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 apex food regulator, Food Safety and Standards Authority of India (FSSAI) has reportedly commenced initiatives to frame guidelines for the safety and labelling of lab-grown meat, …
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’s National Task Force (NTF), panel of eminent doctors constituted to make an action plan for ensuring the safety of healthcare workers, has opined that …
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 …
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 Environment, Forests, and Climate Change has notified the E-Waste (Management) Second Amendment Rules, 2024. The amended rules outline actions to be taken in the …
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 Standards Authority of India, now requires linking of new licenses with the Permanent Account Number (PAN) of the applicants, additionally …
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 FSSAI has issued an advisory urging Food Business Operators (“FBOs”) to ensure compliance with the Hon’ble Supreme Court’s decision in IMA & Anr vs Union of …
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 …
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 National Pharmaceutical Pricing Authority (NPPA) has directed drug manufacturers to reduce the maximum retail price (MRP) of three crucial cancer drugs i.e., Trastuzumab Deruxtecan, Osimertinib, and …
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 …
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 clarified that producers of plastic packaging in the micro & small category do not have to EPR fulfill obligations with …
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 government has expanded the definition of Homeopathic medicine, to include all drugs except those drugs “which is administered by injectable route”. Source: bit.ly/48C6E7n 2. The government …
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 …
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 ministry of environment, forest and climate change has recently issued an office memorandum stating a revised list of high end and high value used / refurbished …
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 Textiles has further extended the timeline for the implementation of the Medical Textiles (Quality Control) Order, 2023. The new deadline is now 1st January …
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 new Amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the Food Safety and Standards Authority of India (FSSAI) has …
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. Export samples of “Cough Syrup” under HSN code 3004 has been exempted from testing by the Directorate General of Foreign Trade (DGFT) provided they are being exported …
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 …
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 Health Ministry (MoH&FW) is considering a proposal to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019 with an aims to reduce animal usage and …
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 …
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 …
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 …
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 Department of Consumer Affairs has requested comments from stakeholders regarding the declaration of units of measurement for the net quantity of food wrapping paper and aluminum …
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 …
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 Food Safety and Standards Authority of India (FSSAI) has waived off the registration fees of hawkers for the grant of registration certificate and renewal of registration …
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 …
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 …
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 …
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, …
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 …
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 …
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 …
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 Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 which will take effect from1st April, 2025.These amended rules outlines the requirements for …
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 …
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 Director General of Foreign Trade has issued a Trade Notice, reducing the amount of export eligible for net-subvention to only Rs. 5 Crore for MSMEs …
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 the Central Drugs Standard Control Organization (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) …
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 Drugs Consultative Committee (DCC) has reportedly recommended to make Sugam portal database of all the products with brand names accessible to the general public to address …
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. Application process for (1) Manufacture/ import a New Drug/ formulation, or conduct clinical trial, (2) Manufacture/ import of new bulk drug substance, and (3) Import of finished …
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 …
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 …
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 Department of Pharmaceuticals (DoP) released the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) providing guidelines to medical device companies for regulating monetary and non-monetary …
