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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. The State Consumer Disputes Redressal Commission (SCDRC) has directed a consultant surgeon at a hospital in Erode to pay ₹5 lakh as compensation to the family of a patient who died during treatment for colon cancer. The Commission concluded that while there was no medical negligence during the surgery, the surgeon failed to secure proper cardiac evaluation prior to the procedure, which was deemed a significant oversight.
Source: bit.ly/3UHgY8t

2. The All India Organization of Chemists and Druggists (AIOCD) has raised concerns over a potential partnership between a popular fast delivery company and an online pharmacy aimed at delivering medicines within 10 minutes. AIOCD warns that this ultra-fast delivery model may bypass essential safety regulations, compromising patient safety and increasing the risk of antimicrobial resistance due to unregulated medicine distribution.
Source: bit.ly/4hzeSBr

3. The Drugs Controller General of India (DCGI) has mandated that no cosmetics can be imported unless their ‘use-by’ date is at least six months from the import date. The regulator also prohibited the import of cosmetics containing hexachlorophene and those tested on animals post-November 2014.
Source: bit.ly/4hElgr2

4. The Supreme Court has directed the National Medical Commission (NMC) to establish new guidelines for admitting persons with disabilities into medical courses, emphasizing the need for inclusivity in the healthcare sector. This decision follows a case involving a candidate with muscular dystrophy who was initially disqualified from pursuing an MBBS due to stringent disability criteria.
Source: bit.ly/3YAwWCG

5. The Central Pollution Control Board (CPCB) has issued guidelines to be used by State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs), to assess and determine the processing capacities of E-Waste recycling facilities.
Source: bit.ly/3YBbcGK

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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 Board (DTAB) has approved a proposal to amend the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to eliminate the two-step certificate issuance process for biomedical and health research ethics committee registration. Now, a system for reviewing and examining all ethics committee documents has been put in place at Department of Health Research (DHR). This process allows for the removal of redundant work and resource use, and only final certificates can be directly issued to ethics committees.
Source: bit.ly/3A8haGQ

2. To improve India’s whole digital healthcare infrastructure, a new certification program for hospital information systems (HIS) and electronic medical records (EMR) has been introduced by the National Accreditation Board for Hospitals and Healthcare Providers (NABH). The program offers Basic and Advanced maturity levels that are valid for two years. The NABH portal will open for registration on December 1, 2024.
Source: bit.ly/3UjzcN7

3. The Drugs Controller General of India (DCGI) plans to amend the Medical Devices Rules, 2017, to include quality control provisions for non-sterile, non-invasive Class A medical devices like thermometers and stethoscopes. Currently exempt from licensing, these devices will now require manufacturers to comply with a quality management system.
Source: bit.ly/3NApDpw

4. The Madras High Court has ruled that Siddha practitioners are permitted to practice modern medicine but are prohibited from storing allopathic drugs without a valid license under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4hs9VKT

5. The World Health Organization (WHO) has prepared a draft guideline for food packaging to include health impact labels on the front, emphasizing the need for clearer consumer information regarding potential health risks associated with food contact materials. The draft received public comments till October 11, 2024 and will release the final guidelines in 2025.
Source: bit.ly/3BQlKKm

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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 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. The Indian Pharmacopoeia Commission (IPC) and India’s Central Drug Authority (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products” wherein they have extended the timelines to report non-serious adverse events within 90 calendar days from the previous proposed timelines of 30 days.
Source: bit.ly/4dctGCs

2. Drugs Consultative Committee (DCC), which advises the Central and State Governments on uniform implementation of drug laws in India, has reportedly advised all the State Licensing Authorities (SLA) to ensure that all applications are exclusively received and processed through the Online National Drugs License System (ONDLS) portal only.
Source: bit.ly/4ejO8Tr

3. The Federal Court of Australia has heavily penalized and ordered one of the leading manufacturers and suppliers of medical devices for unlawfully supplying Infuse Bone Graft Kit without LT Cage. The Australian Register of Therapeutic Goods (ARTG) prevents the supply of Infuse Bone Graft Kit without LT Cage.
Source: bit.ly/3XChUMd
Source: bit.ly/4dlv5H1

4. The World Health Organization (WHO) has released guidance on best practices for clinical trials to improve the design, conduct, and oversight of clinical trials in countries of all income levels. The guidance provides recommendations to the national health authorities, regulatory authorities, funders, and others on how to facilitate clinical trials to generate evidence on health interventions in addition to practical concerns.
Source: bit.ly/47Fc0hI
Source: bit.ly/4ezzQxN

