Blogs, articles and knowledge series from K&G Techlaw Partners.https://kng-sitev4.pages.dev/https://kng-sitev4.pages.dev/blog/medical-devices-amendment-rules-2026-cdsco-licensing-timelines/https://kng-sitev4.pages.dev/blog/medical-devices-amendment-rules-2026-cdsco-licensing-timelines/The Ministry of Health and Family Welfare has proposed reforms to the Medical Devices Rules, 2017, through the draft Medical Devices (Amendment) Rules, 2026, dated 23 June 2026 and notified vide G.S.R. 515(E). The draft does not touch the substantive compliances that govern how a medical device is designed, manufactured, or quality checked. The draft…Thu, 09 Jul 2026 08:26:08 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/jan-vishwas-2-0-act-pharma-industry-impact/https://kng-sitev4.pages.dev/blog/jan-vishwas-2-0-act-pharma-industry-impact/Every few years, a law comes along that does not change what companies must do, but changes what happens to them if they get it wrong. The Jan Vishwas (Amendment of Provisions) Act, 2026 is one of those laws. For pharma, pharmacy and clinical establishment compliance teams, it is worth understanding closely, because it touches…Thu, 09 Jul 2026 07:36:22 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/dpco-amendment-2026-nppa-overcharging-compliance/https://kng-sitev4.pages.dev/blog/dpco-amendment-2026-nppa-overcharging-compliance/On June 30, 2026, the Ministry of Chemicals and Fertilizers notified the Drugs (Prices Control) Amendment Order, 2026 (S.O. 3516(E)), amending the Drugs (Prices Control) Order, 2013 (DPCO). There have been multiple changes introduced by the Drugs Prices Control Amendment Order 2026, which is going to significantly impact the pharma industry. This article will explore…Fri, 03 Jul 2026 13:06:50 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/form-11-drug-import-india-cdsco-2026-proposed-amendment-pharma-companies/https://kng-sitev4.pages.dev/blog/form-11-drug-import-india-cdsco-2026-proposed-amendment-pharma-companies/On 23rd June, 2026, the Ministry of Health and Family Welfare published a draft amendment to the Drugs Rules, 1945, proposing to introduce an acknowledgement-based prior intimation system for import of drugs for analytical and non-clinical testing. The draft replaces the existing Form 11 import license requirement for most drugs imported for testing purposes. The…Wed, 01 Jul 2026 07:14:54 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/schedule-k-amendment-2026-syrup-deletion-india-drug-retail-compliance/https://kng-sitev4.pages.dev/blog/schedule-k-amendment-2026-syrup-deletion-india-drug-retail-compliance/On 9 June 2026, the Central Government notified the Drugs (Fifth Amendment) Rules, 2026 an amendment that, on the surface, removed just one word from a schedule. But that single word, ‘Syrup,’ carried decades of regulatory history, and its deletion from Entry 7 under Serial No. 13 of Schedule K has set off a chain…Sat, 27 Jun 2026 10:56:04 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/schedule-h2-expanded-qr-code-drug-traceability-now-covers-vaccines-antimicrobials-and-anti-cancer-medicines-in-india/https://kng-sitev4.pages.dev/blog/schedule-h2-expanded-qr-code-drug-traceability-now-covers-vaccines-antimicrobials-and-anti-cancer-medicines-in-india/In a landmark move to strengthen drug traceability in India the Union Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945. These amendments significantly expand the ambit of Schedule H2, bringing additional categories of critical drugs under the QR code-based drug track-and-trace framework. What Has Changed in India’s Drug Traceability…Sat, 27 Jun 2026 10:04:20 GMTPharmaceutical, Healthcare & Life SciencesLegal Metrology & Product Compliancehttps://kng-sitev4.pages.dev/blog/why-is-pharmacovigilance-important-cdsco-compliance/https://kng-sitev4.pages.dev/blog/why-is-pharmacovigilance-important-cdsco-compliance/What is Pharmacovigilance? As per the definition of WHO, “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.” So, pharmacovigilance is the process where information related to any side effects or harmful reactions of a drug, vaccine, or medical device is…Mon, 22 Jun 2026 12:52:19 GMTPharmaceutical, Healthcare & Life