the annual return filing date for manufacturers and producers of electrical and electronic equipment (EEE) is 30th April 2024. Source: bit.ly/48Z5npS
𝐌𝐚𝐫𝐤𝐢𝐧𝐠 𝐟𝐞𝐞 𝐟𝐨𝐫 𝐮𝐬𝐞 𝐨𝐟 𝐈𝐧𝐝𝐢𝐚𝐧 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝 (𝐈𝐒) 𝐦𝐚𝐫𝐤 𝐫𝐞𝐝𝐮𝐜𝐞𝐝 𝐟𝐨𝐫 𝐬𝐭𝐚𝐫𝐭-𝐮𝐩𝐬, 𝐦𝐢𝐜𝐫𝐨, 𝐬𝐦𝐚𝐥𝐥 𝐚𝐧𝐝 𝐰𝐨𝐦𝐞𝐧-𝐥𝐞𝐝 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞𝐬 India’s Department of Consumer Affairs has recently introduced concessions for the annual minimum marking fee for use of Indian Standard (IS) mark. As per the revised Bureau of Indian Standards (BIS) (Conformity Assessment) Regulations 2018, micro-scale enterprises and startup enterprises will receive a concession of 80% against the prescribed annual marking fees as applicable to the particular product category, small-scale enterprises will receive a concession of 50%, and women-entrepreneur enterprises will receive an extra concession of 10%. These concessions are available until May 31, 2026. Source: bit.ly/49MllVu
𝐀𝐮𝐬𝐭𝐫𝐚𝐥𝐢𝐚 𝐝𝐫𝐚𝐰𝐬 𝐭𝐡𝐞 𝐥𝐢𝐧𝐞 𝐛𝐞𝐭𝐰𝐞𝐞𝐧 𝐚𝐝𝐯𝐞𝐫𝐭𝐢𝐬𝐢𝐧𝐠 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐬𝐞𝐫𝐯𝐢𝐜𝐞𝐬 𝐭𝐡𝐚𝐭 𝐮𝐬𝐞 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬, 𝐚𝐧𝐝 𝐚𝐝𝐯𝐞𝐫𝐭𝐢𝐬𝐢𝐧𝐠 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 Australia’s drugs and cosmetics regulator, the Therapeutic Goods Administration (TGA), has prohibited direct or indirect references to prescription-only substances including terms such as “anti-wrinkle injections” and “derma fillers” by healthcare service providers such as hospitals. As per TGA, it should be clear in an advertisement for healthcare services that use healthcare products, such as cosmetic injection services, that the customer is being offered a health-practitioner-led consultation and that, depending on the outcome of the consultation, this may or may not lead to the provision of a prescription and injection. Source: bit.ly/49O6Sbw
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