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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 Central Drugs Standard Control Organization (CDSCO) has issued a regulatory update outlining revised procedural and compliance requirements for industry stakeholders, aimed at strengthening regulatory oversight and streamlining approval processes. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines. Companies may now need to review internal compliance processes and align documentation and approval strategies accordingly.
Source: shortlink.uk/1tzqM

2. The Thrissur Consumer Commission held both the seller and the e-commerce platform liable for delivering an expired consumable product, ruling it an unfair trade practice and deficiency in service. Rejecting reliance on a “non-returnable” policy, the Commission ordered refund, compensation, and costs. It emphasized that platforms must ensure grievance redressal and cannot evade liability where defective or unsafe goods are supplied through their marketplace.
Source: shortlink.uk/1tzqU

3. The Ministry of Environment, Forest and Climate Change has amended the Bio-Medical Waste Management Rules, 2016, to include the Department of AYUSH and its nominated representatives in state and district-level waste management committees. This is important as it expands regulatory oversight to AYUSH healthcare facilities and strengthens compliance expectations. AYUSH institutions and related healthcare providers may now need to align with enhanced bio-medical waste management governance and monitoring requirements.
Source: shortlink.uk/1tzqI

4. Stakeholders have urged greater drug regulator oversight of nutraceuticals, citing concerns over quality standards, therapeutic claims, and wide pricing variations, with calls to shift certain nutraceuticals from food regulation to drug-level oversight. This is important as nutraceuticals are increasingly prescribed alongside medicines but lack uniform quality and pricing controls. Companies may now face stricter compliance requirements, enhanced quality standards, and potential regulatory scrutiny.
Source: shortlink.uk/1tzqY

5. The Central Drugs Standard Control Organization (CDSCO) has introduced a prior intimation system pursuant to amendments in the New Drugs and Clinical Trials Rules, 2019 effective April 21, 2026. It applies to bioavailability and bioequivalence studies for export-only drugs, excluding certain high-risk categories. CT-05 applications must be filed via Sugam with ethics approval, while other categories remain under prior approval. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines.
Source: shortlink.uk/1ohEa

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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 Health Authority is developing a national artificial intelligence policy for healthcare to guide wider use of technology to address health challenges including diagnostics, public health programmes, and digital health platforms. This will be a major shift toward structured, large-scale adoption of technology in India’s health system. It can improve access, efficiency, and data-driven decision-making across public healthcare delivery.
Source: shortlink.uk/1tzfD

2. India’s Central government has directed states to uniformise package rates for common medical procedures, adopt uniform treatment guidelines, and implement digital claims processing through the National Health Claims Exchange to improve billing transparency and reduce pricing variations across private hospitals. These disparities have been identified in driving higher insurance premiums and affecting affordability.
Source: shortlink.uk/1ohsz

3. The Bombay High Court delivered a judgment after scrutinising enforcement under the Drugs (Prices Control) Order (DPCO), holding that overcharging determinations and recovery demands must strictly adhere to statutory methodology, including correct price fixation, computation, and grant of hearing. Finding procedural infirmities and inadequate reasoning, the Court set aside the demand and directed fresh adjudication, reinforcing due process and curbing arbitrary.
Source: shortlink.uk/1tzfM

4. The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory communication outlining updated requirements related to drug approvals, compliance, and regulatory submissions for industry stakeholders. This is important as increased regulatory scrutiny may impact approval timelines and documentation standards. Companies may now need to review regulatory submissions, strengthen compliance processes, and align product lifecycle strategies with evolving CDSCO expectations.
Source: shortlink.uk/1tzfQ

5. The Drugs Technical Advisory Board has approved a proposal to amend the Medical Devices Rules, 2017 to introduce a definition of reportable events and mandate adverse event reporting, including for in-vitro diagnostic devices. This is important as it strengthens post-market surveillance and device safety oversight. Manufacturers and importers may now need enhanced reporting systems and tighter compliance processes.
Source: shortlink.uk/1ohsK

