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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 Government has issued draft amendments to the Drugs Rules, 1945, proposing mandatory blue vertical strip on the left side running throughout the body of the label on all antimicrobial drugs and their preparations. The move aims to enhance identification and promote responsible antimicrobial use, with stakeholder comments invited within thirty days.
Source: h7.cl/1iBM0

2. The Kerala High Court has ruled that the title “Doctor” is not exclusive to medical doctors and can be used by physiotherapists and occupational therapists. The Court held that neither the NMC Act nor state law grants doctors an exclusive right over the “Dr.” prefix, which traditionally denotes advanced learning.
Source: h7.cl/1nBW7

3. India’s ministry of consumer affairs has notified amendments to the Legal Metrology Rules, tightening standards for manual blood pressure devices. Effective January 7, 2026, the rules set stricter accuracy limits, ban unsafe connectors, and mandate durability, safety, and environmental stress testing. Manufacturers must update design, labelling, and documentation, and obtain fresh model approvals to continue selling these devices in the Indian market.
Source: h7.cl/1nBWi

4. India’s Bombay High Court has quashed a prosecution after finding serious delays in drug sample analysis beyond the mandatory 60-day limit prescribed under the Drugs Rules. The Court made strong observations regarding the laxity of the Drugs Department, holding that such lapses endanger public health by allowing sub-standard drugs to circulate.
Source: h7.cl/1iBMQ

5. The Tamil Nadu Chemists and Druggists Association has formally complained to the Pharmaceuticals and Medical Devices Bureau of India (PMBI) alleging that Jan Aushadi Kendras across the state are violating scheme guidelines by selling locally procured patented and generic medicines and operating multiple licences per individual. PMBI has confirmed such local sourcing is prohibited and attracts disciplinary action.
Source: h7.cl/1nBWD

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TOP 5 HEALTH LAWS & POLICY UPADATES

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 Pollution Control Board (CPCB) has issued a new SOP for using spent acetic acid from 7ADCA and paracetamol manufacturing to produce Pigment Yellow 12. The guideline lays out strict rules for storage, handling, emissions control, wastewater treatment, and record-keeping to ensure the safe and compliant utilization of hazardous waste.
Source: h7.cl/1fJVZ

2. The Parliamentary Standing Committee on Chemicals and Fertilisers has reported steep disparities between stockist and retail prices of several non-scheduled drugs, with trade margins reaching 600–1,100%. It has urged the NPPA and Department of Pharmaceuticals to review trade-margin practices and strengthen pricing transparency across the supply chain.
Source: h7.cl/1fJW7

3. The Department of Telecommunications (DoT) has reportedly directed messaging platforms to implement SIM-binding, linking user accounts to the SIM used during registration. Under this mandate, web-based sessions of messaging platforms will automatically log users out every six hours and require re-authentication.
Source: h7.cl/1kBdb

4. Pune Municipal Corporation has reportedly issued guidelines urging residents to avoid over-the-counter (OTC) antibiotics to combat rising antimicrobial resistance (AMR), aligning with Union government directives. Residents must use antibiotics only with prescriptions and complete full courses, especially during winter.
Source: h7.cl/1kBdk

5. The government of China will reportedly begin charging a 13 % value added tax on condoms and other contraceptives from January, ending a decades-long exemption. The move aims to encourage higher birth rates, but critics warn it could increase unprotected sex and fail to address high child-rearing costs.
Source: h7.cl/1fJWy

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 Supreme Court of India has urged the Union Government to consider giving legal backing to the Uniform Code of Pharmaceutical Marketing Practices, 2024, noting that the current voluntary framework lacks effective enforcement and leaves patient unprotected. The Court indicated it may issue interim guidelines and sought detailed proposals for a statutory, government-enforced framework.
Source: h7.cl/1jDIt

2. The Competition Commission of India (CCI) has approached the NCLAT to clarify whether privacy safeguards for non-advertising data sharing should also apply when a social media platform shares user data with its parent company for advertising purposes. This follows the lifting of a five-year ban on such data sharing,
Source: h7.cl/1ePhT

3. India’s central drug regulator (CDSCO) reportedly plans for a digital tracking system for high-risk solvents like diethylene glycol and batch-level reporting to prevent cough-syrup contamination. Authorities are also increasing scrutiny of unlicensed rural pharmacies and considering removal of the Schedule K exemption that currently eases regulatory requirements for selling cough syrups.
Source: h7.cl/1ePhW

