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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 Maharashtra Food and Drug Administration has prohibited the sale, distribution and use of three skin-lightening creams after detecting dangerously high levels of mercury and lead, along with labelling violations. The action underscores stricter enforcement of safety and labelling requirements under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020.
Source: short-url.cc/1tgYn

2. India’s Rajasthan government has reportedly introduced a three-tier drug quality testing mechanism for medicines procured under the state’s public healthcare system due to concerns about drug quality. The enhanced measures require quality verification at multiple stages, enhanced oversight by healthcare institutions, and stricter monitoring of medicines and surgical consumables. The state has also expanded its investigation into the concerned drug manufacturer while strengthening procurement and quality assurance processes.
Source: short-url.cc/1tgWb

3. India’s Central Drug Authority, CDSCO has reportedly signed a memorandum of understanding (MoU) with Indonesia’s National Agency of Drug and Food Control (NADFC). The partnership aims to improve cooperation in regulating pharmaceuticals and medical products. The agreement allows for sharing regulatory information, technical skills, and best practices. The agreement seeks to benefit manufacturers by creating a predictable regulatory environment and enhancing international trade.
Source: short-url.cc/1yNWW

4. India’s Telangana government is set to enforce stricter regulations for private In-Vitro Fertilisation (IVF) centres to improve transparency, curb unethical practices and strengthen oversight of Assisted Reproductive Technology (ART) services. The proposed measures include frequent inspections and monitoring of licensing, medicines, record maintenance, and stricter compliance with the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021.
Source: short-url.cc/1tgWl

5. The Indian Medical Association (IMA) has opposed the Maharashtra Clinical Establishments (Registration and Regulation) Bill, expressing adverse effects on the functioning of private medical establishments by imposing excessive regulations and limiting autonomy. The association has urged the state government to reconsider the draft legislation and has warned of a statewide strike and boycott of government healthcare schemes if its concerns are not addressed.
Source: short-url.cc/1tgWq

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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 (CDSCO) has invited stakeholder comments on the use of brand name extensions by pharmaceutical companies. The consultation follows concerns that different drugs marketed under the same established brand name may mislead consumers and create confusion regarding therapeutic use. Comments are invited until 17 July 2026.
Source: short-url.cc/1yKJk

2. India’s Madras High Court held that consignments imported as “waste paper” were in fact used plastic bottles, street sweepings, food waste making their import into India illegal under the Customs Act and Hazardous Waste Rules. The Court rejected the importers’ request to send the waste to Dubai, ruling that “re-export” means returning the waste to the country of origin, not to a third country chosen by the importer. The Court further condemned the practice of developed countries shifting hazardous waste to developing nations as “waste colonialism,” which undermines the environmental justice and threatens public health and ecological security. The Court refused permission to process or dispose of waste within India, to avoid becoming a “disposal destination” for foreign waste. The petitions were dismissed, the waste was ordered to be returned to the exporting countries within 60 days, and costs were imposed on the petitioners.
Source: short-url.cc/1yKL6

3. India’s Pune Municipal Corporation (PMC) has issued show-cause notices to private hospitals for non-compliance with the Bombay Nursing Homes Registration Act, 1949, including the failure to display treatment charges and patients’ rights. PMC has directed the hospitals to rectify the identified deficiencies within the prescribed timeline. The enforcement action follows inspections conducted as part of routine compliance monitoring and in response to public complaints.
Source: short-url.cc/1tdPE

4. The Indian working group on access to medicines and treatments has urged the central government to revise the National List of Essential Medicines (NLEM) by including newer cancer medicines and monoclonal antibodies. The group states that the current NLEM does not reflect the World Health Organization (WHO) model list of essential medicines.
Source: short-url.cc/1tdQ0

5. The Food Safety and Standards Authority of India has issued show cause notices to multiple food business operators for allegedly misleading claims, including the use of terms such as “fresh,” “healthy,” “natural,” “organic,” and “vegan.” The regulator has reiterated that such claims must strictly comply with the applicable labelling and advertising regulations.
Source: short-url.cc/1tdQe