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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 Medical Device Regulator has proposed standardising testing fees at government laboratory by notifying fixed charges under a new schedule. There was no regulation on cost of testing fees from government labs, and small and medium scale medical device manufacturers who actually avail services of external laboratories are bound to benefit from the proposal. Notably, the proposal applies only to government laboratories and does not cover private medical device testing laboratories.
Source: shortlink.uk/1sH3N

2. The Central Government has proposed draft amendments to the Medical Devices Rules, 2017 mandating manufacturers outsourcing sterilisation must mention the sterilisation site’s licence number on device labels using specified descriptors. Currently, no such mandatory declaration exists, and the proposal aims to ensure greater accountability in third-party sterilisation processes.
Source: shortlink.uk/1nrZb

3. The Central Government has proposed amendments to the Medical Devices Rules, 2017 requiring importers of Class A non-sterile and non-measuring devices to also self-certify compliance with a Quality Management System. Currently limited to standards, this change aims to strengthen quality assurance and regulatory oversight of low-risk medical device imports.
Source: shortlink.uk/1sH41

4. The Department of Agriculture & Farmers’ Welfare has directed pesticide manufacturers, importers, and industry associations to submit data on produced, imported, and exported quantities of major insecticides, fungicides, herbicides, and Plant Growth Regulators (PGRs) by April 13, 2026. This is being undertaken to assess the impact of the ongoing Gulf Crisis on pesticide availability and supply chains.
Source: shortlink.uk/1sH4g

5. The Central Government has proposed to amend the Medical Devices Rules, 2017, to expand the scope of jurisdictions by including “European Union countries” alongside the US, UK, Australia, Canada and Japan. Pursuant to this amendment, investigational clinical data may not be required to be submitted for import of a medical device, provided that such device has been approved by the regulatory authority of EU, has been marketed in that jurisdiction for a minimum period of two years.
Source: shortlink.uk/1nrZD

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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. National Pharmaceutical Pricing Authority (NPPA) has exempted Nafithromycin 400 mg tablets from price control under DPCO, 2013 for five years. The exemption starts from launch or patent expiry, whichever is earlier. This allows flexible pricing, but the company must report launch date and price details to the authorities
Source: shortlink.uk/1mYOh

2. The Centre has set April 30, 2026 as the final deadline for private hospitals to complete empanelment under the Central Government Health Scheme. Hospitals failing to sign the Memorandum of Agreement (MoA) by the deadline will be de-empanelled from May 1, losing eligibility to treat CGHS beneficiaries or submit reimbursement claims.
Source: shortlink.uk/1mYOm

3. US pharmaceutical companies have reportedly opposed price caps imposed by the National Pharmaceutical Pricing Authority (NPPA) of India, seeking blanket exemption for patented medicines. Industry stakeholders argue that current controls reduce prices by nearly 50% post-patent expiry, discouraging innovation and limiting availability of advanced therapies in India.
Source: shortlink.uk/1mYOq

4. The Karnataka Department of Health and Family Welfare, in collaboration with National Institute of Mental Health and Neurosciences, released a draft policy to tackle student mobile addiction. The proposal caps recreational screen time at one hour daily, introduces digital wellness committees, and mandates teacher training and counselling support to address rising mental-health concerns among adolescents.
Source: shortlink.uk/1mYOs

5. India’s Ministry of Finance has reportedly temporarily exempted customs duty on forty petrochemical and chemical inputs until June 30, aiming to stabilise supply chains disrupted by Middle East tensions, ease cost pressures on pharmaceuticals and manufacturing sectors, and support industry facing sharp increases in raw material and packaging costs.
Source: shortlink.uk/1mYOu

Posted on

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 government has warned pharmacies, clinics, and online platforms of licence cancellation, fines, and legal action for unauthorised sale of GLP-1 weight-loss drugs. Regulators flagged misuse amid rising availability of generic semaglutide, reiterating that prescriptions are restricted to endocrinologists, internal medicine specialists, and cardiologists only, with nationwide inspections already underway.
Source: shortlink.uk/1mYE-

