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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 Food Safety and Standards Authority of India has issued an advisory directing food businesses to avoid the use of Ashwagandha (Withania somnifera) leaves in crude, extract, or any other form in food products. This is important as Ashwagandha is widely used in nutraceutical and functional food formulations, signalling tighter scrutiny on botanical ingredients. Companies may now need to review formulations and ensure regulatory compliance.
Source: shortlink.uk/1tzwL

2. The Delhi District Consumer Disputes Redressal Commission issued a non-bailable warrant against the managing director of a multinational fast food company, for failing to comply with a November 2024 order to discontinue levying packing charges, pay compensation for unfair trade practices, and repeated non-appearance. This is important as it signals stricter enforcement of consumer rulings and increased personal accountability of senior leadership.
Source: shortlink.uk/1tzwQ

3. Pharmaceutical traders have opposed draft amendments to the Medical Devices Rules, 2017, mandating disclosure of sterilization site licence numbers on labels and revising testing fees. The industry warns this may restrict vendor flexibility, delay supplies, and increase compliance burden, particularly impacting SMEs and overall supply chain efficiency.
Source: shortlink.uk/1ohJu

4. The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 requiring manufacturers to include sterilization site licence numbers on labels when sterilization is outsourced, along with revised testing and annual fees, prompting concerns from industry stakeholders. This is important as the changes may increase compliance costs and disrupt supply chains. Companies may need to redesign labels, reassess vendors, and adjust operations.
Source: shortlink.uk/1tzwY

5. National Comprehensive Cancer Network has updated global breast cancer screening guidelines to include image-based AI risk assessment using mammograms, recommending risk evaluation starting at age 35 to enable personalized screening strategies. This shifts screening from detection to early risk prediction, enabling earlier intervention. Healthcare providers may now adopt AI-based tools and adjust screening protocols.
Source: shortlink.uk/1tzx8

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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 Indian Pharmacopoeia Commission (IPC) has released the draft National Formulary of India (NFI) 2026, inviting stakeholder comments within 45 days of upload of the respective chapters and appendices, ahead of its proposed finalisation. The draft aims to promote rational use of medicines through evidence based prescribing guidance, standardised drug information, and measures to reduce medication errors and antimicrobial resistance.
Source: shortlink.uk/1sKC9

2. The Delhi High Court has directed the discontinuation of the “Olymviq” mark for semaglutide injections on account of its similarity with the “Ozempic” brand. A 30-day transition window has been granted to clear existing stock and shift to the alternative mark “Olymra.” The order reflects heightened judicial scrutiny of pharmaceutical trademarks, particularly in cases involving likelihood of confusion, prompting companies to reassess trademark strategies.
Source: shortlink.uk/1sKCd

3. The Drugs Consultative Committee in its sixty eighth meeting approved recommendations on scheduling of certain medicines, retaining dicyclomine in Schedule H and moving flupentixol, zopiclone, gabapentin and carisoprodol to Schedule H1. This is important as stricter controls will curb misuse and intoxication, improve monitoring and dispensing accountability.
Source: https://shortlink.uk/1sKCi

4. The Central Drugs Standard Control Organisation (CDSCO) reportedly plans to tighten oversight of medicine packaging, emphasizing clear visibility of drug names, strength, and expiry dates. Through stricter inspections and regulatory directions, it aims to reduce medication errors and improve patient safety, prompting pharmaceutical companies to enhance labelling design, printing quality, and compliance standards.
Source: shortlink.uk/1nvq0

5. The Ministry of Environment has amended the Plastic Waste Management Rules, 2016, removing the requirement to declare the percentage of recycled plastic on labels. Instead, packaging must comply with IS 14534:2023 and carry the prescribed marking, simplifying labelling obligations while ensuring adherence to recycling standards.
Source: shortlink.uk/1sKnX

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 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

