Arogya Legal- Health Laws Specialists Law Firm

Top Health Laws & Policy Updates 28 November 2024 #Plastic #PIBOs #ShowCauseNotice #EC #CPCB #Notification India's Central Pollution Control Board (CPCB) has issued a Show Cause Notice to Producers, Importers, and Brand Owners (PIBOs) of Plastic Packaging for non-compliance with the Plastic Waste Management Rules, 2016. PIBOs must file their Annual Report and pay Annual Processing Charges for the FY 2023-24 to fulfill their Extended Producer Responsibility (EPR) obligations by 30th November 2024 to avoid levying of environmental compensation under the Environmental (Protection) Act, 1986. Source: bit.ly/3Zs0XWY   #Import #HSN #DGFT #ITC #Notification India’s Directorate General of Foreign Trade (DGFT) has amended ITC (HS) 2022, Schedule-I (Import Policy), to align the latest tariff schedules and the Finance Act 2024 (No. 2 of 2024). The changes include updates to ITC (HS) codes through additions, deletions, amendments, splits, and mergers, aimed at streamlining import regulations, clarifying compliance standards, and fostering ease of doing business in international trade. Source: bit.ly/3ZrYaNm   #Food #Timelines #Offence #HC #Litigation India's Allahabad High Court has ruled that under the Food Safety and Standards Act, 2006 (FSS Act 2006), an offence will be considered to have occurred when the food analyst's report confirming the violation is received, rather than when the food sample was collected by the Food Safety Officer. The ruling clarifies the timeline for initiating legal action under the Act. Source: bit.ly/3Vc5hqA   #Tax #GSTN #NewApp #B2B #Notification India’s Goods and Services Tax Network (GSTN) has issued an advisory informing taxpayers about the launch of a new e-Services app, replacing the old e-Invoice QR Code Verifier app. The new app offers features like scanning QR codes to verify B2B e-invoices, provides GSTIN search functionality and most up-to-date information regarding approved B2B e-Invoice. Source: bit.ly/4i7crX3   #Health #HSA #HealthProducts #OffList #Policy The Health Sciences Authority (HSA) of Singapore has taken action to combat the illegal sale and distribution of health products by removing over 3,000 unauthorized health products listings from local e-commerce and social media platforms. In the course of this operation, the authority has issued 1,471 warnings to sellers in an effort to safeguard consumers from substandard or counterfeit products. Source: bit.ly/4ic7gF8

Top Health Laws & Policy Updates 27 November 2024 #EnvironmentalProtection #CPCB #HazardousWaste #Quarterly #Filings #Deadline #Extension #Regulation India’s Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022. Source: bit.ly/49ahqlK   #ConsumerProtection #Consumer #Forum #Unfair #Trade #Practice #SubStandard #Product #Return #Litigation A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected. Source: bit.ly/417xJxQ   #Healthcare #MedicalProfession #DelhiMedicalCouncil #Allopathy #Registration #Dentists #AestheticSurgery #Ineligible #Policy In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary. Source: bit.ly/3ZbT0Ur   #IntellectualProperty #India #Treaty #DesignPatent #Protection #Riyadh #DesignLaw #Treaty #International #Law After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.  Source: bit.ly/3CXRxcH Source: bit.ly/4f5AYJz   #PublicHealth #US #Tobacco #Label #Warning #Visual #Challenge #Litigation The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets. Source: bit.ly/415u1EU

Top Health Laws & Policy Updates 26 November 2024 #Food #OnlinePortal #Alerts #Rejection India’s apex food regulator, Food Safety Standard Authority of India (FSSAI), has launched an online portal “Food Import Rejection Alert (FIRA)” for alerts on food import rejections and to ensure traceability and transparency. Also, food consignments from Sri Lanka, Bangladesh, Japan, China & Turkey has been rejected as they fell short of the standards. Source: bit.ly/49aLJIT   #MedicalDevices #Clearance #Disruptions #Report Delay in clearance of import consignments of essential components has reportedly resulted in the disruptions in the manufacture of medical devices in India. Source: bit.ly/3OpyhHx   #MedicalDevices #BIS #Standards #Policy India’s National Standards Body, Bureau of Indian Standards (BIS) to reportedly prioritize development of standards for 214 critical medical devices post consultation with the Department of Pharmaceuticals (DoP). Standards set to be completed by December 2025. Source: bit.ly/3B2ZtZJ   #Environment #Plastic #Ban #Litigation India’s Meghalaya High Court has called for ban on manufacture, marketing and use of plastic of less than 120 microns. Source: bit.ly/3Z4VT9C   #MedicalDevice #Sterilization #EtO #SiteChange #US #Policy The US Food and Drug Administration (FDA) has announced a temporary enforcement policy to enable certain sterilization site changes for Class III medical devices that are sterilized using ethylene oxide (EtO). Affected medical device manufacturers requesting enforcement discretion must submit an “informal notification” along with certain information to FDA. Source: bit.ly/3OpairY Source: bit.ly/3Zpx6OT

