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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 Supreme Court of India has dismissed a review petition against its judgment from October 2023, which refused to recognize the right of same-sex couples to enter into marriages or have civil unions. The review petitions challenged the October ruling as being “manifestly unjust” and inconsistent with constitutional values.
Source: bit.ly/3Cg5BOK

2. India’s Parliamentary Committee, in its fifth report on the Department of Pharmaceuticals’ (DoP) 2024-2025 budget, expressed concern over the unavailability of essential medicines at Jan Aushadhi Kendras (JAKs) under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP). The report highlighted the absence of life-saving drugs such as Benzylpenicillin, Atropine, Streptomycin, and medicines for tuberculosis and mental illnesses. It recommended conducting feasibility studies to include these critical drugs in the PMBJP list.
Source: bit.ly/4gN2Tzf

3. The Karnataka State Dental Council (KSDC) has notified that engaging in facial aesthetic treatments and hair transplant procedures constitutes “unethical practice” for dentists. This could result in their disqualification from the dental register. This comes amidst an ongoing case in the Bombay High Court concerning the qualifications of dentists to perform aesthetic procedures.
Source: bit.ly/3Prz7UW

4. The Goa Human Rights Commission (GHRC) has recommended that the state government establish additional rehabilitation homes for mental health patients. The commission has also directed the government to expedite the establishment of such rehabilitation homes and to submit an action report within 90 days. The aim is to improve the care and reintegration of these patients into society.
Source: bit.ly/4jcCT2c

5. The Indian state of Odisha has launched the Odisha Pharmaceutical Development Cell (OPDC) to position itself as a global leader in the pharmaceutical industry. The initiative aims to attract international investments and foster innovation. According to reports, the Odisha Pharmaceutical Policy 2025 will provide investment incentives, R&D support, and skill development frameworks. The state targets investments worth ₹50,000 crores through these initiatives.
Source: bit.ly/3DQx22b

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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 Supreme Court of India has ruled that company directors and officials are not vicariously liable for corporate offences without specific statutory provisions and evidence of personal involvement. While companies may be held accountable for employee’s misconduct, directors’ liability requires proof of their direct actions. Mere association with the company is insufficient to attract a liability.
Source: bit.ly/3PvHNJK

2. The Supreme Court of India, while hearing a PIL against multinational pharmaceutical companies, raised ethical concerns over clinical trials in poorer countries. It highlighted the exploitation of vulnerable populations and the lack of oversight in such practices thereby urging stricter regulations to protect participants’ rights. The Drugs and Clinical Trial Rules, 2019, notified under the Drugs and Cosmetics Act, 1940, mandate provisions like Ethics Committees and compensation for trial-related injuries or deaths.
Source: bit.ly/3DNYBt4

3. The Jammu & Kashmir and Ladakh High Court has initiated contempt proceedings against a prominent Indian law firm for allegedly misquoting a 2010 judgment related to the Sawalkote Hydro-Electric Project. The court observed that the law firm had misrepresented judicial findings in a legal notice that was issued by the court which might potentially amount to criminal contempt.
Source: bit.ly/423xnZz

4. The Bombay High Court emphasized that intelligence levels should not determine parental rights while deciding a case involving a woman’s right to motherhood with borderline intellectual disability. The court reviewed a petition seeking termination of the woman’s 21-week pregnancy, with a medical report confirming her fitness for pregnancy.
Source: bit.ly/3Cb5Evd

5. India’s healthcare stakeholders, ahead of Budget 2025, are urging reduced customs duties (~37%) on advanced cancer therapies, drugs, and treatment equipment. They seek tax reforms, including GST rationalization, increased healthcare spending to 2.5-3% of GDP, long-term financing options, telemedicine expansion, and infrastructure incentives. Emphasis is also laid on digital health and preventive care to ensure equitable access nationwide
Source: bit.ly/4gJousH

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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 Delhi High Court has granted relief to Dr. Devi Prasad Shetty, a renowned cardiac surgeon and chairman of Narayana Hrudayalaya Ltd. The court has issued a temporary injunction to protect his personality rights, prohibiting the misuse or misappropriation of his name, likeness, photos, videos, or any other aspects of his persona without his consent. The injunction also restricts the unauthorized use of the Narayana trademark for commercial gains.
Source: bit.ly/3BbWZZ1

2. India’s State Blood Transfusion Council (SBTC) of Maharashtra has introduced strict guidelines for blood donation camps in the state, prohibiting organizers from offering extravagant gifts and other high-value items to donors.
Source: bit.ly/49kLTxy

3. The Indian Government has reportedly expanded free treatment benefits under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) to include all senior citizens aged 70 years and above. Also, approximately 1,961 procedures across 27 medical specialties, including General Medicine, General Surgery, Orthopedics, Cardiology, Oncology, and more, can now be availed by different age groups.
Source: bit.ly/3ZAyaiS

4. At the start of the final 2024 pandemic agreement negotiations, experts have reportedly urged countries to finalize the agreement to tackle future pandemic threats. Negotiations are set to continue, with hopes of reaching an agreement before 20th January, 2025
Source: bit.ly/4f1ly99

5. India’s Supreme Court has directed Public Prosecutors and Legal Aid Lawyers to uphold procedural fairness and the fundamental rights of the accused in criminal trials, ensuring effective legal aid. It is the Public Prosecutor’s duty to inform the Court about the need for free legal aid, as they are responsible for ensuring that the trial is fair and lawful.
Source: bit.ly/4fSa0WM

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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 Supreme Court of India has dismissed a Public Interest Litigation (PIL) seeking quality regulation for “prasad” food items distributed at religious places, stating that the Food Safety and Standards Authority of India (FSSAI) already oversees food safety standards.
Source: bit.ly/4eYIJAX

2. The District Consumer Disputes Redressal Commission in Delhi has ordered a compensation of Rs. 48 lakhs against a hospital and its doctors for performing surgery without the necessary expertise and proper disease assessment. The commission found that the medical professionals manipulated records to obscure the actual causes of the complications, which constituted medical misconduct and negligence.
Source: bit.ly/4iiLHTM

3. The Ministry of Consumer Affairs, Food & Public Distribution has issued draft rules for clinical electrical thermometers, inviting feedback from stakeholders by December 30, 2024. The draft rules provides technical standards of clinical electrical thermometers to ensure the accurate measurement of body temperature is recorded in clinical settings.
Source: bit.ly/3CVrjYs

4. India’s food regulator, the Food Safety and Standards Authority of India (FSSAI) has designated packaged drinking water and mineral water as “High-Risk Food Categories” after the removal of mandatory Bureau of Indian Standards (BIS) certification for these products. This decision will now require the manufacturers to undergo annual risk-based inspections and third-party audits before obtaining licenses or registrations.
Source: bit.ly/4i8DO3b

5. The Ministry of Consumer Affairs has released draft rules for non-invasive automated sphygmomanometers, inviting comments from stakeholders by December 30, 2024. The draft rules aim to establish regulatory standards for the measurement of blood pressure using these devices. The scope of the draft includes specifications for the design, performance, and testing methods required to ensure accuracy and reliability in clinical settings.
Source: bit.ly/3OC0Ku6

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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

Posted on

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

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.

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