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 Trade and Economic Partnership Agreement (TEPA) with the European Free Trade Association (EFTA), effective October 1, 2025, reportedly excludes medical devices and pharmaceuticals from duty concessions, keeping them protected to safeguard domestic industries. While 92.2% of EFTA and 82.7% of India’s tariff lines are liberalised, sensitive healthcare products will face phased tariff reductions over 5–10 years.
Source: https://short-url.org/1hoSo

2. Central drug regulator (CDSCO) is reportedly set to conduct nationwide inspections and audits of cough syrup manufacturing units after child deaths in Madhya Pradesh were linked to toxic syrups. States and union territories have been directed to submit lists of manufacturers for surveillance, aiming to strengthen quality control and prevent contamination-related tragedies.
Source: https://short-url.org/1cGQR

3. Department of Pharmaceuticals has launched sensitisation programmes to guide pharmaceutical and medical technology companies on the amended Promotion of Research and Innovation in Pharma-MedTech Sector scheme. The sessions will help companies to understand the revised guidelines, and digital application process to ensure smooth participation.
Source: https://short-url.org/1cGR3

4. India’s Central food authority has issued a draft amendment to Packaging regulations 2018 to restrict the use of Poly- and perfluoroalkyl substances (PFAs) in food contact materials. It also states that food materials made with polycarbonate and epoxy resins must be free from Bisphenol A (BPA) and its derivatives. Objections / suggestions are awaited from the industry stakeholders for a period of 60 days from the date of publication.
Source: https://short-url.org/1hoTb

5. State drug inspectors are reportedly seeking enforceable powers to arrest and detain offenders, aiming to curb the growing menace of spurious drugs. The demand follows the recent incident involving contaminated cough syrup sold to paediatric patients, which resulted in multiple child deaths.
Source: https://short-url.org/1hoTt

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 authority has released guidance to identify spurious drugs under the Drugs Rules, 1945. Earlier, the rules mandated QR codes on all APIs from January 2023 and barcodes or QR codes on the top 300 drug brands from August 2023. The authority has now issued a process flow to verify drug authenticity.
Source : https://short-url.org/1gVQq

2. India’s Central Drug Regulator has allowed manufacturers to apply for Certificate of Pharmaceutical Product/World Health Organization – Good Manufacturing Practices (COPP/WHO-GMP) certificates while product license applications are under review by the State Licensing Authority. Final COPP/WHO-GMP certificate will be issued after product approval.
Source: https://short-url.org/1gVUB

3. India’s central government has proposed the Assistive Technology (Standards and Accessibility) Rules, 2025, requiring all assistive devices to meet Bureau of Indian Standards quality standards. The draft ensures transparent procurement, financial aid, repair support, and a toll-free helpline, with an online Assistive Technology Portal for device certification, supply tracking, and grievance redressal.
Source: https://short-url.org/1ceKb

4. The Food Safety and Standards Authority of India has kept the spice enforcement drive (whole & powder) in abeyance until further orders. All state food safety commissioners and regional directors have been instructed not to initiate any action under the earlier directive until further instructions.
Source:
https://short-url.org/1ceKS
https://short-url.org/1gVSp

5. The US Food and Drug Administration (FDA) is seeking public input on evaluating AI-enabled medical devices, including generative AI tools. The aim is to enhance patient outcomes, public health, and accelerate medical innovation, while regulating these advanced technologies
Source: https://short-url.org/1ceLs

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 Department of Pharmaceuticals is planning to impose a Minimum Import Price (MIP) on certain active pharmaceutical ingredients and intermediates including potassium clavulanate to deter cheap imports (especially from China) and strengthen domestic raw material production under the PLI scheme.
Source: short-url.org/1fZwh

2. The Delhi High Court has allowed the company to use of the phrase “why settle for ordinary Chyawanprash” in advertisements, but directed removal of the reference “made with 40 herbs”, deeming it disparaging. The court said the remaining claim is permissible as puffery and not misleading.
Source: short-url.org/1fZwo

3. The Bombay High Court has quashed the drug regulator’s stop-production orders against two pharmaceutical companies. The court found the actions violated statutory procedures and denied the companies a fair hearing. However, it clarified that regulators may take fresh action if proper procedures are followed.
Source: short-url.org/1fZwB

4. Telecom Regulatory Authority of India has issued the draft Telecommunication (Broadcasting and Cable) Services Interconnection (Addressable Systems) (Seventh Amendment) Regulations, 2025, seeking stakeholder inputs by 6 October 2025. The draft mandates annual financial year audits, stricter infrastructure sharing rules, and aims for enforcement from 1 April 2026.
Source: short-url.org/1fZwO

5. The Directorate General of Trade Remedies has rescheduled the oral hearing in the anti dumping sunset review of methyl acetoacetate imports from China to October 8, 2025. The review will decide if duties must continue to prevent dumping and protect domestic industry.
Source: short-url.org/1fZwV