Scienceshttps://kng-sitev4.pages.dev/blog/medical-device-regulation-india-cdsco-latest-circulars-ivd-updates/https://kng-sitev4.pages.dev/blog/medical-device-regulation-india-cdsco-latest-circulars-ivd-updates/India’s regulatory framework for medical devices and in-vitro diagnostics (IVDs) has seen several important developments in late 2024 and early 2025. Key updates include an expansion of the list of notified medical devices (bringing items like surgical gloves, bandages, and syringes under regulation), revisions to risk-based device classification (with draft lists open for stakeholder feedback),…Fri, 29 May 2026 06:53:42 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/prohibited-drugs-india-nimesulide-chloramphenicol-nitrofurans-drug-law/https://kng-sitev4.pages.dev/blog/prohibited-drugs-india-nimesulide-chloramphenicol-nitrofurans-drug-law/As part of our ongoing legal service India commitment, particularly in the domain of drug law, we bring you a detailed regulatory update on the recent government notifications prohibiting certain veterinary and food-chain drugs. Businesses and practitioners seeking compliance guidance may benefit from consulting a drug law firm India or a tech law partner well-versed…Mon, 25 May 2026 07:55:41 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/indian-pharmaceutical-policy-landscape-pharma-law-firm-india-health-care-law/https://kng-sitev4.pages.dev/blog/indian-pharmaceutical-policy-landscape-pharma-law-firm-india-health-care-law/This chapter gives decision makers and compliance teams a clear, citable map of India’s drug regulatory framework — what laws and rules apply, how approvals work (including imports/exports), how clinical trials are governed, and how price control interacts with market access. For any pharmaceutical company legal advisory India or legal service professional in India advising…Thu, 21 May 2026 06:53:58 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/pharma-medtech-compliance-risk-management-india-cdsco-health-care-law/https://kng-sitev4.pages.dev/blog/pharma-medtech-compliance-risk-management-india-cdsco-health-care-law/Compliance in the Indian healthcare sector operates at the intersection of public health protection, affordability, and industrial regulation. For pharmaceutical and medical device companies, regulatory compliance is no longer confined to licensing and quality assurance; it increasingly encompasses pricing controls, digital traceability, post-market surveillance, and platform-based distribution oversight. As regulatory intensity has grown during 2024–2025,…Mon, 18 May 2026 06:15:41 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/life-sciences-biotech-compliance-india-healthcare-law-firm-legal-guide-2025-2/https://kng-sitev4.pages.dev/blog/life-sciences-biotech-compliance-india-healthcare-law-firm-legal-guide-2025-2/This chapter delves into the evolving regulatory landscape for biologics, biosimilars, biotechnology research, and emerging therapies in India. It highlights core legal frameworks, quality standards, approvals, ethical practices, and future policy directions. For any healthcare legal consultant india or legal service India professional advising life sciences clients, this framework represents one of the most complex…Fri, 15 May 2026 07:25:59 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/deepfakes-synthetic-media-india-it-act-2000-cyberlaw-legal-framework/https://kng-sitev4.pages.dev/blog/deepfakes-synthetic-media-india-it-act-2000-cyberlaw-legal-framework/Introduction The rapid spread of sophisticated content manipulation, largely fueled by Artificial Intelligence (AI) and deep learning, has created an urgent need for new digital governance frameworks worldwide. The fundamental regulatory challenge is twofold: to effectively distinguish between harmless edited media and malicious deepfakes (realistic synthetic content created to deceive), and to balance the critical…Mon, 11 May 2026 06:53:52 GMTArtificial Intelligence & Emerging TechnologiesInformation Technology & Digital Transformationhttps://kng-sitev4.pages.dev/blog/e-pharmacy-digital-health-policies-india-pharmaceutical-law-firm-healthcare-legal-guide/https://kng-sitev4.pages.dev/blog/e-pharmacy-digital-health-policies-india-pharmaceutical-law-firm-healthcare-legal-guide/Objective For any pharmaceutical