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.
1. A recent Right to Information filing before the Ministry of Health and Family welfare has brought to  attention that the Central government has not notified or published procedure in light of the  proposed 2022 Amendment to the National Medical Commission Act, 2019 which aimed to allow appeal against decisions of the State and National Medical Commission before the autonomous Ethics and Medical Review Board.
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2. The Jammu and Kashmir High Court held in a recent decision that the insurance company does not have the discretion to reduce the eligible claim amount solely on the basis that compensation has already been given to the claimant from the government.
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3. The Department of Consumer Affairs has issued the Guidelines for Prevention and Regulation of Greenwashing and Misleading Environmental Claims, 2024. These guidelines regulates the nature of technical terms that can be used in these claims, and prescribes requirements for substantiation of the claims.
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4. The National Accreditation Board for Testing and Calibration Laboratories, has proposed to initiate a program for accreditation of bio-banking facilities modelled after the international standards as prescribed under ISO 20367:2019.
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5. The United States Drug Administrative Science Board has recommended that the United States Food and Drug Administration (USFDA) set up an office to monitor alternatives to animal testing methods, and bring them within the quality control regime of the USFDA.
Source: bit.ly/3U7gW9N

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.

1. India’s Health Minister has reportedly confirmed that Central Drugs Standard Control Organization (CDSCO) will be the sole regulator of veterinary medicines in India and there is no proposals to establish a separate regulatory body for veterinary medicines in India.
Source: bit.ly/4cbgTQe

2. India’s Food regulator (FSSAI) has warned against use of unapproved non-specified ingredients, such as “Deionized apple juice concentrate,” in fruit juices.
Source: bit.ly/46swOZq

3. The State Drug Regulator (FDA) of Maharashtra is reportedly going to start an inspection drive to identify doctors and hospitals which are running an open shop for medicines without holding a valid pharmacy license.
Source: bit.ly/46rtHAZ

4. The Principal Bench and State Benches of Goods and Services Tax Appellate Tribunal (GSAT) have been established with effect from 1st September 2023.
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5. The US Food & Drugs Administration (FDA) has warned a pharmaceutical company for sponsoring a celebrity paid promotion campaign on social media, in which the influencer promoted a drug but did not disclose essential risk information. The FDA found the post to be misleading.
Source: bit.ly/46rtI81

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.

1. Mere title of a person within an organization such as Managing Director/ CEO does not automatically make the person criminally liable for offence committed by Company under Drug Laws. In order to make a person holding a managerial position in the company criminally liable, the complaint should have specific averments against such person which indicates that the person was in charge of and responsible for the conduct of the business of the company so far as it relates to the manufacture of the drug: High Court of Jammu and Kashmir
Source: bit.ly/4cYU4Rl

2. The Government of India is reportedly considering whether to stop marketing of look-alike and sound-alike drug brands in public interest. Under the current proposal, the brand names which were approved first by the drug regulator will be permitted to be marketed, and look-alike or sound-alike drug brands will be prohibited from being marketed.
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3. The Indian Government is reportedly considering whether to exempt Medical Devices which have been approved and sold in the European Union for two years from requirement of conducting clinical investigation in India prior to marketing authorization.
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4. The Delhi High Court has ordered an Ayurvedic medicine manufacturer to delete from all websites on the internet and social-media platforms claims which were beyond the scope of license and implied that the medicine it marketed could treat COVID-19.
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5. A prominent US based health savings account administrator has reported that it has suffered a data breach which has led to the loss of sensitive employee and customer information.
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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. Multinational Pharmaceutical Companies in India have reportedly sought relaxation of mandatory 50% cut in price of essential medicines after expiry of patent on ground that it hinders innovation.

Source: bit.ly/4bWhHIN

2. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued directions to the effect that if any food sample is found to be unsafe in the primary lab report, it would result in an order prohibiting further distribution of such food. If the food sample is confirmed to be unsafe by a referral food lab, then the food will have to be recalled.

