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 has classified packaged drinking water as a high-risk category, mandating pre-licence inspections of packaging facilities and annual risk-based audits for existing licence holders. This move aims to ensure hygiene and quality standards, aligning bottled water regulation with stricter public health norms.
Source: short-link.me/17nQx

2. Big private hospitals in India are opposing the General Insurance Council’s common empanelment proposal, arguing it lacks clarity on tariffs, timely claim settlements, and dispute resolution for short payments. They demand wider consultation and revisions before acceptance, stressing the framework must address operational challenges while ensuring insurers’ goal of streamlined empanelment and policyholder access.
Source: short-link.me/1bQ13

3. The GST Group of Ministers (GoM) has reportedly proposed eliminating the current 18% GST on individual life and health insurance premiums. The constituted panel will present recommendations by October 2025 and the final will be taken by GST Council.
Source: short-link.me/17nQT

4. The Pharmaceuticals Export Promotion Council of India is reportedly collaborating with stakeholders to launch an online logistics platform to integrate exporters, importers, service providers, and regulators. The tool aims to centralise compliance, bidding, warehousing, insurance, routing, digital documentation, tracking and feedback.
Source: short-link.me/1bQ1l

5. India’s central drug regulator has recently mandated that exported drugs must retain at least 60% of their shelf life, prompting pharmaceutical companies to discard older inventory and incur significant financial losses. Industry stakeholders caution that the rule introduces substantial economic and logistical strain without offering adequate flexibility.
Source: short-link.me/1bQ1u

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 Ministry of Commerce & Industry introduced the Jan Vishwas (Amendment of Provisions) Bill, 2025 in Lok Sabha to decriminalise 288 minor offences under 16 central laws, including the Drugs and Cosmetics Act. It proposes replacing imprisonment with monetary penalties and improvement notices to ease compliance, boost business confidence, and cut litigation. The Bill now awaits Parliamentary committee review.
Source 1: short-link.me/1bGZT
Source 2: short-link.me/1bGZX

2. India’s Central Pollution Control Board (CPCB) has introduced an automated alerts protocol for OCEMS (Online Continuous Emission/Effluent Monitoring Systems). Compliance issues now trigger tiered warnings: Yellow (Level I), Orange (Level II), and Red (Level III), requiring escalating actions from record-keeping to immediate shutdowns and detailed incident reporting.
Source: short-link.me/1bH01

3. The Health Ministry has reversed the requirement for doctors to register on the National Medical Register just months after making it mandatory. The change comes after fewer than 1 percent of doctors enrolled, facing a process tangled with Aadhaar mismatches and affidavit demands, leaving most applications unapproved.
Source: short-link.me/1bH03

4. Delhi’s Drug Control Administration issued a strict advisory to chemist associations, mandating the immediate cessation of over-the-counter sales of pregabalin and tapentadol due to rising misuse for intoxication and addiction. The directive demands accurate stock records under the Drugs Rules, 1945, and warns of strict penalties for non-compliance.
Source: short-link.me/17f6F

5. The Food Safety and Standards Authority of India has reportedly formed a committee to evaluate whether added sugar should be permitted in infant food. This follows criticism for major manufacturer of infant food for adding sugar in infant food sold in India. Current food regulations allow limited sucrose/fructose only if essential, capped at 20% of total carbohydrates.
Source: short-link.me/17f6L

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 Mental Health Authority (CMHA) has amended the Central Mental Health Act and introduced a five-category classification for mental health establishments covering spanning stand-alone mental hospitals to psychosocial rehabilitation centres. All the establishments are mandated to register with the Authority effective immediately.
Source: short-link.me/175VU

2. India’s Central Food authority (FSSAI) has amended the Labelling and Display Regulations, 2025 which requires all “Coffee Blended with Chicory” or “Instant Coffee-Chicory Mixture” packages to clearly declare the percentage of coffee and chicory on the front label starting July 1, 2026.
Source: short-link.me/175Xx

3. The Karnataka High Court held that exporters should not be denied incentives over a technical mistake such as ticking “No” instead of “Yes” for reward claims in a shipping bill especially when the intent to claim was clear elsewhere. Even if submitted via restrictive online systems, procedural inflexibility cannot override principles of natural justice.
Source: short-link.me/1bxwd