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TOP 5 HEALTH LAWS AND POLICY UPDATES 19 June

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. Maharashtra Food and Drug Administration (FDA) has directed the recall of a Schedule H prescription cough and cold medication manufactured by a leading pharmaceutical company following concerns over its public advertisement. As advertisements of Schedule H drugs are prohibited, the action highlights continued regulatory scrutiny of promotional practices for prescription medicines.
Source: short-url.cc/1sRrA

2. India plans to establish Centres of Excellence to tackle diabetes-related wounds within 2–3 years. Backed by substantial investments, these centres will integrate advanced imaging, AI-enabled monitoring, and multidisciplinary care to reduce complications like foot ulcers and amputations. These centres will also offer multiple qualified health specialists from various areas for wounds.
Source: short-url.cc/1sRrF

3. The Ministry of Health and Family Welfare has notified the amendment to the Surrogacy rules, introducing a framework for the renewal of surrogacy clinic registrations under the Surrogacy (Regulation) Act, 2021. The amendments prescribe the procedure, timelines, inspection requirements, and fees for renewal applications, provide for the utilisation of registration fees by appropriate authorities, and make renewed registrations valid for a further period of three years.
Source: short-url.cc/1ymC2

4. India’s central food authority, Food Safety and Standards Authority of India (FSSAI) has reportedly directed Food Business Operators (FBOs) to ensure that only corrosion-resistant knives and cutting tools are used in food handling, processing, preparation, and packaging activities. FSSAI has emphasized that food-contact materials and equipment must be maintained in a hygienic condition and be made of suitable materials that do not compromise food safety. Food businesses have been advised to review their operational practices and replace non-compliant equipment to ensure adherence to applicable food safety and hygiene requirements. The advisory is aimed at minimizing the risk of physical and chemical contamination arising from rusted or deteriorating equipment coming into contact with food products.
Source: short-url.cc/1ymCb

5. The Ministry of Health and Family Welfare has notified the Assisted Reproductive Technology (Regulation) Amendment Rules, 2026. The amendment inserts Rules 7A and 8A, introducing a formal renewal framework for registration of Assisted Reproductive Technology clinics and banks. It prescribes renewal application procedures, a 60-day pre-expiry filing timeline, renewal fees, and review processes, while clarifying the utilization of registration fees. Renewed registrations will remain valid for five years.
Source: short-url.cc/1sRsz

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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 Consumer Affairs has clarified that customary units such as inches, feet, yards and square feet may be used only as supplementary declarations alongside standard SI units under the Legal Metrology framework. The clarification aims to ensure uniformity in trade practices while preventing misleading or ambiguous quantity declarations for consumers.
Source: shortlink.uk/1vwL3

2. FSSAI plans to centralize food surveillance by separating sampling from enforcement, reducing state officers’ discretionary powers. Neutral agencies will collect samples, with results uploaded to a national database for quick alerts. This aims to enhance transparency, consistency, and consumer safety while ensuring enforcement remains with state authorities.
Source: shortlink.uk/1vwJ8

3. The Supreme Court has directed Delhi authorities to urgently frame a Standard Operating Procedure (SOP) ensuring private hospitals built on concessional government land provide free treatment to Economically Weaker Section (EWS) patients, addressing widespread non-compliance with the mandate of reserving 10% inpatient beds and 25% outpatient services.
Source: shortlink.uk/1q97l

4. The CDSCO has directed state and Union Territory drug regulators to closely monitor surrogate advertising and promotional activities related to prescription GLP-1 drugs used to treat obesity and metabolic disorders. The regulator has cautioned against indirect promotional practices, including disease-awareness campaigns and digital outreach, that could influence public demand for prescription-only medicines. The move signals intensified regulatory scrutiny of marketing, distribution, and promotion, and may also lead to stricter compliance expectations for pharmaceutical companies, digital platforms, wellness clinics, and marketers involved.
Source: shortlink.uk/1q96J

