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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 Legal Metrology Division has clarified that the label declaration of “Manufactured by” is not required if the complete name and address of the brand owner is provided with the words “Marketed by” or “Brand Owner.” The declaration of manufacturer is a mandatory declaration under the Legal Metrology (Packaged Commodities) Rules, 2011.
Source: urli.info/1jgRA

2. The Department of Consumer Affairs, Legal Metrology Division, has clarified through the recently released Frequently Asked Questions that omission or obscuring of the maximum retail price is permissible on packages marked “Not for Retail Sale–For Institutional Customers Only” or “Evaluation Samples–Not for Sale”.
Source: urli.info/1jgRA

3. The Ministry of Agriculture and Farmers Welfare has issued draft Insecticides (Amendment) Rules, 2025, proposing to extend the compliance deadline for registration and related requirements under Insecticides Rules, 1971 from June 30, 2024 to June 30, 2026. Stakeholders may submit objections or suggestions within 30 days.
Source: urli.info/1jh3Q

4. The Gujarat High Court has held that healthcare services provided by private hospitals to in-patients are composite contracts, where the supply of medicines, implants, and consumables constitutes a “deemed sale” of goods embedded within the service, and hospitals are liable to pay VAT on the goods transferred during treatment as a works contract.
Source: urli.info/1eta4

5. India’s Delhi High Court directed Central Board of Indirect Taxes & Customs (CBIC) to frame a uniform policy on whether imports of products like “body massagers” or “sex toys” should be permitted or prohibited, noting inconsistent Customs practices. The Court said such decisions must follow national and contemporary standards, not the subjective discretion of individual officials.
Source: rb.gy/opp4oe

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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.Kerala High Court has ordered against the usage of “Dr.” prefix by physiotherapists and occupational therapists who do not possess recognized medical qualification. The order came while considering challenges to recent curriculum provisions allowing such usage, the next hearing is scheduled on December 1, 2025.
Source: urli.info/1em0-

2.The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling prices for six scheduled formulations, including riboflavin tablets, peritoneal dialysis solutions, ethyl alcohol, and human normal immunoglobulin. Manufacturers and importers are mandated to align MRPs to the notified prices, file Form V on IPDMS and ensure that retailers/distributors display price list in their premises.
Source: urli.info/1j9u0

3.The Delhi High Court has expressed concern over an advertisement by a leading ayurvedic drug company that labels rival company product as “dhoka” (fraud). The Court questioned whether the use of such terminology crosses the permissible threshold and amounts to impermissible disparagement of a competitor’s product.
Source: urli.info/1j8ZY

4.The Food Safety and Standards Authority of India (FSSAI) has notified the Food Safety and Standards (Import) First Amendment Regulations, 2025, effective May 1, 2026. The amendment allows FSSAI approved or globally recognized analytical methods and mandates that the notified or referral laboratory to submit duly signed food analysis reports within five days of receiving samples.
Source: urli.info/1j9up

5.The Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945 to include cell or stem-cell derived products, gene therapeutic products and xenografts under the regulatory framework currently governing recombinant DNA derived drugs, aligning regulatory provisions and licensing forms with emerging Source:
advanced biological therapies.
Source: urli.info/1j9ta

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 has reiterated that import of drugs, will be permitted only through notified ports under Rule 43-A of the Drugs Rules, 1945. The designated entry points have been mapped with customs’ ICEGATE system to ensure regulatory oversight and streamline import clearances.
Source: https://short-url.org/1h02u

2. India’s Directorate General of Trade Remedies has initiated an anti-dumping probe into imports of harming domestic producers. The investigation will assess the extent of dumping and its impact for need of anti-dumping duties under Indian laws.
Source: https://short-url.org/1gZMy

3. The National Human Rights Commission has reportedly issued notices to several state governments over multiple child deaths allegedly caused by contaminated cough syrup. It has also directed the drug regulator and Health Ministry to investigate spurious drug supply. Recently, similar action was taken over a gas leak in Maharashtra.
Source: https://short-url.org/1ciNX
https://short-url.org/1ciLx

4. Indian government have reportedly assured Jan Aushadhi Kendra retailers that it will review the newly introduced zero-distance policy, which removed the 1 km minimum distance requirement between outlets in cities with populations of over one million. Retailers are seeking rollback, citing significant losses in sales and profitability due to increased competition.
Source: https://short-url.org/1ciMf

5. The All India Organization of Chemists and Druggists (AIOCD) has reportedly incorporated its first pharmaceutical Limited Liability Partnership (LLP) in Kerala, marking a significant step in empowering local wholesalers to compete with corporate and foreign players. This initiative aims to consolidate traditional distributors into corporate entities, enhancing efficiency and resource pooling.
Source: https://short-url.org/1ciLM

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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 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

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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 Directorate General of Trade Remedies (DGTR) has recommended a three-year safeguard duty on select steel imports, which is expected to hike costs for medical devices using 316L stainless steel (e.g., surgical tools, implants). This could pressure production margins, inflate end-user prices, and strain India’s competitiveness in domestic and export markets.
Source: short-link.me/17nS4

2. A high level inter departmental committee has reportedly commenced drafting rules to regulate the import of refurbished medical devices into India. Presently, imports are only allowed for high-end high value devices that haven’t been phased out overseas, contain no hazardous materials, and have a minimum seven-year residual life.
Source: short-link.me/1bQ2x