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 Consumer Affairs Ministry has permitted manufacturers, packers, and importers to revise MRPs on unsold pre-packaged goods post-GST changes, reflecting only the tax difference. Original MRP must remain visible. Revisions via stickers or stamping are allowed. Conditions include newspaper ads, dealer notifications, and apply until December 31, 2025, or stock exhaustion which ever is earlier.
Source: short-url.org/1dU94

2. The Department of Consumer Affairs has proposed an amendment to the Legal Metrology (Approval of Models) Rules, 2011, introducing a validity period of 10 years for domestic and 5 years for imported model approvals. Public comments are invited before October 9, 2025 through emails.
Source: shorturl.at/7wExv

3. The Soybean Processors Association of India has reportedly objected to FSSAI’s ‘Eat Right India’ post promoting olive oil, calling it elitist and biased. They argue it undermines public confidence in affordable, nutritious local oils like soybean and mustard, and urge its withdrawal to protect consumer trust and national interests.
Source: shorturl.at/zkeaL

4. The FSSAI has constituted a committee to modernize India’s organic-food and agricultural products’ regulatory framework by revising certification rules, usage of the India Organic label, and aligning standards with global benchmarks. While the scope spans organic agricultural products, the authority has not provided a timeline for rollout.
Source: shorturl.at/AQnA5

5. The Retail Distribution Chemist Alliance (RDCA) has cautioned that the shift reducing GST on most medicines from 12% to 5%, effective September 22, 2025, is financially unviable for pharmacies due to unrecoverable input tax credit, risking severe medicine shortages without urgent relief.
Source: shorturl.at/oAEhB

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 Department of Pharmaceuticals has amended the UCMPMD 2024, clarifying valuation of free evaluation samples at stockist price if self-manufactured or average purchase price if sourced externally. Companies in multiple associations may submit disclosures through one, with prior intimation to others and notification to the Department when switching.
Source: short-link.me/18ym-

2. India’s Health Ministry has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, enabling simplified approval for bioavailability and bioequivalence (BA/BE) studies of oral drugs approved in India or select countries, for export purposes. The draft exempts certain drug categories and caps sample size at 48. Stakeholders may submit objections or suggestions by 27 September 2025.
Source: short-link.me/1d3UX

3. Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) have released draft protocols for evaluating In-Vitro Diagnostics (IVDs) for tuberculosis, including drug-resistant strains. Stakeholders can submit comments by September 7, 2025. Final protocols will be based on this feedback before final clearance is given by ICMR and CDSCO.
Source: short-link.me/18ylZ

4. India’s Punjab and Haryana High Court has ruled that legible medical prescriptions is a fundamental right of patients and doctors must write prescriptions in capital letters until Digitalization. PGIMER Chandigarh’s “Doctor Desk” e-prescription system is expected to be implemented within two years.
Source: short-link.me/18ym7

5. The Ministry of Health and Family Welfare has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019. The proposals reduce approval timelines from ninety to forty-five working days and introduce a simplified notification system for manufacturing certain drugs meant for analytical and preclinical testing.
Source: short-link.me/1d3Vg

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. India’s central drug regulator (CDSCO)has issued a Subject Expert Committees (SEC) guidance document 2025, which outlines a structured process for evaluating clinical trial and new drug applications. It covers SEC composition, review timelines, quorum, waiver criteria, applicant obligations, and decision protocols to ensure scientific rigor, transparency, and regulatory consistency.
Source: bit.ly/4f2ICpE

2. The Central Pollution Control Board has extended the timeline for filing quarterly and annual E Waste returns for the financial year 2024–25 from June 30, 2025 to August 15, 2025. All registered entities must submit return via the E Waste EPR Portal to avoid penalties under the Environment Protection Act, 1986.
Source: bit.ly/44V6tCM

3. India’s Bureau of Energy Efficiency has issued the Draft Appliance Labelling Regulations, 2025, alongside a repeal order for thirteen earlier label-display regulations affecting appliances like refrigerators, ACs, TVs, washing machines, transformers, lamps, and fans. Stakeholder feedback is invited until August 10, 2025.
Source: bit.ly/4f7if1F

4. The Government of India is being urged by experts and the Thalassemia Patients Advocacy Group (TPAG) to mandate Nucleic Acid Testing (NAT) in all blood banks to detect HIV, Hepatitis B, and C during the early “window period.” The call highlights existing gaps in blood safety, with demands for Ministry of Health action amid rising concerns over patient rights and transfusion-linked infections.
Source: bit.ly/3GXeQpo

5. Advisory panel of US Food and Drug Administration has reportedly recommended removing the strong black box warning from vaginal estrogen products, saying it’s based on outdated data that scares women and doctors. Experts highlighted benefits like heart attack and bone fracture prevention. The FDA has yet to make a final decision.
Source: bit.ly/44DSh2j

