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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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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.

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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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.

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

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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

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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’s new criminal law regime to take effect from July 1, 2024
The three criminal laws, namely, Bhartiya Nyaya Sanhita, Bhartiya Nagrik Suraksha Sanhita, Bharatiya Sakshya Adhiniyam that will replace the erstwhile the Indian Penal Code, 1860; Code of Criminal Procedure, 1898; and the Indian Evidence Act, 1872, respectively, will take effect from July 1, 2024. However, Section 106 (2) of the Bharatiya Nyaya Sanhita, 2023 which provides for punishment of “0-10 years” in “hit and run” cases, has been put on hold.
Source: bit.ly/3P13RMz
Source: bit.ly/3TbqvUU
Source: bit.ly/3wxhexO

Cosmetic Importers in India who are not directly authorized by foreign manufacturer must submit annual statement of import to Cosmetics Regulator
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular reminding cosmetics importers who have obtained Import Registration Number (IRN) in Form Cos-4A, that is on the strength of prior import registration issued to an importer authorized by the foreign manufacturer, to provide annual statement of cosmetics imported in India from date of grant of IRN. The importers have also been advised to furnish details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details.
Source: bit.ly/49L6bzl

Timeline for obtaining Standard Mark for sanitary napkins, baby diapers and reusable sanitary pad/napkins extended to 1st October.
India’s Ministry of Textiles has extended the date of enforcement of Medical Textiles (Quality Control) Order, 2023 from 1st April to 1st October 2024. The said order requires that Foreign as well as Indian manufacturers of sanitary napkins, baby diapers and reusable sanitary pad/napkins to obtain a standard mark and label the products with a standard mark before the products are sold in India.
Source: bit.ly/3IjAWiV

Inspection of food manufacturers/processors in non-mandatory classes should be completed within 15 days: India’s food regulator
The Food Safety and Standards Authority of India (FSSAI) has issued an advisory to State Food Licensing Authorities for processing licensing applications of manufacturers of food categories which do not warrant mandatory inspection such as prepared foods, Indian sweets, egg and egg products, foodstuff intended for nutritional supplements. The FSSAI has advised that such applications should ideally be cleared without inspection, but if for some reason an inspection is deemed to be warranted, then such inspection should be concluded within 15 days from date when the application is marked for inspection.
Source: bit.ly/3wwHNTN

Germany legalises private cultivation and recreational use of cannabis
Germany has passed a law legalizing cultivation of up to three cannabis plants and for owning 25 grams of cannabis for private consumption. The law also permits establishment of cannabis clubs to facilitate consumption with a cap of 500 members. Germany has become ninth country to legalise private recreational use of cannabis.
Source: bit.ly/3OSK6a3

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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.

Guidelines to differentiate brand extension from surrogate advertising issued
In a meeting with stakeholders, the Department of Consumer Affairs (DoCA) has clarified the difference between brand extension advertisements which are permitted, and surrogate advertisements which are not permitted. A brand extension advertisement should not contain direct or indirect references to prohibited products. It should also not use colour, layout, or presentations associated with the prohibited products.
Source: bit.ly/42PKVGk

Draft Pharmacovigilance Guidance Document published for comments
A draft of the revised Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products has been published for comments. The last date for providing comments is March 23, 2024. This guidance document facilitates MAHs to setup & implementation of uniform Pharmacovigilance System for pharmaceutical products in the Indian market in the post-licensure period.
Source: bit.ly/3SSrfgw

Many small and medium pharmaceutical manufacturing units have been ordered shut down after increased surveillance
India’s central drug regulator, Central Drugs and Standards Control Organization (CDSCO), and state-level drug licensing authorities have reportedly issued show-cause notices to several drug small and medium manufacturers in the State of Punjab and Himachal Pradesh on grounds of poor quality control, and have also directed some of them to stop manufacturing.
Source: bit.ly/3I88UqP

Pharma MNCs exit domestic market due to regulatory headwinds
Many multinational pharmaceutical companies are reportedly cutting back on operations and manufacturing in India as part of a global strategic review due to regulatory headwinds on account of price control, rising costs, competition, and unfavourable intellectual property climate.
Source: bit.ly/42PaWW9

Frozen embryos should be treated as children: US Court
The Alabama State Supreme Court has ruled that frozen embryos in test tubes should be treated as ‘children’. This ruling has forced in vitro fertilization (IVF) providers in Alabama to stop treating patients, raising questions about the procedure’s continued availability in the state.
Source: bit.ly/3I8T4vR

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Couples seeking surrogacy will be allowed to use donor gametes only if either partner suffers from a disabling medical condition
India’s Ministry of Health and Family Welfare has notified the Surrogacy (Regulation) Amendment Rules, 2024, which removes the earlier requirement that barred the use of donor gametes for surrogacy. Now, couples intending to opt for surrogacy, can use donor gametes if either spouse is certified by the District Medical Board as having a medical condition which prevents the spouse form contributing the gamete.
Source: bit.ly/3T4Ortd

Antibiotics to be sold in blue cover by medical stores and hospital pharmacies in Kerala
In a first of its kind development, the Health Department of the Government of Kerala has instructed all the hospital pharmacies and medical stores in Ernakulum to sell antibiotics in a blue cover effective immediately. All medical stores have also been directed to display a poster stating that antibiotics will not be given without a doctor’s prescription. This initiative has reportedly been taken to control the use of antibiotics.
Source: bit.ly/3T4OiGb

Insurance companies should cover costs of medical equipment if it forms an integral part of the medical treatment: Consumer Court
India’s Vadodara District Consumer Disputes Redressal Commission has upheld the complaint of a person who was denied insurance coverage for cost of BPAP device for Sleep Apnea treatment post discharge from hospital. As per the consumer court, medical insurance should cover the cost of equipment required for treatment after discharge from the hospital, because it forms integral part of the medical treatment.
Source: bit.ly/3SLOjgJ

Smartwatches and rings should not be used for measuring blood sugar levels for diabetes management: USFDA
The US Food and Drug Administration (USFDA) has warned users that it has not approved any non-invasive smartwatches or rings that use sensors to measure blood sugar levels for diabetes management, and relying on them for blood sugar measurements could have serious implications.
Source: bit.ly/3wt4B6P

New Medical Device Quality Management System Rules published by USFDA
The US Food and Drug Administration (USFDA) has issued a final rule on Quality Management System Regulation (QSMR) for medical devices. The rule intends to reduce regulatory burden on the manufacturers and importers of medical device by enhancing global harmonization in device regulation for Quality Management Systems.
Source: bit.ly/48pxmyy