company legal advisory india or healthcare legal consultant india, this section serves as an essential reference. Equip healthcare, pharma, and med tech stakeholders with a clear, citable map of India’s current framework for online drug sale (e pharmacy), telemedicine, digital health data protection, and platform/intermediary compliance—including what’s in force, what’s still…Thu, 07 May 2026 07:56:33 GMTE-Commerce & Digital HealthcarePharmaceutical, Healthcare & Life SciencesData Privacy, Cybersecurity & Digital Governancehttps://kng-sitev4.pages.dev/blog/fssai-bans-ors-in-food-branding-health-care-law-update-healthcare-legal-consultant-india-guide-2025/https://kng-sitev4.pages.dev/blog/fssai-bans-ors-in-food-branding-health-care-law-update-healthcare-legal-consultant-india-guide-2025/Introduction On 15 October 2025, the Food Safety and Standards Authority of India (FSSAI), issued an Order withdrawing all previous permissions for the use of the term “ORS” with any brand names [1]. Earlier orders dated 14 July 2022 [2] and 2 February 2024 [3] had permitted use of “ORS” as part of a trademark…Mon, 04 May 2026 10:35:12 GMTFMCG, Food & Consumer Productshttps://kng-sitev4.pages.dev/blog/health-ministry-proposes-new-rules-to-differentiate-household-and-hospital-grade-antiseptics/https://kng-sitev4.pages.dev/blog/health-ministry-proposes-new-rules-to-differentiate-household-and-hospital-grade-antiseptics/The Union Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945, introducing a key regulatory distinction under Schedule K between liquid antiseptics meant for household use and those intended for hospital or institutional use. The draft amendment has been notified as G.S.R. 759(E) in the Gazette dated 16…Wed, 22 Apr 2026 09:34:47 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/scientific-promotion-of-pharmaceuticals-products-in-india/https://kng-sitev4.pages.dev/blog/scientific-promotion-of-pharmaceuticals-products-in-india/Scientific Promotion of Pharmaceuticals Products in India Principles for promotion promote medicines in a country after marketing authorizations have been granted in that country. medicines are promoted only for the approved indication(s), consistent with approved prescribing information. Promotional information Consistent with FDA-approved prescribing information (where it includes benefit claims for the medicine). Promotional materials…Mon, 17 Jul 2023 02:54:44 GMTPharmaceutical, Healthcare & Life SciencesAnti-Bribery & Anti-Corruption and Corporate Compliancehttps://kng-sitev4.pages.dev/blog/the-regulatory-filing-ma-for-formulations-in-the-eu/https://kng-sitev4.pages.dev/blog/the-regulatory-filing-ma-for-formulations-in-the-eu/THE REGULATORY FILING MA FOR FORMULATIONS IN THE EU What is the process for regulatory filings for formulations in the EU? What are the costs involved & the usual timeline for approval? Either the European Medicines Agency (EMA) or a national Competent Authority considers the dossier submitted by the applicant and determines whether or not…Mon, 17 Jul 2023 02:08:55 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/the-environmental-social-and-governance-esg-understanding-and-mitigating-the-risk/https://kng-sitev4.pages.dev/blog/the-environmental-social-and-governance-esg-understanding-and-mitigating-the-risk/THE ENVIRONMENTAL, SOCIAL, AND GOVERNANCE (ESG) Understanding and Mitigating the Risk The environmental, social and governance (ESG) landscape is rapidly expanding and becoming increasingly diverse, complex, and risk laden. We are entering a new pivot point for ESG, moving from voluntary to mandatory disclosure of many ESG-related risks, observing a global increase…Sun, 16 Jul 2023 15:04:01 GMTCorporate, Mergers and Acquisitions & Commercial AdvisoryDispute Resolution & Litigationhttps://kng-sitev4.pages.dev/blog/the-doctrine-of-equivalency-explained-and-upheld/https://kng-sitev4.pages.dev/blog/the-doctrine-of-equivalency-explained-and-upheld/The function of patent law is to enable a patent holder to prohibit a third party from making, using, selling, importing, or otherwise violating their rights with respect to a patented invention. Primarily, patents can be classified into three types: utility patents, design patents, and plant patents. Utility patents