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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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 Supreme Court extends scope of misleading advertisement review to multinational and domestic FMCG manufacturers, doctors
In a proceeding against a major Ayurvedic products manufacturer for publication of misleading advertisements, India’s Supreme Court has clarified that the decisions and orders made in the ongoing case is not limited to the a particular manufacturer, rather is directed to all FMCG companies who are publishing misleading advertisements and doctors who are endorsing medicines to public after accepting consideration from pharmaceutical companies.
Source: bit.ly/44b832P

Indian Government to scrutinize organ transplants closely after receiving reports of foreign nationals involvement in organ donation
India’s Union Health Ministry, through the office of Director General of Health Services (DGHS), has ordered state authorities to compulsorily create a NOTTO (National Organ and Tissue Transplantation Organization) ID maximum within 2 days for the donor and recipient for both living-donor and deceased-donor transplants, citing reports of purported commercial dealings in organ transplants involving foreign nationals.
Source: bit.ly/3WcUKgk

New Telehealth Accreditation Program introduced in US
It has been reported that leading not-for-profit agencies in the US such as Joint Commission and National Committee for Quality Assurance (NCQA) will begin offering accreditation for telehealth services to qualified hospitals, ambulatory care centres, and behavioural health organizations in 2024. The accreditation is aimed at filling the gap of legally enforceable telehealth standards in the US.
Source: bit.ly/3W8MKgg

Employee non-compete clauses may soon be illegal in the US
The US Federal Trade Commission (FTC) has issued a final rule to promote competition by banning non-compete clauses in employee contracts nationwide. As per FTC, non-compete covenants in contracts prevent workers from taking a new job or starting a new business, which in turn harms competition.
Source: bit.ly/3UtDRg2

French Government to turn down bid from foreign pharmaceutical companies to buy domestic generic company
The Government of France is reportedly going to block foreign bidders including two Indian pharmaceutical companies from attempting to purchase a domestic generic pharmaceutical manufacturer. As per the French government, this decision has been taken in the national interest to safeguard the supply chain of medicines.
Source: bit.ly/3W8MIFa

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 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.

Manufacturers of tobacco products required to register their packing machine(s) with tax authorities
India’s Central Board of Indirect Taxes and Customs (CBIC) has postponed the timeline for manufacturers of tobacco products such as pan-masala, chewing tobacco, smoking mixtures, etc. to report their production capacity. CBIC had in January this year announced that producers must register their filling and packing machines and report these details. The measure was set to be implemented from 1st April 2024. However, the new effective date for implementation of the timeline is now 15th May 2024.
Source: bit.ly/3xz7400

NPPA releases draft ceiling price calculation sheets of seven scheduled formulations
The National Pharmaceutical Pricing Authority (NPPA) has published a preliminary calculation of ceiling prices for seven drug and vaccine formulations, inviting feedback from stakeholders within a ten-day period. These ceiling prices have been adjusted to reflect the minimum and maximum market prices of the products, in accordance with the updated Schedule I of the Drugs (Prices Control) Order, 2013, aligning with the National List of Essential Medicines (NLEM), 2022. The move shall be affecting major pharmaceutical giants in the business of ORS, vaccines and more.
Source: bit.ly/3UhjK4J

High Courts should interfere only when the case in lower court was decided by fraud or collusion: Supreme Court of India
While deciding an appeal against the order of the High Court, the Supreme Court of India observed that the High Court should apply care and caution while entertaining the petitions under Article 226 of the Constitution. The Court further explained that, in case of an already available alternative statutory remedy, the High Court should interfere in the matter only when the case is decided by fraud or collusion, otherwise an order in the same matter by the High Court will mean reopening the issues that have achieved finality.
Source: bit.ly/4cNGwIJ

Goa FDA to get the status of “US FDA observer” amid surge in increase in retail and wholesale licenses
The Goa Food and Drug Administration (FDA) has been extended the invitation to participate as “FDA observer” for inspections conducted by the USFDA India Office. This development came as a result of increase in retail and wholesale licenses issued by Goa FDA and their familiarity with the US FDA’s inspection process.
Source: bit.ly/3UfqIHq

Rejecting apology of the Directors of a Company for misleading advertisements, the Supreme Court sets caution for FMCG companies
Observing caution for fast-moving consumer good (FMCG) companies, the Supreme Court of India has refused to accept an apology from a major Indian Ayurvedic medicine manufacturer for misleading advertisements regarding its products in contravention of an undertaking provided to the Court. The Supreme Court stated that misleading advertisements by FMCG companies result in deceiving innocent consumers and play with public health.
Source: bit.ly/3PYqoKq

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.

E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD

Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg

Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw

Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5

Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo

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.

All manufacturers, importers and brand owners of products using plastic packaging must register by 31st March 2024 with Pollution Control Board

India’s Pollution Control Board has given a final opportunity to manufacturers, importers and brand owners of products which use plastic packaging, to register with appropriate Pollution Control Board under provisions of Plastic Waste Management Rules, 2016. Such entities are required to register and discharge Extended Producer Responsibility (EPR) by buying EPR Credits from registered recyclers of plastic packaging waste.