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 government has made it mandatory for students pursuing medical education in Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, and Homoeopathy (AYUSH) to clear the …
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 Government of India, reportedly plans to establish a distinct category for advanced coronary stents and increase its ceiling price. This change is intended to ensure that …
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. Due to a recent spike in cases, the Karnataka Government has declared dengue as an “epidemic” and to that effect has issued a notification under the Karnataka …
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. Pharmaceutical companies will have to submit details of their expenditures incurred on sponsoring activities to the medical professionals within two months after the end of each financial …
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) is set to develop guidelines for the safe disposal of pharmaceutical waste which are expired and unused drugs and medicines, to curb …
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 has stayed the repeal of Sec. 170 of the Drugs, Rules 1945 which regulated Advertisement of AYUSH products by the AYUSH Ministry, to address …
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. Use of artificial yellow food coloring ‘Tartrazine’ in food items like moong dal is not food adulteration as ‘Tartrazine’ is a permitted food coloring under the Prevention …
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. All medical practitioners (doctors) who practice modern medicine will have to mandatorily register on the new National Medical Register established by the National Medical Commission. Source: bit.ly/3YYlPoE …
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, Food Safety and Standards Authority of India (FSSAI) has said that it is misleading to differentiate milk and milk products on whether they …
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 pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports. Source: bit.ly/3MAGjg9 …
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. India’s Environment Ministry has proposed to introduce extended producers responsibility for scrap of non-ferrous metals by way of amendment to Hazardous and Other Wastes (Management and Transboundary …
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 Drug Controller in Kerala has reportedly stated that there is no objection to display discount on flex board of retail drug stores. However, all retail drug …
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. A national association of medical professionals, the Indian Medical Association has declared a 24-hour nationwide withdrawal of non-emergency services from 6 a.m. on 17th August, 2024 to …
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 State Excise Department of Orissa has recently issued a notification to declare separated leaves of the Cannabis plant, also referred to as Bhang, as “intoxicant” under …
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 number of cosmetic products which can be added to a single application for the import registration certificate of cosmetics has been limited to fifty (50) products …
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 Ministry of Agriculture and Farmers Welfare of India has issued Millets Grading and Marking Rules, 2024 (“Millet Rules”) which regulates packing, marking and labelling of millets …
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. Doctors can sell medicines to their patients without obtaining a separate license for selling drugs after complying with all the conditions specified under the Drugs Rules, 1945: …
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. A leading pharmaceutical association reportedly has urged the Indian government to implement a predictable drug pricing policy by refraining from using Para 19 of the Drug Pricing …
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. India’s Central Board of Indirect Taxes and Customs (CBIC) has restored the concessional 10% import duty on lab chemicals starting August 1, with the condition that the …
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. India’s Health Minister has reportedly confirmed that Central Drugs Standard Control Organization (CDSCO) will be the sole regulator of veterinary medicines in India and there is no …
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 …
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. Mere title of a person within an organization such as Managing Director/ CEO does not automatically make the person criminally liable for offence committed by Company under …
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. A Missouri State Court has directed a multinational healthcare company to pay $495 million in damages over its specialised formula for premature infants which caused a girl …
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. A Public Interest Petition has been filed in the Delhi High Court, highlighting the need to require the use of verifiable Digital Signature on medical records and …
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. In its recent annual Budget announcement, the central government has proposed to waive customs tariffs on three additional drugs, used in treatment of cancer. Source: bit.ly/4dinoSC 2. …
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 Union Health Ministry of India has been allocated a budget of Rs 90,958.63 crore for the financial year 2024-2025 in the Parliament’s interim Union Budget 2024 …