𝐇𝐚𝐩𝐩𝐲 𝐍𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐋𝐚𝐰 𝐃𝐚𝐲! On this significant day, we celebrate the spirit of the Constitution and the core values of justice, equality, and the Rule of Law. At Arogya Legal, we take immense pride in our team’s dedication, hard work, and unwavering commitment to excellence. Together, we believe in upholding the principles of law, fairness, and justice, making a real difference every single day. Let’s continue striving for justice and fairness together. #NationalLawDay #ProudTeam #ConstitutionDay #ArogyaLegal #SamvidhanDivas #26thNovember Anay Shukla, Anil Upadhyay, Saloni Kedia, Bhumika Sehgal, Shriya Pandita, Shabnam S., Tanya Kanchan Soni & Sairam Kaushik

Top Health Laws & Policy Updates 25 November 2024 #Healthcare #MedicalNegligence #Compensation #EyeSurgery #Litigation A State Consumer Disputes Redressal Commission (SCDRC), Punjab has exonerated a private eye hospital from medical negligence allegations, finding no evidence that surgery was performed on the patient. The commission ruled that the claims were unfounded, thus dismissing the case against the hospital with no liability for damages. Source: bit.ly/499Wxr0    #DelhiHighCourt #Guidelines #Doctors #DigitalSignature The Delhi High Court has requested that the government create clear guidelines regarding doctors' digital signatures on medical documents in order to reduce the use of unauthorized and fraudulent signatures in medical practices and to make clear the legal and regulatory implications of using digital signatures in healthcare. Source: bit.ly/3YWXD4A   #Food #Drug #Safety #GlobalStandards #BFDA India’s Finance Minister, Nirmala Sitharaman has proposed to establish the creation of Bharat Food and Drug Administration (BFDA) to set global benchmarks for food and drug safety, similar to the US FDA. The emphasis to create such standard is to enhance India's regulatory framework and strengthen its position in the global market. Source: bit.ly/3V9E7Rb   #Drugs #Regulation #Licensing #SLA #CLA #StemCell #GeneTherapy The Indian government plans to amend the Drugs and Cosmetics Rules, 1945 to allow State Licensing Authorities (SLAs) and the Central Licensing Authority (CLA) to issue manufacturing licenses for products derived from stem cells and gene therapies. This move aims to streamline the regulatory process and promote the development of innovative therapies in India, enhancing compliance with global standards. Source: bit.ly/3Os1VMx   #USFDA #MedicalDevice #Clearance #Guidance #ThirdPartyReview The USFDA has finalized guidance for its 510(k) Third Party Review Program, which permits accredited third-party organizations to evaluate specific low- to moderate-risk medical devices for market clearance. The guidance is designed to expedite the review process to enhance efficiency in device approvals, ultimately facilitating quicker access to innovative medical technologies for patients. Source: bit.ly/414wwHC  

Top Health Laws & Policy Updates 21 November 2024 #Cosmetics #DCGI #UnusualClaims #RegulatoryCompliance #Policy The Drugs Controller General of India (DCGI) has directed the cosmetics industry to follow regulatory protocols and warned them against making “unusual and misleading claims” about the product that may overlap with the pharmaceutical sector. During a meeting with the cosmetics industry, the industry stakeholders sought relaxation of strict regulations for imported cosmetics, citing frequent custom rejections and significant financial losses. Source: bit.ly/4eBnhBK   #Pharmaceutical #IPC #PVGuidance #1stFebruary2025 #Notice The Indian Pharmacopoeia Commission (IPC) has announced the implementation of the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs). Version 2.0, will be effective from 1st February 2025. The document aims to strengthen the pharmacovigilance systems of MAHs in India. Source: bit.ly/4hRV1xH   #Pharmaceutical #PCI #ABHA #DIGIPHARMed #Notice The Pharmacy Council of India (PCI) has directed all registered pharmacists to verify their profiles on DIGI-PHARMed portal with their Ayushman Bharat Health Account (ABHA) numbers within 45 days. This verification aims to integrate pharmacists with the Healthcare Professional Registry (HPR). Source: bit.ly/4fOxgVk   #Drugs #IndianDrugMaker #Regulatory #NonCompliance #USFDA #Notice The U.S. Food and Drug Administration (FDA) has issued a warning to an Indian pharmaceutical company for manipulating product data, reports, and relevant details, as well as violating Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Source: bit.ly/491sW2M Source: bit.ly/4i249j5   #Drugs #ChineseDrugMaker #Regulatory #NonCompliance #USFDA #Notice The U.S. Food and Drug Administration (FDA) has issued a warning to a Chinese drugmaker for restricting investigators' access to its facility and records, as well as limiting photography during a recent inspection. The manufacturer received a warning letter outlining significant violations of Current Good Manufacturing Practice (CGMP) guidelines for finished pharmaceuticals. Source: bit.ly/491sW2M Source: bit.ly/4i249j5

