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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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), […]
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 […]
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 […]