5. India’s Central Drug Licensing Authority has reportedly introduced new guidelines to lower the frequency of drug testing for imports from nations like the US, Australia, Japan, Canada, and the European Union, to one sample from every two years’ worth of consignments or one sample out of every 20 consecutive consignments, whichever occurs first provided the drug samples maintain a clean record with no quality failures in the last five years.
Source: bit.ly/3Bgacjo

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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

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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 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

 

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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 Pollution Control Board (CPCB) has issued Environmental Compensation (EC) Guidelines to address non-compliance with Extended Producer Responsibility (EPR) registration, labelling requirements, failure to fulfill EPR obligations, and non-filing of annual returns, among other violations under the Battery Waste Management Rules, 2022. The guidelines outline formulas for determining Environmental Compensation (EC) in different cases of non-compliance with the Battery Waste Management Rules, 2022.
Source: bit.ly/3ZkGVOe
Source: bit.ly/4ehqaI4

2. India’s Food Safety and Standards Authority of India (FSSAI)  has extended the availability of Instant (Tatkal) Food License and Registration nationwide, with the exception of Chandigarh, Himachal Pradesh, and Meghalaya. Previously, this provision was limited to few states and Union Territories. The Instant (Tatkal) Food License and Registration provision came into effect on 31st August, 2024.
Source: bit.ly/3XGxBDo

3. India’s Bureau of Indian Standards (BIS) has notified amendments to various products, including Disposable Baby Diapers, Absorbent Cotton Gauze, Cotton Bandage Cloth, Sanitary Napkins, and Disposable Baby Diapers. All products imported, sold, or marketed in India must comply with these revised standards by 22nd February, 2025.
Source: bit.ly/4dZsFz8

4. India’s Department of Pharmaceuticals (DoP) has issued a issued notification under Drug Price Control Order,2013 (DPCO) thereby extending the current ceiling price for orthopedic knee implant systems until 15th September, 2025.
Source: bit.ly/3Tn6ASI

5. India’s central drug regulator (CDSCO) has suspended the manufacturing and marketing license of a pharmaceutical company due to the false and misleading claims that its eye drops could augment near vision within 15 minutes and the company’s failure to address queries raised by the drug regulators concerning these claims.
Source: bit.ly/4e04yAn

6. India’s Supreme Court, while hearing a case on the ban of commercial surrogacy, observed that the interests of surrogate mothers must be safeguarded. The Court emphasized the need for a regulatory system like “surrogate banks” to ensure that surrogate mothers are not exploited and their rights are upheld.
Source: bit.ly/4gePgsS

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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 Ministry of Corporate Affairs (MCA) has set a Deal Value Threshold (DVT) of ₹2,000 crore for mergers and acquisitions under the Competition (Amendment) Act, 2023. Transactions wherein the target company having substantial business in India if exceeds the given threshold, will have to obtain prior approval from the Competition Commission of India (CCI).
Source: bit.ly/3MGohZM

2. Ayurvedic businesses seeking to advertise ayurvedic drugs in Kerala must reportedly must secure permission from Kerala Drugs Control Department before making misleading and exaggerated claims via advertising. Advertisements made without approval will face legal repercussions.
Source: bit.ly/3AYOsbu

3. India’s Central Pollution Control Board (CPCB) has issued Environmental Compensation (EC) guidelines to address non-compliance with Extended Producer Responsibility (EPR) registration requirements, non-fulfilment of EPR obligations, non-filing of annual returns, among other violations under the E-waste Management Rules, 2022. These guidelines also regulate the cost of EPR certificates for fulfilling EPR obligations.
Source: bit.ly/3B05aY8

4. India’s Goods and Services Tax (GST) Council has decided to reduce the tax rate on cancer drugs – Trastuzumab Deruxtecan, Osimertinib and Durvalumab to 5% from the previous tax rate of 12%. The Council is reportedly set to finalize reductions in tax rates for health and life insurance premiums in its next meeting in November 2024.
Source: bit.ly/3zd6NB2

5. Medical Colleges in India must reportedly meet the safety and security measures of women doctors, nurses and students to get recognition from the Medical Education Regulator, National Medical Commission.
Source: bit.ly/3XEGNrT