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 Plastic Waste Management Rules, 2016, has been amended by introducing phased mandatory recycled plastic content targets, carry-forward provisions for shortfalls, and stronger audit mechanisms. Pharma, FMCG, and packaging companies must reassess packaging strategies and EPR compliance, as regulators expand enforcement and introduce verification through registered environmental auditors and certificate-based compliance mechanisms.
Source: shortlink.uk/1mYB5

2. The Government has notified the Transgender Persons (Protection of Rights) Amendment Act, 2026, introducing stricter penalties for coercion, forced identity changes, and abuse, while formalising medical board certification and identity updates. The amendment also mandates reporting by medical institutions post-gender surgery, signaling stronger accountability obligations across healthcare providers and institutions.
Source: shortlink.uk/1mYB9

3. The Government has notified the Cookware, Utensils and Cans for Foods and Beverages Quality Control Order, 2026, mandating Bureau of Indian Standards certification for specified products, including stainless steel utensils, sinks, and metal cans, with phased implementation and limited exemptions for exports, existing stock, and research imports.
Source: shortlink.uk/1mYBl

4. The Jan Vishwas (Amendment of Provisions) Bill, 2026 was introduced in Lower House of Indian Parliament, which proposes decriminalisation of 717 provisions across 79 central laws, replacing imprisonment with monetary penalties and administrative actions. The reform aims to reduce regulatory burden, promote ease of doing business, and shift toward trust-based governance, significantly impacting compliance frameworks for businesses across sectors
Source: shortlink.uk/1mYBq

5. The Centre has proposed amendments to the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021, to bring social media users sharing news and current affairs under regulatory oversight. The draft expands government advisory compliance, strengthens content monitoring, and empowers authorities to review user-generated news content. Stakeholder comments are invited until April 14, 2026.
Source: shortlink.uk/1mYBx

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 Union Health Ministry, has reportedly directed all academic and research institutions under its purview to refrain from sharing data, trial results, or research information with foreign agencies without prior approval. Sectors including pharmaceuticals, animal sciences, and plant biotechnology have been flagged by Indian intelligence agencies for unauthorised informal engagements.
Source: shortlink.uk/1mobc

2. Central Drugs Standard Control Organization (CDSCO) of India has issued a notice stating that Sodium Hyaluronate Eye Drops 0.3% w/v are being manufactured and marketed without mandatory approval. Since it is classified as a new drug, prior permission is mandatory under the New Drugs and Clinical Trials Rules, 2019. State and UT authorities have been directed to cancel approvals and report compliance.
Source: shortlink.uk/1rA6g

3. Food Safety and Standards Authority of India (FSSAI) has integrated a Food Recall module into its FoSCoS compliance portal, enabling enforcement authorities and food businesses to log and monitor recalls online. Consumers can now check recalled product details on the FoSCoS homepage, strengthening food safety oversight across India’s food supply chain.
Source: shortlink.uk/1rA6l

4. The Central Pollution Control Board (CPCB) has issued show cause notices under the Environment (Protection) Act, 1986 to PIBOs for failing to meet EPR targets for FY 2022–23. The entities are required to submit their response within 15 days of issuance of notice along with fulfilment of obligation. The response should be shared to CPCB on email id along with the hard copy to divisional head Delhi.
Source: shortlink.uk/1mobG

5. US FDA has issued a draft guidance to help companies reduce animal studies of experimental drugs and adopt non-animal testing tools such as newer methods, such as computer simulations and devices that mimic functions of human organs. This guidance is issued because it signals a strategic shift toward integrating non-animal data in preclinical studies, reshaping global expectations for safety evidence generation.
Source: shortlink.uk/1mobN

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 Health and Family Welfare mandates all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Hard copy submissions will not be accepted. A step-by-step procedure and contact details for support have also been provided.
Source: bit.ly/3HWGXWd

2. CDSCO has informed all states and union territories that a loan license is no longer required for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under MDR-2017. Manufacturers must submit documentation and include the sterilization site’s license number on labels of the device.
Source: bit.ly/44nGKCX