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. India’s Environment Ministry is planning to exempt white category industries i.e., low environment risk industries from the requirement to obtain consent before establishing and operating an Industry …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. Multinational Pharmaceutical Companies in India have reportedly sought relaxation of mandatory 50% cut in price of essential medicines after expiry of patent on ground that it hinders innovation. Source: bit.ly/4bWhHIN 2. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued directions to the effect that if any food sample …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. India’s Central Food Regulator the Food Safety Standards Authority, has introduced registration process for direct sellers to differentiate from Retailers, and make it easier to preserve exemption granted from regulation to direct sellers. Source: bit.ly/4feuedl 2. The Kerala High Court in following with a recent decision of the Punjab High Court has held …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. India’s drug regulator will implement the mandate of printing of QR codes to curb counterfeiting. The top-selling brands have reportedly said that they have already started integrated QR codes and bar codes for tracking and compliance checks. Source: bit.ly/4d80PzG 2. Indian Health Ministry has issued draft rules under the Drugs and Cosmetics Act, 1940 …
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 …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. The Supreme Court has issued its decision in a matter concerning the legality of exercise of powers by the National Pharmaceutical Pricing Authority (NPPA) in levying overcharging fees against an entity that claimed not to be a “distributor” or a “dealer” as defined under the Drugs (Prices Control) Order, 1995, since it had a …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. India’s Consumer Affairs Ministry’s is proposing to amend labelling and packaging regulations for pre-packaged goods. Currently, certain large packages, like those exceeding 25 kilograms or liters, are exempt from displaying crucial information. This includes details like the maximum retail price (MRP), the date by which the product should ideally be consumed (best before date), …
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 …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. The Indian Government has informed the Delhi High Court that it has been unable to notify rules for regulation of online sale of medicines. The Delhi High Court will now proceed to decide the legality of online sale of medicines in India. Source: bit.ly/4cZRrOJ 2. A Swiss Biotech MNC has successfully obtained an …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. India’s Supreme Court has reportedly asked the Ministry of Information and Broadcasting to appropriately modify the self-declaration requirement imposed by the Supreme Court on all advertisements, such that the consumers remain protected against misleading advertisement, but the industry is not overly inconvenienced in the process of complying with the self-declaration requirement. Source: bit.ly/3xYqk7C 2. …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. India’s central food regulator has approved a proposed Amendment to the Food Safety Standards (Labelling and Display) Regulations, 2020, to now indicate the per-serving Recommended Dietary Allowances, sugar, salt and sodium content in larger font. Source: bit.ly/4bB3IYw 2. Association of Indian Medical Device Industry has requested the Ministry of Finance to increase the import …
TOP 5 HEALTH LAWS AND POLICY UPDATES
1. The Madras Court in a recent order, held that the current status-quo regarding online sale of Drugs i.e. sale being facilitated only through licensed chemists and pharmacists shall prevail, until either the Central Government frames rules or the Delhi High Court issues further orders/judgment. Source: bit.ly/45Uxfv2 2. The Jharkhand High Court has reaffirmed precedent …
TOP 5 HEALTH LAWS AND POLICY UPDATES
The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024. Source: bit.ly/3RXnx5t The Central Pollution Control Board …
TOP 5 HEALTH LAWS AND POLICY UPDATES
In order to procure equipment from foreign manufacturers, by floating a Global Tender Enquiry for any procurement up to INR 200 Crore, normally the concerned ministry is required to seek prior approval, and that too in exceptional circumstances. This requirement has now been exempted for certain medical devices upon request by the Ministry of Health …
TOP 5 HEALTH LAWS AND POLICY UPDATES
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 July 31st, 2024. The prior date for filing the self-declaration was June 30th, 2024. Source: bit.ly/4coX09h The Central Drugs Standard Control Organization (CDSCO is considering making the international nomenclature of cosmetic …
TOP 5 HEALTH LAWS AND POLICY UPDATES
The Central Drugs Standard Control Organization (CDSCO) may initiate the process of developing a guidance document that will outline methods for the safe disposal, collection, storage, and transportation of unused and expired drugs in accordance with various international recommendations. This follows a recent modification to Schedule M of the Drug Rules, which outlines standards for …
TOP 5 HEALTH LAWS AND POLICY UPDATES
India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment. Source: bit.ly/4cgRsxK India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for …
TOP 5 HEALTH LAWS AND POLICY UPDATES