refer to patents that are…Sun, 16 Jul 2023 05:33:01 GMTIntellectual PropertyDispute Resolution & Litigationhttps://kng-sitev4.pages.dev/blog/compliance-requirements-for-single-use-plastic-guidelines/https://kng-sitev4.pages.dev/blog/compliance-requirements-for-single-use-plastic-guidelines/Compliance Requirements for Single-Use Plastic Guidelines Company must adhere to the Plastic Waste Management Rules, 2016, as amended, which provide the statutory framework for the enforcement of the rules. The Company must comply with the ban on identified single-use plastic items listed below, effective from 1st July 2022: – Earbuds with…Sun, 16 Jul 2023 05:29:54 GMTFMCG, Food & Consumer ProductsRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/dark-patterns-compliance/https://kng-sitev4.pages.dev/blog/dark-patterns-compliance/Dark patterns are exploitative practices used on the internet to deceive consumers. They include actions like adding items to a shopping cart without user consent, changing prices during checkout, and creating false urgency to prompt purchases. The Advertising Standards Council of India (ASCI) has issued new guidelines to combat deceptive…Sun, 16 Jul 2023 05:24:37 GMTE-Commerce & Digital HealthcareData Privacy, Cybersecurity & Digital Governancehttps://kng-sitev4.pages.dev/blog/14-fdcs-prohibited/https://kng-sitev4.pages.dev/blog/14-fdcs-prohibited/14 FDCs prohibited. S.O. 2394(E) The Central Government u/s26 A of the Drugs and Cosmetics Act, 1940 vide SO 2394 (E) prohibited the manufacture for sale, sale, and distribution for human use of drug fixed dose combination of 14 FDCs. This is pursuant to the directions given by the Hon’ble Supreme…Sun, 16 Jul 2023 05:15:21 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/voluntary-code-of-conduct-for-e-pharmacies-in-india/https://kng-sitev4.pages.dev/blog/voluntary-code-of-conduct-for-e-pharmacies-in-india/Key Components of the Code of Conduct: All members commit to hold ourselves to the highest standards and voluntarily commit that our operations shall operate with the following safeguards: Processing of medicines against Prescription Scheduled medicines must be processed only against a copy of a prescription (physical or scanned copy) of a registered…Sun, 16 Jul 2023 05:11:49 GMTE-Commerce & Digital HealthcarePharmaceutical, Healthcare & Life Scienceshttps://kng-sitev4.pages.dev/blog/software-as-a-medical-device-regulatory-compliances/https://kng-sitev4.pages.dev/blog/software-as-a-medical-device-regulatory-compliances/INTRODUCTION The company has developed software medical devices that are supported by AI, with their flagship products being SYmpi and CIE, which cater to the needs of both patients and doctors. They have already received the testing licensing from CDSCO, and are now looking to acquire further clinical trials and other licenses.…Sun, 16 Jul 2023 04:59:12 GMTPharmaceutical, Healthcare & Life SciencesInformation Technology & Digital TransformationArtificial Intelligence & Emerging Technologieshttps://kng-sitev4.pages.dev/blog/registration-of-medical-practitioners-and-licence-to-practice-medicine-regulations-2023/https://kng-sitev4.pages.dev/blog/registration-of-medical-practitioners-and-licence-to-practice-medicine-regulations-2023/Key observations on “Registration of Medical Practitioners and Licence to Practice Medicine Regulations, 2023”. National Medical Commission (Ethics And Medical Registration Board) notification dated 10th May 2023 No. R.15021/04/2022-EMRB-Reg. has notified certain regulations relating to the registration and licensing of Indian medically qualified doctors and foreign medically qualified doctors (“Regulation”). The Regulation…Sun, 16 Jul 2023 04:57:22 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/e-commerce-guidelines-on-ondc/https://kng-sitev4.pages.dev/blog/e-commerce-guidelines-on-ondc/E-commerce Guidelines ON ONDC India’s e-commerce market is projected to grow from $83 billion in 2022 to $150 billion in 2026, according to the FIS 2023 Global Payments Report. In 2019, (https://pib.gov.in/Pressreleaseshare.aspx?PRID=1575760) the Ministry of Commerce & Industry came up with a draft National e-Commerce policy that has been prepared and placed in…Sun, 16 Jul 2023 04:54:58 GMTE-Commerce & Digital