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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 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

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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 Central Drugs Standard Control Organization has cancelled the import registration of a cosmetic product after finding misleading drug-related claims on its website, which were inconsistent with the approved product labels, including claims relating to treatment of medical conditions.
Source: h7.cl/1hoPv

2. CDSCO has issued guidelines and SOPs under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, detailing eligibility, application process, authorities, and conditions for compounding certain regulatory offences, enabling settlement through monetary penalties and compliance measures instead of prosecution, supporting ease of doing business while maintaining regulatory oversight.
Source: h7.cl/1mlwh

3. The Food Safety and Standards Authority of India has notified that all amendments to food labelling and display regulations will come into force from 1 July of the year of notification. It has also revised the compliance timeline, extending the mandatory transition period for industry from 180 days to 365 days.
Source: h7.cl/1mlvZ

4. The Union Health Ministry is reportedly in discussions with state drug authorities to consider granting a six-month, case-by-case extension for pharmaceutical companies to comply with revised GMP requirements. The updated Schedule M introduces stricter manufacturing quality standards to align India’s drug production framework with global norms.
Source: h7.cl/1mlw4

5. India’s pharma regulator reportedly plans to introduce a dedicated wholesale licensing regime for bulk drugs, APIs and key starting materials. The move, along with a national supplier database, aims to improve traceability of imported materials and strengthen accountability and supply-chain oversight amid rising quality concerns.
Source: h7.cl/1hoPC

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 Health Ministry has prohibited the manufacture, sale and distribution of all immediate-release oral formulations containing Nimesulide above 100 mg, citing potential risks to human safety and availability of safer alternatives. The ban, issued under Section 26A of the Drugs and Cosmetics Act, takes immediate effect across India.
Source: h7.cl/1h4DA

2. The Ministry of Health and Family Welfare has issued draft rules to amend the Drugs Rules, 1945, proposing deletion of “Syrup” from Schedule K, following approval by the Drugs Consultative Committee. Once implemented, syrups would lose regulatory exemptions. Stakeholders are invited to submit objections within 30 days of the notification.
Source: h7.cl/1h4DF

3. India’s drug regulator reportedly cancelled the import licence of a hair loss product after it was promoted as a treatment for post chemotherapy hair loss and other medical conditions. Since the product was approved only as a cosmetic, such therapeutic claims were found misleading and in violation of cosmetic regulations.
Source: h7.cl/1h4DM

4. Leading oral nicotine pouch makers are seeking CDSCO approval to market high dose products as therapeutic nicotine replacement, raising concerns among regulators and health experts about addiction, youth initiation and long-term cardiovascular risks. The move could trigger stricter regulatory scrutiny in India’s pharma and public health landscape.
Source: h7.cl/1h4DN

5. The Telecom Regulatory Authority of India (TRAI) has issued recommendations to regulate the sale of foreign SIM/eSIM cards used in M2M/IoT devices meant for export, proposing a light-touch “International M2M SIM Service Authorisation” with online approval, no entry fees, and 10-year validity to boost exports, support Make in India
Source: h7.cl/1m0FU

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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 Finance Ministry has amended the Narcotic Drugs and Psychotropic Substances Rules, 1985 to replace Form 4A and revise Form 5, tightening procedures for import and export of narcotic drugs. The new rules mandate stricter documentation, separate accounting, monthly returns, transport permits, export-only restrictions, and compulsory surrender of unused morphine, codeine, thebaine and their salts to government facilities.
Source: h7.cl/1l0Dd

2. The Finance Ministry has authorized 15 pharma companies to import morphine, codeine, thebaine and their salts solely for producing export-bound formulations under strict conditions including use within 180 days, limits on waste, and surrender of unused material. The order is valid until December 31, 2027, with import certificates valid for 180 days.
Source: h7.cl/1g7yD

3. The Delhi High Court recorded an undertaking that a major Indian pharmaceutical company will not sell its semaglutide-based drug in India until March 20, 2026 when the secondary patent on the medicine is set to expire of another pharma company, while permitting it to manufacture and export the product to markets where no patent rights exist. The company’s assurance was noted by the court amid ongoing patent disputes, with similar relief previously granted to another domestic manufacturer in related proceedings.
Source: h7.cl/1g7xa