The US Food and Drug Administration (FDA) has finalized guidance on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The latest guidance extends the US FDA’s existing inspection standards for drug manufacturing companies to include device manufacturing companies as well. Source: bit.ly/3XCVD2s The Department of Pharmaceuticals (DoP) expanded its committee …
TOP 5 HEALTH LAWS AND POLICY UPDATES
India’s Central Consumer Protection Regulator has issued draft Guidelines for Prevention and Regulation of Unsolicited and Unwarranted Business Communication, 2024 for public consultation and suggestions till 21st July, 2024 Source: bit.ly/4cdCxV0 India’s Consumer Protection Regulator is in discussion with electronic manufacturers to change the warranty period of electronic appliances from purchase date to installation date …
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. Absence of essential medicines in a hospital constitutes medical negligence India’s National Consumer Dispute Redressal Commission (NCDRC) has held that absence of an essential injectable medicine within the …
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. NOC for the manufacture of unapproved drugs meant for export will be issued by the Central Drug Regulator India’s Central Drug Regulator (CDSCO) will be the competent authority …
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. Indian Drug Manufacturers will have to put in place prompt and effective recall procedure soon At a meeting called by India’s Health Ministry with drug manufacturers, the Ministry …
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. Manufacturers of Ayurvedic Drugs cannot claim “Certified by” or “Approved by”: Ministry of AYUSH India’s AYUSH Ministry has reportedly issued a warning to all ayurveda, siddha, unani and …
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. New Framework to be created to separately regulate prices of Medical Devices In response to demands from industry associations, India’s Central Drug Price Regulator, the National Pharmaceutical Pricing …
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. Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions India’s Supreme Court has laid down the situations in which a patient’s claim for …
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. India’s Supreme Court extends scope of misleading advertisement review to multinational and domestic FMCG manufacturers, doctors In a proceeding against a major Ayurvedic products manufacturer for publication of …
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. Strict quality checks to be done by the food regulatory authority of powdered spices in India Food Safety and Standards Authority of India (FSSAI) has announced plans to …
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. Insurance Regulator Removes Barrier to offering Insurance Policy to Senior Citizens among other underserved demographics India’s Central level Insurance regulator the IRDAI has recently issued the Insurance Regulatory …
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. Indian Government may introduce Digital Competition Bill before the Parliament in November 2024 In an effort to curb anticompetitive conduct in the digital marketplace, the Indian government may …
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. Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect The Central Government has recently published a draft …
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. Draft GDP guidelines for pharmaceutical products published for comments India’s Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document titled “Guidelines on good distribution practices …
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. Guidance for making regulatory applications for biological and biotechnology products such vaccines may be revised soon India’s central drug regulator, Central Drugs Standards Control Organization (CDSCO), has issued …
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. Manufacturers of tobacco products required to register their packing machine(s) with tax authorities India’s Central Board of Indirect Taxes and Customs (CBIC) has postponed the timeline for manufacturers …
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. Delay condonation should be evaluated based on reasons provided and not merits of case: Supreme Court In a recent decision, the Supreme Court held that in condoning delay for a filing …
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. Environmental Compensation Guidelines for Plastic Waste Published India’s Central Pollution Control Board (CPCB) has issued guidelines for the assessment of Environmental Compensation (EC) for violation of The Plastic …
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. Indian Government may soon have to explain why traditional medicines are outside the scope of its flagship Universal Health Coverage scheme, or include it India’s Delhi High Court …
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. Indian government intends to create a new AI law to protect news publishers’ rightsThe Indian government plans to introduce a new artificial intelligence (AI) law that will safeguard …
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. No significant hike in prices of essential medicines: Indian GovernmentIndia’s Ministry of Health and Family Welfare has issued a clarification in response to reports about the significant increase …
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. E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory …
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. Supreme Court of India pulls up State Licensing Authority for failing to take action against misleading advertisements by leading ayurvedic manufacturerIndia’s Central Ayush Ministry recently filed an affidavit …
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. Corporate hospitals may soon have to comply with advertisement norms applicable to doctors India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the …
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. Star-rating for energy efficiency on white goods to be under stricter government regulation Indian Government may reportedly introduce rules for non-branded products to validate star rating for energy …
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. Criminal prosecution for drug related offences can start only on the basis of a drug inspector’s complaint: Supreme CourtIndia’s Supreme Court has confirmed that only a drug inspector, …
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. All manufacturers, importers and brand owners of products using plastic packaging must register by 31st March 2024 with Pollution Control Board India’s Pollution Control Board has given a …
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. Good Distribution Practices may be implemented in India for pharmaceutical products soonIndia’s Drugs Consultative Committee (DCC) has recommended that draft of revised Good Distribution Practices (GDP) guidelines for …
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. Body massagers cannot be ‘sex toys’ just because they can have alternative use: High Court In a recent ruling, the Bombay High Court has held that body massagers cannot be …
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. Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facilityThe Indian government is reportedly reconsidering its decision to act against …
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. Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCOThe Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has …
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. Prior Government approval not necessary for using unreliable or untested artificial intelligence (AI) in IndiaIndia’s Ministry of Electronics and Information Technology (MeitY) has revised its controversial advisory 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. Hospitals and pharma companies in India bought electoral bonds worth 9 billion RupeesIndian hospitals and pharma companies have reportedly bought electoral bonds for approximately Rs. 900 crore. Electoral …
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. Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: GovernmentThe Secretary, Department of Pharmaceuticals, has reportedly said that the …
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. New marketing code for pharmaceutical companies notified; Pharmaceutical Associations to set up dedicated portal for handling complaints of violationsThe Department of Pharmaceuticals has notified Uniform Code for Pharmaceutical …
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. 𝐃𝐨𝐜𝐭𝐨𝐫 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐯𝐢𝐜𝐚𝐫𝐢𝐨𝐮𝐬𝐥𝐲 𝐥𝐢𝐚𝐛𝐥𝐞 𝐭𝐨 𝐩𝐚𝐲 𝐜𝐨𝐦𝐩𝐞𝐧𝐬𝐚𝐭𝐢𝐨𝐧 𝐞𝐯𝐞𝐧 𝐢𝐟 𝐡𝐢𝐬 𝐚𝐝𝐯𝐢𝐜𝐞 𝐰𝐚𝐬 𝐩𝐫𝐨𝐩𝐞𝐫 𝐛𝐮𝐭 𝐰𝐚𝐬 𝐧𝐨𝐭 𝐟𝐨𝐥𝐥𝐨𝐰𝐞𝐝 𝐛𝐲 𝐡𝐨𝐬𝐩𝐢𝐭𝐚𝐥 𝐬𝐭𝐚𝐟𝐟: 𝐍𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐬𝐮𝐦𝐞𝐫 𝐂𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧India’s apex consumer forum, the …
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. Airlines have to obtain single caterer license and provide invoice containing description of license number for chargeable in-flight mealsIndia’s food regulator, The Food Safety and Standards Authority of …
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. Surgical gloves and single-use medical gloves to be under Quality ControlIndia’s Department of Pharmaceuticals (DoP) is reportedly considering regulating surgical gloves and single-use medical examination gloves by way …
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. Policy on online sale of drugs to be framed within four monthsIndia’s Delhi High Court has directed the Ministry of Health and Family Welfare to come up with …
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. Discount offered by Pharmacies and Chemist Stores through bill boards and social media will result in action against Pharmacists in MaharashtraThe State-level Council responsible for regulation of Pharmacists …
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. Scientific works are not protected under India’s Copyright Law: High CourtIndia’s High Court of Andhra Pradesh has held that India’s copyright law only protects original literary, dramatic, musical …
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. India takes baby steps in regulation of Artificial Intelligence, puts in place prior consent requirement before deployment of AIIndia’s Ministry of Electronic & Information Technology has reportedly advised …
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. State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplaceA State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of …
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. India announces completion of Genome Sequencing ProjectThe Department of Biotechnology (DBT) has announced the completion of the Genome India Project, the largest project to sequence 10,000 genomes of …
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. Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisementsIndia’s Supreme Court is reportedly set to issue a Contempt Notice to …