5. The Indian Council of Medical Research (“ICMR”) has introduced a single-window approval mechanism for medical research studies, replacing the earlier fragmented process requiring approvals from multiple ethics committees and institutions. The framework is intended to streamline ethics clearances, reduce procedural delays, and accelerate approvals for multicentric and collaborative research projects.
The development is significant for India’s clinical research ecosystem as it is expected to improve regulatory efficiency, transparency, and coordination in study approvals.
Source: shortlink.uk/1q96K

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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 (CDSCO) has issued a regulatory update outlining revised procedural and compliance requirements for industry stakeholders, aimed at strengthening regulatory oversight and streamlining approval processes. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines. Companies may now need to review internal compliance processes and align documentation and approval strategies accordingly.
Source: shortlink.uk/1tzqM

2. The Thrissur Consumer Commission held both the seller and the e-commerce platform liable for delivering an expired consumable product, ruling it an unfair trade practice and deficiency in service. Rejecting reliance on a “non-returnable” policy, the Commission ordered refund, compensation, and costs. It emphasized that platforms must ensure grievance redressal and cannot evade liability where defective or unsafe goods are supplied through their marketplace.
Source: shortlink.uk/1tzqU

3. The Ministry of Environment, Forest and Climate Change has amended the Bio-Medical Waste Management Rules, 2016, to include the Department of AYUSH and its nominated representatives in state and district-level waste management committees. This is important as it expands regulatory oversight to AYUSH healthcare facilities and strengthens compliance expectations. AYUSH institutions and related healthcare providers may now need to align with enhanced bio-medical waste management governance and monitoring requirements.
Source: shortlink.uk/1tzqI

4. Stakeholders have urged greater drug regulator oversight of nutraceuticals, citing concerns over quality standards, therapeutic claims, and wide pricing variations, with calls to shift certain nutraceuticals from food regulation to drug-level oversight. This is important as nutraceuticals are increasingly prescribed alongside medicines but lack uniform quality and pricing controls. Companies may now face stricter compliance requirements, enhanced quality standards, and potential regulatory scrutiny.
Source: shortlink.uk/1tzqY

5. The Central Drugs Standard Control Organization (CDSCO) has introduced a prior intimation system pursuant to amendments in the New Drugs and Clinical Trials Rules, 2019 effective April 21, 2026. It applies to bioavailability and bioequivalence studies for export-only drugs, excluding certain high-risk categories. CT-05 applications must be filed via Sugam with ethics approval, while other categories remain under prior approval. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines.
Source: shortlink.uk/1ohEa

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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 National Health Authority is developing a national artificial intelligence policy for healthcare to guide wider use of technology to address health challenges including diagnostics, public health programmes, and digital health platforms. This will be a major shift toward structured, large-scale adoption of technology in India’s health system. It can improve access, efficiency, and data-driven decision-making across public healthcare delivery.
Source: shortlink.uk/1tzfD

2. India’s Central government has directed states to uniformise package rates for common medical procedures, adopt uniform treatment guidelines, and implement digital claims processing through the National Health Claims Exchange to improve billing transparency and reduce pricing variations across private hospitals. These disparities have been identified in driving higher insurance premiums and affecting affordability.
Source: shortlink.uk/1ohsz

3. The Bombay High Court delivered a judgment after scrutinising enforcement under the Drugs (Prices Control) Order (DPCO), holding that overcharging determinations and recovery demands must strictly adhere to statutory methodology, including correct price fixation, computation, and grant of hearing. Finding procedural infirmities and inadequate reasoning, the Court set aside the demand and directed fresh adjudication, reinforcing due process and curbing arbitrary.
Source: shortlink.uk/1tzfM