2. The Delhi High Court granted a 30 day stock clearance window to the pharmaceutical manufacturer for its diabetes drug under the existing brand, following its agreement to adopt a new name. Thereafter, unsold inventory will be supplied free to government hospitals under supervision, with immediate cessation of all commercial use.
Source: shortlink.uk/1mYF1

3. A Hyderabad-based paediatrician has criticised a company for introducing similar-looking packaging following the Food Safety and Standards Authority of India crackdown on misleading ORS branding. The doctor alleged that despite rebranding, the product retains strong recall value, potentially misleading consumers and raising ongoing public health concerns over confusion between therapeutic ORS and commercial electrolyte drinks.
Source: shortlink.uk/1mYF3

4. The US FDA clarified that compounded versions of GLP-1 weight-loss and diabetes drugs can only be produced during official shortages. With supply stabilising, compounders must stop manufacturing copycat versions once drugs are removed from the shortage list. The regulator warned of enforcement action against non-compliant pharmacies and telehealth providers.
Source: shortlink.uk/1sbL5

5. India’s Drugs Technical Advisory Board, has recommended amending the Drugs Rules, 1945 to introduce licensing provisions for drug marketers. The move aims to strengthen regulatory oversight and monitoring of entities that market drugs manufactured by other companies under their own label.
Source 1: shortlink.uk/1mYF8
Source 2: shortlink.uk/1mYFb

Posted on

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 is preparing a policy response after seeking inputs from the pharmaceutical industry on the ongoing shortage and price surge of critical solvents and chemicals. Industry reported sharp increases in inputs like isopropyl alcohol and other petrochemical-based solvents, impacting production costs and supply continuity, prompting urgent intervention and long-term supply-chain stabilisation measures.
Source: shortlink.uk/1mYxw

2. The Delhi High Court has reserved its verdict on an interim plea filed by Asian News International in a copyright infringement case against OpenAI. The case questions whether copyrighted news content can be used to train AI models like ChatGPT without permission, marking a first-of-its-kind legal challenge in India.
Source: shortlink.uk/1mYy0

3. The Government is considering invoking the Essential Commodities Act, 1955 to regulate prices of bulk drugs and active pharmaceutical ingredients amid supply disruptions linked to West Asia tensions. The Department of Pharmaceuticals is consulting industry stakeholders to curb hoarding, stabilize prices, and ensure uninterrupted medicine production.
Source: shortlink.uk/1mYxH

4. The Food Safety and Standards Authority of India has released FAQs on the Food Safety and Standards (Licensing and Registration of Food Businesses) Amendment Regulations, 2026, clarifying key reforms including perpetual licence validity, revised turnover thresholds, expanded petty food business definition, and risk-based inspections to simplify compliance and strengthen food safety oversight.
Source: shortlink.uk/1sbDB

5. The Food Safety and Standards Authority of India has notified the Food Safety and Standards (Labelling and Display) First Amendment Regulations, 2026, introducing revised labelling exemptions, non-retail container requirements, and updated warning declarations. The amendments will come into force from 1 July 2027, giving industry transition time for compliance.
Source: shortlink.uk/1mYxL

Posted on

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 notified a 0.64956% increase in the Wholesale Price Index (WPI) for 2025 over 2024. Importers and manufacturers of Scheduled drugs and medical device are now permitted to increase the prices on the basis of WPI without prior approval from the government from April 1, 2026.
Source: shortlink.uk/1mYsg

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that all IVF-related devices, including sperm washing kits and intrauterine insemination tools, are regulated as medical devices under the Drugs and Cosmetics Act. Import, manufacture, and sale of these devices require proper licensing to ensure compliance and prevent unauthorized trade.
Source: shortlink.uk/1mYsj

3. India’s Central Drug authority, (CDSCO) has streamlined the procedure for review and processing Written Confirmation certificate (WCC) applications submitted through the SUGAM portal for export of Active Pharmaceutical Ingredients (API) to EU for human use. The move aims to improve efficiency aligning with EU GMP compliance requirements under Article 46(2)(b) of Directive 2001/83/EC.
Source: shortlink.uk/1sbyd

