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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.

Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facility
The Indian government is reportedly reconsidering its decision to act against pharmaceutical companies who are manufacturing nutraceuticals, health supplements and drugs in the same facility, due to objections raised by small scale manufacturers. The previous Good Manufacturing Practices (Schedule M) for drugs gave some concession to manufacturers of drugs to manufacture nutraceuticals and health supplements in the same facility. However, no such concession exists under revised Good Manufacturing Practices (Schedule M) published in December 2023.
Source: bit.ly/3x59lQo

Exporters of Indian farm produce are facing phytosanitary challenges
Indian agricultural exports, including fruits and vegetables, are reportedly finding it difficult to enter regions like Europe, Australia, and the US due to tough phytosanitary requirements and thresholds such as high pesticide content. In response, India’s Commerce Ministry is reportedly creating a data set on export consignments of agricultural exports that were refused by European countries and other nations on grounds of phytosanitary non-compliances, resulting in significant trade hurdles regardless of duty relaxations. A phytosanitary certificate is required for the export of agricultural products to ensure that the produce is pest-free, disease-free, and meets other health requirements such as traceability at the farm level.
Source: bit.ly/4ctvxnB

Indian government has established Fact Check Units to check spread of fake news
The Indian Ministry of Electronics and Information Technology has appointed the Press Information Bureau of the Ministry of Information and Broadcasting as Fact Check Unit to address fake and misleading news against Central Government. The fact check unit of the central government is expected to vet all the online content related to the business of the central government. Any content identified as fake by the unit will be taken down from the internet.
Source: bit.ly/3Px3Yj8

The Centre gives more time to states to establish Allied Healthcare Councils
India’s Ministry of Health and Family Welfare has extended the timeline for states to establish state allied and healthcare councils by six months. State Governments have to setup State Councils for Allied Healthcare by November 2024. The National Commission for Allied and Healthcare Professions Act 2021, which regulates quality of allied and other healthcare professionals in India, will be operationalized once the State Councils have been established.
Sourve : bit.ly/3PxeZ4d

Integrated Veterinary Health Certificates (VHC) mandatory after 30th June,2024 for import of milk and milk products into India
The Food Safety and Standards Authority of India (FSSAI) has extended the deadline for implementing its decision to require imported food consignment of milk and milk products to be supported by an integrated veterinary health certificate. The requirement will take effect on July 1, 2024. From that date, only those milk and milk products that are supported by integrated veterinary health certificates will be allowed importation into India. The Integrated Veterinary Health Certificate must demonstrate that imported milk and milk products meet both the FSSAI’s food safety standards and the Department of Animal Husbandry and Dairying’s (DAHD) sanitary criteria.
Source: bit.ly/3TIh53F

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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.

Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B

Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ

Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ

Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu

EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK

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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.

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.

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.

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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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.

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

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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.

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