4. India’s Central Food authority (FSSAI) in a recent stakeholder’s meeting stressed on ethical food labelling, advertising and scientific claims, calling for external validation to curb misleading practices. It announced that label changes will be implemented annually, giving businesses predictability while strengthening consumer protection and trust in food safety regulations.
Source: short-link.me/1bxwn
  
5. The Ministry of Ayush and India’s Central Food authority (FSSAI) has recently unveiled a curated list of over 90 “Ayurveda Ahar” food products (e.g., khichdi, curds, soups), grounded in classical Ayurvedic texts. These standardized recipes aim to promote preventive health, support Indian manufacturers, and cultivate both domestic and global markets.
Source: short-link.me/1bxwu

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 Council of Medical Research and India’ central drug authority “CDSCO” have released draft standard protocols for evaluating In-Vitro Diagnostic kits for Influenza, SARS-CoV-2, RSV, Malaria, Dengue, Nipah, and other pathogens. Pharma and diagnostics stakeholders can submit comments by 25 August 2025, after which revisions will be minimal before final adoption.
Source: short-link.me/1b0iM

2. India’s Supreme Court has disposed of a plea challenging misleading AYUSH medicine ads and vacated its stay on the omission of a rule which had removed the requirement for state-level pre-approval of Ayurvedic, Siddha, and Unani drug advertisements. With the rule deleted, companies can advertise without state clearance.
Source: short-link.me/16ALo

3. The All India Organisation of Chemists and Druggists has urged the government to ban ultra fast ten minute delivery of high risk prescription medications by quick commerce platforms, citing threats to public health, rising drug misuse, ghost prescriptions, and a disregard for established regulatory safeguards.
Source: short-link.me/1b0iY

4. India’s Health Ministry has launched SHRESTH Index to benchmark and strengthen state drug regulatory systems. The data-driven framework will guide improvements in infrastructure, manpower, digitization, inspections, and grievance redressal. Upcoming measures include expanding the Not of Standard Quality (NSQ) Dashboard to all states as well.
Source: short-link.me/1b0j6

5. India’s public health organisations call for mandatory front of pack warning labels on food items high in fats, sugar, and salt, replacing Indian Nutrition Rating (or Health Star Rating) system. They cite rising diet related deaths and rapid ultra processed food growth.
Source: short-link.me/16ALH

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 NPPA’s Multi-Disciplinary Committee (MDC) flagged a typographical error in major pharmaceutical drug manufacturing company’s IPDMS Form I, reporting retail price of tablet as ₹13 per tablet instead of ₹91, leading to incorrect pricing. MDC has cautioned the manufacturer to avoid such negligence to prevent procedural delays.
Source: short-link.me/1aSCE

2. The Indian government has reportedly clarified that there is no official classification of drugs as “life-saving drugs.” However, to ensure affordability and accessibility, 930 formulations listed in the National List of Essential Medicines (NLEM) are under price control, leading to significant price reductions and improved patient access.
Source: short-link.me/16tjO

3. The Chhattisgarh High Court, in a recent interim order, has permitted Bachelor of Pharmacy (B.Pharm) graduates to apply for Pharmacist (Grade-II) posts under the National Health Mission (NHM). The court deemed the NHM’s exclusion of degree holders as arbitrary, a violation of Articles 14 and 16 of the Constitution.
Source: short-link.me/1aSCL

4. Indian pharmaceutical exports specifically generics and biosimilars -are currently exempt from the U.S. tariffs, underscoring their indispensable role in ensuring affordable, high-quality medicines for U.S. consumers. With about 40% of generics and 15% of biosimilars in the U.S. supplied by India, Pharmexcil has reportedly urged sustained collaboration to preserve stable, resilient pharmaceutical supply chains.
Source: short-link.me/1aSCW

5. United States Food and Drug Administration experts recommended dropping the “black box” warning on estrogen-based menopause therapies, especially low dose vaginal estrogen arguing the label has deterred women from effective treatment. They cited updated evidence showing benefits in reducing heart attack and bone fracture risk. In India, doctors are optimistic this move will boost confidence in hormone therapy, which remains underused despite its potential benefits for millions of postmenopausal women.
Source: short-link.me/1aSCZ