Top Health Laws & Policy Updates 20 November 2024 #FSSAI #Guidelines #Regulation #LabMeat #Dairy 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, dairy, and egg products, reflecting a growing interest in sustainable food options within India. Source: bit.ly/490hvIG   #DelhiHighCourt #Trademark #Infringement #Injuction #MisleadingUse The Delhi High Court has granted a renowned food brand an injunction against its competitor for trademark infringement of its brand, which has been registered since 1986. The court determined that the competitor’s use of the mark for products could mislead consumers and harm the reputation of the original band, directing them to cease using the trademark and remove infringing products from e-commerce platforms. Source: bit.ly/4fTj2Cp   #Drugs #DoP #Disposal #Unused #ExpiredDrugs The Department of Pharmaceuticals (DoP) is reportedly developing a 'Disposal Policy' to safely remove unused and expired drugs from sale premises and households, addressing environmental concerns linked to improper disposal. Source: bit.ly/4eFRlfF   #CPCB #SPCB #Direction #LabellingRequirements #PlasticCarryBags The Central Pollution Control Board (CPCB) has issued a direction to all State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs) to enforce Rule 4(h) and 4(ha) of the Plastic Waste Management (PWM) Rules which provides mandatory marketing and labelling compliance for the manufacturers of compostable plastic carry bags or commodities before selling such products in the market. Source: bit.ly/3YXveeD   #CCI #DominantPosition #OptOutPolicy #Fine The Competition Commission of India (CCI) has fined a major tech company ₹213.14 crore for misusing its dominant position over a messaging app's 2021 privacy policy, which forced users to accept new data sharing terms. The CCI found this policy unfair because it didn't allow users to opt out, and it ordered the company to make changes to provide clearer choices about data sharing and better explanations for users. Source: bit.ly/3CxU9Oi

Top Health Laws & Policy Updates 19 November 2024 #Healthcare #SafetyOfDoctors #ActionPlan #Policy 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 there is no requirement for enacting a separate central legislation to protect the doctors as there are already enough legal provisions to ensure their safety. Source: bit.ly/4fVmIDK #Pharma #ExportPolicy #TradeNotice #Policy #Draft India’s Directorate General of Foreign Trade (DGFT) has issued a trade notice to harmonize and streamline pharma export process and bring in line Schedule-II (Export Policy) with the latest tariff codes under the Finance Act, 2024. A draft of Schedule-II covering Chapters 01-98 of the ITC (HS) codes is open for public feedback and comments till 27th November 2024. Source: bit.ly/3Zo7SR3   #Environment #AnnualReturns #AutoFiling #Notification India's Ministry of Environment, Forest, and Climate Change has informed that all registered Producers, Importers, and Brand Owners (PIBOs) under the Extended Producer Responsibility (EPR) regime of Plastic Packaging registered during FY 2022-24 are required to file their Annual Returns (AR) for FY 2023-24 by 30th November 2024. Failure to do so will result in their AR being auto-filed and levy of penalty i.e., EPR targets for FY 2024-25 will be increased by 25% over and above the EPR target for FY 2023-24.  Source: bit.ly/3JqZRBH   #Hospital #DataProtection #Cybersecurity #Report To safeguard patient data and mitigate cybersecurity risks posed by vendor networks, Indian hospitals are reportedly advancing in cybersecurity practices. 89% of hospitals have implemented third-party risk management systems however only 10% hospitals have adopted holistic data privacy programs, underscoring area for improvement. Hospitals are reportedly recommended to allocate 12-15% of their budget over the next two years to cybersecurity and digital infrastructure to remain resilient against cyber threats. Source: bit.ly/3Oj1ggl   #Drugs #Telehealth #US #Extension #Oneyear #Policy The United States Drug Enforcement Administration (DEA) has reportedly extended pre-pandemic telehealth regulations for prescribing controlled substances till 31st December, 2025. This decision allows telemedicine providers to continue prescribing controlled medications without requiring in-person visits, while the agency evaluates public feedback on proposed permanent regulations. Source: bit.ly/3YTYUcK

