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 drug regulator, CDSCO has directed state drug regulators to direct manufacturers of Doxycycline formulations to incorporate CNS side Effects as an adverse drug reaction such as restlessness, anxiety, irritability, nervousness, and dizziness in the caution section of the package insert/ Promotional literature following recommendation by the Subject Expert Committee on Antimicrobial and Ant Parasite.
Source: short-url.org/1perz

2. India’s National Consumer Disputes Redressal Commission (NCDRC) ruled that prescribing allopathic medicines without a recognised medical qualification is negligence and deficiency in service. It directed an eye centre to pay ₹2 lakh compensation plus interest to a patient who permanently lost vision due to such unqualified prescriptions.
Source: short-url.org/1k96-

3. The Directorate of Drugs Control under the Government of Tamil Nadu has issued a public advisory warning citizens against the manufacture, sale and online distribution of unapproved oral nicotine pouches. Show-cause notices have been served to major online sellers for marketing products whose safety, efficacy and quality have not been established in India.
Source: short-url.org/1perD

4. The Multidisciplinary Committee advising the National Pharmaceutical Pricing Authority has recommended a five-year exemption from the Drug Price Control Order, 2013 for nafithromycin, India’s first indigenous antibiotic. The move follows patent confirmation by the Central Drugs Standard Control Organisation and the Indian Patent Office, allowing pricing flexibility and encouraging domestic antibiotic innovation.
Source: short-url.org/1k973

5. India’s National One Health Mission has reportedly invited expressions of interest from qualified organisations to develop artificial intelligence tools for early detection of emerging pathogens across human, animal and environmental systems. The government-backed programme will fund research and development to strengthen disease surveillance and pandemic preparedness nationwide efforts.
Source: short-url.org/1k977

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 has in the Union Budget 2026–27, removed basic customs duty on 17 cancer drugs to reduce treatment costs. The move aims to ease the financial burden on patients, particularly for high-cost imported therapies, and improve access to essential cancer medicines across the country.
Source: h7.cl/1nZbu
#Drugs #Cancer #CustomDuty #Slashed #Budget2026

2. The Supreme Court of India has held that administering stem cell therapy for Autism Spectrum Disorder (ASD) outside an approved clinical trial setting is unethical and amounts to medical malpractice. The Court clarified that such therapy is not recognised as a sound and established medical practice due to the lack of scientific validation of safety and efficacy. The same is permissible only for an approved and monitored clinical trial with the intent to advance science.
Source: h7.cl/1nZbb

3. Maharashtra’s State Blood Transfusion Council has reportedly warned blood banks against collecting excess blood and transferring it to other states for profit. Violations, including commercial supply to plasma fractionation companies, may invite licence cancellation, as centres are directed to collect only patient-linked requirements to protect voluntary donation ethics.
Source: h7.cl/1iYh-

4. The Enforcement Directorate reportedly conducted searches at twenty six locations across multiple states as part of a probe into illegal international narcotics trafficking and money laundering. Investigations revealed a structured interstate drug network, leading to seizure of cash, narcotic substances, contraband, and incriminating documents indicating organised distribution and laundering activities.
Source: h7.cl/1nZbD

5. The Government of India has proposed amending the Drugs Rules, 1945 to designate Navi Mumbai International Airport (NMIA) as an authorised drug import entry point, making it a 12th approved airport, improving logistics and reducing congestion at existing ports. Stakeholders have been requested to submit comments withing 30 days.
Source: h7.cl/1nZbN

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 Kerala High Court ruled that brand ambassadors are not liable for unfair trade practices or deficient services under the Consumer Protection Act unless a direct transactional link with consumers is proven. Endorsers face penalties only for misleading advertisements, and are protected where due diligence to verify claims is demonstrated by law.
Source: h7.cl/1hJqC

2. State Drugs Regulator of Telangana has recently issued a stop-use advisory for a children’s syrup prescribed for allergies, hay fever, and asthma, after a CDSCO lab detected toxic ethylene glycol contamination. The public was advised to stop use immediately, report possession, and authorities ordered freezing of affected stocks to avert health risks.
Source: h7.cl/1mGN8

3. A Parliamentary Standing Committee has urged the Ministry of AYUSH to integrate allopathy and traditional medicine, recommending AYUSH departments in all AIIMS, stronger collaboration with the Health Ministry, and time-bound action to create a pluralistic, integrated healthcare system nationwide.
Source: h7.cl/1mGNc

4. The Bureau of Indian Standards has notified amendments to 22 Indian Standards covering dairy products, infant foods, milk substitutes, and special medical nutrition. Amendments were established from 15 December 2025, and existing standards will remain in force till 14 June 2026, giving business operators a defined transition period for compliance.
Source: h7.cl/1hJqz

5. The US Food and Drug Administration has relaxed the oversight of general wellness devices, clarifying that low-risk products such as fitness trackers and wellness apps will not be actively regulated as medical devices if they avoid disease-related claims. The move aims to reduce regulatory burden and encourage innovation in consumer and digital health technologies.
Source: h7.cl/1hJqP
Source: h7.cl/1hJqT