4. The Directorate General of Foreign Trade (DGFT) has resolved a long-standing issue affecting pharmaceutical exporters by clarifying redemption of Advance Authorisations (AAs) impacted by the old CGST Rule 96(10). The move addresses compliance hurdles for duty-free raw material imports for the pharma sector.
Source: h7.cl/1jDHw

5. Indian government has launched the National Action Plan on Antimicrobial Resistance (NAP-AMR) 2.0 (2025–29) to counter rising drug resistance. The plan sets clear timelines, strengthens surveillance, curbs antibiotic misuse, boosts lab and infection-control capacity, and adopts a One Health approach through coordinated, multi-ministerial action against the growing AMR threat.
Source: h7.cl/1jDHD

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 Delhi government has directed state-run hospitals to procure medicines and consumables exclusively through the Central Procurement Agency (CPA), aiming to streamline procurement and reduce costs, as earlier methods through direct purchases or via the cart feature on the Government e-Marketplace (GeM) portal often resulted in inflated pricing.
Source: bit.ly/4krkAX0

2. Central Pollution Control Board (CPCB) has reportedly initiated action against pan masala brands in Delhi for using plastic sachets to pack and store tobacco and pan masala. Companies may face fines unless they switch to eco-friendly packaging alternatives, per CPCB directives.
Source: bit.ly/4kJM7CW

3. Public health and consumer organisations are reportedly urging the government to add mandatory warning labels on the front of packaged food products that are high in salt, sugar, and fat. They want the Health Star Rating system to be scrapped, saying it misleads people and protects food companies.
Source: bit.ly/3ZjbNOu

4. The Delhi Pollution Control Committee (DPCC) has issued a Standard Operating Procedure (SOP) to streamline the imposition and recovery of environmental compensation from violators of environmental norms. The SOP mandates timely issuance of show cause notices within five days of inspection, a 15-day response window for violators, and follow-up actions within 30 days.
Source: bit.ly/3ZjTVmx

5. India’s Health Ministry is reportedly expanding Schedule H under the Drugs Rules, 1945, raising the number of prescription-only drugs from 536 to over 700. This includes remdesivir, dexamethasone, favipiravir, ivermectin, and mebrofenin etc. The move aims to curb antimicrobial resistance by restricting OTC sales, covering drug classes like cardiovascular, neurological, respiratory, anesthetic, immunological, NSAIDs, and sterile formulations
Source: bit.ly/3ZKZACb

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 Food Safety and Standards Authority of India (FSSAI) has proposed halting new registrations and the renewal of existing registrations for the manufacturing of certain high-risk foods, such as dairy products and infant nutrition. They have also proposed permitting only state or central licenses and implementing pre-license inspections for manufacturers in these categories. They have sought public feedback on these proposed changes by 30th May, 2025.
Source: bit.ly/3RRy4Po

2. The Bombay High Court directed the state government to consider a separate registration facility for patients who are not yet on dialysis but will soon need an organ transplant. This came after a CKD Stage-V patient was denied registration. The Court said such denial violates the right to life.
Source: bit.ly/3RM4xqh

3. India’s ministry of commerce and industry has prohibited the use of specified antibiotics, antivirals, and antimicrobial medicinal products in fish, shrimp, hatchery operations or any manufacturing, pre-processing and processing unit to prevent antimicrobial resistance and safeguard export quality.
Source: bit.ly/44ZamIz

4. India’s Central Drugs Standard Control Organization (CDSCO) has released the guidelines for the safe disposal of expired and unused medicines by hospitals and the general public. The initiative is aimed at addressing the growing concerns of antimicrobial resistance and minimizing environmental hazards. 
Source: bit.ly/4iOmj7d
Source: bit.ly/4d3ywnf

5. Under the Stockholm Convention, 40 nations worldwide have agreed to phase out the use of chlorpyrifos, a hazardous pesticide on food crops. However, India secured a five-year exemption for its use on 12 essential crops to manage certain pests and termites, as well as the lack of immediate alternatives.
Source: bit.ly/4iL0q8M