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3. A nutritional supplement firm was fined by District Consumer Commission for making misleading claims on the label of its protein supplement regarding the nature of protein content. According to the commission, making misleading claims on label amounts to deficiency of services.

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4. India’s Jammu and Kashmir High Court has dismissed a criminal complaint instituted against a retailer of medicines for failing to reveal details of manufacturer of a spurious drug. The High Court held that since the Drug Inspector already had the details, the non-provision of requested information did not constitute an offence under The Drugs and Cosmetics Act, 1940.

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5. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has introduced a new license category for registration of direct sellers. Direct sellers are not permitted to sell infant milk and infant milk substitutes.

Source: bit.ly/4fdxhlZ

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Supreme Court ruled that mixing samples collected from contraband contained in various packages after a seizure violates the terms of the Narcotic Substances and Psychotropic Substances Act and the rules enacted under it. The court noted that the statutory rules require a specific procedure to be followed, and the Detecting Officer is obligated to follow the authorized procedure. No one can presume the nature of the substance based on speculations and conjectures.
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2. The Central Consumer Protection Authority fined a firm selling ayurvedic oil ₹ 10 lakh for violating consumer protection laws on misleading advertisements which claimed relief from joint pain without surgery or physiotherapy while promoting their joint-pain-relieving product.
Source: bit.ly/3W1YJum

3. Following the Central Government’s decision to replace British-era criminal procedure codes with Bharatiya Sanhitas, the Government of India held a meeting with the Drugs Control Officers (India) Welfare Association (DCO India) to change the name of the Drugs and Cosmetics Act, 1940, passed by the British Rulers to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’. The national conference of Indian drug regulators will hold in-depth discussions on the subject.
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4. The National Health Authority (NHA) and the Insurance Regulatory and Development Authority of India (IRDAI) collaborated to launch the National Health Claim Exchange (NHCX), a digital platform for exchanging insurance claims-related information among healthcare and insurance stakeholders. The NHCX will enable seamless interoperability of health claims processing, allowing citizens to track their insurance claim progress via mobile devices.
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5. The US Food and Drug Administration (FDA) issued final question-and-answer guidance outlining how it assesses user fees for combination products, as well as the various programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Amendments (MDUFA). The guideline offers background information on combination goods, how the agency calculates user fees for single and multiple applications, and how to request waivers or reductions in user costs.
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TOP 5 HEALTH LAWS AND POLICY UPDATES

The Department of Pharmaceuticals (DoP) has extended the deadline for filing a self-declaration under the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) to July 31st, 2024. The prior date for filing the self-declaration was June 30th, 2024.
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The Central Drugs Standard Control Organization (CDSCO is considering making the international nomenclature of cosmetic ingredients (INCI) mandatory on all cosmetic product labels to improve transparency and identification. The unified INCI method will help customers understand product compositions while assisting dermatologists and regulators in monitoring component safety. The move is intended to avoid confusion, improve compliance, and increase the marketability of safe products.
Source: bit.ly/3L6jz6J

A Super Speciality Hospital and one of its doctors were ordered by the State Consumer Disputes Redressal Commission (SCDRC) to compensate its patients for medical negligence. The reason for the directive was that the specialist doctor had given his responsibility to a junior and neglected to attend to the patient, which led to an incorrect diagnosis and treatment, which constituted medical misconduct.
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The Central Drugs Standard Control Organization has ordered the closure of more than 36% of the 400 drug manufacturing facilities located throughout India after an increase in inspection following deaths associated with substandard cough syrups.
Source: bit.ly/4eKMs5Y

In an effort to regulate false and misleading nutritional claims and health claims made by e-commerce platforms, the Food Safety and Standards Authority of India (FSSAI) is planning to impose stricter controls on advertisement and sale of protein supplements and shakes in India.
Source: bit.ly/45KzjpF

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.
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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

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.
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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.
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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.
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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

 

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.
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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

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