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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 Health and Family Welfare (MoH&FW) has released the Drugs Amendment Rules, 2025, extending the deadline for implementing revised Good Manufacturing Practices (GMP) under Schedule M for small and medium drug manufacturers until December 31, 2025. Manufacturers are required to submit an application to the Central Licensing Authority for seeking the extension within three months of the notification.
Source: bit.ly/4gCo0U8

2. The Supreme Court has virtually summoned the Chief Secretaries of Andhra Pradesh, Delhi, and Jammu & Kashmir to explain their failure to act on misleading medical advertisements. The Court found these states non-compliant with previous orders on enforcing Rule 170 of the Drugs Rules, which prohibits advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities’ approval.
Source: bit.ly/42Sm6vn

3. India’s National Medical Commission (NMC) has clarified that the Telemedicine Practice Guidelines 2020 do not allow Registered Medical Practitioners (RMPs) to remotely authenticate pathology and radiology lab reports without physical presence and supervision. This follows an RTI application which sought clarification on the use of cloud-based technologies like Telepathology and Teleradiology for signing and authenticating lab reports.
Source: bit.ly/40VinKX

4. India’s Ayushman Bharat Digital Mission (ABDM) has made significant strides, with millions of Ayushman Bharat Health Accounts (ABHA) created and a large number of health records linked to ABHA. This is part of the mission’s effort to build an interoperable digital health ecosystem. Thousands of health facilities have registered on the Health Facility Registry (HFR), and many healthcare professionals are now listed on the Healthcare Professional Registry (HPR). The mission also focuses on supporting rural areas through technology interventions like telemedicine, enhancing access to healthcare services.
Source: bit.ly/41ektXT

5. The European Medicines Agency (EMA) has introduced a standard procedure for manufacturers of certain high-risk medical devices to receive scientific advice on their intended clinical development strategy and proposals for clinical investigations. This initiative aims to enhance safety and performance by offering expert guidance on regulatory requirements before devices are submitted for approval. The move is designed to foster innovation while ensuring that devices meet rigorous standards.
Source: bit.ly/4jWxfRZ

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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 Karnataka health department has become the first state to implement the Supreme Court’s 2023 directive on a patient’s right to die with dignity. The government issued an order appointing medical experts to a secondary medical board to determine when life-sustaining treatment can be halted for terminally ill patients.
Source: bit.ly/3CEYPlX

2. Central government of India has published amended Water Pollution Guidelines to streamline the process of obtaining consent for industrial plants that may cause water pollution with an aim to simplify compliance and enhance ease of doing business for industries. The guidelines outline procedures for obtaining, renewing, and potentially losing consent to establish or operate such plants. These guidelines exempt certain category of project from obtaining the clearances. It also states that the projects that required the Environmental Clearance (EC) as per Environmental Impact Assessment (EIA) Notification, 2006 are exempted from obtaining the Consent to Establish (CTE) separately.
Source: bit.ly/3WOVyaK

3. India’s National Medical Commission (NMC) thereby upholding the patients’ rights is considering to authorize the patients to appeal against the orders of State Medical Commission (SMC). Earlier, only doctors were authorized to file an appeal against the decision of SMC.
Source: bit.ly/4grUoZq

4. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) are working together to improve the accuracy of In-Vitro Diagnostic (IVD) tests in India. They have released a draft manual for Standard Performance Evaluation Protocols, inviting stakeholder comments. These protocols outline methods for evaluating the performance of IVDs used to diagnose diseases like Chikungunya, Dengue, and Zika. After the consultation period, ICMR and CDSCO will review the feedback and finalize the protocols for official adoption.
Source: bit.ly/3QhIAyF

5. Major drug manufacturer in India has received approval from the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to import and market tislelizumab injection, a cancer treatment drug. SEC waived the local clinical trial requirement under certain conditions, recognizing the drug as an orphan drug for an unmet medical need in India. Noting its approval in the USA, Europe, UK, Australia, China, and other countries, the committee also advised the company to submit safety and efficacy data for Indian patients, ensuring patient rights are considered.
Source: bit.ly/4hHyKSi

