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TOP 5 HEALTH LAWS & POLICY UPADATES

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 Pollution Control Board (CPCB) has issued a new SOP for using spent acetic acid from 7ADCA and paracetamol manufacturing to produce Pigment Yellow 12. The guideline lays out strict rules for storage, handling, emissions control, wastewater treatment, and record-keeping to ensure the safe and compliant utilization of hazardous waste.
Source: h7.cl/1fJVZ

2. The Parliamentary Standing Committee on Chemicals and Fertilisers has reported steep disparities between stockist and retail prices of several non-scheduled drugs, with trade margins reaching 600–1,100%. It has urged the NPPA and Department of Pharmaceuticals to review trade-margin practices and strengthen pricing transparency across the supply chain.
Source: h7.cl/1fJW7

3. The Department of Telecommunications (DoT) has reportedly directed messaging platforms to implement SIM-binding, linking user accounts to the SIM used during registration. Under this mandate, web-based sessions of messaging platforms will automatically log users out every six hours and require re-authentication.
Source: h7.cl/1kBdb

4. Pune Municipal Corporation has reportedly issued guidelines urging residents to avoid over-the-counter (OTC) antibiotics to combat rising antimicrobial resistance (AMR), aligning with Union government directives. Residents must use antibiotics only with prescriptions and complete full courses, especially during winter.
Source: h7.cl/1kBdk

5. The government of China will reportedly begin charging a 13 % value added tax on condoms and other contraceptives from January, ending a decades-long exemption. The move aims to encourage higher birth rates, but critics warn it could increase unprotected sex and fail to address high child-rearing costs.
Source: h7.cl/1fJWy

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TOP 5 HEALTH LAWS & POLICY UPADATES

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 Government of India has notified the Legal Metrology (Packaged Commodities) Second Amendment Rules, 2025, effective 1 February 2026. The amendment removes pan masala from an earlier exemption, mandating that all pan masala packages, regardless of size, must fully comply with the standard declaration requirements prescribed under the rules.
Source: h7.cl/1kzQU

2. Central Pollution Control Board has issued a notice allowing plastic packaging producers, importers, and brand owners facing a shortage of Cat II/III recycling certificates to use End-of-Life (EOL) certificates to meet their FY 2024–25 recycling obligations. Now, 1 ton of Cat II/III recycling obligation can be fulfilled using 1.5 tons of EOL certificates.
Source: h7.cl/1kzQI

3. The U.S. Food and Drug Administration (FDA) has issued draft guidance reducing or eliminating the requirement for non human primate toxicity testing for certain monoclonal-antibody therapies. This change may shorten preclinical timelines and lower costs, while promoting alternative safety evaluation methods.
Source: h7.cl/1fEU5

4. India’s drug regulator has been alerted that fake versions of widely used medicines may be circulating after Puducherry officials seized several suspected counterfeit samples. States and Union Territories have also been asked to maintain “strict vigil” on the movement of these batches of widely popular medicines.
Source: h7.cl/1kw0M

5. The Supreme Court has issued notice to the Union Government on a petition seeking a statutory framework for criminal prosecution in medical negligence cases. The plea highlights that no rules have been created despite the Jacob Mathew judgment in 2005 and urges independent, multi-stakeholder inquiry panels to ensure fair, unbiased investigations.
Source: h7.cl/1fETM

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 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. 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 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

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. 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

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 Council for Research in Ayurvedic Sciences has launched SIDDHI 2.0, a national industry research interface platform, to accelerate scientifically validated Ayurvedic product development. The initiative brings together regulators, researchers, and manufacturers to promote quality, safety, regulatory compliance and global competitiveness of Ayurvedic pharmaceuticals.
Source: h7.cl/1fbDr

2. The Telangana Drugs Control Administration (DCA) has issued a circular requiring all licensed retail and wholesale pharmacies across the state to prominently display a QR code and toll-free number to report adverse drug reactions (ADRs). This step enforces compliance with Central Drugs Standard Control Organisation (CDSCO) guidelines, strengthening pharmacovigilance under the national Pharmacovigilance Programme of India (PvPI).
Source: h7.cl/1k1Ny