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 is reportedly preparing to ramp up oversight of quick commerce platforms following a series of hygiene and food safety lapses at their dark store facilities. FSSAI plans to conduct unscheduled surprise inspections nationwide to enforce stricter compliance, particularly concerning hygiene and the sale of near-expiry products.
Source: bit.ly/43QmomR

2. The Department of Pharmaceuticals (DoP) has revised its 2024 guidelines for its Capacity Building and Skill Development sub scheme under the Strengthening of Medical Device Industry initiative. New criteria include minimum admission thresholds at least 30% in the first year and 50% in subsequent years failure of which results in withdrawal of funding.
Source: bit.ly/4dW0OR2

3. The Supreme Court of India ruled that the right to shut down a business is part of Article 19(1)(g), subject to reasonable restrictions like protecting workers and following legal procedures. It emphasized that authorities cannot delay valid closure requests or overstep their powers.
Source: bit.ly/4e2FABh

4. The Indian Pharmaceutical Association has reportedly urged reforms in e-prescription rules to prevent misuse through repeated use of digital prescriptions. It recommends a mandatory ‘dispensed’ stamp, encrypted prescriptions or direct doctor-to-pharmacy transmission, but experts warn this could restrict patient rights, access, and create pharmacy monopolies.
Source: bit.ly/4ejdfa1

5. FSSAI has released the Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2025, proposing new standards for cheese powder, removing “fish” from the animal definition, and banning additives in atta, rice, millet, and mixed millet flours. Public feedback is invited until August 8, 2025.
Source: bit.ly/4e8UW7i

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 Consumer Protection Authority (CCPA) has directed all e-commerce platforms to conduct self-audits within three months to eliminate ‘dark patterns’. Platforms are encouraged to submit self-declarations affirming compliance with the 2023 Guidelines for Prevention and Regulation of Dark Patterns.
Source: bit.ly/43SkWPg

2. Indian Government is reportedly planning to introduce a Minimum Import Price (MIP) on pharmaceutical raw materials including Key Starting Materials (KSMs), drug intermediates, and Active Pharmaceutical Ingredients (APIs) to curb the influx of low-cost Chinese imports and support domestic manufacturers.
Source: bit.ly/3Tjvdz6

3. The Ministry of Agriculture and Farmers Welfare has notified the draft Insecticides (Amendment) Rules, 2025, aimed at simplifying licences for insecticides used for household purposes. The amendments reduce application timelines from 90 to 30 days, mandate QR codes on retail packs, and applicants applying for renewal must now meet the educational qualification requirement and require applicants renewing their licences to meet the prescribed educational qualifications.
Source: bit.ly/43PCD23

4. India’s National Consumer Disputes Redressal Commission upheld LIC’s appeal, affirming that insurance contracts require utmost good faith (uberrimae fidei) and placing the burden of disclosure on the insured. Citing the insured’s failure to disclose a prior medical condition as material, it found the State Commission’s award flawed and ordered a fresh review.
Source: bit.ly/3SHoBKU

5. India’s Ministry of Finance has revised several General Financial Rules (GFRs) to ease and expedite procurement processes for scientific equipment and consumables in government-funded research and S&T institutions, by raising financial limits for direct purchases and tenders by head of institutes.
Source: bit.ly/3Zlo8lo

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 Medical Commission (NMC) has reportedly not initiated any action against 30 doctors involved in a pharma freebies case. An RTI response reveals that the Department of Pharmaceuticals has not directed action, despite earlier findings of violations by the pharmaceutical company sponsoring lavish trips.
Source: bit.ly/44xs6e4

2. The Indian Pharmacopoeia Commission (IPC) has announced changes to certain monograph titles and synonyms in the upcoming Indian Pharmacopoeia (IP) 2026 which is effective from July 2026. Manufacturers have been advised to assess the impact on existing products and start taking necessary steps to update the label.
Source: bit.ly/4dtuq8p

3. India’s Ministry of Health has reportedly raised concerns that only a small fraction of small and medium-sized pharmaceutical companies have applied to the government for an extension of the timeline to comply with the Revised Good Manufacturing Practices (GMP) under Schedule M and to submit their facility upgradation plans. With the 12th May 2025 deadline approaching, state health secretaries have been asked to coordinate with local manufacturers and ensure timely compliance.
Source: bit.ly/4ka44u3

4. The Government of Odisha has reportedly announced plans to draft a state-wide mental health policy, including early intervention frameworks and counselling centres, to address rising mental health issues particularly among vulnerable groups such as youth and the elderly
Source: bit.ly/44peMIy

5. The European Medicines Agency (EMA) has officially recognized suicidal thoughts as a potential side effect of a medication commonly used to treat male pattern baldness. While the EMA maintains that the benefits of the drug continue to outweigh the risks, it has mandated that all 1 mg packages include a patient card highlighting these risks.
Source: bit.ly/3SgZLBr