Healthcarehttps://kng-sitev4.pages.dev/blog/meit-report-of-committee-b-on-leveraging-ai-for-identifying-national-missions-in-key-sectors/https://kng-sitev4.pages.dev/blog/meit-report-of-committee-b-on-leveraging-ai-for-identifying-national-missions-in-key-sectors/REPORT OF COMMITTEE – B ON LEVERAGING AI FOR IDENTIFYING NATIONAL MISSIONS IN KEY SECTORS Intelligent tools are required to analyse the interaction between treatment, disease variability, gender, age, and other variables. While intuitive understanding just grows among experts. In the absence of analytical tools, patterns cannot be identified easily. Low-cost Medical Screening…Sun, 16 Jul 2023 04:52:31 GMTArtificial Intelligence & Emerging TechnologiesInformation Technology & Digital Transformationhttps://kng-sitev4.pages.dev/blog/compliance-for-wholesalers-and-packers-under-legal-metrology-packaged-commodity-rules-2011/https://kng-sitev4.pages.dev/blog/compliance-for-wholesalers-and-packers-under-legal-metrology-packaged-commodity-rules-2011/COMPLIANCE FOR WHOLESALERS AND PACKERS UNDER LEGAL METROLOGY (PACKAGED COMMODITY) RULES 2011 Following are applicable for AHL under Legal Metrology Act: Dealer: An individual who carries on, directly or else, the business of selling, supplying, buying or distributing any weight or measure for a valuable consideration. “wholesale dealer” in relation to any…Sun, 16 Jul 2023 04:47:31 GMTLegal Metrology & Product ComplianceFMCG, Food & Consumer Productshttps://kng-sitev4.pages.dev/blog/planning-to-introduce-sexual-wellness-toys/https://kng-sitev4.pages.dev/blog/planning-to-introduce-sexual-wellness-toys/PLANNING TO INTRODUCE SEXUAL WELLNESS TOYS PREFACE: Products categorized as sex toys may violate obscenity law under IPC and various other regulations. The sale/import of Sexual Wellness Toys is governed by: The Customs Act, 1962 The Foreign Trade (Development and Regulation) Act, 1992 Information Technology Act 2000. Penal Provisions in case…Sun, 16 Jul 2023 04:44:42 GMTFMCG, Food & Consumer ProductsE-Commerce & Digital HealthcareRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/hiv-testing-laws-and-compliances/https://kng-sitev4.pages.dev/blog/hiv-testing-laws-and-compliances/The Government of India has notified guidelines under Section 46 to carry out the different provisions of the HIV and AIDS (Prevention & Control) Act, 2017. As provided under section 46 of the HIV and AIDS (Prevention & Control) Act, 2017, a total of nine guidelines have been notified. The purpose of…Sun, 16 Jul 2023 04:41:08 GMTPharmaceutical, Healthcare & Life Scienceshttps://kng-sitev4.pages.dev/blog/data-protection-bill-compliance/https://kng-sitev4.pages.dev/blog/data-protection-bill-compliance/DATA PROTECTION BILL COMPLIANCE Amendments to Current Law The Indian government released a new draft of the Digital Personal Data Protection Bill in November 2022. The DPB (Data Protection Bill) will replace the current laws in India that deal with data protection. It will replace Section 43A of the Information Technology Act,…Sun, 16 Jul 2023 04:37:43 GMTData Privacy, Cybersecurity & Digital GovernanceInformation Technology & Digital Transformationhttps://kng-sitev4.pages.dev/blog/privacy-policy-recommendations-for-e-pharmacy/https://kng-sitev4.pages.dev/blog/privacy-policy-recommendations-for-e-pharmacy/Privacy Policy Recommendations for E-Pharmacy Definition of Personal Information: It includes any information which can be used to identify the user directly or indirectly and rejects any data which has been irreversibly anonymised or aggregated. Definition of Sensitive Personal Data or Information: personal information of any individual relating to password; financial information such…Sun, 16 Jul 2023 04:33:11 GMTData Privacy, Cybersecurity & Digital GovernanceE-Commerce & Digital Healthcarehttps://kng-sitev4.pages.dev/blog/artificial-intelligence-in-healthcare-industry-icmr-guidelines/https://kng-sitev4.pages.dev/blog/artificial-intelligence-in-healthcare-industry-icmr-guidelines/Presently, there is NO specific legal regulation in place in India that regulates or guides the development and implementation of AI in healthcare sector. The Indian Council of Medical Research (ICMR) has come up with the country’s first Ethical Guidelines for the Application