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. Drug manufacturing facility cannot manufacture food products: Central Drugs RegulatorIndia’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to …
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. India’s new criminal law regime to take effect from July 1, 2024The three criminal laws, namely, Bhartiya Nyaya Sanhita, Bhartiya Nagrik Suraksha Sanhita, Bharatiya Sakshya Adhiniyam that will …
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. Guidelines to differentiate brand extension from surrogate advertising issuedIn a meeting with stakeholders, the Department of Consumer Affairs (DoCA) has clarified the difference between brand extension advertisements which …
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. Couples seeking surrogacy will be allowed to use donor gametes only if either partner suffers from a disabling medical conditionIndia’s Ministry of Health and Family Welfare has notified …
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. Greenwashing Regulations Published for CommentsIndia’s Ministry of Consumer Affairs has published the Draft Guidelines for the Prevention and Regulation of Greenwashing, 2024, which seek to regulate the advertisement …
TOP 5 HEALTH LAWS & 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. India’s Competition Watchdog gets new powers to issue interim orders to stop potentially infringing action, until case is finally decidedThe Indian Government has made Section 33 of The …
TOP 5 HEALTH LAWS & 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. Indian Government tacitly endorses use of AI in screening patientsIndia has started a pilot telemedicine project called “Aarogya-Doctor on Wheels”. The unique aspect of the pilot project is …
TOP 5 HEALTH LAWS & 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. Doctor’s failure to co-operate with Drug Administration in disclosing name of manufacturer of drugs found in his possession is unlawful, but does not warrant imprisonment if the quantity …
TOP 5 HEALTH LAWS & 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. Central Drug Regulator to have open-door meetings with Industry twice a weekIn a first, perhaps anywhere in the world, India’s top officer in the Drug Regulator’s office, the …
TOP 5 HEALTH LAWS & 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. New Departmental Guidelines for sampling of Spurious Drugs, Medical Devices and Cosmetics PublishedIndia’s apex regulatory body for drugs, medical devices and cosmetics, the Central Drugs Standards Control Organization, …
TOP 5 HEALTH LAWS & 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. Human Rights body to probe sale of drugs with identical brand names in IndiaThe National Human Rights Commission (NHRC) in India has taken suo motu cognizance of a …
Top 5 Health Laws & 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. Innovator Pharma Company questions biosimilar trial on ground of non-procurement of comparator drug from authorized sourcesA multinational pharmaceutical company has questioned the veracity of a biosimilar drug trial …
Daily Health News Wrap - 01 Feb 2024
01 Feb 2024 Important clarifications issued by Central Pollution Control Board w.r.t. Extended Producer Responsibility (EPR) compliances under E-waste Management Rules, 2022.India’s Central Pollution Control Board (CPCB) has released certain notices and guidance document under E-Waste (Management) Rules, 2022 which have a significant impact on EPR obligations. Sources: – FAQ for E-waste: bit.ly/3HHuiCU Fee Structure …
Rounding-off Principles for Drugs and Medical Devices under Drugs (Prices Control) Order, 2013
In this article, we have discussed rounding-off principles that manufacturers and importers of drugs and medical devices should follow while determining the maximum retail price (MRP) of their products. What is rounding-off?Rounding-off refers to adjusting a fractional price of a drug or medical device to the nearest rupee, or the nearest paisa, depending on the …
PERMISSIBLE PRICE INCREASE AND CALCULATION OF OVERCHARGED AMOUNT UNDER DRUG PRICES CONTROL ORDER (DPCO)
The Division Bench of the High Court of Delhi, in the case of Union of India v Bharat Serums, has laid down how the overcharged amount should be calculated by India’s drug price control regulator, National Pharmaceutical Pricing Authority (“NPPA”). The judgement will have a significant impact on existing as well as future demands for …
Frequently Asked Questions on the New Menu Labelling Requirement for Food Service Establishments in India
The packaging and labelling of food items served in a food service establishment in India is regulated by The Food Safety and Standards (Packaging and Labelling) Regulations, 2011 (“Regulations”). The Regulations were amended in August 2020 to introduce the concept of menu labelling for the first time in India. Menu labelling means the process of …
All fertility and surrogacy clinics in India now required to obtain registration under new law
Starting April 22, 2022, all fertility clinics, gamete banks and surrogacy clinics across India will have to commence the process of applying for registration with the National ART and Surrogacy Registry. The Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 (which, for the sake of convenience, will be collectively referred to …
Pricing Information of Medical Devices Marketed in India to be Submitted to National Pharmaceutical Pricing Authority (NPPA) by March 10, 2021
