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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 has invited proposals under the CFMDC scheme to strengthen shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, endoscopic systems, imaging equipment such as X-ray and MRI, and Class B, C, and D IVDs. The initiative aims to improve access to common testing facilities in India.
Source: h7.cl/1hMz2

2. The Department of Pharmaceuticals (DoP) has issued a public notice proposing the inclusion of 11 additional pharmaceutical formulations, including patented biologics and proprietary insulin products, under the Global Tender Enquiry (GTE) exemption list for FY 2025–26. Domestic manufacturers have been invited to submit objections by January 19, 2026, in the attached form.
Source: h7.cl/1hMz7

3. The Supreme Court of India has issued notices to the Union Ministries of Law, Health and AYUSH on a PIL seeking to declare AYUSH practitioners as Registered Medical Practitioners (RMP) under the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954. An RMP is allowed to display a signboard or notice on their clinic premises indicating that they provide treatment for diseases listed in the Act, which others are prohibited from advertising.
Source: h7.cl/1hMz8

4. Delhi High Court held that in patent disputes involving life-saving drugs, courts must prioritise public interest. Injunctions should not block patient access unless infringement is clearly established through product-to-claim mapping. Where issues are technical and triable, alternative safeguards can protect patentees without withdrawing essential therapies during litigation.
Source: h7.cl/1mK20

5. Indian importers of aluminium beverage cans are reportedly requesting the government to extend the deadline for BIS certification and marking requirements. This follows shortages caused by rising demand and delays in BIS approvals. The quality control order was issued in April 2025, beverage companies have increased imports from West Asia and Sri Lanka to prevent supply disruptions.
Source: h7.cl/1hMzd

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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
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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. Indian Supreme Court has in a recent judgement held that corporate social responsibility cannot be limited to philanthropy and must inherently include environmental protection. It emphasized that companies have a constitutional duty to protect ecosystems and prevent environmental degradation, making sustainability and biodiversity conservation integral to CSR obligations.
Source: https://h7.cl/1hniW

2. The Indian medical devices regulator has issued an updated risk classification list for oncology devices, superseding the earlier 2020 notification. The revision introduces new categories such as AI-based diagnostics and advanced ablation and hyperthermia systems, and reclassifies certain devices, thereby impacting regulatory pathways under the Medical Devices Rules, 2017.
Source: https://h7.cl/1mjWw

3. The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released a new guide on preparing quality manuals and management system documentation for labs seeking NABL accreditation under ISO/IEC standards.
Source: https://h7.cl/1hnlv

4. The Department of Pharmaceuticals under Ministry of Chemicals and Fertilizers has invited applications under Marginal Investment Scheme for Reducing Import Dependence and Medical Device Clinical Studies Support Scheme, both of which form part of the broader Scheme for Strengthening of Medical Device Industry.
Source: https://h7.cl/1mjYL

5. The Ministry of Finance released detailed FAQs on the Health Security se National Security (HSNS) Cess Act and Rules, clarifying registration, cess computation, returns, machine declaration, abatement and compliance procedures effective from 1 Feb 2026. This guidance supports industry readiness for new cess obligations under the Act.
Source: https://h7.cl/1mjXk

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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 Karnataka Health Department has proposed introducing QR codes on medicine strips and boxes to help visually impaired patients access key drug information via smartphone scanning under the IMPACT-VIP programme. Details such as dosage, composition, and expiry dates can be accessed, and the proposal may be sent to the Centre for wider implementation.
Source: h7.cl/1o2Wy

2. India’s central drugs regulatory authority (CDSCO) has released a draft guidance outlining regulatory requirements and online procedures for importing in-vitro diagnostic medical devices. The document aims to streamline approvals under Medical Devices Rules, 2017. Comments from stakeholders are invited within 15 days.
Source: h7.cl/1j0Wg

3. The Government of India has in the Union Budget 2026–27 announced measures to position India as a hub for medical tourism, biopharmaceutical manufacturing and traditional medicine. The government will establish five regional medical hubs, expand Ayurveda, Yoga, Unani, Siddha and Homeopathy infrastructure, and strengthen research, manufacturing capacity and employment across the healthcare value chain.
Source: h7.cl/1o2WE

4. The Government of India is planning to amend the Drugs and Cosmetics Act to tighten oversight of pharmaceutical opioids, proposing stricter penalties, higher fines, and enhanced monitoring of manufacturing and sales to curb misuse, diversion, and illegal distribution while strengthening regulatory enforcement.
Source: h7.cl/1j0Wr

5. Indian Pharmacopoeia Commission has issued a formal circular urging all Medical Device Marketing Authorisation Holders (MAHs) to strictly comply with adverse event reporting requirements under the Materiovigilance Programme of India (MvPI). The move is aimed at bolstering patient safety and enhancing the post-market surveillance ecosystem for medical devices across India.
Source: h7.cl/1o2WQ

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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 Government of India has launched Market Access Support under the Export Promotion Mission to strengthen global market access for Indian exporters. The initiative offers structured support for trade fairs, buyer seller meets, delegations and digital tools, prioritising small exporters, new markets, predictable planning and outcome driven export growth nationwide.
Source: h7.cl/1m6xR

2. The Food Safety and Standards Authority of India (FSSAI) issued an office order mandating a standardized format for food businesses operators, industry bodies, and other stakeholders to submit representations seeking food safety risk assessment. The move aims to ensure complete data submission, improve evaluation, enhance transparency, and speed up regulatory decision-making.
Source: h7.cl/1hakR

3. The Delhi High Court has granted an interim injunction restraining a manufacturer from selling biscuits bearing an identical name, shape and packaging to a registered trademark holder’s product. The court cited prima facie trademark infringement and passing off on triple identity and directed removal of infringing products from the market and e-commerce platforms.
Source: h7.cl/1m6y3