of Artificial Intelligence in Biomedical Research and Healthcare[1] [“the…Sun, 16 Jul 2023 04:28:35 GMTArtificial Intelligence & Emerging TechnologiesPharmaceutical, Healthcare & Life Scienceshttps://kng-sitev4.pages.dev/blog/advisory-on-digital-prescription/https://kng-sitev4.pages.dev/blog/advisory-on-digital-prescription/ADVISORY ON DIGITAL PRESCRIPTION PRESCRIPTIONS WHERE THE DOCTORS HAVE MENTIONED “SUBSTITUTES ALLOWED” IN THE PRESCRIPTION. Generic drug/medicine: A generic drug is defined as a drug product that is comparable to the brand/reference listed product in dosage in dosage form, strength, route of administration, quality, and performance characteristics, and intended use. Only a…Sun, 16 Jul 2023 04:24:20 GMTPharmaceutical, Healthcare & Life SciencesE-Commerce & Digital Healthcarehttps://kng-sitev4.pages.dev/blog/accessibility-guidelines-across-health-sector-for-persons-with-disabilities/https://kng-sitev4.pages.dev/blog/accessibility-guidelines-across-health-sector-for-persons-with-disabilities/The RPwD Act 2016 requires the Central Government, in consultation with the Chief Commissioner, to establish rules for persons with disabilities to ensure accessibility standards in various areas. Compliance with these standards is outlined in the RPwD Rules under Rule 15. The following guidelines have been notified or are in draft…Sun, 16 Jul 2023 04:17:51 GMTPharmaceutical, Healthcare & Life Scienceshttps://kng-sitev4.pages.dev/blog/key-features-of-the-rights-of-persons-with-disabilities-act-2016/https://kng-sitev4.pages.dev/blog/key-features-of-the-rights-of-persons-with-disabilities-act-2016/KEY FEATURES OF THE RIGHTS OF PERSONS WITH DISABILITIES ACT, 2016 Applicability of RPwD Act, 2016 The RPwD Act, 2016 applies to both government establishments and private establishments. The term “establishment” includes government establishments, which are corporations established under Central or State Acts, authorities or bodies owned, controlled, or aided by…Sun, 16 Jul 2023 04:13:58 GMTCorporate, Mergers and Acquisitions & Commercial Advisoryhttps://kng-sitev4.pages.dev/blog/whether-one-can-sell-and-deliver-cut-strip-medicine-in-india/https://kng-sitev4.pages.dev/blog/whether-one-can-sell-and-deliver-cut-strip-medicine-in-india/The West Bengal drug control administration issued a circular in October 2018 directing all the chemists and druggists in the state to dispense medicines as per the requirement of the consumers, whether it is one tablet or one capsule rather than giving the entire strip of the drug. Giving…Sun, 16 Jul 2023 04:09:07 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/e-shop-shiping-charge-on-sale-of-drugs/https://kng-sitev4.pages.dev/blog/e-shop-shiping-charge-on-sale-of-drugs/Currently, Delivery Charge is shown as “E SHOP SHIPING CHARGE” and is covered under HSN Code — 30049099 — this HSN code is reserved for Pharma products. Is current implementation legal? Whether they are shipping non-pharma products under the same HSN. Further, since HSN code 30049099 is only applicable for “pharma products”,…Sun, 16 Jul 2023 04:04:49 GMTE-Commerce & Digital HealthcarePharmaceutical, Healthcare & Life Scienceshttps://kng-sitev4.pages.dev/blog/track-trace-for-pharmaceutical-products-compliance/https://kng-sitev4.pages.dev/blog/track-trace-for-pharmaceutical-products-compliance/Track & Trace for Pharmaceutical Products compliance Background: Following the recommendation of the drugs technical advisory board, the national drug regulatory body is getting ready to introduce a tracking mechanism and has identified 300 top brands for the purpose on the basis of moving annual total data. The plan,…Sun, 16 Jul 2023 03:55:02 GMTPharmaceutical, Healthcare & Life SciencesLegal Metrology & Product Compliancehttps://kng-sitev4.pages.dev/blog/repacking-of-drugs/https://kng-sitev4.pages.dev/blog/repacking-of-drugs/REPACKING OF DRUGS Important Laws Drugs and Cosmetics Rules, 1945 Drugs and Cosmetics Act, 1940 Repacking of Drugs – Allowed (After Obtaining a license). Drugs – Repacking can be done only for which the license is granted. Repacking will fall under the category of manufacturing – Section 3 (f)…Sun, 16 Jul 2023 03:52:37 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/qr-code-and-anti-counterfeit-measures/https://kng-sitev4.pages.dev/blog/qr-code-and-anti-counterfeit-measures/Applicable