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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 Parliamentary Committee on Consumer Affairs, Food and Public Distribution, has noted in a recent report, that the National Test House (NTH) of the Consumer Protection Department does not currently have the expertise or offer the services for regulation certification of Radiation Emitting Medical Devices (including MRI machines and X-Ray machines etc.).
Source: bit.ly/4iKKIfi

2. The National Human Rights Commission of India, having taken Suo-Moto cognizance of a recent report concerning the negligent transfusion of blood to a patient in Rajasthan, has issued Notices to the Chief Secretary of the State of Rajasthan to conduct a thorough investigation into the circumstances of negligent blood transfusion.
Source: bit.ly/3ZCj4Z0

3. The Indian Minister of State for Health has clarified that the Central Drug Regulator, currently does not have any intention or proposal to ban Rantidine in the country, and that State Drug Controllers have been instructed to test for the levels of possible carcinogen N-nitrosodimethylamine in the wake of a warning issued by the United States Food and Drug Administration and European Medicines Agency.
Source: bit.ly/3P2aKgf
Source: bit.ly/49GB4pR

4. India’s Central Drugs Regulator, in supersession of an earlier Amendment in 2022, has issued an amendment to the Medical Devices Rules, specifying laboratories, and the Medical Devices that the laboratories are designated to test.
Source: bit.ly/3PnjiyF

5. The European Medicines Agency is set to implement to the proposed Electronic Product Information program to adapt pharmaceutical label information for easier representation on e-commerce platforms after conducting a successful pilot program.
Source: bit.ly/3DyWkS8

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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. A Public Interest Litigation before the Bombay High Court is being opposed by the Association of Oral and Maxillofacial Surgeons of India, arguing on the basis of a notification of the Dental Council of India dated 6th December 2021, that specialized Oral and Maxillofacial Surgeons registered with State Dental Councils should be permitted to carry on hair transplant surgeries.
Source: bit.ly/49yFtLx

2. The Central AYUSH Minister (Ayurveda, Unani, Siddha and Homeopathy) has stated in response to query in the Indian Parliament, that the ministry has followed a policy of co-location of AYUSH facilities at primary healthcare centres to encourage patients to make choice of treatment.
Source: bit.ly/41ssp8c

3. A lawsuit has been filed in the United States against the manufacturers of consumer food products, alleging that the products manufactured by the companies are “ultra-processed” and prone to causing chronic diseases among consumers.
Source: bit.ly/4goMQXO

4. The Union Health Ministry of India has reportedly urged states to classify snakebites as a notifiable disease, meaning it must be reported to the government by hospitals. This follows the launch of the National Action Plan for Prevention and Control of Snakebite Envenoming (NAPSE), which aims to reduce snakebite deaths by 50% by 2030. One of NAPSE’s recommendations is that snakebites be made a notifiable disease to better track and address the issue.
Source: bit.ly/4gxDPvG

5. The Ministry of Health and Family Welfare has stated that data on disciplinary actions against Registered Medical Practitioners (RMPs) over the past five years is not centrally maintained. It has advised states to promote the prescription of generic drugs and conduct prescription audits in public health facilities. The Indian Medical Council’s 2002 regulations mandate that physicians prescribe drugs by their generic names, legibly and preferably in capital letters, ensuring rational and appropriate use.
Source: bit.ly/3ZRLujb

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 Central Food regulator, the Food Safety and Standards Authority of India (FSSAI) has issued a advisory to e-commerce Food Business Operators (FBOs) to ensure that: (1) Last-mile delivery systems are made more robust, and persons handling last-mile delivery are given suitable training to handle the food items, and (2) The e-commerce FBOs are compliant with the labelling requirements as specified in relevant regulations, keeping the listings on the website consistent with content of actual food label.
Source: bit.ly/4f0zEaA

2. India’s Ministry of Finance has published an Office Memorandum seeking public comment up to the 10th of December, on certain amendments to the prevailing insurance regulations in the country. These proposed amendments include among other things, permitting a 100% Foreign Direct Investment in the insurance sector through the automatic-route, and permitting insurers to undertake offer of more than one class of insurance.
Source: bit.ly/4ifYwxT

3. India’s Central Ministry of Consumer Affairs is reportedly developing an online portal to handle the licensing, verification and stamping of weighing and measurement instruments as well as to provide a source of information on verified trade instruments for consumers.
Source: bit.ly/41km5Q6