Source: bit.ly/3PGd79b

 Central Consumer watchdog and Industry Regulators of Advertisements enter into collaboration to curb misleading advertisements

India’s Central Consumer Protection Authority (CCPA) has announced a collaboration with the industry’s self-regulatory advertisement body called Advertisements Standards Council of India (ASCI). Under the collaboration, ASCI will forward details of advertisement found to be in breach of its own misleading advertisement guidelines to the CCPA since such advertisements may also be violative of the law on misleading advertisement in India.

Source: bit.ly/3Q1U3CL

Imported devices containing foreign embedded SIM for use in M2M communication have to mandatorily shift to services provided by Indian telecom providers within six months

India’s telecommunication regulator, Telecom Regulatory Authority of India (TRAI), has issued specifications and licensure requirements for the implementation of use of embedded Sim technology in Machine-to-Machine (M2M) communication, which is seeing more and more use for remote diagnosis and monitoring in healthcare sector, since launch of 5g sim technology in the country. All communication profiles on any M2M eSIM fitted in an imported device on international roaming in India should be mandatorily converted/reconfigured into communication profiles of Indian telecom service providers (TSPs) within a period of six months from the date of activation of international roaming on such M2M e-SIM or on change of ownership of the device, whichever is earlier.

Source: bit.ly/4cyHEPZ

US FDA’s scientific authority to regulate drugs under challenge

A suit before the United States Supreme Court is challenging the decision of the United States Food and Drug Administration (FDA) in 2016 to expand scope of prescription of Mifepristone 2000, a drug that is commonly used to carry out medicated abortion procedures, and permit its prescription via telemedicine. Ex-Commissioners of US FDA have expressed concern that a decision in favour of the petitioners may lead to an environment of uncertainty where any US FDA approval granted to a drug could be challenged in future on scientific grounds even if it was approved by the US FDA.

Source: bit.ly/49dk4p2 

New reserve sample retention quantity requirements for BA and BE studies in US

The United States Federal Food and Drug Administration (US FDA) has published the final version of a guidance document that prescribes new reserve sample retention requirements for Bioavailability (BA) and Bioequivalence (BE) Studies. In the Guidance Document, US FDA has prescribed retention of 30 Single Dose, and 3 Multi Dose samples (with at least 1 unit in original container) across all sites carrying out In-Vivo studies, and 30 Single Dose, and 3 Multi Dose samples in original container for In-Vitro studies.

Source: bit.ly/3xeLrC7  

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.

Body massagers cannot be ‘sex toys’ just because they can have alternative use: High Court

In a recent ruling, the Bombay High Court has held that body massagers cannot be treated as ‘sex toys’ merely because they can be used for alternative purposes. While coming to this conclusion, the Court observed that it would be incorrect to classify massagers
as items of objectionable description or as obscene figures in the absence of any substantial justification.

Source: bit.ly/3Vvxp9k

Homeopathy practitioners cannot present themselves as gynaecologist; amounts to medical negligence and deficiency in service: State Consumer Commission

The State Consumer Disputes Redressal Commission, Lucknow (SCDRC) has taken the view that cross-practicing of medicine by doctors trained in branches other than allopathy constitutes medical negligence and a deficiency in service. SCDRC imposed a compensation of Rs. 30 Lakhs on a city-based private nursing home and a homeopathy practitioner for medical negligence. The practitioner misrepresented herself as a gynaecologist, and prescribed allopathic medicines. The SCDRC held both the practitioner and the nursing home liable for their negligence and deficiency in service.

Source: bit.ly/3xavblG

A leading ayurvedic Indian FMCG company has tendered an unconditional apology for its misleading advertisement to Supreme Court

Following a contempt notice on misleading advertisements and the issue of summons, the co-founders of a major ayurvedic FMCG company have tendered an unconditional apology for the company’s misleading advertising practices. The Supreme Court had directed that the co-founders of the company appear personally before the Court on the date of the next hearing. 

Source: bit.ly/43vV5wj 

Government proposes ban on 23 dangerous dog breeds in India

The Indian Government proposed a ban on 23 dog breeds in the country that are deemed “dangerous for human life” in an effort to address the growing number of dog attack cases. Additionally, the government has urged state governments to desist from granting licenses or permits for the sale and breeding of these dog breeds. 

Source: bit.ly/43xEjgi 

Draft Resolution introduced by the UN General Assembly on Artificial Intelligence

The UN General Assembly adopted its first resolution on artificial intelligence (AI) to ensure the technology benefits all nations while respecting human rights and ensuring safety.
Co-sponsored by 123 states, the resolution was adopted by consensus without a vote. Recently, the European Parliament has also taken steps to adopt the Artificial Intelligence Act, considered the world’s first comprehensive legal framework for AI.

Source: bit.ly/490W88s

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