Top Health Laws & Policy Updates 08 November 2024 #NPPA #Reduction #MRP #CancerDrug #GST #CustomDuty 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 Durvalumab. This is in line with reduction of customs duty and GST rates on these medications. Source: bit.ly/4fBQ3Dd #Pharma #CopyrightInfringement #Label #Injunction Delhi High Court has granted a permanent injunction against a pharma company which had imitated the design and presentation of a drug manufactured by another pharma company. This ruling highlights the requirement for pharma companies to ensure a distinctive packaging to avoid copyright Infringement claims. Source: bit.ly/40AprhH #OnlineDelivery #Restriction #Pharma #PatientSafety #DGCI #AIOCD The All India Organization of Chemists and Druggists (AIOCD) has urged the Drug Controller General of India (DCGI) to restrict a partnership between a rapid delivery platform and an e-pharmacy, citing concerns over regulatory and quality compliance issues that could potentially jeopardize patient safety. Source: bit.ly/4fDJEqS #Drug #Quality #QRcode #Consumer #Information The Himachal Pradesh High Court has directed the state government to implement a QR code system to assess the quality of medicines in the state. This QR code will provide consumers with key information about the medicine, including production and expiry dates, unit details, batch numbers, and component specifics in order to enhance consumer awareness and transparency in medicine quality. Source: bit.ly/3YE20Bw #UK #Launching #Pandemic #WarningSystem #Genomics UK government is set to launch ‘World-First’ Genomics-Led pandemic warning system. The system will utilize the technology to flag and monitor potential outbreaks of bacterial or viral diseases. Source: bit.ly/4fBdyw6
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Top Health Laws & Policy Updates 28 October 2024 #SupremeCourt #MedicalNegligence #Litigation 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 he fails to use his reasonable skill in providing treatment, not because his treatment was unsuccessful. Source: bit.ly/4e2eEzN #FDA #Cosmetics #MisleadingClaims The Food and Drug Administration (FDA), Pune division has seized stock worth ₹1 crore due to misleading claims in two separate incidents. This includes ₹78 lakh worth of toothpaste with anti-inflammatory claims and ₹22 lakh worth of cosmetics with suspicious labels. In both cases, the FDA has alleged a violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the samples have been sent for laboratory analysis. Source: bit.ly/40hcyJa #CDSCO #Drugs #NotForSale India's central drug regulator (CDSCO) has identified a list of 18 drugs declared as Not of Standard Quality (NSQ). The action has come after several states and union territories failed to report NSQ data, prompting the CDSCO to emphasize the need for timely submissions to enhance drug safety oversight. Source: bit.ly/48njBSE #Drugs #CDSCO #Spurious #Counterfeit India's central drug regulator (CDSCO) has identified four drug samples as spurious after drug inspectors in several states inspected them in September. Since the seized batch was not manufactured by the relevant pharmaceutical businesses, the manufacturer reported it as counterfeit. Drug samples are collected from sales and distribution locations as part of ongoing regulatory monitoring, and examined, and a list of spurious drugs is posted on the CDSCO portal once a month. Source: bit.ly/3YqYqdE #Healthcare #Pharmacopoeia #Draft #IPC #Comments To enhance guidelines and standards for the use of disinfectants and antiseptics in healthcare settings, the Indian Pharmacopoeia Commission (IPC) has released a draft of the new general chapter on disinfectants and antiseptics (Version 3.0) for public comments. The last date to submit comments is 8th December 2024. Source: bit.ly/3YmXtmL
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𝐓𝐨𝐩 𝐇𝐞𝐚𝐥𝐭𝐡 𝐋𝐚𝐰𝐬 & 𝐏𝐨𝐥𝐢𝐜𝐲 𝐔𝐩𝐝𝐚𝐭𝐞𝐬 11 𝐉𝐮𝐥𝐲 2024 #Pharma #Drugs #EPharmacies #Regulation #Litigation 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 #Pharma #Biologic #Patent #Infringement #Litigation A Swiss Biotech MNC has successfully obtained an interim injunction against an Indian Biosimilar Manufacturer which will prevent the manufacturer from launching the Biosimilar of Perjeta (Pertuzumab) on ground that it deliberately withheld information about receipt of regulatory marketing approval from the High Court. Source: bit.ly/3zLi9Ms #Healthcare #Hospital #MedicalEquiment #Corruption #Bribery #Litigation India’s apex investigation agency, the Central Bureau of Investigation, has filed a charge sheet alleging violation of India's bribery laws against a cardiologist, senior employees of a medical equipment MNC, and some distributors of medical equipment. The cardiologist was an employee of prominent government hospital and the complaint revolves around the collection of bribes by the cardiologist from medical equipment and stent suppliers for recommending their products to patients. Source: bit.ly/3zy0PdM #Food #PanMasala #Advertisement #Litigation India’s Delhi High Court has upheld the regulation which mandates pan masala companies to display statutory health warnings about the harmful effects of pan masala on 50% space on the front side of the packaging of such products. The Court ruled that the regulation brought in by the government gives effect to the legislative intent of safeguarding the larger public interest, which is paramount, and does not disproportionately impact the rights of the Petitioners. Source: bit.ly/4cWwPHa #Healthcare #Food #Drugs #Misinformation #Regulation #Policy The United States Food and Drug Administration (FDA) releases draft guidance for companies on addressing online misinformation about their approved medical devices and drugs. The draft guidance stipulates that US FDA won't enforce rules restricting promotion and marketing of drugs and medical devices, whenever drug and medical device companies issue specific communications to correct online misinformation about their approved drugs/devices or relevant therapeutic category. Source: bit.ly/4deP3DZ
