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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 introduce Digital Competition Bill before the Parliament in November 2024
In an effort to curb anticompetitive conduct in the digital marketplace, the Indian government may introduce a draft Digital Competition Bill in the Parliament in November 2024. Laws regarding predatory pricing, exclusive tie-ups that restrict market access for users of digital platforms from accessing third-party applications are all intended to be covered by the bill.
Source: bit.ly/3W5ADk1

Supreme Courts rejects apology of a major Ayurvedic medicine manufacturer in an ongoing contempt case
In an ongoing proceeding against a major Ayurvedic medicine manufacturer for publication of misleading advertisements and the ongoing contempt case, the Supreme Court rejected manufacturer’s apology to the Court and gave it a week’s time to issue a public statement apologising for misleading advertisements and making comments against allopathic medicines.
Source: bit.ly/49HMFTV

Specific law to apply over general law only if the offense perfectly covers all elements of the offence under general law: Bombay High Court
The Bombay High Court has held that the Information Technology Act, 2000 will supersede the Indian Penal Code if an offence is covered under both the legislations. The Court reasoned the ruling by stating that where an offence matches the definition in both general and specific laws, but specific law encompasses all elements of the general law’s definition, the specific law will take precedence over a general law. However, if the special law provision does not exhaustively deal with all the ingredients of the offence, the general law will take precedence.
Source: bit.ly/3Qc2CuK

India’s food regulator may investigate presence of sugar infant food products
India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), is reportedly investigating the presence of sugar in infant products of a major food company, in light of news reports that the company did not sell infant food products with sugar in developed countries.
Source: bit.ly/3Q8Lx4Q

Colorado introduces first law to protect consumer’s brainwaves
The state of Colorado has introduced a first of a kind law in the United States that aims to protect the data found in a person’s brainwaves. The legislation is seen to be a measure to protect consumers’ personal data in the light of rapid advancements in neurotechnology making scanning, analysing and selling mental data increasingly accessible.
Source: bit.ly/3xKHipO

 

Posted on

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 intends to create a new AI law to protect news publishers’ rights
The Indian government plans to introduce a new artificial intelligence (AI) law that will safeguard the rights of news publishers and content creators while also minimizing harm to users. The new law will reportedly also have provisions for sharing the ‘proceeds’ among news publishers, content creators and AI-enabled technologies.
Source: bit.ly/4aF3DmM

Decrees from civil courts may be legally binding on criminal court in the matter of sentences and damages
The Supreme Court of India has held that while the outcome of civil law proceedings would not command the results of criminal law proceedings, they would have a significant influence on the latter while considering sentences or damages in such proceedings. However, such influence will operate only to the extent of holding the sentences or damages arising out of criminal proceedings as unsustainable in law.
Source: bit.ly/4aHiUmX

FDI inflow in pharma sector declines for FY 2023-24
The Foreign Direct Investment (FDI) equity inflow into the pharmaceutical sector has reportedly seen a decline of fifty percent (50%) in the first nine months of the Fiscal Year 2023-24 as compared to Fiscal Years 2022-23. The decline in FDI inflow during the FY 2023-24 comes after a significant growth of 45% reported for the 12 months ending in March, 2023.
Source: bit.ly/4aFlQ3F

DTAB plans to mandate free medicine from pharma companies as part of CSR
The Drugs Technical Advisory Board (DTAB) plans to amend the Drugs Rules, 1945 to include a requirement for pharmaceutical companies to donate at least one percent (1%) of their net profits to the distribution of free medications in medicine banks which will then be used by the Central and State governments at times of illness, calamity, or any other situation, as per necessity. A comparable amendment was proposed by DTAB in 2018 as well, however, it was only voluntarily implemented during that year. DTAB is a committee constituted by the Central Drugs Standard Control Organisation (CDSCO) entrusted to make policy decisions and send recommendations to the government of India in relation to technical aspects of the Drugs and Cosmetics Act and Rules. 
Source: bit.ly/3J4K8sb

Government introduces Ayushman Bharat Health Accounts to digitize health records
The Indian Government has introduced the Ayushman Bharat Health Account (ABHA) as part of its national healthcare scheme, aiming to digitize health records with unique account numbers and to enhance fund accessibility, medical transparency and easy upkeep of medical records. ABHA will be used by government hospitals, however, private hospitals will have the option to use ABHA for the creation and linking of health records making it non-binding at present.
Source: bit.ly/49nSHsM

Posted on

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.

Hospitals and pharma companies in India bought electoral bonds worth 9 billion Rupees
Indian hospitals and pharma companies have reportedly bought electoral bonds for approximately Rs. 900 crore. Electoral bonds bought by businesses are later encashed by political parties, and until recently, the identity of businesses that bought electoral bonds was kept confidential.
Source: bit.ly/43qtXyz

New portal for filing consumer complaints to be introduced
India’s Central Consumer Protection Authority (CCPA) will reportedly launch a dedicated online complaint portal for consumers to file complaints against misleading advertisements and unfair trade practices. The timing of the launch of the portal is intended to coincide with World Consumer Rights Day (March 15).
Source: bit.ly/3ViSKCP

New guidelines that will differentiate brand extension and surrogate advertisements to be notified soon
India’s Central Consumer Protection Authority (CCPA) has reportedly formed a committee to deal with the issue of differentiation of genuine brand extensions from surrogate advertisements. Brand extensions are advertisements by companies that extend existing brands into new product categories. For example, advertisements by alcohol companies to sell music CDs, glasses, soda, etc. under the same brand name. However, if the products covered brand extensions are not available for sale in the open market, then such advertisements become surrogate advertisements.
Source: bit.ly/3Tll3hn

EU may soon adopt a single compulsory license regime for medicines in crisis situations
The European Union Parliament is reportedly going to consider a proposal to allow manufacturers of critical medicines to manufacture them for all member states without the consent of the patent holder in crisis situations. Under the current law, even if one State of the EU grants a compulsory license to a manufacturer to manufacture a critical medicine in a crisis situation, the medicine cannot be exported or sold in other EU states unless the concerned State also grants some kind of immunity against the import of such medicine into that State.
Source: bit.ly/3Vp0Iud

Brand owners now responsible for collection of any plastic packaging waste
The Ministry of Environment has amended the Plastic Waste Management (Amendment) Rules, 2024. All brand owners who use plastic packaging on the product package are obligated to collect plastic packaging waste. However, if the brand owners have met the Extended Producer Responsibility targets by contracting with a registered recycler, then physical collection of plastic packaging waste may not be required.
Source: bit.ly/3PrvG0L

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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

Posted on

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

Posted on

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’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