4. The Consumer Protection (Amendment) Bill, 2025, proposes to expand the definition of unfair trade practices to include nondisclosure of key terms and dynamic pricing, algorithmic manipulation of consumer behaviour, and the use of complex barriers that impede cancellations, returns, or opting out of services, thereby strengthening India’s legal framework against dark patterns.
Source: h7.cl/1l0Ca

5. India will reportedly invite the World Health Organization to audit and rate its drug regulatory system, aiming to strengthen quality oversight and restore global confidence in its pharmaceutical sector. The initiative follows recent safety concerns and seeks to align national processes with international regulatory maturity standards.
Source: h7.cl/1l0Ce

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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 Ministry of Corporate Affairs has amended the Companies (Specification of Definition Details) Rules, 2014, revising the financial criteria for “small companies.” The updated norms increase the paid-up capital limit to INR 10 crore and turnover limit to INR 100 crore. The change, effective immediately, expands eligibility for compliance relaxations particularly benefiting many mid-sized pharma entities by reducing regulatory burden and easing governance requirements.
Source: h7.cl/1ko76

2. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has deferred approval for a leading manufacturer’s RSV vaccine. The SEC has requested the complete Phase III study data, including six-month safety results for adults aged 60 and above, before considering new drug approval.
Source: h7.cl/1fxf9

3. Telangana’s Drugs Control Administration has reportedly urged citizens to verify medical shop licences through its Online Drug Licensing System’s Third-Party Verification tool. The initiative follows a raid in Khammam that seized medicine varieties from an unlicensed outlet, reinforcing the state’s focus on public safety and regulatory compliance.
Source: h7.cl/1fxfe

4. The World Health Organization has issued its first guideline on using Glucagon Like Peptide One therapies for long term obesity treatment. The guidance provides conditional recommendations due to limited evidence and high costs, stressing fair access and comprehensive care alongside healthier environments and early interventions for all.
Source: h7.cl/1ko7n

5. The Department of Telecommunications has reportedly directed smartphone manufacturers to preinstall the Sanchar Saathi cybersecurity application on all new devices and update existing phones. The mandatory, non-removable app enables reporting of fraud and tracing stolen phones, reflecting the government’s push to strengthen digital security through nationwide efforts.
Source: h7.cl/1fxfm

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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 central food authority (FSSAI) has extended the enforcement date for the amended labelling requirements under the Alcoholic Beverages Regulations, 2025. The earlier deadline of 1 January 2026 is now postponed to 1 July 2026. The decision follows stakeholder concerns that mid-year labelling changes would disrupt operations, cause wastage of pre-printed labels, and create additional costs, especially due to State Excise label-registration cycles.
Source: h7.cl/1kc0S

2. India is reportedly negotiating mutual recognition agreements (MRAs) with major partners such as the US, EU, UK, Singapore and ASEAN to align inspection and testing systems. The aim is to cut rejections, ease trade friction and streamline exports of basmati rice, spices, tea, coffee, marine products, fruits and vegetables, improving global competitiveness.
Source: h7.cl/1flqZ

3. India’s central food authority (FSSAI) has issued amendments to the FSS (Alcoholic Beverages) Regulations, 2018 wherein the permissible maximum level of ethyl acetate esters in alcoholic beverages has been increase from “0.2” g/l to “3.0” g/l.
Source: h7.cl/1kc16

4. India’s Drugs Consultative Committee has agreed to add levonorgestrel tablets in 0.75 mg and 1.5 mg widely known as morning-after pills to Schedule K, enabling continued OTC sales. This also includes provisions for a boxed warning on packaging highlighting side effects, no protection against HIV/STIs, limits on use, and recommendations for consulting practitioners on alternatives.
Source: h7.cl/1kbV8

5. The Supreme Court of India has reportedly directed Noida District Hospital to constitute a primary medical board within two weeks to assess passive euthanasia for a 31-year-old man who has been quadriplegic and in a vegetative state for more than a decade.
Source: h7.cl/1flra

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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. Government hospitals in Delhi will now use a different coloured bedsheet each day of the week (white, pink, green, purple, blue, light-grey, peach) under a new rotation system. The measure aims to enforce daily linen change, boost hygiene standards and reduce hospital-acquired infections.
Source: shorturl.at/kzVxx

2. The Department of Pharmaceuticals has invited applications under the Production Linked Incentive Scheme (PLI) for domestic manufacturing of Meropenem and Ritonavir. Eligible manufacturers can apply online from 27 November to 26 December 2025. The scheme specifies minimum annual production capacities and limits the number of applicants for each product.
Source: shorturl.at/DNuCk