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 District Consumer Disputes Redressal Commission in Hyderabad has ordered a compensation of Rs. 10 lakh to a patient after cardiologists at a local hospital made the patient undergo multiple procedures in one go without understanding the need for multiple procedures, and failed to follow standard protocols during treatment. The commission determined that the doctor’s negligence led to significant complications, proving a deficiency of service which was against patient safety and care.
Source: bit.ly/3VufMps

2. The National Medical Commission (NMC) has released comprehensive guidelines to identify and prevent the admission of fake patients in medical colleges, a practice that undermines patient care and ethical standards. The guidelines highlight red flags such as unusually high admissions on inspection days, absence of significant medical conditions, and lack of necessary investigations. Institutions found engaging in this unethical practice may face stringent penalties, including hefty fines and restrictions on student admissions.
Source: bit.ly/4iDw5ua

3. India is set to introduce “nafithromycin”, the first indigenous macrolide antibiotic, pending final approval from the Central Drugs Standard Control Organization (CDSCO). This innovative antibiotic, which is ten times more effective than azithromycin, offers a rapid three-day treatment for community-acquired bacterial pneumonia caused by drug-resistant bacteria, marking a significant advancement in the fight against antimicrobial resistance (AMR).
Source: bit.ly/4f4vuP6

4. The Indian government is intensifying efforts to eliminate tuberculosis (TB) by 2025, targeting 347 high-focus districts across 33 states and Union territories. A 100-day TB elimination campaign will be launched by the Union Health ministry in this regard to enhance case detection, reduce diagnostic delays, and improve treatment outcomes, particularly among high-risk groups.
Source: bit.ly/49qNnXb

5. The USFDA is considering a ban on Red 3, a synthetic food dye linked to potential health risks, including cancer and behavioural issues in children. This decision follows increasing public pressure and legislative actions in several states, including California, which has already prohibited the dye in food products. The FDA aims to act on a petition to revoke Red 3’s authorization in the coming weeks, reflecting growing concerns over food safety standards in the U.S.
Source: bit.ly/3Vvxed0

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. In a new Amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the Food Safety and Standards Authority of India (FSSAI) has clarified that BIS standards mark requirement may no longer be necessarily applicable for manufacture and sale of infant milk food, infant formula and milk cereal based weaning food etc. as well as Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened.
Source: bit.ly/4hkwSPN
Source: bit.ly/3BXUuK4

2. In a recent amendment to the  Food Safety and Standards (Contaminants, toxins and Residues) First Regulations, 2011, which shall come into force from 1st April 2025 the Food Safety and Standards Authority of India (FSSAI)has: (1) Simplified and reduced the number of prohibited use Antimicrobials including chloroform, stilbenes and other steroids, (2) Increased the permissible concentration for Antimicrobials in Honey, (3) reduced the concentration of antimicrobials in cattle.
Source: bit.ly/3AdyXMN

3. The Rajasthan Authority for Advance Rulings held that the vanilla mix being sold by a major manufacturer of consumer food products in the country would not be classified as an “ice-cream” for the purpose of taxation under the Goods and Services Act, 2017 (GST Act) due to sugar being the major ingredient at about 65%. This decision in contrast to the Supreme Court’s decision on similar grounds.
Source: bit.ly/3BW78sY
Source: bit.ly/3BQh9I0

4. The Supreme Court quashed a criminal case which had been filed against a major Indian bank for non-compliance with an order of the authority under the Income Tax Act, holding that an allegation of mens rea cannot be made against a juristic person such as the bank and that the intention of the officers and functionaries cannot be construed to be that of the juristic person itself.
Source: bit.ly/3C5fH4y

5. The Therapeutic Goods Administration (TGA), Australia’s regulator for Medical Devices has clarified some queries concerning its updated Essential Principles, which are necessary compliances for getting approval for devices in Australia. In this new update to the checklist, the TGA has reiterated its existing commitment to recognizing foreign approval standards, and has placed obligation on Sponsors to update the TGA if their Manufacturer Evidence may be expiring in 50 days, among other things.
Source: bit.ly/48jlWxM
Source: bit.ly/4eSYR7P

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. To combat antimicrobial-resistance the Drugs Consultative Committee, which advises the Central and State Governments on conduct of Drug regulation in the country, has, in its 64th meeting recommended amendment to the Drug Rules to regulate sale of antibiotic Drugs to manufacturers who may not have a license under the Drug regulations.
Source: bit.ly/4evHfhA