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Top Health Laws & Policy Updates 26 September 2024 #Drugs #AdverseEvent #Nonserious #Timelines #Guidance The Indian Pharmacopoeia Commission (IPC) and India's Central Drug Authority (CDSCO) have released Version 2.0 of the "Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products” wherein they have extended the timelines to report non-serious adverse events within 90 calendar days from the previous proposed timelines of 30 days. Source: bit.ly/4dctGCs #Drugs #Application #SLA #ONDLSPortal #Policy Drugs Consultative Committee (DCC), which advises the Central and State Governments on uniform implementation of drug laws in India, has reportedly advised all the State Licensing Authorities (SLA) to ensure that all applications are exclusively received and processed through the Online National Drugs License System (ONDLS) portal only. Source: bit.ly/4ejO8Tr #MedicalDevice #UnlawfulSelling #Penalty #Order #Australia The Federal Court of Australia has heavily penalized and ordered one of the leading manufacturers and suppliers of medical devices for unlawfully supplying Infuse Bone Graft Kit without LT Cage. The Australian Register of Therapeutic Goods (ARTG) prevents the supply of Infuse Bone Graft Kit without LT Cage. Source: bit.ly/3XChUMd Source: bit.ly/4dlv5H1 #Health #ClinicalTrials #WHO #Guidance The World Health Organization (WHO) has released guidance on best practices for clinical trials to improve the design, conduct, and oversight of clinical trials in countries of all income levels. The guidance provides recommendations to the national health authorities, regulatory authorities, funders, and others on how to facilitate clinical trials to generate evidence on health interventions in addition to practical concerns. Source: bit.ly/47Fc0hI Source: bit.ly/4ezzQxN #Drugs #Testing #Frequency #Guidelines India’s Central Drug Licensing Authority has reportedly introduced new guidelines to lower the frequency of drug testing for imports from nations like the US, Australia, Japan, Canada, and the European Union, to one sample from every two years' worth of consignments or one sample out of every 20 consecutive consignments, whichever occurs first provided the drug samples maintain a clean record with no quality failures in the last five years. Source: bit.ly/3Bgacjo
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#Thailand: Revised #Compliance on #Drug #Compositons! #ไทย: กำหนดแบบคำขอต่ออายุใบสำคัญการขึนทะเบียนตำรับยา! Thailand’s Ministry of Public Health (MOPH) has updated regulations on the declarations for the #registration drug compositions for imported or manufacturing drugs. A Notification to this effect has been published in the Royal Gazette, January 4, B.E. 2567, under the Ministerial Regulations, on the extension of the Certification, on the registration of drugs compositions, B.E. 2566, under the Royal Enactments on Drugs, B.E. 2560. Under the revised regulations, importers and manufacturers would required to provide declarations on the drug compositions, in the revised document formats prescribed by the MOPH, for approval of extension of the drugs registrations. This Notification is effective January 5, B.E. 2567 (2024) (Analyzed and Summarized by the Author) Acknowledgements: Ministry of Public Health, Thailand #ทะเบียน #แบบ #ขอต่ออายุ #ใบสำคัญ #ตำรับยา #imports #drugs #declaration #กระทรวงสาธารณสุข
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-Delhi HC exempts custom duties on medicines for rare diseases. Custom duties and charges will not be applied to medicines, drugs, and therapies used for treating rare diseases. -False labelling claims will lead to cancellation of license and legal prosecution: FSSAI Follow us here at NKG Advisory Business & Consulting Services Pvt. Ltd. for more intriguing content on Compliance, Regulatory services, and consulting for D2C brands visit our website www.nkgabc.com to know more To start your registration process: Email- navraj@nkgabc.com or call 9711197602 #regulatorycompliance #regulatory #cosmetics #NKGadvisory #insights #product #registration #Compliance #Journey #Business #Success
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The Narendra Modi government's latest move to enforce a mandatory marketing code for pharmaceutical companies signals a significant shift towards transparency and ethical practices. With the prohibition on offering perks to doctors, including travel benefits and gifts, this initiative aims to foster a culture of accountability and integrity within the industry. Under the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), announced by the Department of Pharmaceuticals, adherence to ethical marketing standards is now compulsory, emphasizing the government's commitment to upholding the highest standards. This proactive step, initiated by Prime Minister Narendra Modi in 2019, follows concerns raised regarding unethical practices such as bribery within the industry. By implementing stringent regulations and penalties, the government seeks to promote fair and transparent practices while ensuring the well-being of patients and healthcare professionals. As stakeholders in the pharmaceutical sector, let's embrace this positive change and collectively work towards building a more ethical and transparent industry for the benefit of all. Stay at the forefront of #HealthcareInnovation, #BiotechBreakthroughs, and industry insights. Join us on this informative journey - Follow RESONACLE for your daily dose of impactful news and stay ahead in the world of #PharmaNews and #LifesciencesUpdates! #PharmaceuticalIndustry #EthicalPractices #Transparency #HealthcareIntegrity #ModiGovernment #UCPMP #NarendraModi #HealthcareEthics
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#ayushministry #clinicaltrial #clarification #regulatory #regulatoryaffairs AYUSH MINISTRY clarification letter w.r.t. Supreme Court Order regarding Clinical Trials applicability on AYUSH Drugs.
