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TOP 5 HEALTH LAWS AND POLICY 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.

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

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TOP 5 HEALTH LAWS AND POLICY 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.

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

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TOP 5 HEALTH LAWS AND POLICY 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.

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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TOP 5 HEALTH LAWS AND POLICY UPDATES

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Airlines have to obtain single caterer license and provide invoice containing description of license number for chargeable in-flight meals
India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued an advisory to flight operators directing them to ensure that they have appropriate license for providing in-flight food. The regulator has also directed flight operators to ensure that appropriate invoice with license number is issued for sale of food, and that both ready-to-serve and pre-packaged food carries appropriate labelling declaration.
Source: bit.ly/48NrSxN

In medical negligence matters, exoneration by medical council will not automatically mean exoneration before consumer forum, especially if contradictory medical evidence has been furnished: Supreme Court
India’s Supreme Court has held that a consumer commission which is deciding a complaint of medical negligence against a medical practitioner, should not solely rely on favourable report from State Medical Council especially if the complainant has submitted contradictory expert testimony from another medical practitioner.
Source: bit.ly/3Isb30J

Import of medicines to get boost from India’s free-trade agreement with four countries of European Free Trade Association (EFTA)
Four European Free Trade Association states, namely, Iceland, Liechtenstein, Norway and Switzerland, have signed a Trade and Economic Partnership Agreement with India for facilitating trade and investment flows. While India has secured soft investment commitments under the Agreement, EFTA states have been given concession on import duty on pharmaceutical products exported to India and have been promised simplified customs procedure.
Source: bit.ly/3TuP8w9

Limits for automatic exemption in combination cases before CCI increased
The Indian government has increased the asset and turnover thresholds for automatic exemption under India’s anti-trust regulations. For claiming the exemptions from prior approval requirement, the value of assets being acquired should be Rs. 450 crores as opposed earlier threshold of Rs. 350 crores. Similarly, the turnover should be Rs. 1250 crores as opposed earlier threshold of Rs 1000 crores.
Source: bit.ly/3VaYle6

Electrical appliances for hair and skin care would require Indian Standard Marks for sale in India from 4th March 2025
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 skin and hair electrical appliances to obtain an Indian Standard Mark (IS mark) from Bureau of Indian Standards (BIS) in order to be able to sell 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.
Source: bit.ly/4c8wSzW

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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

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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

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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

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Scientific works are not protected under India’s Copyright Law: High Court
India’s High Court of Andhra Pradesh has held that India’s copyright law only protects original literary, dramatic, musical and artistic works. It does not protect scientific works, as covered under books of Mathematics, Physics, Chemistry, Botany and Zoology used by Students. The Court clarified that mathematical equations and science subjects do not qualify as ‘original works’ because they are the matter of fact and nature.
Source: bit.ly/432GSqc

All rare disease drugs imported into India will be exempted from requirement to pay customs duty: High Court
India’s Delhi High Court has issued an order exempting drugs and medicines used in therapy for rare diseases from requirement of payment of customs duty. Prior to the order, the exemptions from payment of customs duty was limited to drugs used for treatment of Spinal Muscular Atrophy (SMA) or Duchenne Muscular Dystrophy (DMD). Earlier the Court had directed the National Rare Diseases Committee to hold deliberations with manufacturing and marketing companies to explore the possibility of procuring the medicines at a reasonable price.
Source: bit.ly/3T1H2JN

Flow of counterfeit products into Indian market to be checked through a new surveillance system
India’s Ministry of Consumer Affairs is planning to develop a new surveillance system to identify counterfeit products sold in the retail market. The Ministry proposes to collect samples soon after they enter the retail market and test them under new laboratories which will be set-up specifically for the purposes.
Source: bit.ly/3T5EKta

Online gaming guidelines to prevent compulsive gaming in India to be published
India’s Department of Consumer Affairs (DoCA) is planning to commission a research on the disruptive impulse control behavioural patterns of digital consumption that may cause vulnerabilities. The initial part of the research will be focused on online gaming addiction. The research would later be expanded to identify the underlying factors of excessive consumption of online content. The findings of the research would be used to provide policy inputs for framing of the Guidelines for protecting the interests of the consumers.
Source: bit.ly/3T1hXPb

US BioSecure Act to impact Indian biotechnology companies providing services or manufacturing products for US market
The BIOSECURE Act which has been introduced in the US House of Representatives prohibits US federal agencies from entering into contract with any entity that uses biotechnology equipment or services from a biotechnology company of concern to perform a federal contract. Some Chinese companies have been identified as biotechnology company of concern, and the list may be expanded to include companies from Russia, Iran and North Korea as well.
Source: bit.ly/3V5yQeq

