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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.

1. An interministerial committee constituted by the Department of Pharmaceuticals has proposed that health-supplements and nutraceuticals should be regulated as “Drugs” to ensure better quality control and to streamline insurance regulation as well.
Source: bit.ly/40QCmfk

2. In its recent meeting, the Ayurveda Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) has proposed to amend the Drugs Rules and regulate the retail sale of AYUSH medicine, which would empower drug inspectors to inspect these premises and collect and examine samples.
Source: bit.ly/3Cve0xR

3. The CDSCO is set to hold a round-table meeting for all Cosmetics industry stakeholders, including manufacturers and marketers to discuss issues including expansion of permission for cosmetics manufacturers to manufacture topical products.
Source: bit.ly/4ey6nDX

4. The Supreme Court dismissed a Special Leave Petition filed in response to the decision of the Delhi High Court seeking Order to mandate Doctors to explain side-effects to patients, holding that since there is no obvious issue highlighted with the side-effect information legally required to be presented by manufacturers, it is not necessary to require Doctors to do the same.
Source: bit.ly/48WLP70
Source: bit.ly/3UV5MoM

5. In a recent decision, the Supreme Court held that when examining petitions concerning procedural irregularities under the Arbitration and Conciliation Act, 1996, Courts should limit their examination to merely determining whether a valid arbitration agreement is existing and whether there is a preliminary dispute regarding appointment of Arbitrators.
Source: bit.ly/4ezdTP6

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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.

1. The Madras High Court has refused to impose a ban on advertisements by doctors and hospitals in the media, stating that it cannot expect media outlets to verify every advertisement on fake drugs, hospitals and treatments. The court acknowledged concerns about misleading advertisements and stated that doctors and hospitals should have self-regularisation and in case of violation the Medical Commission should take action.
Source: bit.ly/3CzfDu4
2. The Supreme Court of India raised serious concerns about live surgery broadcasts, citing risks to patient safety and informed consent. The court noted the absence of officials from the National Medical Commission and the Central Government during a hearing, emphasizing the need for guidelines to regulate such practices effectively.
Source: bit.ly/4fyc8CM3.

3. The Union Minister for Chemicals and Fertilizers, Jagat Prakash Nadda, has launched a new initiative called the “Scheme for Strengthening the Medical Device Industry,” to enhance manufacturing, skill development, clinical studies, and infrastructure in the medical device sector. It includes five sub-schemes designed to reduce import dependence and promote domestic production, ultimately supporting India’s goal of self-reliance in healthcare.
Source: bit.ly/4fjICRq

4. The Supreme Court of India has ordered the government to enforce mandatory accessibility rules under the Rights of Persons with Disabilities (RPWD) Act, 2016 emphasizing the need for compliance to ensure public spaces are accessible for disabled individuals. The court has given the government three months to establish clear guidelines and penalties for non-compliance.
Source: bit.ly/3UNULWl

5. Reportedly, government entities in India are exempt from the Digital Personal Data Protection (DPDP) Act, 2023, which permits them to process personal data under specific circumstances without following the Act’s normal provisions. Hospitals, however, are not granted this exemption and must therefore abide with data privacy regulations.
Source: bit.ly/3CkdRwZ

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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.

1. India’s Supreme Court has ruled that a medical practitioner can only be held accountable for medical negligence if he lacks the necessary training or expertise or if he fails to use his reasonable skill in providing treatment, not because his treatment was unsuccessful.
Source: bit.ly/4e2eEzN

2. The Food and Drug Administration (FDA), Pune division has seized stock worth ₹1 crore due to misleading claims in two separate incidents. This includes ₹78 lakh worth of toothpaste with anti-inflammatory claims and ₹22 lakh worth of cosmetics with suspicious labels. In both cases, the FDA has alleged a violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the samples have been sent for laboratory analysis.
Source: bit.ly/40hcyJa