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 CDSCO has issued detailed FAQs to enhance public awareness regarding the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. The FAQs clarify the procedure for compounding offences, the stage at which an application may be filed, and the information and documentation required to support such applications.
Source: shorturl.at/Mkg3L

2. India’s Central Drug Authority has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
Stakeholders intending to apply for compounding of offences under these rules are required to submit the application in the prescribed format as a physical copy, along with an advance copy via email to raj[dot]shree64[at]cghs[dot]nic[dot]in, addressed to the Compounding Authority.
Source: h7.cl/1mrDG

3. India’s Delhi High Court directed the Central Health Ministry to respond by January 20, 2026 to a contempt plea alleging illegal operations of online health service aggregators. The petition claims these platforms violate the Clinical Establishments Act by functioning without mandatory registration, posing risks to public health and regulatory compliance.
Source: h7.cl/1hvu5

4. The Delhi government will declare human rabies a notifiable disease, requiring mandatory reporting of all suspected, probable and confirmed cases by government and private healthcare facilities. The move aims to strengthen disease surveillance, enable timely intervention, and support the capital’s goal of eliminating rabies-related human deaths.
Source: h7.cl/1hvts

5. A major infant nutrition manufacturer has initiated a large-scale recall of select infant formula products across multiple countries after detecting a potential toxin contamination linked to a supplier ingredient. No illnesses have been reported. The company is strengthening supply chains, activating alternate suppliers, and increasing production to ensure uninterrupted availability.
Source: h7.cl/1msn9

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 government has reportedly updated the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) policy, mandating a 500-metre minimum distance between Jan Aushadhi stores in major urban centres to protect existing outlets’ financial viability while continuing expansion of affordable generic drugs across the nation. Major metros and million-plus cities are in scope; exemptions apply for government hospitals.
Source: h7.cl/1gK1R

2. The Parliamentary Panel on Health and Family Welfare has urged the Ministry of Ayush to introduce strict penal provisions against false and misleading advertisements, strengthen enforcement mechanisms, improve public awareness, ensure transparency in action taken, and prioritise establishment of Ayush institutes and Yoga Ashrams in underdeveloped states.
Source: h7.cl/1lEmX

3. The Food Safety and Standards Authority of India clarified that eggs sold in the country are safe for consumption and claims linking them to cancer are misleading. It stressed that nitrofuran residues are strictly regulated, trace detections pose no health risk, and consumers should rely on verified scientific evidence.
Source: h7.cl/1gK2z

4. India’s central food authority (FSSAI) has issued a Scheme of Testing for Packaged Drinking Water (PDW) and Mineral Water (MW) to ensure product safety after removing mandatory BIS certification. Effective January 1, 2026, all food business operators must follow detailed microbiological, chemical and packaging testing protocols and maintain compliant batch records via FSSAI-notified NABL labs.
Source: h7.cl/1lEoa

5. The WHO and India’s Ministry of AYUSH held a two-day technical meeting in New Delhi to develop a dedicated Traditional Medicine module within the International Classification of Health Interventions (ICHI), aiming to standardise Ayurveda, Siddha, and Unani globally. India is providing financial and technical support, with expert and member-state participation to strengthen evidence-based global health standards.
Source: h7.cl/1gK2s

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 notified the establishment of a National Control Room (NCR) to coordinate and monitor nationwide enforcement of the ban on identified single-use plastic items. The NCR will support clarity, compliance tracking, stakeholder guidance, state control room reporting, inspections and awareness campaigns.
Source: h7.cl/1lmmL

2. The National Medical Commission has directed medical colleges to establish committees to monitor prescription practices, emphasising clear and legible handwriting and the use of generic drug names. The directive aims to strengthen patient safety, promote rational prescribing, and integrate these practices into medical education nationwide.
Source: h7.cl/1lmm6

3. Food Safety and Standards Authority of India has reportedly directed all states and Union Territories to launch a nationwide enforcement drive against adulteration and misbranding of milk, paneer and khoya. The move follows repeated detections and aims to protect public health through strict inspections and penalties across country.
Source: h7.cl/1gsAC

4. More than 60% of registered small and medium pharmaceutical units in India reportedly risk shutting down by December 2025 due to non-compliance with revised GMP (Schedule M) quality standards. Industry stakeholders warn of potential medicine shortages, job losses, and export disruptions if compliance challenges are not addressed promptly.
Source: h7.cl/1gsAd

5. The EU’s Medical Device Coordination Group has issued new guidance clarifying criteria for qualifying breakthrough medical and IVD devices under MDR/IVDR. It defines key criteria such as significant clinical benefit, unmet medical need, and innovation level, aiming to harmonize interpretation across authorities and support early regulatory engagement without lowering safety or evidence requirements.
Source: h7.cl/1lmli