4. The High Court of the States of Punjab and Haryana held that outside of introduction of evidence to the effect, the mere failure of a medical surgery/ procedure would itself not be sufficient to establish medical negligence claims, especially if the patient had been appropriately sensitized of the risks involved.
Source: bit.ly/49nlkrJ

5. In its finalized version of the regulations regarding Pre-determined Change Control Plans, the US Food and Drug Administration has plainly classified Artificial Intelligence (AI) as a sub-set of Machine Learning softwares when it comes to regulation of Medical Devices, and further makes it mandatory that in making submissions the version of the device software need to be submitted with the FDA to ensure version control.
Source: bit.ly/4imQQu2

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 Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU

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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. 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.
Source: bit.ly/486DMnN
Source: bit.ly/4h3sHaZ

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.
Source: bit.ly/48a2Bz6

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.
Source: bit.ly/3A3vIYi

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.
Source: bit.ly/3BJfa8z

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

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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 Drugs Technical Advisory Body, in its 91st meeting, has recommended the exemption of several chemical contraceptives at specific dosage values, from the labelling requirements under Schedule H which would have limited sale by prescription only.
Source: bit.ly/3ZWiqqU

2. The Directorate General of Foreign Trade has amended the export policy for cough Syrup, amending an earlier notification, exempting the requirement for pre-export testing for jurisdictions including the USA, EU, and South Korea which may already have granted approval.
Source: bit.ly/3YfvOVP
Source: bit.ly/3YeH6tI

3. The Ministry of Environment Forest and Climate change has notified the Liquid Waste Management Rules, 2024 set to come into force from 1st October; which govern the treatment and management of liquid effluents arising from domestic and industrial activities including treatment of wastewater, sludge generated during treatment of wastewater and reuse/reutilization of any wastewater or sludge generated.
Source: bit.ly/3YhCpzl

4. In a recent public notice, the Central Government Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has clarified that it does not license or ratify any AYUSH products or medicines, and warned against the advertising of AYUSH products as “Miracle Cures”. This comes in the light of the Ministry of AYUSH having repealed Rule 170 of the Drugs Rules, 1945, which regulated AYSUH advertising.
Source: bit.ly/4dzToBi
Source: bit.ly/3XXf9Fi

5. The European Commission’s Medical Device Coordination Group (MDCG) has issued a voluntary document to supplement its earlier Designation, re-assessment and notification of conformity assessment bodies and notified bodies, which is intended to guide notified bodies to impose corrective and preventative action.
Source: bit.ly/4eYr4JJ

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. In the most recent 91st Meeting of the Drugs Technical Advisory Board (DTAB) which advises the central government on drug regulatory policy matters, the DTAB has recommended the use of QR code to identify genuine anti-cancer medication, in recognition of recent cases of spurious drugs sale coming to light.
Source: bit.ly/3zP609I

2. The DTAB, has provided rationale for its decision to reject waiver of Clinical Performance Evaluation for IN-Vitro Devices (IVDs) which are already approved internationally. The DTAB expressed its opinion that the performance of IVDs are variable based on the population, and their performance and effectiveness cannot be taken for granted across demographic lines.
Source: bit.ly/3ZV6hT7

3. The Indian Ministry of Environment Forest and Climate Change has notified the new Ecomark Rules, aimed at replacing the erstwhile Ecomark Scheme, 1991. These rules specify criteria for approving ecomark for a product including: recyclability, reduction in pollution and use of non-recyclable resources, and sustainability of production process.
Source: bit.ly/3TXRP9a

4. The Bombay High Court clarified that any seized sample would have to be separated and the individual components of the Cannabis plant identified, because Ganja is defined under the Narcotic Drugs and Psychotropic Substances, Act 1985 only as the “flowering tops” of the Cannabis plant, and for that reason the seeds and leaves cannot be counted towards identifying whether an accused was carrying “commercial quantity” of Ganja.
Source: bit.ly/3NgyD2P

5. In a departure from government policy, the Drugs Consultative Commission (DCC) decided that including the International Nomenclature of Cosmetics Ingredients would be difficult to accommodate, and for that reason all cosmetics manufacturers should continue to adhere to the applicable standards set by the Bureau of Indian Standards (BIS) for their ingredients.
Source: bit.ly/3NduBbB