Laws on QR Code: The Ministry of Health and Family Welfare, on 14 June 2022, issued a notification vide G.S.R. 448(E) amending a certain rule in the Drugs Rules 1945, for mandating Barcode or Quick Response (QR) code on the label of top 300 brands of drugs from May 1, 2023. The…Sun, 16 Jul 2023 03:50:14 GMTPharmaceutical, Healthcare & Life SciencesLegal Metrology & Product Compliancehttps://kng-sitev4.pages.dev/blog/the-sale-of-h1-drugs-by-e-pharmacy-site-on-the-basis-of-a-narcotics-license/https://kng-sitev4.pages.dev/blog/the-sale-of-h1-drugs-by-e-pharmacy-site-on-the-basis-of-a-narcotics-license/There is no separate definition for the term E-pharmacy, while the term pharmacy has been explained under Rule 64 of the Drugs and Cosmetics Rules, 1945. As per Rule 64- For the purpose of this rule the term ‘Pharmacy’ shall be held to mean to include every store or shop or other place:…Sun, 16 Jul 2023 03:48:04 GMTPharmaceutical, Healthcare & Life SciencesE-Commerce & Digital HealthcareRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/dont-miss-the-bus-eba-guidelines-and-compulsory-implementation/https://kng-sitev4.pages.dev/blog/dont-miss-the-bus-eba-guidelines-and-compulsory-implementation/Don’t Miss the Bus – EBA Guidelines and compulsory implementation. Banking companies and financial institutions have five months before the deadline to bring legacy outsourcing arrangements into compliance with the European Banking Authority “Guidelines on outsourcing arrangements” (“EBA “). In this article, we set out the background and applicability of EBA for…Sun, 16 Jul 2023 03:42:44 GMTBanking, Finance, Payments & InsolvencyInformation Technology & Digital Transformationhttps://kng-sitev4.pages.dev/blog/uniform-code-for-medical-device-marketing-practices/https://kng-sitev4.pages.dev/blog/uniform-code-for-medical-device-marketing-practices/The Medical Device sector in India is an essential and integral constituent of the Indian healthcare sector particularly for the prevention diagnosis treatment and management of medical conditions, diseases, illnesses, and disabilities. it forms an important pillar in the healthcare industry system along with healthcare providers pharmaceuticals and health insurance industry thereby helping achieve the…Sun, 16 Jul 2023 03:40:18 GMTPharmaceutical, Healthcare & Life SciencesAnti-Bribery & Anti-Corruption and Corporate Compliancehttps://kng-sitev4.pages.dev/blog/regulation-of-schedule-k-drugs-in-india/https://kng-sitev4.pages.dev/blog/regulation-of-schedule-k-drugs-in-india/Introduction: The Union Government, vide GSR no 393 (E) dated May 25, 2022, for the first time, proposed to introduce over-the-counter (OTC) drugs in India through an amendment in the Drugs and Cosmetics Rules, 1945 (D&C Rules) to allow their sale in the retail market without the prescription of a Registered Medical Professional (RMP).[1] To…Sun, 16 Jul 2023 03:37:03 GMTPharmaceutical, Healthcare & Life SciencesRegulatory Affairs, Licensing & Government Approvalshttps://kng-sitev4.pages.dev/blog/advertisement-and-promotion-of-pharma-products/https://kng-sitev4.pages.dev/blog/advertisement-and-promotion-of-pharma-products/Mumbai, New Delhi, Jaipur, Ahmedabad, Allahabad, Patna, Bangalore, Hyderabad , Chennai, Ranchi, Kolkata, Berlin , Dubai , Princeton, New York, Moscow and Australia Position under: Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 1.9 Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating the practice of medicine…Sun, 16 Jul 2023 03:34:46 GMTPharmaceutical, Healthcare & Life SciencesAnti-Bribery & Anti-Corruption and Corporate Compliancehttps://kng-sitev4.pages.dev/blog/artificial-intelligence-regulatory-landscape/https://kng-sitev4.pages.dev/blog/artificial-intelligence-regulatory-landscape/Do We Need to Be Concerned About Artificial Intelligence Ethics Frameworks? By Sanjay Kumar LL.M What are the critiques charged against artificial intelligence (AI) ethics frameworks? And do we care about the role of law in the regulation of AI? In any case, we can constantly act to get closer to the point…Sun, 02 Jul 2023 16:12:42 GMTArtificial Intelligence & Emerging TechnologiesInformation Technology & Digital Transformation