3. The Kerala High Court has upheld the Kerala Clinical Establishments Act, requiring hospitals to display all service details and rates at reception areas and on their websites. Hospitals must also provide grievance-redressal information and cannot deny emergency care for lack of advance payment.
Source: shorturl.at/Cm1AZ

4. The Drugs Consultative Committee has urged nationwide uniformity in enforcing drug standards, highlighting delays, inadequate infrastructure, and low conviction rates. It recommended that the Union Government direct states to strengthen laboratories, manpower, and regulatory capacity under the State Health Regulatory Excellence Index to ensure consistent national drug quality.
Source: shorturl.at/ARjaQ

5. The Patents (Amendment) Rules, 2025 establish a fully digital system for investigating IP contraventions, issuing penalties, and processing appeals. New Forms 32 and 33 enable electronic filing of complaints and appeals, with strict timelines of 3 months for adjudication and 6 months for appeals, enhancing compliance certainty for industry innovators.
Source: h7.cl/1figr

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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 CDSCO via a circular has directed all licensing authorities to ensure that retail and wholesale pharmacy stores prominently display the designated Pharmacovigilance Programme of India (PVPI) QR code and toll-free number. This initiative aims to facilitate easy and seamless reporting of adverse drug reactions (ADR) by the public, strengthening drug safety monitoring.
Source: h7.cl/1jLf0

2. FSSAI has issued an advisory for dairy units selling milk/milk products via vending machines and kiosks, directing them to maintain approved rapid-test kits on-site for detecting common adulterants. The machines must display usage instructions, enable consumer self-tests or staff-demonstrations, retain usage records, and ensure kit validity and proper storage.
Source: h7.cl/1jLfi

3. The Food Safety and Standards Authority of India (FSSAI) has reportedly directed immediate removal of fruit-based beverages, R-T-S drinks and energy drinks labelled with the term “ORS” from retail and e-commerce platforms, reaffirming that only formulations meeting WHO oral-rehydration-solution standards may use “ORS”.
Source: h7.cl/1jLft

4. Indian Government reportedly plans to amend the Drugs and Cosmetics Act by adding sale licensing conditions a per which advertising of high-risk drugs in Schedules G, H, H1 and X will be explicitly banned, including via e-commerce and digital platforms, in order to curb self-medication, misleading claims an misuse of potent medicines.
Source: h7.cl/1jLfQ

5. Indian Government is reportedly framing a broader medical-device manufacturing policy aimed at cutting the country’s heavy import dependence. The plan focuses on boosting domestic production, introducing quality standards for thousands of devices, promoting zero-defect manufacturing, and strengthening India’s global competitiveness in the healthcare technology sector.
Source: h7.cl/1eWCg

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.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. The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document outlining regulatory pathways, quality standards, and risk management requirements for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Stakeholders are requested to submit feedback within 30 days.
Source: h7.cl/1iyvi

2. India’s Ministry of Consumer Affairs has amended the Legal Metrology (Packaged Commodities) Rules, 2011, to exempt medical devices from the standard packaging declaration requirements. Packages containing medical devices will adhere to the Medical Devices Rules for height and width of numerals and letters used in declarations. This amendment will ensure regulatory consistency and eliminate duplication of compliance requirements.
Source: h7.cl/1iyuq

3. The Health Ministry has issued draft amendments to the Drugs Rules, 1945, proposing that oral formulations with over 12% v/v ethyl alcohol and packed in bottles over 30 ml will be excluded from Schedule K and included in Schedule H1 for prescription-only sale. Stakeholders are requested to submit comments within 30 days.
Source: h7.cl/1dNdh

4. The Ministry of Environment, Forest & Climate Change (MoEF&CC) has amended the list of “White Category” of industries, which are exempted from air pollution consent requirements. Now the list includes 86 non-polluting sectors, such as food packaging, small bakeries, etc. to simplify compliance, especially for MSMEs.
Source: h7.cl/1dNcN

5. The Food Safety and Standards Authority of India (FSSAI) has recently issued an order introducing a dedicated “seasonal food business” registration category in the FoSCoS portal. Effective from August 01, 2025, the provision allows retailers and food vending agencies at fairs and festivals to register for up to three months by paying a ₹100 fee.
Source: h7.cl/1dNdx