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 Central Drug Regulator the Central Drugs Standards Control Organization (CDSCO) has been made an affiliate member of the International Medical Device Regulators Forum (IMDRF). The application submitted by the Indian Government has been accepted contingent on the adoption of comprehensive regulation of Medical Devices in alignment with the existing international standards.
Source: bit.ly/3TQ1GOb

2. India’s Ministry of Health and Family Welfare has introduced Guidelines for Withdrawal of Life Support in Terminally Ill Patients, which sets out the institutional oversight requirements to facilitate ethical and informed decision-making in this regard.
Source: bit.ly/4eReyf6

3. The Supreme Court has held that in case of criminal suits which have an overwhelming civil quality, i.e. are based on private wrongs, where the parties to such criminal suits have already settled with each other, High Courts should exercise their powers under Sec. 482 of the CrPC and quash the underlying criminal proceedings.
Source: bit.ly/4dyF1wQ

4. India’s Central Drugs regulatory authority the Central Drugs Standards Control Organization (CDSCO) has decided that it will initiate action against a manufacturer of eye-drops, which had recently made social-media posts and conducted conferences regarding its new product, which had come under scrutiny for the claim that it would manage near-sightedness, and in pursuance of that, forwarded the matter to the State Drug Regulator of the state of Gujarat where the company is based.
Source: bit.ly/4dtuYJL

5. A prominent US based medical systems and medical devices manufacturer which has suffered a data-breach of its systems leading to the leak of sensitive personal and medical information of its patients, is currently facing a class-action lawsuit on grounds that the breach was caused due to non-adherence to industry standard practices in data storage and security.
Source: bit.ly/3BHdjRl

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. Indian government is planning to launch the Trinetra portal to register complaints against Ayurvedic product advertisements making exaggerated, misleading or deceptive claims, concealing important details, or showing deceptive images that can misguide consumers, influence their decisions and result in unfair practices. The portal will enable speedy redressal of complaints through a central registry system and an AI-based redressal mechanism.
Source: bit.ly/3ZGp1pp

2. The government has notified draft rules to amend the Cigarettes and other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Rules, 2004. The draft rules aim to mandate the display of non-skippable anti-tobacco health spots and disclaimers about the harmful effects of tobacco use for films and online curated content platforms.
Source: bit.ly/3MWfUt8

3. The Union Health Ministry has announced that the National Medical Register (NMR) has received 20,000 applications, linking doctor registration to Aadhaar for authenticity. The National Medical Commission has further been asked to initiate efforts for increasing medical seats to add 75,000 more undergraduate and postgraduate seats for aspiring medical professionals.
Source: bit.ly/3XCGcpe

4. India’s Narcotics Commissioner has extended the deadline for companies dealing with psychotropic substances to register themselves on the CBN Online Portal to December 31, 2024. Earlier, this deadline was September 30, 2024. Any failure to register by the revised date will result in the cancellation of registrations, while companies are advised to continue submitting quarterly returns as previously required.
Source: bit.ly/3TDTSPC

5. The High Court of Jammu and Kashmir has recommended proper training for officials of the Drug Controller department to address the high rate of technical defects in prosecutions related to substandard drugs. The court highlighted that many cases fail due to procedural non-compliance, urging the Health and Medical Education Department to implement corrective measures to prevent premature quashing of complaints under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4etb82g

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 central drug regulator (CDSCO) has released draft guidelines on Good Clinical Practices Rules to align India’s clinical trial rules with international standards. The draft is open for comments by October 12, 2024.
Source: https://bit.ly/3XpPdSr

2. India’s premier consumer forum ordered a major medical device manufacturer to pay compensation to one of the claimants who had suffered adverse reactions as a result of faults in the surgical-implants which they had received from it.
Source: https://bit.ly/3ztLCe5

3. India’s statutory body regulating medical education, National Medical Commission (NMC) has issued revised guidelines removing sodomy and lesbianism from the category of unnatural sexual offences from its curriculum of medical education.
Source: https://bit.ly/3Xr5Kp7

4. India’s union health ministry has expanded the health insurance scheme under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) to cover citizens aged 70 years and above, regardless of their income. The ministry will issue new, unique cards to senior citizens for the availment of the benefit.
Source: https://bit.ly/3XsD2nQ

5. The US Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) hearing aid. The hearing aid will be integrated into the hearing device of a giant electronic brand through software updates allowing the device to function as personalised hearing aid. The feature is aimed at helping users with their perceived mild-to-moderate hearing impairment.
Source: https://bit.ly/4e2LEsn