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Fostering Growth in the Pharma Sector- Reducing Business Compliance Burden!! Unnecessary requirements for renewal of registration for health care devices have been eliminated. For details: https://lnkd.in/dyQAbSt6 #PRMI #RegulatoryReforsms #regulatorycompliance #investinpakistan #pharmaceuticalindustry #promotingdomesticindustry #localmanufacturers #genericdrugs #PakistanPharmaGrowth #HealthcareInnovation #DomesticIndustryRising #RisingDomesticPharma #InnovationInMedicine #HealthcareEvolution Drug Regulatory Authority of Pakistan Ministry of National Health Services, Regulations & Coordination
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The Union Health Ministry's recent notification mandating new manufacturing standards under the revised Schedule M guidelines marks a significant shift towards enhanced drug safety and quality control. This is a clear message to the industry about the government's commitment to patient safety and the integrity of Indian pharmaceuticals on the global stage. The new guidelines necessitate a more transparent relationship with the licensing authority, especially concerning drug recalls and reporting of product defects or production faults. This shift towards accountability is in response to serious concerns raised by a series of overseas incidents linked to Indian-manufactured drugs, which have propelled the government to take decisive action to safeguard the reputation of our $50 billion pharma sector. From a legal standpoint, the emphasis on manufacturers' responsibility to ensure product quality, efficacy, and safety introduces a more stringent compliance landscape. Companies are now required to market products only after obtaining "satisfactory results" from ingredient and final product tests and must retain samples for potential future testing. These steps, while ensuring patient safety, also place a significant operational and financial burden on manufacturers, particularly the small-scale sector, which has voiced concerns over the feasibility of meeting these standards without additional support. For the legal community, this represents an opportunity to guide clients through the complexities of compliance, ensuring that their operations not only meet the current legal standards but are also positioned for resilience and growth in an increasingly quality-conscious global market. https://lnkd.in/dcqWKAfS #india #innovation #health #healthcare #pharma #law #legal #compliances #future
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*Whether Bhang is a prohibited drug as per NDPS Act?* *VIKRAM KUMAR. A_0325_09062024* On bare reading of the provision under Section 2(iii)(a) and (b) that charas and ganja or (c) i.e., any mixture, with or without any neutral material, of any of the above forms of cannabis or any drink prepared therefrom, there is no scientific evidence before this Court to show that the Bhang is prepared out of either charas or ganja or ganja leaves. Since ganja leaves and seeds are excluded from the definition of ganja and no where in the NDPS Act the Bhang is referred as a prohibited drink or prohibited drug. Even the State Government has not made any rules under the NDPS and mentioned about the Bhang as prohibitory drug or issued any notifications in respect of Bhang. {Para 8} 9. It is worth to mention that the Bhang is a traditional drink, most of the people used to drink in North India especially near the Shiva temples and it is also available in Lassi shops like all other drinks. That apart, the said Bhang were sold in the market with branded names. Therefore, until the receipt of forensic science lab report, in order to confirm that this bhang is prepared out of the by the charas or ganja, the Court cannot come to any conclusion that the bhang is prepared out of the substance of ganja. Therefore, at present, I am agreeing with the judgments of the Bombay High Court as well as Punjab and Haryana High Court in the above said decisions that bhang is not covered under the NDPS Act. In the High Court of Karnataka{ Principal Bench at Bengaluru} (Before K. Natarajan, J.) Roshan Kumar Mishra Vs State of Karnataka Criminal Petition No. 6611 of 2022 Decided on August 26, 2022 Citation: 2022 SCC OnLine Kar 1484
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