India’s medical device price regulator has issued a direction to importers and manufacturers of 24 categories of medical device to submit price-related information, including the price at which they sell medical devices to distributors and hospitals in India, by March 10, 2021. Background In India, medical devices are regulated not just for quality, but also …
Legal Considerations for Awareness Campaigns on Persons with Disabilities in India
Across the world, December 3 is observed as the International Day of Disabled Persons. The United Nations has designated it as a day that “aims to promote the rights and well-being of persons with disabilities in all spheres of society and development, and to increase awareness of the situation of persons with disabilities in every …
Legality of use of CBD Oil in India, and why NDPS Act does not apply to it
Recreational use of Cannabis (Ganja) and its resin (Charas or Hashish) was outlawed in India in 1985 by the Narcotic Drugs and Psychotropic Substances Act, 1985 (“NDPS Act”). The NDPS Act itself was the result of India’s commitment under the Single Convention on Narcotic Drugs, 1961 (“Single Convention”). Interestingly, neither the NDPS Act nor the …
Indian Law on advertisement of brand extensions of alcohol and tobacco products and how it poised to become tougher
India’s Ministry of Information & Broadcasting (MIB) recently put out an advisory for private satellite TV channels to ensure that liquor, tobacco and other intoxicants are not advertised directly or indirectly on their channels in violation of existing law, i.e. the Cable Television Network Rules, 1995 (CTNR). Under CTNR, satellite TV channels are prohibited from …
Draft risk classification of all yet-to-be regulated medical devices and IVDs in India published, comments invited until Oct. 2
In February of this year, India’s Health Ministry had notified a new definition of medical devices with an intent to bring all medical devices under the purview of Medical Devices Rules, 2017 (MDR). Prior to such notification, only 37 categories of medical devices that it had notified were regulated by MDR. The new definition took …
Dedicated portal for online filing of consumer grievances under new consumer protection law in India now live
The Consumer Protection Act, 2019 (CPA) was enforced on July 20, 2020 and it replaced the decades old The Consumer Protection Act, 1986. One of the key features of the CPA is the option with consumers to file a complaint electronically. The portal where consumers can file their complaint electronically is now live at the …
Legality of making COVID-19 defence or immunity claims in India
India’s central drug regulator, the Drugs Controller General of India, has reportedly served a notice on a major FMCG company in India to explain why action should not be taken against it for making a misleading claim that its hand sanitizer is a “immunity booster” and that it “kills inactive coronavirus”. This points to an …
New Consumer Protection law in India: A Simple Overview (Seller Beware!)
On July 20th, 2020, the new Consumer Protection Act, 2019 came into force in India, replacing the previous enactment of 1986. The new Act overhauls the administration and settlement of consumer disputes in India. It provides for strict penalties, including jail terms for adulteration and for misleading advertisements. More importantly, it now prescribes rules for the …
Alcohol-Based Hand Rubs and Sanitizers - Regulatory requirements, uncertainties and important considerations for doing businesses in India
Summary: Due to the sudden spurt of demand for hygiene products due to COVID-19 virus pandemic, several manufacturers and marketers in India are now selling hand sanitizers containing ethanol or isopropyl alcohol as an active ingredient. However, regulatory uncertainties, especially surrounding requirement of drug license for stock and sale and scope of price control are …
India’s new price regulation for medical devices and equipment – impact on price and supply chain due to Drugs (Prices Control) Order, 2013
Summary On February 11, 2020, the Indian Government had gazetted a notification that brought all medical devices and medical equipment sold in India under existing quality and safety regulatory framework by declaring them as “drugs”. However, this notification has exposed all medical devices to India’s drug price control regulation that was put in place to …
India’s new Telemedicine Practice Guidelines – Analysis and Do’s and Don’ts for Doctors offering teleconsultation
Summary: The Indian Government has published Telemedicine Practice Guidelines (“Telemedicine Guidelines”) on March 25, 2020. These guidelines finally clarify India’s position on the legality of teleconsultation. It is now perfectly legal to provide teleconsultation by registered medical practitioners (M.B.B.S and above) in line with the requirements of the Telemedicine Guidelines. It has been clarified that …
All medical devices in India to be regulated as “drugs” – Medical Devices (Amendment) Rules, 2020
Summary: The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020. Prior to the amendment, only 37 categories of medical devices were regulated or were notified to be regulated in near future in India. The immediate consequence of …
All medical devices to be regulated: Draft rules notified in India
The Ministry of Health and Family Welfare in India has notified the Draft Medical Devices (… Amendment) Rules, 2019 (Draft Rules) for public comments on October 18, 2019. By notifying these rules, the Indian Government has made its intention clear to regulate all medical devices in a phased manner. As of date, only twenty-three categories …