4. The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory communication outlining updated requirements related to drug approvals, compliance, and regulatory submissions for industry stakeholders. This is important as increased regulatory scrutiny may impact approval timelines and documentation standards. Companies may now need to review regulatory submissions, strengthen compliance processes, and align product lifecycle strategies with evolving CDSCO expectations.
Source: shortlink.uk/1tzfQ

5. The Drugs Technical Advisory Board has approved a proposal to amend the Medical Devices Rules, 2017 to introduce a definition of reportable events and mandate adverse event reporting, including for in-vitro diagnostic devices. This is important as it strengthens post-market surveillance and device safety oversight. Manufacturers and importers may now need enhanced reporting systems and tighter compliance processes.
Source: shortlink.uk/1ohsK

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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 Medical Device Regulator has proposed standardising testing fees at government laboratory by notifying fixed charges under a new schedule. There was no regulation on cost of testing fees from government labs, and small and medium scale medical device manufacturers who actually avail services of external laboratories are bound to benefit from the proposal. Notably, the proposal applies only to government laboratories and does not cover private medical device testing laboratories.
Source: shortlink.uk/1sH3N

2. The Central Government has proposed draft amendments to the Medical Devices Rules, 2017 mandating manufacturers outsourcing sterilisation must mention the sterilisation site’s licence number on device labels using specified descriptors. Currently, no such mandatory declaration exists, and the proposal aims to ensure greater accountability in third-party sterilisation processes.
Source: shortlink.uk/1nrZb

3. The Central Government has proposed amendments to the Medical Devices Rules, 2017 requiring importers of Class A non-sterile and non-measuring devices to also self-certify compliance with a Quality Management System. Currently limited to standards, this change aims to strengthen quality assurance and regulatory oversight of low-risk medical device imports.
Source: shortlink.uk/1sH41

4. The Department of Agriculture & Farmers’ Welfare has directed pesticide manufacturers, importers, and industry associations to submit data on produced, imported, and exported quantities of major insecticides, fungicides, herbicides, and Plant Growth Regulators (PGRs) by April 13, 2026. This is being undertaken to assess the impact of the ongoing Gulf Crisis on pesticide availability and supply chains.
Source: shortlink.uk/1sH4g

5. The Central Government has proposed to amend the Medical Devices Rules, 2017, to expand the scope of jurisdictions by including “European Union countries” alongside the US, UK, Australia, Canada and Japan. Pursuant to this amendment, investigational clinical data may not be required to be submitted for import of a medical device, provided that such device has been approved by the regulatory authority of EU, has been marketed in that jurisdiction for a minimum period of two years.
Source: shortlink.uk/1nrZD

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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. National Pharmaceutical Pricing Authority (NPPA) has exempted Nafithromycin 400 mg tablets from price control under DPCO, 2013 for five years. The exemption starts from launch or patent expiry, whichever is earlier. This allows flexible pricing, but the company must report launch date and price details to the authorities
Source: shortlink.uk/1mYOh

2. The Centre has set April 30, 2026 as the final deadline for private hospitals to complete empanelment under the Central Government Health Scheme. Hospitals failing to sign the Memorandum of Agreement (MoA) by the deadline will be de-empanelled from May 1, losing eligibility to treat CGHS beneficiaries or submit reimbursement claims.
Source: shortlink.uk/1mYOm

3. US pharmaceutical companies have reportedly opposed price caps imposed by the National Pharmaceutical Pricing Authority (NPPA) of India, seeking blanket exemption for patented medicines. Industry stakeholders argue that current controls reduce prices by nearly 50% post-patent expiry, discouraging innovation and limiting availability of advanced therapies in India.
Source: shortlink.uk/1mYOq

4. The Karnataka Department of Health and Family Welfare, in collaboration with National Institute of Mental Health and Neurosciences, released a draft policy to tackle student mobile addiction. The proposal caps recreational screen time at one hour daily, introduces digital wellness committees, and mandates teacher training and counselling support to address rising mental-health concerns among adolescents.
Source: shortlink.uk/1mYOs