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 Supreme Court has ruled against the notification issued by ministry of environment that had initially exempted educational institutions, industrial sheds, and hostels from mandatory environmental clearance under the Environment Impact Assessment 2006 regime. The court affirmed that projects over 20,000 sqm must now obtain prior approval typically from the State Environment Impact Assessment Authority.
Source: short-link.me/1aM5s

2. India’s Central Drugs Standard Control Organization (CDSCO) has reaffirmed that all WHO-GMP (COPP) applications must be submitted exclusively via the ONDLS portal by August 15, 2025. No further extensions will be granted for physical submissions beyond this date.
Source: short-link.me/16m-3

3. The Union Health Minister informed Parliament that India does not maintain central data on medical negligence cases. States handle such cases individually under the National Medical Commission Act, 2019. Calls for centralized tracking were raised, but the government emphasized health is a State subject with existing regulatory mechanisms.
Source: short-link.me/16m-d

4. India’s Department of Consumer Affairs has released draft rules for “Clinical Electrical Thermometers for Continuous Measurement” under the Legal Metrology Act. The draft rules outline metrological, technical, safety, and labelling standards, along with performance limits, testing methods, and manufacturer obligations. Stakeholder comments are invited by August 30, 2025.
Source: short-link.me/16m-f

5. The Mumbai CESTAT ruled that orthopaedic appliances and implants qualify for customs duty exemption under Serial No. 578, clarifying it covers assistive devices, rehabilitation aids, and goods for disabled persons. The tribunal interpreted the notification broadly and stated that the exemption applies to implants as assistive or rehabilitation aids, and not meant solely for disability use.
Source: short-link.me/1aM5T

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 Ministry of Health and Family Welfare has amended the Cosmetics Rules, 2020 introducing clearer expiry labelling, redefining terms, updating recordkeeping norms, and empowering authorities to suspend or cancel licences. Notable changes include labelling for exports, new batch record rules, and designation of the Central Cosmetics Laboratory.
Source: short-link.me/1aoFG

2. In order to enhance ease of doing business, India’s central drug authority (CDSCO) has streamlined the process of issuance of Dual Use NOC through Sugam Portal for importing bulk drugs for non-medicinal use. Further to reduce the compliance burden, CDSCO has initiated issue of 1 year NOC, subject to prescribed conditions for such drugs. The new online Dual use system will be effective from 31st August 2025.
Source: short-link.me/1aoEr

3. The Food Safety and Standards Authority of India (FSSAI) has mandated all food business operators such as restaurants, cafes, dhabas and cloud kitchens to display their licence or registration along with a QR code linking to the Food Safety Connect app. This helps consumers access details, lodge complaints and provide feedback, promoting transparency and accountability.
Source: short-link.me/1aoOH

4. The Indian government enacted the Vegetable Oil Products, Production and Availability (VOPPA) Regulation Order, 2025, replacing the 2011 framework. It mandates mandatory registration for all vegetable oil producers, monthly online reporting of production, stocks, sales, and pricing, and grants authorities inspection and enforcement powers to boost market transparency and curb hoarding.
Source: short-link.me/1aoEM

5. Karnataka’s Health & Family Welfare Department has filed 29 legal cases under the Drugs & Cosmetics Act, and has served show-cause notices to 231 pharmacies for dispensing prescription drugs without prescriptions; simultaneously, authorities have flagged food vendors using synthetic colors and have issued warnings.
Source: short-link.me/1aoEW

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 Government has issued the Medical Textiles (Quality Control) Second Amendment Order, 2025. As per this amendment, any manufacturer or importer certified by the Bureau, or those who have applied for certification, and who have declared their existing stock of products, manufactured or imported prior to the implementation date specified in the principal order dated 23rd October 2024, will be permitted to sell, offer for sale, or display such non-BIS-marked stock until 31st December 2025.
Source: short-link.me/19ypP
Source: short-link.me/19yp3
Source: short-link.me/19ypb

2. India’s Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, Brand Owners, and Plastic Waste Processors for Year 2024-25 till 30th September 2025.
Source: short-link.me/15cIv

