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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. India’s National Pharmaceutical Pricing Authority (NPPA) in public interest has approved 50% increase of ceiling price of eleven scheduled formulations of eight drugs from the current ceiling prices along with annual price increase as per the Wholesale Price Index (WPI) in April. This comes as a recommendation from the Inter-Ministerial Committee.
Source: bit.ly/3zOtSKV

2. Income Tax Appellate Tribunal (ITAT) of Ahmedabad has upheld the disallowance of amount claimed by a leading pharmaceutical company relating to promotional activities for doctors like accommodation, freebies etc and declared it as inadmissible for tax deductions. The activities were claimed as marketing tools rather than business necessities
Source: bit.ly/4eZ8fH7

3. India’s Central Drug Authority (CDSCO) along with National Regulatory Authority of India (NRA) and affiliated institutions after an evaluation by global experts have satisfied the WHO’s requirements for a functional vaccine regulatory system. Safety, efficacy, and quality are three basic parameters for the assessment of vaccines.
Source: bit.ly/4eJmn6S

4. The National Council for Clinical Establishments (NCCE) has recommended to allow the physiotherapists to own and run the clinics as per the amendment proposed in the Clinical Establishments (CE) Act, 2010. The decision comes as a relief to the physiotherapists and their organizations, which has been fighting legally to attain its right to own and run a clinic, which was not allowed as per the Act notified in 2010.
Source: bit.ly/3BMLs2s

5. The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has issued a Trade Notice to give clarification on the import and re-import provisions for “Exhibits and Samples” that are exported for display or exhibition purposes. This move is expected to support businesses and industries, including the pharmaceutical industry participating in both domestic and foreign exhibitions to facilitate effortless import or re-import of goods for exhibition or display without imposing further bureaucratic obstacles.
Source: bit.ly/4h7x9FD

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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 Union AYUSH Ministry has prohibited to advertise Ayurveda, Siddha, Unani, and Homeopathy drugs with claims of “miraculous or supernatural effects” in order to prevent misleading advertisements with unverified claims. The ministry instructed that such drugs should contain a caution to be taken under medical supervision on its label. Additionally, the ministry issued a public notice clarifying that it does not certify, grants license or approves any company for making ayurvedic drugs.
Source: bit.ly/4eXXjsL
2. India’s central drug regulator (CDSCO) is actively investigating social media influencers who promote false claims, quick fixes and misleading medical content.
Source: bit.ly/4eGfqDC 

3. The Pune division of the Food and Drug Administration (FDA) has taken action against three drug firms for violating the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The firms were found selling Ayurvedic medicines with misleading claims to cure diabetes, arthritis, and kidney ailments, leading to the seizure of products.
Source: bit.ly/3XUC5Fe

4. The Delhi High Court ruled that a mere fraction of a cause of action occurring in a jurisdiction is insufficient to invoke the court’s territorial jurisdiction. The decision of the court said that in order to raise the territorial jurisdiction of a specific court, there must be a significant link of the matter to the specified territory, reinforcing the standards for filing cases in the court.
Source: bit.ly/3ZXxPr1

5. The Medicines and Healthcare products Regulatory Agency (MHRA) in UK has unveiled its 2024/25 business plan, which prioritizes enhancing access to innovative healthcare technologies while optimizing service delivery. Key initiatives of the plan include the implementation of new IT systems and a commitment to public engagement and diversity in regulatory processes, aimed at reinforcing the UK’s position in life sciences and improving pandemic preparedness.
Source: bit.ly/3BES5Ux

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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. 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

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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 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

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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 National Consumer Disputes Redressal Commission (NCDRC) has directed one of the medical device company to pay ₹35 lakh to a consumer as compensation for medical complications arising from the inherently defective design of hip replacement device.
Source: bit.ly/3XP4bla

2. India’s Ministry of Environment, Forest and Climate Change has issued the Ecomark Rules, 2024, detailing the criteria for granting the “Ecomark”. These rules intend to promote environmentally friendly products and support green industries.
Source: bit.ly/47PY0ly

3. India’s District Consumer Dispute Redressal Commission (DCDRC) of North East Delhi, has ordered a leading hospital to pay compensation for negligence to a patient who had met with a road accident on the ground of deficiencies in the services and failure to meet medical obligations.
Source: bit.ly/3ByeP8E

4. India’s Bombay High Court has issued a restraining order in a trademark infringement case against five juice center outlets in Kerala for unauthorized use of the Haji Ali trademark. The court observed the outlets continued using the name, trademark, and logo of Mumbai’s iconic Haji Ali Juice Centre despite the termination of their franchise agreement.
Source: bit.ly/3XP4RXK

5. The Indian Pharmacopoeia Commission (IPC), under India’s Health Ministry, has issued a drug alert regarding the rampant use of “Tetracycline.” The commission advises both doctors and patients to exercise caution while prescribing this medication, as it may cause adverse reactions, specifically Fixed Drug Eruption (FDE).
Source: bit.ly/3Yb5nkp