4. The Gujarat High Court has upheld a ruling by the Customs Authority for Advance Rulings allowing duty free import of inshell walnuts by treating the product as “dietary fibre.” The decision confirms that inshell walnuts qualify for exemption from Basic Customs Duty under the Transferable Duty-Free Import Authorization (DFIA) scheme.
Source: h7.cl/1m6y8

5. India’s major pharmaceutical company has signed an exclusive agreement with the other giant to introduce needle-free injection systems for IVF and gynaecology therapies across India. The high-pressure jet delivery tech aims to reduce pain, anxiety and improve patient compliance, with a targeted all-India rollout in FY 2026, addressing millions of injections in the growing fertility market.
Source: h7.cl/1hakq

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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. A leading food products manufacturer has moved the Bombay High Court against a YouTube channel alleging that an online video falsely questioned the safety of its product despite regulatory approval. The company contends the content contradicts findings of the Food Safety and Standards Authority of India and seeks removal and restraint to prevent consumer misinformation.
Source: h7.cl/1lpNb

2. India’s Health Ministry has reportedly clarified that failing to prescribe medicines by their generic names constitutes professional misconduct and may attract disciplinary action under National Medical Commission (NMC) regulations. Doctors are required to prescribe drugs legibly and rationally, with State Medical Councils and the NMC empowered to act against violations.
Source: h7.cl/1lpNg

3. European Medicines Agency (EMA) released Revision 3 of its stability testing guideline for marketing authorisation variations. The update clarifies stability data expectations for post-approval changes, aligns with lifecycle management principles, and strengthens requirements for Type I and II variations, supporting quality, safety, and efficacy of medicinal products across the EU.
Source: h7.cl/1lpNi

4. The U.S. Food and Drug Administration has issued two guidance documents clarifying safety reporting responsibilities for sponsors and investigators in investigational drug and device studies, including IND, bioavailability (BA), and bioequivalence (BE) trials. The guidance provides detailed recommendations on adverse event reporting and safety data assessment in clinical research.
Source: h7.cl/1gvVH
Source: h7.cl/1lpNs

5. U.S. President Donald Trump has signed an executive order instructing federal agencies to reclassify marijuana from Schedule I to Schedule III, thereby easing its regulatory status to support medical research. He has also approved a pilot program enabling Medicare reimbursement for products containing CBD, a widely used non-psychoactive cannabis compound.
Source: h7.cl/1lpNy

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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 Pollution Control Board (CPCB) has notified the establishment of a National Control Room (NCR) to coordinate and monitor nationwide enforcement of the ban on identified single-use plastic items. The NCR will support clarity, compliance tracking, stakeholder guidance, state control room reporting, inspections and awareness campaigns.
Source: h7.cl/1lmmL

2. The National Medical Commission has directed medical colleges to establish committees to monitor prescription practices, emphasising clear and legible handwriting and the use of generic drug names. The directive aims to strengthen patient safety, promote rational prescribing, and integrate these practices into medical education nationwide.
Source: h7.cl/1lmm6

3. Food Safety and Standards Authority of India has reportedly directed all states and Union Territories to launch a nationwide enforcement drive against adulteration and misbranding of milk, paneer and khoya. The move follows repeated detections and aims to protect public health through strict inspections and penalties across country.
Source: h7.cl/1gsAC

4. More than 60% of registered small and medium pharmaceutical units in India reportedly risk shutting down by December 2025 due to non-compliance with revised GMP (Schedule M) quality standards. Industry stakeholders warn of potential medicine shortages, job losses, and export disruptions if compliance challenges are not addressed promptly.
Source: h7.cl/1gsAd

5. The EU’s Medical Device Coordination Group has issued new guidance clarifying criteria for qualifying breakthrough medical and IVD devices under MDR/IVDR. It defines key criteria such as significant clinical benefit, unmet medical need, and innovation level, aiming to harmonize interpretation across authorities and support early regulatory engagement without lowering safety or evidence requirements.
Source: h7.cl/1lmli

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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 Drugs Standard Control Organization (CDSCO) has launched a new online Risk Classification Module for medical devices, excluding IVDs. Effective 27 November 2025, applicants can seek classification for devices not listed in CDSCO’s published list via the portal, simplifying regulatory approvals for Medical Devices.
Source: h7.cl/1kNrH

2. Indian Council of Medical Research (ICMR) and India’s Central Drug authority CDSCO (IVD Division) has jointly developed the MedTech Mitra IVD Innovators Handbook to guide developers through clinical validation. It outlines key milestones, regulatory and ethical expectations, and evidence requirements, helping innovators plan effectively and generate strong clinical data to support the safety and efficacy of their diagnostic products.
Source: h7.cl/1kNrK

3. Rajya Sabha members urged the government to ban misleading surrogate ads promoting tobacco and liquor, citing rising cancer and heart disease cases. During debate on the Central Excise (Amendment) Bill, 2025, they sought stricter controls, awareness campaigns and higher taxes to curb tobacco use and protect public health.
Source: h7.cl/1fVMQ

4. The Delhi High Court has declined to grant injunctive relief against an Semaglutide manufacturer, thereby permitting the manufacture and export of semaglutide to jurisdictions where no valid patent protection subsists. The Court clarified that while export to non-patent markets is permissible, the sale or distribution of the drug within India remains prohibited until expiry of the relevant patent.
Source: h7.cl/1kNrT

5. The Indian government has introduced the Health Security se National Security Cess Bill, 2025, proposing a new cess on the installed machinery or processes used for the manufacture of goods such as pan masala, with scope to include other products in future. The cess will apply across all production methods, machine-based, manual, or hybrid.
Source: h7.cl/1kNrW

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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 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

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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