3. India’s central drug regulator (CDSCO) has identified a list of 18 drugs declared as Not of Standard Quality (NSQ). The action has come after several states and union territories failed to report NSQ data, prompting the CDSCO to emphasize the need for timely submissions to enhance drug safety oversight.
Source: bit.ly/48njBSE

4. India’s central drug regulator (CDSCO) has identified four drug samples as spurious after drug inspectors in several states inspected them in September. Since the seized batch was not manufactured by the relevant pharmaceutical businesses, the manufacturer reported it as counterfeit. Drug samples are collected from sales and distribution locations as part of ongoing regulatory monitoring, and examined, and a list of spurious drugs is posted on the CDSCO portal once a month.
Source: bit.ly/3YqYqdE

5. To enhance guidelines and standards for the use of disinfectants and antiseptics in healthcare settings, the Indian Pharmacopoeia Commission (IPC) has released a draft of the new general chapter on disinfectants and antiseptics (Version 3.0) for public comments. The last date to submit comments is 8th December 2024.
Source: bit.ly/3YmXtmL

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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.

1. The Supreme Court, while hearing the Patanjali case on misleading advertisements, has asked the Union of India to respond to a question about whether the clinical trial rules for AYUSH drugs have been diluted, particularly in the context of new indications. The amicus for the Court while presenting the matter proposed strict measures for regulating misleading advertisements, such as the effective use of existing penalty mechanisms, prior approval of ads before issuance of licenses, effective inter-state cooperation, and a tie-up between the GoI and ASCI to address complaints.
Source: bit.ly/4d21OSv

2. The Supreme Court while hearing a petition filed by the Indian Medical Association (IMA) challenging Patanjali Ayurved’s misleading advertisements has directed the Ministry of Ayush to create a centralised dashboard where citizens across the country can access information about the action taken in response to their complaints.
Source: bit.ly/4d35inT

3. 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 August 31st, 2024. The prior date for filing the self-declaration was July 31st, 2024.
Source: bit.ly/3LLmm5R

4. The Consumer Product Safety Commission (CPSC) in the United States has reportedly placed responsibility on large e-commerce companies for the sale of dangerous third-party products on its platforms, issuing a directive covering more than 400,000 products that violated flammability standards.
Source: bit.ly/3YtFwom

5. The US Food and Drug Administration (USFDA) warned several giant online retailers about selling unapproved chemical peel skin products and asked them to immediately stop marketing them as they could potentially harm customers. The USFDA issued the directive after determining that the items in question included chemicals in high amounts that necessitated medical care.
Source: bit.ly/4caYQJY

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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.
Source: bit.ly/3zN4yV9

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.
Source: bit.ly/3WphadL

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.
Source: bit.ly/3xQ9EPX

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.
Source: bit.ly/3y3roHw

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Central Government is mulling including non-prescription Neutraceuticals currently regulated by the Central government food regulator the Food Safety Standards Authority of India, under the price control regime similar to Drug price regulation under the Drugs (Prices control) Order, 2013.
Source: bit.ly/4cRZVb7

2. The Supreme Court in continuation of prior orders issued acknowledging the concerns raised in a petition seeking to address the shortage of life saving Antiretroviral Drugs in the country, has granted the request of the petitioner to discuss the access of quality Antiretroviral Drugs to persons dealing with HIV.
Source: bit.ly/4cAATg9

3. The Central Government has issued a Draft Notification proposing amendment to the Drugs Rules, 1945, mainly intending to introduce restriction on advertising Drugs listed in Schedule G of the Rules.
Source: bit.ly/3Whm0Ke
Source: bit.ly/3VZZ0Or

4. Then United States Federal Trade Commission is set to take action against Drug supply middlemen and major pharmacy chains for use of anticompetitive tactics in negotiating Drug prices.
Source: bit.ly/3WgtAom