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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 Council of Medical Research (ICMR) has issued an Expression of Interest (EoI) for organizations, companies, and manufacturers to develop and produce a lateral flow-based point-of-care device for serum ferritin quantification. Serum ferritin is an important biomarker for diagnosing iron deficiency or anemia. The deadline for submitting the EoI is February 28, 2025.
Source: bit.ly/4jCmvrJ

2. The Pharmacy Council of India (PCI) has requested pharmacists facing registration issues on the DIGI-PHARMed portal due to existing identity proof in the system, to submit their details along with a declaration. This initiative is part of the Council’s efforts to eliminate fake or incorrect data by blocking incomplete entries and asking affected pharmacists to create new profiles with valid information.
Source: bit.ly/3Ee0e3q

3. The Federation of Pharma Entrepreneurs (FOPE) is urging the Union government to address GST rationalization due to challenges like low liquidity and increasing compliance burdens in the pharmaceutical industry. FOPE highlighted that the current GST structure has created an inverted duty structure, causing significant working capital blockages and operational inefficiencies, which impacts the critical role of the Indian pharma sector in healthcare, employment, and exports.
Source: bit.ly/3WC6Nmu

4. The National Medical Commission (NMC) is investigating around 30 doctors who took foreign trips to Monaco and Paris, sponsored by a drug manufacturer under the pretext of a dermatology conference. The doctors may face censure or suspension from the Indian Medical Register for three months to over a year, depending on the severity of the violation. This follows a reprimand from the Department of Pharmaceuticals (DoP) over the drug company’s sponsorship of the Rs 1.91 crore trips.
Source: bit.ly/4aCPis9

5. India’s Chhattisgarh High Court has ruled that when determining whether a mixture of narcotic drugs or psychotropic substances constitutes a “small quantity” or “commercial quantity,” both the quantity of the offending drug and the neutral substance mixed with it should be considered.
Source: bit.ly/4jAW8Ti

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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 a landmark ruling, the Chhattisgarh High Court emphasized that the entire mixture of a narcotic substance, including neutral substances, must be considered when determining whether the seized quantity qualifies as “small,” “intermediate,” or “commercial” under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act).
Source: bit.ly/40LD39o

2. The Jabalpur Bench of the Madhya Pradesh High Court, in an interim order, directed the police, narcotics bureau, and Drug Controller to take immediate action against manufacture and sale of banned drugs on wholesale basis online. This move is aimed at enhancing public safety and stricter regulation of online drug sales.
Source: bit.ly/40vjl0h

3. The Union Ministry of Health has announced a key amendment to the Drugs Rules, 1945, introducing Rule 158B (VI). This mandates licensing authorities to follow newly defined guidelines under Schedule TB when issuing licenses for Ayurvedic, Siddha, and Unani (ASU) nasal sprays, aimed at bringing standardization in formulation, safety, and efficacy.
Source: bit.ly/4asMVbt

4. India’s Ministry of Environment, Forest, and Climate Change has allowed entities registered as producers, importers, or brand owners under the Plastic Waste Management Rules, 2016, to make the mandatory labeling declarations via barcodes printed on plastic packaging, product brochures, or unique identification numbers, effective from July 1, 2025.
Source: bit.ly/40Jv2ln

5. The National Medical Commission (NMC) has initiated a probe into doctors whose foreign trips to Monaco and Paris were sponsored by a well-known pharma company, for violation of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.  This follows the reprimanding of Department of Pharma (DoP) against the pharma company for violating the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) for foreign events sponsorship.
Source: bit.ly/3E9Vmw7

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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 called for urgent input from the pharmaceutical industry on regulatory challenges and opportunities for innovation. Stakeholders in the pharmaceutical industry, including companies, researchers, and healthcare providers, are invited to share obstacles to drug approval, difficulties in meeting compliance requirements, and barriers to entering new markets and are encouraged to reach out to CDSCO through its official communication channels.
Source: bit.ly/3PNEUnW

2. The National Medical Commission (NMC) has proposed a draft regulation that grants a one-year senior residency exemption to doctors with foreign postgraduate medical qualifications from five English-speaking countries (United Kingdom, United States of America, Canada, Australia, and New Zealand) to join medical colleges as faculty.
Source: bit.ly/4hlIQZn