2. The Punjab and Haryana High Court upheld the position that under the Narcotic Drugs and Psychotropic Substances Act, 1985, upon seizure, the entirety of the bulk of the seized substance need not be sent to the Forensic Laboratory, rather merely a select homogenized sample thereof would be sufficient.
Source: bit.ly/4gx15uL

3. The Supreme Court has ordered the Central Government Ministry of Health and Family welfare, and the Government of Kerala to file counter-affidavits explaining the delayed action in setting up a special committee to study the effectiveness of the Rabies vaccine.
Source: bit.ly/3MXwwAE

4. The High Court of Bombay has struck down the insertion of Rule 3 of Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules, 2023, which empowered the government to set up fact-check units on the ground that this violated the fundamental right to equality and to carry on trade and business.
Source: bit.ly/4diYthg

5. The United States Federal Trade Commission has formally initiated litigation against Pharmacy Benefit Managers which act as middlemen between Drug Companies and Insurers, for deliberately driving the price of insulin higher for consumers and receiving rebates from manufacturers in the process.
Source: bit.ly/3zrNfcq

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 Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products”. This document facilitates the submission of the safety profiles of drugs by MAHs (manufacturer, marketer, or importer of a drug) and outlines the timeline for the process.
Source: bit.ly/4dctGCs

2. India’s Central Drug Regulator (CDSCO) is reportedly considering a proposal to change the color of all antimicrobial drug strips to blue for safer usage and to visually differentiate these drugs to curb antimicrobial resistance (AMR). This proposal would apply to pharmaceutical drugs and medicines, including antibiotics, antivirals, anti-parasitics, and antifungal drugs.
Source: bit.ly/47BUL0P

3. India’s Department of Food and Public Distribution (DFPD) has asked the leading edible oil associations in India to maintain the maximum retail price (MRP) of edible oil until the stocks of the edible oil that are imported at 0% and 12.5% basic customs duty (BCD) are exhausted. The Government of India has increased the BCD on various edible oils, which is effective from 14th September 2024, to support domestic oilseed prices.
Source: bit.ly/4e9Gwmj

4. The International Organization for Standardization (ISO) has released the second edition of ISO 23500-1:2024, outlining requirements for the preparation and quality management of fluids used in hemodialysis and related therapies. This standard guides practitioners on handling dialysis and substitution fluids for advanced treatments like hemodiafiltration and hemofiltration.
Source: bit.ly/3Bjlzqt
Source: bit.ly/4gskk8H

5. India’s Maharashtra Food and Drugs Administration (FDA) has taken action against an Ayurvedic drug manufacturing company by seizing its products and prohibiting the further distribution of its Ayurvedic drugs due to improper labeling. The company has made false and misleading claims about the drugs and its treatment in its advertisements, which are prohibited under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and Rules, 1955.
Source: bit.ly/3ZucKUU

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 of India, reportedly plans to establish a distinct category for advanced coronary stents and increase its ceiling price. This change is intended to ensure that stent manufacturers launching next-generation devices in India are not affected by price control measures.
Source: bit.ly/4cOGnU4

2. India’s Department of Pharmaceuticals (DoP) is reportedly developing a ‘Disposal Policy’ for sound disposal of expired, leftover, substandard, spurious, and adulterated drugs from the sale premises and from the households to prevent environmental damage and curb antimicrobial resistance (AMR).
Source: bit.ly/47dCgQ2

3. The Karnataka High Court has directed the Drug Controller General of India to establish an efficient online system whereby the drug samples which are sent for test/analysis are expeditiously tested and analysed by the Government Analyst within 60 days and the reports sent by them are available online on a real-time basis.
Source: bit.ly/3Te2Umc

4. India’s Department of Telecommunications (DoT) has advised all unregistered Machine to Machine Service Providers (M2M SPs) and WPAN/WLAN Connectivity Providers for M2M services to register with the DoT by September 30, 2024, to prevent any disruption to their services. Failure to comply may result in the withdrawal of telecom resources from authorized telecom licensees.
Source: bit.ly/3Xeknft

5. The Indian Council of Medical Research (ICMR) is reportedly developing evidence-based guidelines for the empirical use of antibiotics to address antimicrobial resistance (AMR), which is a significant public health challenge in India
Source: bit.ly/4cROOhl