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India takes baby steps in regulation of Artificial Intelligence, puts in place prior consent requirement before deployment of AI
India’s Ministry of Electronic & Information Technology has reportedly advised platforms and intermediaries which employ artificial intelligence (“AI”) models or generative AI software, algorithms to mandatorily obtain government approval before offering their services. Additionally, platforms or intermediaries using unreliable AI models or algorithms should label themselves as “under testing” and take explicit consent from users, making them aware of potential errors in the technology.
Source: bit.ly/430rwT8

Indian Government to hold discussions with private hospitals on capping of medical treatment rates
India’s Ministry of Health and Family Welfare is reportedly in discussion with major corporate hospitals on the possibility of capping of medical treatment rates. India’s Supreme Court last week had directed the Ministry to exercise its powers under Clinical Establishment Rules for prescribing ceiling prices of medical treatments, and threatened that if it did not do so, the Court will itself direct the Ministry to notify Central Government Health Scheme (CGHS) rates as ceiling prices for medical treatments across the country.
Source: bit.ly/3wGw6di

Eye drops in India may soon have to be sold in transparent bottles to detect contamination
India’s central drug regulator, the Drugs Controller General of India, has called a meeting with pharmaceutical manufacturer associations to propose the use of transparent bottles in packaging eye drops. It is expected that use of transparent bottles will help detect contamination and particulate matter, so that any damage to the eye due to contaminated or spurious eye drops may be avoided. Most eye drops are currently sold in opaque bottles.
Source: bit.ly/3UX4Lxv

Yogurt makers may lawfully claim that it can reduce the risk of type 2 diabetes: US FDA
The U.S. Food and Drug Administration has reportedly allowed dairy-based yogurt makers to claim that Yogurt may reduce the risk of type 2 diabetes. However, the US FDA has recommended that the claim may be used carefully in yogurts that contain high levels of added sugar.
Source: bit.ly/3STFDF2

Legal validity of US Medicare drug price negotiation program upheld
A federal judge in Delaware in US has upheld the legal validity of U.S government’s condition that manufacturers of Top 10 drugs which are used in Medicare health insurance program will have to reduce prices or stop supplying to the program. This is the third positive court ruling in favour of US Government in the last few weeks on the subject of price negotiations.
Source: bit.ly/4bZbOM8

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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.

State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplace
A State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of incorrect goods to customers, on the grounds that since it offered a ‘fulfilling’ service on behalf of the seller, it was not merely an intermediary but also an agent of the seller. The marketplace was made to pay punitive damages, in addition to mental harassment, on grounds that it may have unscrupulously exploited an unknown uncounted number of consumers.
Source: bit.ly/49VuNW0

Kochi and Thiruvananthapuram proposed to be added to the list of airports from where drugs may be imported
India’s Ministry of Health and Family Welfare has issued a draft notification that will add Kochi and Thiruvananthapuram to the list of airports from which pharmaceutical drugs may be imported into India. The Drugs Rules, 1945 specify that pharmaceutical drugs may be imported into India from a specified number of airports only. The clearance of drugs requires the approval of the Additional Drugs Controller (ADC) Customs, who is generally posted at the customs wing of the airport.
Source: bit.ly/49zbUZ8

Dengue Vaccine Clinical Trials to start soon in India
A major Japanese drug maker has reportedly received clearance from India’s vaccine regulator, Central Drugs Standards Control Organization, to start clinical trials of the dengue vaccine. The vaccine will be contract manufactured by a major biotech company in India.
Source: bit.ly/49OyQ7b

Many medical device companies settled allegations of kickbacks given to doctors in 2023: US Department of Justice
The US Department of Justice (DoJ) has issued a press release that it has recorded the highest number of settlements and judgements in its history. Some of major settlements involved allegations of unlawful kickbacks medical device companies to doctors, in form of above-fair market value supervision fees or remuneration for medical directorships and improper donation of capital equipment.
Source: bit.ly/49X0H4H

Fair-use defense against copyright infringement by AI companies will be tested in new trial by media companies against Open AI
In a new set of lawsuits in the US, media companies are not alleging copyright infringement by AI companies to train the algorithm, but instead alleging that before training, the AI companies removed information from the training material which established that the material was copyrighted, such as the name of the author the news. The Digital Millennium Copyright Act or DMCA, law in the US reportedly prohibits the removal of information that can help copyright holders detect infringement, including article titles, author names, and copyright dates.
Source: bit.ly/3Ih1MbA