5. The World Health Organization has issued a new and updated list of pathogens, to reorient the prioritization in combating Antimicrobial Resistance.
Source: bit.ly/4czZdiw

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Supreme Court has reportedly asked the Ministry of Information and Broadcasting to appropriately modify the self-declaration requirement imposed by the Supreme Court on all advertisements, such that the consumers remain protected against misleading advertisement, but the industry is not overly inconvenienced in the process of complying with the self-declaration requirement.
Source: bit.ly/3xYqk7C

2. The Supreme Court has ruled that not disclosing critical or material information about safety at the time of promotion of the product amounts to unfair trade practices.
Source: bit.ly/460Duxr

3. Central Drugs Standard Control Organization (CDSCO), India’s drug regulatory authority, is reportedly planning to take action against pharmaceutical companies that fail to implement barcodes or QR codes on the top 300 medicine brands identified by the National Pharmaceutical Pricing Authority (NPPA).
Source: bit.ly/3zJllrU

4. MeDevIS (Medical Devices Information System) online portal, the first worldwide open access clearing house for information on medical devices, was launched by the World Health Organization (WHO). It is intended to assist governments, regulators, and users in making decisions about the selection, procurement, and use of medical devices for diagnosing, testing, and treating diseases and health conditions. MeDevIS refers to two international naming systems for medical devices: the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN), which attempt to maintain data uniformity across borders.
Source: bit.ly/3zJQIm9

5. The U.S. Federal Trade Commission recently stated that a pharmacy benefit managers (PBM), who operate as middlemen between pharmaceutical firms and customers, have an excessive amount of influence over prescription drug costs due to the years-long dealmaking which has ultimately resulted in the consolidation of pharmacies and health insurance companies.
Source: bit.ly/3W0Mhee

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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

 

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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 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

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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.

Star-rating for energy efficiency on white goods to be under stricter government regulation

Indian Government may reportedly introduce rules for non-branded products to validate star rating for energy efficiency on white goods. White goods refer to household appliances of daily use such as air conditioners, refrigerators, television sets, etc. The National Test House (NTH), along with Bureau of Energy Efficiency (BEE), will conduct testing to help improve the quality of products and put a check on substandard products with a view to save energy.
Source: bit.ly/3TAWopa  

US FDA to train Indian drug regulators on cGMP inspection

The US FDA has invited drug regulators of the State of Gujarat, Telangana, Goa, and Karnataka to act as observers during checks and inspections of drug facilities in India, so that they develop a greater understanding of the US FDA inspection protocol.
Source: bit.ly/43FfvD9

GST officials should refrain from doing fishing inquiries: Government

The Directorate General of GST Intelligence (DGGI) has reportedly issued a new guideline for GST officials stating that they should refrain from “fishing inquiries” to check evasion of goods and service tax (GST). The Guidelines state that tax officers should clearly state the nature of the investigation in formal letters to designated company officials and avoid using ambiguous language in letters and summons. Terms like “GST enquiry,” “evasion of GST,” or “GST evasion,” among others, should not be used in a letter sent to an ordinary taxpayer.
Source: bit.ly/3IZO9Og  

Indian Courts will be slow to intervene in enforcement of foreign arbitral awards on grounds of bias: Supreme Court 

India’s Supreme Court has held that intervention in enforcement of a foreign arbitral award on the grounds of bias should be discouraged. Indian courts will be permitted to entertain a claim for arbitral bias in an enforcement proceeding only after the ground has been raised before the arbitral tribunal. In order to assess arbitral bias, the Courts will have to prioritize international standards above domestic ones, even while it permits the execution of a foreign arbitral award. 
Source: bit.ly/3J48bqR  

Chemicals used to decaffeinate coffee beans may be banned in US 

Consumer Health Groups have petitioned US Food and Drug Administration to ban methylene chloride, a chemical which is used as additive to decaffeinate coffee beans, because it has been proven to cause cancer in rodents.
Source: bit.ly/3vx2n6a