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 food regulator, FSSAI, has reportedly initiated a nationwide surveillance drive to collect and test egg samples (branded and unbranded) for banned antibiotics like nitrofurans. Additionally, FSSAI is also scrutinising declarations such as ‘100% chemical-free’, ‘antibiotic-free’, ‘100% pure’, or ‘fresh’, checking compliance with permissible labelling declarations.
Source: h7.cl/1gl8j

2. India will host the Second World Health Organization Global Summit on Traditional Medicine in New Delhi from 17 to 19 December 2025, bringing global leaders together to strengthen science-based, ethical and sustainable integration of traditional medicine into national health systems and the global health policy framework.
Source: h7.cl/1leF9

3. India’s Parliamentary Standing Committee on Health & Family Welfare has reportedly called on the National Medical Commission (NMC) to issue clear guidelines to establish new medical colleges in states with fewer than 100 MBBS seats per million population, addressing uneven seat distribution, high costs, faculty shortages and access gaps in medical education.
Source: h7.cl/1gl9d

4. The Indian Council of Medical Research has reportedly funded a pan India clinical trial, Intermittent PARP Inhibitor Regimen in Ovarian Cancer, to evaluate intermittent dosing of the PARP inhibitor rucaparib in ovarian cancer, aiming to reduce treatment costs and side effects while maintaining clinical efficacy and improving patient access.
Source: h7.cl/1leFj

5. The Telangana Drugs Control Administration conducted a statewide inspection of retail medical shops and raided an unlicensed fertility centre, issuing notices to 180 outlets and seizing multiple medicines, reinforcing enforcement against illegal drug sales and violations of the Drugs and Cosmetics Act, and ensuring patient safety across the state.
Source: h7.cl/1gl8A

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 Competition Commission of India has ordered three Maharashtra liquor trade associations to cease anti-competitive practices, including influencing prices and restricting market access. The CCI found the groups violated the Competition Act and directed them to stop such conduct, though no monetary penalties were imposed.
Source: h7.cl/1g7kN

2. The Punjab government has issued strict new directives for private hospitals to curb exploitation, including mandated humane treatment protocols and safeguards in sensitive situations like patient death. The move aims to strengthen patient rights and accountability in healthcare delivery amid public concerns over unethical practices.
Source: h7.cl/1l0ob

3. Karnataka’s Health Minister has reportedly cautioned private hospitals against conducting unnecessary caesarean deliveries for financial gain, stating that violations under the Karnataka Private Medical Establishments Act may attract penalties up to fifty thousand rupees and potential cancellation of registration, following due process, if establishments fail to comply with regulatory directions.
Source: h7.cl/1l0p7

4. The All India Organisation of Chemists and Druggists has reportedly urged the Prime Minister to halt illegal e-pharmacy operations and withdraw proposed drug regulations, warning that unregulated online medicine sales, especially antibiotics, violate key laws and dangerously accelerate antimicrobial resistance, creating a significant threat to India’s public health system.
Source: h7.cl/1l0o0

5. The Indian Medical Parliamentarians’ Forum has reportedly warned that funding gaps and delays in India’s Rare Disease Policy are disrupting life-saving enzyme therapy for Lysosomal Storage Disorder patients. Over 60 patients have exceeded the ₹50-lakh cap and nearly 100 face imminent treatment loss, prompting urgent calls for expanded funding and sustained government support.
Source: h7.cl/1g7iS

Posted on

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 & 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. The Government of India has notified the Legal Metrology (Packaged Commodities) Second Amendment Rules, 2025, effective 1 February 2026. The amendment removes pan masala from an earlier exemption, mandating that all pan masala packages, regardless of size, must fully comply with the standard declaration requirements prescribed under the rules.
Source: h7.cl/1kzQU

2. Central Pollution Control Board has issued a notice allowing plastic packaging producers, importers, and brand owners facing a shortage of Cat II/III recycling certificates to use End-of-Life (EOL) certificates to meet their FY 2024–25 recycling obligations. Now, 1 ton of Cat II/III recycling obligation can be fulfilled using 1.5 tons of EOL certificates.
Source: h7.cl/1kzQI

3. The U.S. Food and Drug Administration (FDA) has issued draft guidance reducing or eliminating the requirement for non human primate toxicity testing for certain monoclonal-antibody therapies. This change may shorten preclinical timelines and lower costs, while promoting alternative safety evaluation methods.
Source: h7.cl/1fEU5

4. India’s drug regulator has been alerted that fake versions of widely used medicines may be circulating after Puducherry officials seized several suspected counterfeit samples. States and Union Territories have also been asked to maintain “strict vigil” on the movement of these batches of widely popular medicines.
Source: h7.cl/1kw0M

5. The Supreme Court has issued notice to the Union Government on a petition seeking a statutory framework for criminal prosecution in medical negligence cases. The plea highlights that no rules have been created despite the Jacob Mathew judgment in 2005 and urges independent, multi-stakeholder inquiry panels to ensure fair, unbiased investigations.
Source: h7.cl/1fETM