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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.

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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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.

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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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.

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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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.

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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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.

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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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.

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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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.

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

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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.

India announces completion of Genome Sequencing Project
The Department of Biotechnology (DBT) has announced the completion of the Genome India Project, the largest project to sequence 10,000 genomes of the Indian population. The initiative was launched in 2020. Owing to the project, the DBT has now created a reference genetic database as well as a biobank of Indian blood samples for future research.
Source: bit.ly/48C0G55

Draft guidance on post approval changes of biologics published by India’s drug regulator
India’s central drug regulator (CDSCO) has published draft guidance on ‘Post Approval Changes in Biological Products: Quality Safety and Efficacy Documents’ for comments. The draft guidance categorizes post approval changes relating to safety and efficacy depending on their seriousness and reporting requirements.
Source: bit.ly/48Bhnxi

Hospitals in India report increase in the average revenue per occupied bed (ARPOB)
As per reports, the average revenue per occupied bed (ARPOB) in major hospitals in India has increased in the last nine month and is set to increase 8-10% in next financial year. The ARPOB was estimated to be Rs. 45,800 per day in FY23. The factors driving growth are focus on specialized procedures and fast (morning/evening) discharges.
Source: bit.ly/3P0YxZy

USFDA to increase annual inspection of pharmaceutical facilities in India
The US Drug Administration (USFDA) is reportedly set to increase the number of inspections at Indian drug manufacturing units in 2024 due to increasing concerns about the quality of pharmaceuticals manufactured in those facilities.
Source: bit.ly/3UVrM3O

World’s biggest beef producer sued for greenwashing
The New York Attorney General has filed a lawsuit against the world’s largest beef producer on the ground that it has no viable plan to achieve net zero greenhouse gas emissions by 2040, as claimed by it. The Attorney General has accused the beef manufacturer of misleading the public about its environmental impact to increase sales.
Source: bit.ly/3P3Ak4V

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Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisements
India’s Supreme Court is reportedly set to issue a Contempt Notice to a major Ayurvedic medicines manufacturer in India after it found out that the manufacturer had published a misleading advertisement claiming permanent relief for certain chronic conditions such as Diabetes and Liver Cirrhosis. In November 2023, the manufacturer had given an undertaking to the Supreme Court that it will not publish misleading advertisements or disparage allopathy. The Supreme Court has also questioned the Indian government for its inaction over publication of misleading advertisements by the manufacturer despite existence of a law which makes publication of misleading advertisement punishable with imprisonment.
Source: bit.ly/42U33yI

Doctors will have to obtain registration with State Medical Council of every State where they practice: Delhi HC
The High Court of Delhi has upheld the legality of a notice issued by Delhi Medical Council which made it mandatory for Doctors to register with the Council if they wanted to practice in the State of Delhi. The Doctors argued that it was an onerous requirement which would require them to register in every State they practice in. However, the Court held that the intent of the law is to require Doctors to register in every State that they practice in, and that Doctors have the option to register with multiple State Medical Councils in India.
Source: bit.ly/3TgHANw

Cosmetic Importers asked to provide sales details in a bid to curb import of counterfeit cosmetics
In an effort to curb the import of counterfeit cosmetic products, India’s Central Cosmetics Regulator, Drugs Controller General of India, has directed importers of cosmetics who import cosmetics already registered by authorized importers, to furnish annual sales details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details.
Source: bit.ly/42T2IMR

Central Government has to fix ceiling prices of medical treatment within 2 months: Supreme Court
The Supreme Court has directed the Central Government publish ceiling prices for medical treatments offered by Hospitals all over the country within 2 months. If the Central Government fails to do so, the Supreme Court has said that it will direct Central Government to fix medical treatment costs stipulated under Central Government Health Scheme as ceiling price of medical treatment offered by Hospitals for the whole country.
Source: bit.ly/3wsyHHs

India Seeks to delay implementation of EU Carbon Emissions Limits
India is set to conduct negotiation with the European Union regarding the implementation of the Carbon Control Regime, seeking a complete elimination of the Carbon Border Adjustment Mechanism, failing which India will seek an extension of timelines for reduction of emissions. It is expected that in order to comply with requirements under EU Carbon Control Regime, Indian exporters will have to make significant capital investment will increase cost of production.
Source: bit.ly/42S7DxH

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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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4