3. The Union Cabinet approved the continuation of the National Health Mission (NHM) for another five years, until 2030, which was scheduled to end in 2025. This decision comes after the NHM achieved significant milestones in the past decade, improving healthcare access and quality in India.
Source: bit.ly/4h2YEzV

4. The National Pharmaceutical Pricing Authority (NPPA) has asked pharmaceutical companies and marketing companies of Iohexol, a diagnostic agent to submit price and market data. This action follows a directive from the Department of Pharmaceuticals (DoP) to review the drug’s pricing.
Source: bit.ly/4h9DqR4

5. The U.S. Food and Drug Administration (FDA) has approved a nasal spray as a monotherapy for the treatment of adults with treatment-resistant depression. This marks a significant advancement in mental health treatment, as the nasal spray is the first and only medication approved for this purpose.
Source: bit.ly/40G1bdv

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 issued an instruction manual for manufacturers and importers of devices not having predicate devices, to file Periodic Safety Update Report on the Medical Device Portal.
Source: bit.ly/4g5ORaV

2. India’s Delhi High Court held in a recent order that petitions regarding patent infringement, during the lifetime of a patent will continue to be valid even after the expiry of the term of the patent itself, since the cause of action has arisen at a time when the patent was still active.
Source: bit.ly/3PL3TYU

3. India’s central level regulator of the medical profession and education, the National Medical Commission has issued a draft Teachers’ Eligibility Qualifications, where it is proposed to permit non-medical personnel with Masters and PhD level degrees to teach Anatomy, Physiology and Biochemistry at medical educational institutions.
Source: bit.ly/40HAW6o

4. A premier commercial body of India’s restaurant business operators are currently mulling legal action against quick-commerce companies which have created a business model of undercutting the restaurant business through the use of private-label food products.
Source: bit.ly/4auFgsV

5. The European Pharmacopoeia has adopted three general standards for mRNA based vaccines, (1 mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, (2) mRNA substances for the production of mRNA vaccines for human use, and (3) NA templates for the preparation of mRNA substances. These standards are expected to set a framework of control for regulatory control and approval of mRNA vaccines across the EU and all jurisdictions that accept EU Pharmacopoeia standards.
Source: bit.ly/4ar8HMK

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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 District Consumer Disputes Redressal Commission in Hyderabad has ordered a compensation of Rs. 10 lakh to a patient after cardiologists at a local hospital made the patient undergo multiple procedures in one go without understanding the need for multiple procedures, and failed to follow standard protocols during treatment. The commission determined that the doctor’s negligence led to significant complications, proving a deficiency of service which was against patient safety and care.
Source: bit.ly/3VufMps

2. The National Medical Commission (NMC) has released comprehensive guidelines to identify and prevent the admission of fake patients in medical colleges, a practice that undermines patient care and ethical standards. The guidelines highlight red flags such as unusually high admissions on inspection days, absence of significant medical conditions, and lack of necessary investigations. Institutions found engaging in this unethical practice may face stringent penalties, including hefty fines and restrictions on student admissions.
Source: bit.ly/4iDw5ua

3. India is set to introduce “nafithromycin”, the first indigenous macrolide antibiotic, pending final approval from the Central Drugs Standard Control Organization (CDSCO). This innovative antibiotic, which is ten times more effective than azithromycin, offers a rapid three-day treatment for community-acquired bacterial pneumonia caused by drug-resistant bacteria, marking a significant advancement in the fight against antimicrobial resistance (AMR).
Source: bit.ly/4f4vuP6

4. The Indian government is intensifying efforts to eliminate tuberculosis (TB) by 2025, targeting 347 high-focus districts across 33 states and Union territories. A 100-day TB elimination campaign will be launched by the Union Health ministry in this regard to enhance case detection, reduce diagnostic delays, and improve treatment outcomes, particularly among high-risk groups.
Source: bit.ly/49qNnXb

5. The USFDA is considering a ban on Red 3, a synthetic food dye linked to potential health risks, including cancer and behavioural issues in children. This decision follows increasing public pressure and legislative actions in several states, including California, which has already prohibited the dye in food products. The FDA aims to act on a petition to revoke Red 3’s authorization in the coming weeks, reflecting growing concerns over food safety standards in the U.S.
Source: bit.ly/3Vvxed0

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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. 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. 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