Top Health Laws & Policy Updates 18 November 2024 #Drugs #CDSCO #Nutraceuticals #Regulation #InterministerialBoard #Recommendation #Policy 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 streamline insurance regulation as well. Source: bit.ly/40QCmfk   #AYUSH #Drugs #Sale #Regulation #ASUDTAB #Recommendation #Policy In its recent meeting, the Ayurveda Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) has proposed to amend the Drugs Rules and regulate the retail sale of AYUSH medicine, which would empower drug inspectors to inspect these premises and collect and examine samples. Source: bit.ly/3Cve0xR   #Cosmetics #CDSCO #Conference #Topical #Manufacture #Policy The CDSCO is set to hold a round-table meeting for all Cosmetics industry stakeholders, including manufacturers and marketers to discuss issues including expansion of permission for cosmetics manufacturers to manufacture topical products. Source: bit.ly/4ey6nDX   #Healthcare #Drugs #SupremeCourt #Doctors #SideEffects #Obligation #Litigation The Supreme Court dismissed a Special Leave Petition filed in response to the decision of the Delhi High Court seeking Order to mandate Doctors to explain side-effects to patients, holding that since there is no obvious issue highlighted with the side-effect information legally required to be presented by manufacturers, it is not necessary to require Doctors to do the same. Source: bit.ly/48WLP70 Source: bit.ly/3UV5MoM   #SupremeCourt #Arbitration #Arbitrator #Appointment #PrimaFacie #Litigation In a recent decision, the Supreme Court held that when examining petitions concerning procedural irregularities under the Arbitration and Conciliation Act, 1996, Courts should limit their examination to merely determining whether a valid arbitration agreement is existing and whether there is a preliminary dispute regarding appointment of Arbitrators. Source: bit.ly/4ezdTP6 

Top Health Laws & Policy Updates 16 November 2024 #Environment #WasteManagement #EWasteRules #Notification 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 event of any non-compliance and violation of the E-Waste (Management) Rules, 2022. Previously, the rules specified prosecution for certain violations such as providing false information, using forged certificates, willfully disregarding directions, or failing to cooperate in verification and audit proceedings along with the imposition of environmental compensation.  Source: bit.ly/4fR1F5c   #Food #Safety #FSSAI #Circular India's Food Safety and Standards Authority of India (FSSAI) has instructed e-commerce Food Business Operators (FBOs) to ensure that food products have a minimum shelf life of 30% or at least 45 days remaining until expiration at the time of delivery to the consumer. The authority also issued a warning against unsupported online claims and reiterated that no FBO can operate on e-commerce platforms without a valid FSSAI license or registration, underscoring the need for regulatory compliance. Source: bit.ly/3Z9lzmA   #Environment #AirPollution #AirRules #Inquiry #Notification India’s Ministry of Environment, Forests and Climate Change has notified the Air (Prevention and Control of Pollution) (Manner of Holding Inquiry and Imposition of Penalty) Rules, 2024. The rules establish the process for holding inquiries, including procedures for issuing notices, determining penalties, and addressing complaints regarding any act in contravention of the Air (Prevention and Control of Pollution) Act, 1981 Source: bit.ly/40Pwt21   #Healthcare #MedicalNegligence #Compensation #NCDRC #Litigation India’s top consumer forum, the National Consumer Disputes Redressal Commission (NCDRC), has awarded a compensation of Rs. 25,000 in a medical negligence case in which the doctor issued an incorrect scan report, demonstrated deficiency in diagnosing the patient’s illness, and provided erroneous test results. Source: bit.ly/4fSYUAF #POSH #AppellateAuthority #InterimStay #Litigation India’s Karnataka High Court has ruled that the Appellate Authority has the implied power to issue an interim stay on the Internal Committee’s report under the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act 2013 (POSH Act). The court observed that the Act does not explicitly prohibit the appellate authority from passing such an order. Since the authority can set aside the impugned proceedings, it also has the implied power to grant an interim stay. Source: bit.ly/4fLZn7u