3. The Indian government has implemented a Central Sector Scheme to promote awareness about Ayurveda, Yoga, Unani, Siddha, and Homoeopathy through fairs, media campaigns, research, and quality certification. Measures also include strengthening drug testing, safety monitoring, international collaborations, and regulatory compliance for traditional medicine systems.
Source: short-link.me/19yqL

4. The Ministry of AYUSH has implemented the Central Sector Scheme “AYURGYAN” to boost research, education, and innovation in traditional medicine. It supports capacity building, clinical research, and interdisciplinary studies, including Ayurveda biology. The scheme promotes evidence-based AYUSH practices through collaborations with academic institutions and national research councils.
Source: short-link.me/19yqQ

5. Food Safety and Standard Authority of India has recently issued an advisory directed all licensed food businesses to display the QR code or download link of the “Food Safety Connect” app at their premises. This enables consumers and regulators to verify license details and lodge complaints easily, promoting transparency, digital access, and improved compliance in the food safety ecosystem.
Source: short-link.me/19yqW

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 Government has issued the Legal Metrology (General) Third Amendment Rules, 2025 to regulate non-invasive automated sphygmomanometers and their accessories. The rules specify standards for measurement accuracy, safety, and labelling to ensure reliability in blood pressure monitoring at the arm, wrist, or thigh.
Source: tinyurl.com/d6ftzhv7

2. The Maharashtra Medical Council (MMC) has transitioned its “Know Your Doctor” QR based KYD platform from voluntary to mandatory for all MBBS practitioners in the state. Doctors must prominently display their unique QR code in clinics, allowing patients to verify credentials instantly.
Source: tinyurl.com/mrx234ds

3. India’s Supreme Court reserved its order in cases involving couples who froze embryos before the Surrogacy Act, 2021. Now over the statutory age limit, they seek exemption from restrictions. Petitioners argue retroactive application is unfair. The decision may set a precedent for application of reproductive laws prospectively or retroactively.
Source: tinyurl.com/49tkfp5r

4. The Drug Controller General of India will soon direct states and Union territories to identify pharmaceutical companies not following Good Manufacturing Practices, especially Micro, Small and Medium Enterprises. This action follows global concerns over drug safety and aims to raise India’s pharmaceutical quality to international standards.
Source: tinyurl.com/wpnc2vjy

5. The National Health Authority has unveiled comprehensive Hospital Empanelment & Management (HEM) Guidelines to ensure consistent service quality across AB PMJAY facilities. Key updates include introduction of HEM 2.0 with stringent physical verifications, geo-tagged photo submissions, and mandatory periodic reviews for private hospitals.
Source: tinyurl.com/2s3k863r

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 Health Ministry has approved adding the HPV vaccine to the Universal Immunisation Programme, targeting girls aged 9–14. This aligns with the June 2022 NTAGI recommendation and is supported by ongoing frontline healthcare worker training and rollout planning.
Source: shorturl.at/3e0T0

2. Meghalaya announced plans to introduce legislation requiring mandatory HIV/AIDS testing prior to marriage. The government is drafting a cabinet note and engaging district stakeholders to advance a mission mode HIV control policy.
Source: tinyurl.com/yfhymxdx

3. The India-UK Free Trade Agreement, signed on July 24, 2025, excludes patent term extensions and data exclusivity, safeguarding India’s generic drug industry. However, experts warn it restricts compulsory licensing by promoting voluntary licences and “adequate remuneration” clauses, and that this could undermine India’s ability to supply affordable medicines to developing countries.
Source: tinyurl.com/3wm9wwz9

4. The All-India Organisation of Chemists and Druggists (AIOCD), representing over 12 lakh chemists nationwide has reportedly urged the Drug Controller General of India to take urgent action, alleging that State Licensing Authorities are failing to stop illegal e pharmacies misusing draft notifications leading to unregulated online medicine sales and posing risks to public health.
Source: tinyurl.com/39b9a44n

5. Nathealth urged Niti Aayog to simplify healthcare regulations through a digital single-window system, highlighting burdensome compliance from 10–12 ministries. A white paper identified 85 regulatory challenges, calling for harmonisation across states to boost efficiency, innovation, and patient-focused care in hospitals, diagnostics, and medtech.
Source: tinyurl.com/5582rp5n