5. India’s Ministry of Finance has reportedly temporarily exempted customs duty on forty petrochemical and chemical inputs until June 30, aiming to stabilise supply chains disrupted by Middle East tensions, ease cost pressures on pharmaceuticals and manufacturing sectors, and support industry facing sharp increases in raw material and packaging costs.
Source: shortlink.uk/1mYOu

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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 government has warned pharmacies, clinics, and online platforms of licence cancellation, fines, and legal action for unauthorised sale of GLP-1 weight-loss drugs. Regulators flagged misuse amid rising availability of generic semaglutide, reiterating that prescriptions are restricted to endocrinologists, internal medicine specialists, and cardiologists only, with nationwide inspections already underway.
Source: shortlink.uk/1mYE-

2. The Delhi High Court granted a 30 day stock clearance window to the pharmaceutical manufacturer for its diabetes drug under the existing brand, following its agreement to adopt a new name. Thereafter, unsold inventory will be supplied free to government hospitals under supervision, with immediate cessation of all commercial use.
Source: shortlink.uk/1mYF1

3. A Hyderabad-based paediatrician has criticised a company for introducing similar-looking packaging following the Food Safety and Standards Authority of India crackdown on misleading ORS branding. The doctor alleged that despite rebranding, the product retains strong recall value, potentially misleading consumers and raising ongoing public health concerns over confusion between therapeutic ORS and commercial electrolyte drinks.
Source: shortlink.uk/1mYF3

4. The US FDA clarified that compounded versions of GLP-1 weight-loss and diabetes drugs can only be produced during official shortages. With supply stabilising, compounders must stop manufacturing copycat versions once drugs are removed from the shortage list. The regulator warned of enforcement action against non-compliant pharmacies and telehealth providers.
Source: shortlink.uk/1sbL5

5. India’s Drugs Technical Advisory Board, has recommended amending the Drugs Rules, 1945 to introduce licensing provisions for drug marketers. The move aims to strengthen regulatory oversight and monitoring of entities that market drugs manufactured by other companies under their own label.
Source 1: shortlink.uk/1mYF8
Source 2: shortlink.uk/1mYFb

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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 is preparing a policy response after seeking inputs from the pharmaceutical industry on the ongoing shortage and price surge of critical solvents and chemicals. Industry reported sharp increases in inputs like isopropyl alcohol and other petrochemical-based solvents, impacting production costs and supply continuity, prompting urgent intervention and long-term supply-chain stabilisation measures.
Source: shortlink.uk/1mYxw

2. The Delhi High Court has reserved its verdict on an interim plea filed by Asian News International in a copyright infringement case against OpenAI. The case questions whether copyrighted news content can be used to train AI models like ChatGPT without permission, marking a first-of-its-kind legal challenge in India.
Source: shortlink.uk/1mYy0

3. The Government is considering invoking the Essential Commodities Act, 1955 to regulate prices of bulk drugs and active pharmaceutical ingredients amid supply disruptions linked to West Asia tensions. The Department of Pharmaceuticals is consulting industry stakeholders to curb hoarding, stabilize prices, and ensure uninterrupted medicine production.
Source: shortlink.uk/1mYxH

4. The Food Safety and Standards Authority of India has released FAQs on the Food Safety and Standards (Licensing and Registration of Food Businesses) Amendment Regulations, 2026, clarifying key reforms including perpetual licence validity, revised turnover thresholds, expanded petty food business definition, and risk-based inspections to simplify compliance and strengthen food safety oversight.
Source: shortlink.uk/1sbDB

5. The Food Safety and Standards Authority of India has notified the Food Safety and Standards (Labelling and Display) First Amendment Regulations, 2026, introducing revised labelling exemptions, non-retail container requirements, and updated warning declarations. The amendments will come into force from 1 July 2027, giving industry transition time for compliance.
Source: shortlink.uk/1mYxL