4. The National Medical Commission (NMC), following a Supreme Court of India ruling, now limits stem cell therapy to approved conditions only, so far there are 32 approved conditions. Unproven uses outside clinical trials are banned, with strict ethical rules and legal action to prevent misuse and protect patients.
Source: shortlink.uk/1mYsV

5. The Central Consumer Protection Authority (CCPA) has directed hotels and restaurants to stop adding charges such as “LPG charges” and “fuel cost recovery” to customer bills, terming the practice an unfair trade practice, and warning of strict action. The CCPA clarified LPG and electricity, are part of running a business and should be factored into final menu prices.
Source: shortlink.uk/1mYt2

Posted on

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 Jammu and Kashmir and Ladakh High Court ruled that prosecution under the Drugs and Cosmetics Act cannot proceed if the accused is deprived of the statutory right to seek re-analysis of a drug sample by the Central Drugs Laboratory. The court quashed proceedings where the expiry of the sample’s shelf life prevented the accused from exercising this legal safeguard of having the samples tested by the Central Drugs Laboratory.
Source: shortlink.uk/1mQEt

2. India’s central food regulator (FSSAI) has amended the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. Key changes allow the authority to set turnover thresholds for registration, grant instant registration on document submission, recognize street vendors registered under the Street Vendors law, introduce risk-based inspections and audits, and suspend licences for non-payment of fees or failure to file returns.
Source: shortlink.uk/1mQEx

3. The Central Drugs Standard Control Organisation (CDSCO) has delegated key regulatory functions related to veterinary drugs to its zonal offices. Zonal offices will now process Test License (Form 11) applications for import and issue NOCs for Form 29 licenses for manufacturing veterinary drugs for testing or analysis, excluding biologicals.
Source: shortlink.uk/1s3ug

4. India’s Drugs Technical Advisory Board, in its 93rd meeting, recommended amending the Drugs Rules, 1945 to introduce licensing provisions for drug marketers. The move aims to strengthen regulatory oversight and monitoring of entities that market drugs manufactured by other companies under their own label.
Source: shortlink.uk/1s3uq

5. The Food Safety and Standards Authority of India has reportedly encouraged plant-based food manufacturers to include QR codes on product labels to help consumers easily access ingredient lists and nutritional information. The regulator said the move currently voluntary can address label space limitations, improve transparency, and build consumer trust in the rapidly growing plant-based food sector.
Source: shortlink.uk/1s3uD

Posted on

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 Central Pollution Control Board (CPCB) has extended the deadline for registered Producers, Importers and Brand Owners (PIBOs) to file Annual Returns for FY 2024–25 under the Plastic Waste Management Rules, 2016 until March 31, 2026. Non-compliance may attract environmental compensation.
Source: shortlink.uk/1rAfG

2. The Central Pollution Control Board has issued show cause notices to PIBOs for failing to meet EPR obligations and not submitting Annual Returns for FY 2022–23 under the Plastic Waste Management Rules, 2016. Defaulters will face environmental compensation and tighter enforcement from authorities
Source: shortlink.uk/1rAg8
Source: shortlink.uk/1rAga

3. The Central Pollution Control Board (CPCB) has issued show cause notices to producers, importers, and brand owners (PIBOs) for failing to meet Extended Producer Responsibility obligations, fulfil targets, and file annual returns under the Plastic Waste Management Rules, 2016 for FY 2022–23. Non-compliant entities may have to pay environmental compensation, face penalties, and higher future targets. Entities must respond latest by 26.03.2026or face further regulatory and legal action.
Source: shortlink.uk/1mol6

4. The Karnataka government has released a draft policy promoting responsible digital use among students, focusing on curbing screen addiction, cyber risks, and mental health impacts. The move aligns with its broader push to restrict social media access for minors and regulate device usage.
Source: shortlink.uk/1mol8

5. Parliamentary panel has reportedly urged the Department of Pharmaceuticals to address administrative delays affecting the Promotion of Research and Innovation in Pharma MedTech Sector scheme after significant underutilisation of funds. Despite increased allocations, spending remained low. Revised guidelines and stronger monitoring are expected to improve execution and outcomes.
Source: shortlink.uk/1rAgj