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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 Ministry of Electronics and Information Technology has notified phased enforcement of the Digital Personal Data Protection Act 2023. Implementation will follow a phased timeline of 12-18 months, introducing consent-based processing, mandatory breach reporting, children’s safeguards, expanded data rights, and a digital-only Data Protection Board, marking the structured rollout of India’s data protection framework.
Source: minilink.pro/1jA7S

2. India’s Ministry of Electronics and Information Technology (MeitY) has recently notified the Digital Personal Data Protection Rules, 2025. The rules mandate clear consent, breach reporting, children’s data safeguards, and a digital-only Data Protection Board. Compliance is phased over 18 months, along with penalties for violations.
Source: minilink.pro/1eLQj

3. The National Pharmaceutical Pricing Authority has extended the existing ceiling prices for orthopaedic knee implants by one more year until November 15, 2026. Manufacturers and importers of orthopaedic knee implants will have to maintain the existing prices till November 15, 2025.
Source: minilink.pro/1jA8h

4. The Food Safety and Standards Authority of India has integrated its Food Import Clearance System with the Central Board of Indirect Taxes and Customs under the SWIFT 2.0 platform. This integration enables faster, more transparent, and technology-driven food import clearance, reducing delays, improving efficiency, and supporting India’s broader trade facilitation objectives.
Source: minilink.pro/1jA97

5. The Union Cabinet has approved the Credit Guarantee Scheme for Exporters (CGSE), offering up to INR 20,000 crore in collateral-free credit with 100 % guarantee via National Credit Guarantee Trustee Company (NCGTC). Including both MSME and non-MSME exporters, the scheme aims to boost liquidity, aid market diversification, and enhance global competitiveness of Indian exports.
Source: minilink.pro/1eLQH

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 Consumer Affairs has uploaded the list of revised retail sale prices declared by companies in response to the recent GST rate changes. This update reflects company’s adjustments to the new tax rates, impacting pricing across various product categories, including drugs and medical devices.
Source: https://short-url.org/1cK-p

2. Investigations into the cough syrup incident have reportedly revealed that the manufacturer allegedly paid a 10% commission to the doctor for prescribing the syrup. Authorities are continuing their probe, focusing on both the manufacturer and the doctor’s involvement in the case.
Source : https://short-url.org/1cK-H

3. The National Medical Commission is reportedly planning to prohibit pharma and medical device promotions during live surgery broadcasts, citing misuse for marketing over education. Live surgeries will be allowed only for new procedures, with recordings preferred for others, to prevent ethical breaches and ensure patient safety in medical demonstrations
Source: https://short-url.org/1cK-P

4. The Delhi High Court has permitted the launch of an affordable generic version of a drug used to treat spinal muscular atrophy, upholding that a credible challenge was raised to the patent and emphasising that affordable access to life-saving treatment outweighs the need for injunctive relief in public interest.
Source : https://short-url.org/1cL07

5. The US Food and Drug Administration (FDA) reviewed a direct-to-consumer TV advertisement by a major drug manufacturer and found it false and misleading. According to the FDA, the ad’s rapid visuals, background music, and frequent scene changes distracted viewers, hindering understanding of important risk information and creating a misleading perception of the drug’s effectiveness among consumers.
Source : https://short-url.org/1cL04

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. 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

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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 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. The National Medical Commission has directed all medical colleges to form and register adverse event monitoring committee chaired by the medical superintendent under the Materiovigilance Programme with Indian Pharmacopoeia Commission to monitor, assess and prevent adverse events from medical devices by July 31, 2025.
Source: bit.ly/3TI4mxc

2. The Maharashtra government paused its decision to let homeopaths prescribe modern medicine, forming a 7-member committee to review the issue within two months. The move comes amid strong opposition from medical associations concerned about public safety and standards. The matter remains pending in Bombay High Court.
Source: bit.ly/4lYxuMI

3. India’s Ministry of Environment, Forest and Climate Change has notified the Environment (Protection) Fourth Amendment Rules, 2025, introducing revised emission norms for thermal power plants. Based on plant categorization, sulphur dioxide emission standards have been prescribed, along with timelines and penalties for non-compliance, including environmental compensation.
Source: bit.ly/40iWJRx

4. The District Consumer Commission in Ernakulam, Kerala, found a fertility clinic guilty of unfair trade practices and service deficiency for giving misleading assurances about IVF success rates. The Commission awarded ₹2.66 lakh in compensation the couple, emphasizing that such conduct is a breach of duty owed to consumers, violating their right to truthful information and fair services.
Source: bit.ly/4lzmghO