3. Karnataka Pharma Retailers & Distributors Organization (KPRDO) has reportedly urged the government to halt ten-minute medicine delivery services, warning that treating prescription drugs as fast-moving consumer goods violates drug safety laws. They argue that medicines require prescription verification and pharmacist oversight, and that instant access to antibiotics and addictive drugs could lead to misuse, antimicrobial resistance, and public-health risks.
Source: h7.cl/1fbDv

4. Public commenters are calling on the US Food and Drug Administration (FDA) to loosen clinical trial requirements, particularly for rare diseases and drug development. Commenters are urging the FDA to allow more flexible trial designs and reduced burden to accelerate access to therapies, especially for rare or underserved conditions like disseminated coccidioidomycosis.
Source: h7.cl/1k1NB

5. A major US retail chain has recalled several bottles of saline nasal spray after US Food and Drug Administration (FDA) tests detected contamination with Pseudomonas lactis. The Class II recall covers two production lots with 2027 expiry dates. While the risk is considered medically reversible, regulators advise consumers to stop using the affected batches immediately.
Source: h7.cl/1k1NE

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 penalised an online pharmacy for automatically renewing customers’ three-month subscriptions without explicit consent and termed its as an unfair trade practice. CCPA has held that “auto-add” feature amounted to a dark-pattern by pre-selecting paid options.
Source: h7.cl/1jXQH

2. India’s food regulator has invited inputs from original equipment manufacturers (OEM) or suppliers on draft technical specifications for LC-HRMS, LC-IRMS and EA-IRMS systems by December 1, 2025. A physical presentation will be held on December 3 in New Delhi, with priority given to OEM submissions.
Source: h7.cl/1jXRD

3. The Department of Pharmaceuticals (DoP) has proposed to exempt an additional 84 patented, proprietary and upcoming drug formulations from the Global Tender Enquiry cap. Domestic manufacturers have been invited to submit objections to the proposed list by December 5, 2025.
Source: h7.cl/1jXRR

4. The government has made enzyme-linked immunosorbent assay based infectious disease screening compulsory in all licensed blood centres after HIV infections linked to contaminated transfusions in Jharkhand. It will also impose stricter inspections and enforce licensing rules to strengthen national blood-safety standards.
Source: h7.cl/1jXR8

5. Kerala’s government is preparing to launch “Genome City” in early 2026 at the Bio360 Life Sciences Park in Thonnakkal. The 60-acre facility will host pharmaceutical, biotech and medical device companies, alongside high-end research centres. The initiative will leverage excellent connectivity and aims to drive innovation, create thousands of jobs, and accelerate approvals via a single-window system.
Source: h7.cl/1f7O-

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 clarification stating that only Indian-issued manufacturing, import, and sale licenses from the Central or State Licensing Authorities as applicable are mandatory for all medical devices in India. Procurement agencies and hospitals must require these licenses in technical bids. Any foreign certifications may be added but cannot replace mandatory Indian approval.
Source: h7.cl/1jTDc

2. India’s pharmaceutical industry is reportedly upgrading quality systems, regulatory alignment and scientific rigour as the Central Drugs Standard Control Organization (CDSCO) as tightens requirements for bioavailability and bioequivalence of oral drugs. Post-approval changes now require stronger data, dissolution studies, and risk-based evaluation. The move aligns India with global regulatory expectations and aims to enhance drug reliability, consistency, and overall patient safety.
Source: h7.cl/1jTDs

3. MNC drugmakers are urging CDSCO to grant 10-year regulatory data exclusivity for novel drugs, arguing it will protect first-mover clinical trial data, boost innovation, and attract R&D investment. This follows CDSCO’s sought industry feedback on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials.
Source: h7.cl/1jTDC

4. Raids by the Kerala Drugs Control Department in Kozhikode, Thrissur and Thiruvananthapuram revealed that discount pharmacies are stocking a wide array of counterfeit and poor-quality medicines, facilitated by weak inspection and unregulated distribution networks. Stakeholders are now urging Central Drugs Standard Control Organization (CDSCO) intervention.
Source: h7.cl/1jTDY

5. The National Accreditation Board for Testing and Calibration Laboratories has issued a guidance document to strengthen quality at medical laboratory sample collection centres, outlining requirements, hygiene and transport protocols, temperature control measures, and strict oversight to ensure integrity and reliability of patient test results across all facilities.
Source: h7.cl/1jTEn

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 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