3. The Ministry of Health and Family Welfare has formed a national committee to draft guidelines for brain stem death certification, including for children. The expert panel will also develop training modules, certification criteria, monitoring tools, and audit systems to improve organ donation and critical care practices across the country.
Source: short-link.me/17nSk

4. NATHEALTH urges standardizing the GST input slab at 5% for healthcare and enabling input tax credit wherever output GST applies. The move aims to reduce hidden embedded taxes, estimated at 5.5–6% of provider revenue easing cost burdens on hospitals and diagnostic labs.
Source: short-link.me/1bQ2O

5. A parliamentary standing committee has reportedly recommended accelerating the rollout of a single-dose HPV vaccine to strengthen cervical cancer prevention. The panel also urged expansion of oncopathology infrastructure, especially in underserved regions like the Northeast.
Source: short-link.me/17nSB

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. India’s Supreme Court added the National Human Rights Commission (NHRC) to a 2018 PIL enforcing the Mental Healthcare Act, 2017. It condemned inhumane practices like chaining mentally ill patients, noted failure to set up mental health authorities and review boards, and directed the Centre to file a detailed affidavit on steps taken to implement the Act nationwide.
Source: bit.ly/4lB9e3f

2. Indian government has initiated a formal investigation into the growing import of medical devices from China, targeting potential cybersecurity and patient data privacy threats. Rising imports across diagnostics, surgical instruments and IoT enabled monitoring systems have raised concerns over malware, or data misuse, prompting scrutiny from commerce and health authorities.
Source: bit.ly/3IFimWg

3. The Indian Council of Medical Research (ICMR) has issued an Expression of Interest inviting eligible organisations, companies and manufacturers for transfer of technology for commercial production of recombinant multi stage malaria vaccine, AdFalciVax, by August 17, 2025.
Source: bit.ly/4eWGiAi

4. The Delhi government plans to exempt restaurants and eateries from obtaining the mandatory health trade license from the Municipal Corporation of Delhi (MCD). Currently, obtaining this licence is a prerequisite for opening eateries in the city.
Source: bit.ly/46ld2B6

5. Delhi High Court has temporarily barred pharmaceutical company from manufacturing, selling importing, exporting or dealing a biosimilar of patented cancer immunotherapy drug after finding credible evidence of patent infringement and potential irreparable harm.
Source: bit.ly/46Vlkjh

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 launched a new CT 04 application module on its SUGAM online portal, streamlining the issuance of import licences for cell & gene therapeutic products to simplify and accelerate regulatory compliance and imports.
Source: bit.ly/3TGuNmR

2. A Central Drugs Consultative Committee panel has noted consumer complaints over unreadable expiry dates, tiny fonts, glossy packaging, and generic-brand confusion on medicinal products. It recommends forming a DCGI-led sub committee including a packaging expert to overhaul labelling norms and evaluate regulatory requirements for packaging suppliers under Drugs Rules, 1945.
Source: bit.ly/3IpVF8h

3. Food Safety and Standards Authority of India (FSSAI) has recently directed licensing authorities to audit annual returns filed by food business operators on the FoSCoS platform. Authorities have been directed to flag inconsistencies, permit revisions via updated portal features, and enforce penalties for false declarations.
Source: bit.ly/4lpGH0p

4. The Central Board of Indirect Taxes and Customs has mandated that customs officers verify the registration of plastic raw material importers on the Centralized Extended Producer Responsibility (EPR) Portal before clearing consignments. This directive aligns with the Plastic Waste Management (Amendment) Rules, 2024.
Source: bit.ly/3TYREu9

5. The Government of India has reportedly planned to transfer the National Health Claims Exchange (Insurance claims platform) from the health ministry to the finance ministry under Insurance Regulatory and Development Authority’s oversight to combat inflated hospital bills for insured patients.
Source: bit.ly/40hID2M

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. Directorate General of Foreign Trade (DGFT)Trade Connect ePlatform has reportedly expanded the ‘Source from India’ portal to include all pharma Status Holder exporters with valid IECs. This upgrade enhances global discoverability, boosts buyer-supplier connectivity, and further promotes India’s position as a key player in global pharmaceutical trade.
Source: bit.ly/3Ts7gWt

2. The global pharma market is reportedly shifting toward specialty drugs like biologics and oncology therapies. India, while leading in generics, is investing heavily in biosimilars, innovation, and digital health—strengthening its dual role in high-volume supply and cutting-edge pharmaceutical R&D.
Source: bit.ly/4n6JKvN

3. Association of Southeast Asian Nations (ASEAN) has issued new harmonised guidance for medical device classification and borderline products. The update refines risk categories (A–D), defines ambiguous products, and promotes faster regulatory approvals, supporting pharma-medtech innovators in expanding across the Southeast Asian market.
Source 1 : bit.ly/43P2g4t
Source 2 : bit.ly/3HKZ8xN

4. The Confederation of Indian Alcoholic Beverage Companies has reportedly expressed their concern Maharashtra’s government to revisit its decision to raise excise duty on Indian-made foreign liquor(IMFL), country liquor, and imports by up to 50–85%. Industry leaders warns this could trigger a surge in illicit trade, harm legal sales, and reduce long-term state revenues despite short-term ₹14,000 crore projections.
Source: bit.ly/4jQJ3UN

5. The U.S. Food and Drug Administration (FDA) has finalized guidance to streamline the pre-submission facility correspondence (PFC) process for priority abbreviated new drug applications (ANDAs). By submitting complete and accurate facility information at least 60 days before ANDA submission, applicants can qualify for an expedited 8-month review timeline.
Source: bit.ly/4jRpNq0