3. The Bombay High Court has issued an interim injunction restraining a company from using packaging, labels, bottles, and trade dress that closely resemble those of an established hair-oil brand. The court found that the packaging was “slavishly copied,” potentially misleading consumers and amounting to trademark infringement and unfair competition.
Source: bit.ly/4kd5DXM

4. The Andhra Pradesh High Court has ruled that under the Narcotic Drugs and Psychotropic Substances Act, 1985, “Ganja” refers only to the flowering or fruiting tops of the cannabis plant, explicitly excluding seeds and leaves when not accompanied by the tops.
Source: bit.ly/4ls1iRl

5. India’s Central Board of Indirect Taxes and Customs (CBIC), following DGTR recommendations, has slapped anti dumping duties for five years on four key chemicals from China—PEDA, acetonitrile, Vitamin A palmitate and insoluble sulfur—to shield domestic pharma, agro and rubber industries, signalling a strategic push to rebalance imports and promote local manufacturing.
Source: bit.ly/4lNeEYX

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. Health Ministry’s proposal to amend the Drugs and Magic Remedies Act, aimed at curbing misleading medical advertisements, has been stalled since year 2022. The outdated Act allows deceptive ads, especially in AYUSH and modern medicine sectors, to persist unchecked has been revealed by an RTI.
Source: bit.ly/4kvddgY

2. Karnataka Government has suspended all Jan Aushadhi Kendras inside government hospitals, ensuring patients receive all medicines free of cost from hospital pharmacies. Kendras outside hospitals will remain open.
Source: bit.ly/4dtDZE2

3. GS1, the non-profit standards organisation is set to replace traditional barcodes with advanced 2D bar code technology by 2027 to improve product traceability, safety, and transparency, allowing consumers and businesses to access key details like origin, expiry, and recall information with one scan.
Source: bit.ly/45ahMsP

4. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is enhancing its Manufacturer’s Online Reporting Environment (MORE) to improve medical device safety. Effective June 16, 2025, manufacturers must submit Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs) through the updated MORE platform. The changes aim to strengthen post-market surveillance and facilitate better risk management
Source: bit.ly/3SRvQje

5. US Government is pressing India for tariff reductions on medical equipment as part of ongoing bilateral trade negotiations. After the US imposed a steep 26% tariff on Indian medical device exports in April 2025 up from previous rates of near-zero to 6%. India is seeking full exemption from these duties, which have been temporarily suspended for 90 days until July 9.
Source: bit.ly/4kv9WOu

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 Health and Family Welfare has developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr

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 Foreign Trade regulator, the Directorate General of Foreign Trade (DGFT) has recently issued a Trade Notice, cautioning exporters to no longer accept physical copy Certificate of Origin, and to only accept electronically issued Certificates of Origin since the deadline for using physical copies has passed on 31st December 2024.
Source: bit.ly/439cxs0
Source: bit.ly/439ayEk

2. In light of a recent international report regarding the misuse of drug combinations in various countries in the African continent, India’s Ministry of Health and Family Welfare has rescinded the export license and No Objection Certificate (NoC) of a manufacturer of the said combinations.
Source: bit.ly/4353Mzp

3. India’s Supreme Court, in its recent order has expressed that the medical educational institution admission guidelines, which requires that “both hands [should be] intact” for a person suffering from a disability to gain admission to a medical educational institution, is violative of disability rights and has no basis under law.
Source: bit.ly/3QyRKH0

4. In a recent order, the High Court of Kerala has instructed the State Government to issue a circular to all Doctors in the state, requiring the preservation of foetus in case of a Medical Termination of Pregnancy of a minor, and require permission from the State Government for the destruction of said foetus.
Source: bit.ly/4bblB1L

5. The recent decision of the United State Government to terminate employment of several employees of the United States Food and Drug Administration (FDA) has the possibility to cause delay in obtaining approvals and licenses from the FDA by members of the Medical Device industry.
Source: bit.ly/4hRolDN