5. The recently signed “One Big Beautiful Bill” introduces stricter Medicaid work and eligibility verification from 2027, in addition to funding cuts that may force insurers to exit low-margin markets. The Congressional Budget Office warns this could leave 7.8 million Americans uninsured by 2034, while driving up premiums and administrative burdens.
Source: bit.ly/4ls9HEN

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. Indian Government has notified Extended Producer Responsibility Rules for non-ferrous metal waste, effective April 2026. Applicable to pharma, food, and consumer goods sectors, these rules mandate registration, traceability, annual returns, and recycling targets to boost circular economy efforts and environmental compliance.
Source: bit.ly/4loNjMw

2. The Customs, Excise & Service Tax Appellate Tribunal (CESTAT), New Delhi, recently ruled that HIV viral load (HIV VL) test kits constitute “life saving diagnostic kits,” making them eligible for customs duty exemption. This landmark decision is poised to reduce import costs, boost accessibility, and support public health initiatives within India.
Source: bit.ly/3GmAVxA

3. The panel set by the Drugs Controller General of India has reportedly recommended a complete ban on cosmetics containing more than 1 part per million (ppm) of mercury, aligning with the Minamata Convention. The Central Drugs Standard Control Organisation will enforce self declarations and random lab testing to protect public health.
Source: bit.ly/401j99Q

4. The Delhi High court has directed the Drug Controller General of India (DCGI) to review the approval and sale of weight loss drugs like Semaglutide, Tirzepatide, and Liraglutide. Responding to a PIL citing safety concerns and lack of India specific trials the court ordered expert consultations and a detailed report within three months.
Source: bit.ly/3IaT69X

5. The Madras High Court of India has held that the Customs Department is legally bound by the Director General of Foreign Trade’s classification of capital goods under the Export Promotion Capital Goods (EPCG) Scheme. This ruling provides clarity for exporters and importers by ensuring uniform interpretation of capital goods classification under the Foreign Trade Policy.
Source: bit.ly/4ldsFyZ

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. Medical device companies have raised concerns over Uniform Code for Marketing Practices for Medical Devices (UCMPMD) and have approached the Department of Pharmaceuticals, citing overreach and operational challenges, particularly in the context of a DGHS advisory that restricted medical representative’s interactions with HCPs in government hospitals.
Source: bit.ly/3InfXiu

2. India’s Central Drugs Standard Control Organisation (CDSCO) is working on making drugs/medicine packaging more readable. The move aims to improve visibility of key details like expiry dates and dosages, addressing concerns over hard-to-read glossy labels. Proposed measures include clearer print standards and digital aids such as voice-enabled QR codes and Braille cards to enhance accessibility and consumer safety.
Source: bit.ly/46oMIpA

3. India’s Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945, to include Good Distribution Practices (GDP) guidelines for pharmaceutical products as a separate schedule. The decision follows detailed deliberations and stakeholder consultations to align with revised WHO guidelines.
Source: bit.ly/4lxABuC

4. The U.S. FDA is reportedly planning to revise the labeling for all extended-release stimulants prescribed for attention-deficit hyperactivity disorder (ADHD), requiring inclusion of a “limitation of use” section with a statement on higher rates of adverse reactions in children younger than six years.
Source: bit.ly/4l2REoA

5. The European Commission has amended its regulation to allow electronic instructions for use (eIFUs) for all medical devices intended for professional use, not just high-risk ones. Paper instructions are still required if the device could also be used by patients. eIFUs must be linked in Eudamed (the European medical device database).
Source: bit.ly/4lcdMx1

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 mandates all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Hard copy submissions will not be accepted. A step-by-step procedure and contact details for support have also been provided.
Source: bit.ly/3HWGXWd

2. CDSCO has informed all states and union territories that a loan license is no longer required for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under MDR-2017. Manufacturers must submit documentation and include the sterilization site’s license number on labels of the device.
Source: bit.ly/44nGKCX

3. The Bombay High Court has issued an interim injunction restraining a company from using packaging, labels, bottles, and trade dress that closely resemble those of an established hair-oil brand. The court found that the packaging was “slavishly copied,” potentially misleading consumers and amounting to trademark infringement and unfair competition.
Source: bit.ly/4kd5DXM

4. The Andhra Pradesh High Court has ruled that under the Narcotic Drugs and Psychotropic Substances Act, 1985, “Ganja” refers only to the flowering or fruiting tops of the cannabis plant, explicitly excluding seeds and leaves when not accompanied by the tops.
Source: bit.ly/4ls1iRl

5. India’s Central Board of Indirect Taxes and Customs (CBIC), following DGTR recommendations, has slapped anti dumping duties for five years on four key chemicals from China—PEDA, acetonitrile, Vitamin A palmitate and insoluble sulfur—to shield domestic pharma, agro and rubber industries, signalling a strategic push to rebalance imports and promote local manufacturing.
Source: bit.ly/4lNeEYX