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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 Punjab and Haryana High Court has urged the Indian government to introduce a legislation to regulate the preservation and disposal of blood in the country. Currently, the sale and disposal of blood is governed by executive instructions issued as guidelines by Centre and State governments.
Source: bit.ly/3TSStVv

2. India’s Central Pollution Control Board has further extended the timeline for filing the Annual Returns for Plastic Packaging Waste for the FY 2023-2024 for Producers, Importers and Brand Owners with Extended Producers Responsibility Registration to 30th November 2024. Previously, this deadline had been extended from 30th June 2024 to 30th September 2024.
Source: bit.ly/3JqZRBH

3. India’s Central Drugs Control Authority may reportedly direct drug regulators across all States and Union Territories (UTs) for uniform implementation of norms for new drugs, specifically regarding the approval of gastro-resistant and delayed-release dosage forms under the New Drugs and Clinical Trial (NDCT) Rules, 2019. The 64th Drugs Consultative Committee (DCC) meeting highlighted inconsistencies in the approval process for these products, which are classified as “New Drugs.”
Source: bit.ly/3XPOtq4

4. India’s Allahabad High Court has directed the Uttar Pradesh government to issue a standard operating procedure (SOP) for Chief Medical Officers (CMOs) and doctors regarding the medical termination of pregnancy (MTP) for timely abortions and proper implementation of existing laws.
Source: bit.ly/47MSBvk

5. India’s National Organ & Tissue Transplant Organization (NOTTO) has released a Standard Operating Procedure (SOP) for Human Organ Transportation by various modes like air, ambulance/ other vehicle, Trains, etc. The SOP includes standardized packaging, mandatory labelling with detailed donor and recipient information, handling of organ box and requirement of a medical personnel to accompany the organs along with necessary documentation.
Source: bit.ly/3BovUBR

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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 central drug regulator (CDSCO) has identified 59 drug samples as Not of Standard Quality (NSQ) in August, including products from major pharmaceutical manufacturers. 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/4drUUFz
Source: bit.ly/3zCDmJ0

2. The District Consumer Disputes Redressal Commission-II in Visakhapatnam has awarded a compensation of Rs. 15 lakhs in a medical negligence case and has found the private eye institute, its director, and two ophthalmologists guilty as they failed to meet their medical obligations by neglecting the crucial pre-surgery test of the patient leading to a loss of eyesight of the patient.
Source: bit.ly/3N6HST2

3. The Punjab and Haryana High Court has ordered the attachment of the salaries of several health officials, including the state health secretary for a potential diversion and unauthorised use of funds. The court held that the state cannot withhold the amount released by the central government due to hospitals under the Ayushman Bharat scheme and has asked for a detailed explanation from the state in the matter.
Source: bit.ly/3zCDt7o

4. India’s health ministry has issued draft regulations amending the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 to limit the Maximum Residue Limits (MRL) of pesticides/insecticides in each food community. The notification invites objections and suggestions from stakeholders regarding the proposed changes till November 17, 2024.
Source: bit.ly/47MlQOV

5. The Indian government has released a notification to include Acupuncture under the category “Other Care Professionals” in the schedule of the National Commission for Allied and Healthcare Professions Act, 2021.
Source: bit.ly/3ZJqXNO

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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. 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

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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. To combat antimicrobial-resistance the Drugs Consultative Committee, which advises the Central and State Governments on conduct of Drug regulation in the country, has, in its 64th meeting recommended amendment to the Drug Rules to regulate sale of antibiotic Drugs to manufacturers who may not have a license under the Drug regulations.
Source: bit.ly/4evHfhA

2. The Punjab and Haryana High Court upheld the position that under the Narcotic Drugs and Psychotropic Substances Act, 1985, upon seizure, the entirety of the bulk of the seized substance need not be sent to the Forensic Laboratory, rather merely a select homogenized sample thereof would be sufficient.
Source: bit.ly/4gx15uL

3. The Supreme Court has ordered the Central Government Ministry of Health and Family welfare, and the Government of Kerala to file counter-affidavits explaining the delayed action in setting up a special committee to study the effectiveness of the Rabies vaccine.
Source: bit.ly/3MXwwAE

4. The High Court of Bombay has struck down the insertion of Rule 3 of Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules, 2023, which empowered the government to set up fact-check units on the ground that this violated the fundamental right to equality and to carry on trade and business.
Source: bit.ly/4diYthg

5. The United States Federal Trade Commission has formally initiated litigation against Pharmacy Benefit Managers which act as middlemen between Drug Companies and Insurers, for deliberately driving the price of insulin higher for consumers and receiving rebates from manufacturers in the process.
Source: bit.ly/3zrNfcq