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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 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

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 Drugs Consultative Committee (DCC) has approved a proposal to delete the exemption under Entry 13 of Schedule K for cough syrups. The move follows recent incidents involving deaths linked to contaminated cough syrups.
Source: h7.cl/1ft5I

2. The Drugs Consultative Committee (DCC) has observed gaps in monitoring drug marketers’ responsibility for product quality, safety, and efficacy, as their details are often unavailable for regulatory communication. To enhance accountability, the DCC has recommended amending the Drugs Rules, 1945 to mandate a licensing framework for all drug marketers.
Source: h7.cl/1kjPG

3. India is reportedly planning to introduce a Quality Control Order (QCO) requiring Bureau of Indian Standards compliance for food-processing machinery, aiming to curb unsafe imports, especially from China. The measure seeks to improve equipment reliability, ensure food-grade materials, strengthen domestic manufacturing, and minimise disruption for smaller processors across the industry.
Source: h7.cl/1ft5T

4. The government will reportedly introduce a Bill in the Lok Sabha seeking a new “health & national security” cess to replace the expiring GST compensation cess on cigarettes, pan masala, gutkha and other tobacco products. The aim is to keep overall tax incidence unchanged, sustaining high indirect-tax levels on “sin goods” while tying levy proceeds to public-health and national-security objectives.
Source: h7.cl/1kjPJ

5. The Food Safety and Standards Authority of India (FSSAI) has directed all state and central food-safety authorities to conduct inspections, sampling and testing of roasted chana and similar products following complaints that the banned industrial dye Auramine, which is not permitted under food-safety rules, was being illegally used for colouring. The order mandates action across manufacturing, storage, distribution and e-commerce channels and requires a consolidated compliance report to be submitted within 15 days.
Source: h7.cl/1kjQl

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 Health Ministry has amended the New Drugs and Clinical Trials Rules, 2019, permitting bioavailability or bioequivalence (BA/BE) studies in human subjects for export purposes for certain drugs approved in India or any one of the regulated markets (USA, EU, Japan, Australia, Canada, UK) through submission of an online application as notification and its acknowledgement by the Central Licensing Authority, subject to certain conditions. The conditions are mainly ethics committee approval, record-keeping, and minimum sample size.
Source: urli.info/1iRyM

2. India’s Health Ministry has issued the draft amendments to Schedule K of the Drugs Rules, 1945. Liquid antiseptics are now categorized separately for household and hospital use, with distinct labelling and licensing conditions to ensure proper manufacturing, packaging, and sale compliance by licensed manufacturers and wholesalers.
Source: urli.info/1e4F-

3. Indian Food Authority (FSSAI) has issued an advisory to all Designated Officers, Food Safety Officers, and Enforcement Teams to ensure proper disposal of seized, rejected, and expired food, including packaging, through approved methods like incineration, sanitary landfilling, or composting. Disposals must be supervised, video-recorded, and certified by authorised food safety officials.
Source: urli.info/1iRz4

4. Indian medical devices regulator (CDSCO) has issued an updated list of about 1,700 Indian Standards (IS) under the BIS Medical Equipment and Hospital Planning (MHD) division, covering around 20 categories including surgical, diagnostic, orthopaedic, dental, and hospital-planning equipment. All medical devices manufactured, imported, and marketed in India must mandatorily conform to BIS standards for regulatory and quality compliance.
Source: urli.info/1iRz9

5. India’s Health Ministry has proposed amending Schedule H2 of the Drugs Rules, 1945, which contains a category of medicines that are mandated to carry a barcode or QR code on their label, to expand it with a new “Table 2” listing key therapeutic categories vaccines, antimicrobials, narcotic and psychotropic drugs, and anticancer drugs. Stakeholders can submit comments within 30 days.
Source: urli.info/1iRzg

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