Category: Latest Updates

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.

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

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

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.

Surgical gloves and single-use medical gloves to be under Quality Control
India’s Department of Pharmaceuticals (DoP) is reportedly considering regulating surgical gloves and single-use medical examination gloves by way of Quality Control Order (QCO). These products are medical devices, but are routinely imported under non-medical device HSN codes. The department hopes that by bringing them under a QCO, it will be easier to regulate the quality as the gloves may be referred to BIS testing laboratories for testing.
Source: bit.ly/4c5k3GA

Use of third party trade mark as internet ad words may not result in trademark infringement if it does not cause confusion: Supreme Court
India’s Supreme Court has dismissed challenge to an order of Delhi High Court, which differentiated between bidding and use of ad words in advertisements and trademark infringement. The Delhi High Court had held that use of third party trade mark as ad words will not result in infringement or passing-off of the registered trade mark if there is no scope of confusion amongst the consumers.
Source: bit.ly/3PeayLs

Refurbishing original equipment and selling under different brand may be unlawful: High Court
India’s Delhi High Court has ruled refurbishing a used branded product, and selling under a different brand name, would constitute reverse passing-off under India’s trade mark law. It has restrained a technology company from selling hard disks of a popular brand under its own brand after refurbishing.
Source: bit.ly/3wHumAh

New guidelines published for LGBTQIA+ reporting in news and media
The News Broadcasting and Digital Standards Authority (NBDSA) has framed guidelines for news and media networks who cover LGBTQIA+ stories. All news channels have been directed to ensure that their news reporting does not promote homophobia or transphobia or negative stereotypes about the LGBTQIA+ community.
Source: bit.ly/3T8Flun

Manufacturers supplying drugs to US market may have to provide notice of discontinuation or interruption of production to US FDA
The US Food and Drug Administration (US FDA), in an attempt to avert medical shortages, has released draft guidance which requires manufacturers to notify the agency of any changes in the production of certain finished products including Active Pharmaceutical Ingredients (API), biological products, and finished drug products. The draft guidance provides a detailed mechanism and timeframe for notification in case of permanent discontinuance or interruption in manufacturing of products covered by the guidance.
Source: bit.ly/3wHX842

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.

Policy on online sale of drugs to be framed within four months
India’s Delhi High Court has directed the Ministry of Health and Family Welfare to come up with a policy on online sales of drugs within four months without fail, i.e., before July 3, 2024. The next date of hearing is July 8, 2024.
Source: bit.ly/3wHBvAT

Suspension/cancellation of license or registration in public interest without grant of hearing will not be legally tenable if the adjudicating authority does not give justification as to how public interest is affected
The Supreme Court of India ruled that if an authority exercises the power of suspension or cancellation of a license or registration in the public interest, then the authority is required to provide reasons as to how it has arrived at the opinion that the public interest will be served by the suspension or cancellation of the license or registration. Authorities typically use their powers to take action in the public interest and do not give notice to businesses before taking action, which is contrary to the principles of natural justice.
Source: bit.ly/49WyWtv

Indian Government to consult state government to standardize the medical treatment charges across the country
India’s Ministry of Health is reportedly taking steps to consult all state governments before notifying uniform ceiling prices for treatment at healthcare facilities across the country. The Supreme Court has recently directed the government to exercise its powers and fix ceiling prices for medical treatment given by hospitals, or else the Supreme Court will fix ceiling prices as prevalent in the Central Government Health Scheme.
Source: bit.ly/49X39rI

Gujarat’s State Pollution Control Board takes stringent action against recyclers for not complying with the EPR guidelines
India’s Gujarat State Pollution Control Board has directed the closure of the manufacturing unit of one of the recyclers and imposed an environment compensation of Rs. 5,74,10,000/- on account of a violation of the Extended Producer Responsibility (EPR) guidelines under the Plastic Waste Management Rules, 2016. The board has debarred the EPR registration issued to the unit of the recycler on the EPR portal and revoked the consent order issued to the unit for violating EPR guidelines by submitting false information regarding the actual processing capacity of the unit and generating EPR certificates in excess of the actual processing capacity.
Source: bit.ly/3V8X3Ay

World Health Organization launches Neonatal Screening Guidelines for detection of disabilities
The World Health Organization has launched its Neonatal Screening Implementation Guidelines in Southeast Asia. These guidelines have been launched to help build capacity for pre-symptomatic detection of hearing and sight disabilities and neonatal jaundice.
Source: bit.ly/3T98chW

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.

Discount offered by Pharmacies and Chemist Stores through bill boards and social media will result in action against Pharmacists in Maharashtra
The State-level Council responsible for regulation of Pharmacists and their conduct in the State of Maharashtra has recently warned all registered pharmacists operating in Maharashtra, that if their medical store offers discounts, rebates or gifts through any kind of advertisement, then action will be taken against them for misconduct. As per law, presence of a registered pharmacist is required to operate a medical store in India.
Source: bit.ly/48EOXCF

Standards of Disinfectants and Antiseptic published for comments
The Indian Pharmacopoeia Commission has released a draft of standards for testing and use of Disinfectants and Antiseptics in healthcare settings. All manufacturers and stakeholders have been invited to provide feedback on the standards before the 15th April 2024.
Source: bit.ly/48IbfDH

Controversial new standards for Undergraduate Medical Institutions may be deferred
India’s Health Ministry has reportedly requested the country’s Medical Profession Regulator, The National Medical Commission (NMC), to defer the date of enforcement of new infrastructure and personnel standards the NMC has prescribed for new Undergraduate Medical Institutes on the ground that the new standards are unrealistic. One of the controversial standards limited ability of existing medical colleges to expand seats they had more than 100 seats for every 10 lakh population in the State.
Source: bit.ly/3V4mOBM

No generic IP Exemption for COVID-19 therapies and diagnostics as WTO members fail to reach consensus
The Trade Related Aspects of Intellectual Property Council (TRIPS Council) of the World Trade Organization (WTO) announced that it has failed to reach consensus on the decision to protect COVID-19 therapeutics and diagnostics from enforcement of intellectual property claims by private players in domestic settings. In June of 2022, the members had agreed for an IP exemption for COVID-19 vaccines.
Source: bit.ly/3V4WreY
Source: bit.ly/48KoaVD

US FDA to Collaborate with Industry Group to Develop AI Regulations for Health AI
One of the United States’ largest association focused on AI in health space, The Coalition for AI (CHAI), which counts major players such as Google and Microsoft as members, has announced that it will be collaborating with the US Food and Drug Administration, and several other government institutions, to develop quality, safety and evaluation standards for regulation of Artificial Intelligence in health space. The Board of Office of the National Coordinator for Health Information Technology.
Source: bit.ly/3IquxTm