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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 Delhi High Court granted interim relief to Pharmaceutical company by restraining other pharmaceutical company from using “ALKAKIND” or similar marks. The Court held that the “KIND” suffix has acquired distinctiveness through extensive use, creating a strong likelihood of consumer confusion and reinforcing trademark protection for established pharma brands.
Source: shortlink.uk/1n47Q

2. The Government of India has issued the Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2026, making BIS certification mandatory for 90 categories of electrical appliances. It will come into force on 1 October 2026, with phased timelines for MSMEs. Non-compliance will attract penalties under the BIS Act, 2016.
Source: shortlink.uk/1n48h

3. Indian pharma manufacturers have reportedly urged the National Pharmaceutical Pricing Authority of India to approve up to a 50% price increase for platinum-based chemotherapy drugs such as carboplatin, cisplatin, and oxaliplatin, after platinum prices nearly doubled from ₹3,869 to ₹8,000 per gram in six months, making production financially unviable and risking supply disruptions.
Source: shortlink.uk/1n48q

4. The Drug Technical Advisory Board (DTAB) has proposed extending PSUR timelines under the New Drugs and Clinical Trials Rules, 2019 for modified or sustained release drugs, novel drug delivery systems, and advanced biologics across their lifecycle, with annual and triennial reporting beyond four years. Currently, PSURs are submitted semi-annually for two years and annually thereafter.
Source: shortlink.uk/1sisG

5. India’s affordable generic medicines under the Jan Aushadhi scheme may see price increases as shipping disruptions linked to the West Asia conflict have raised raw material costs and constrained supply. The supply crunch is affecting local manufacturing, with smaller pharma units facing margin pressure, potentially impacting availability of low-cost medicines across Jan Aushadhi Kendras.
Source: shortlink.uk/1n48A

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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

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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 Pharmaceutical Pricing Authority (NPPA) has notified a 0.64956% increase in the Wholesale Price Index (WPI) for 2025 over 2024. Importers and manufacturers of Scheduled drugs and medical device are now permitted to increase the prices on the basis of WPI without prior approval from the government from April 1, 2026.
Source: shortlink.uk/1mYsg

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that all IVF-related devices, including sperm washing kits and intrauterine insemination tools, are regulated as medical devices under the Drugs and Cosmetics Act. Import, manufacture, and sale of these devices require proper licensing to ensure compliance and prevent unauthorized trade.
Source: shortlink.uk/1mYsj

3. India’s Central Drug authority, (CDSCO) has streamlined the procedure for review and processing Written Confirmation certificate (WCC) applications submitted through the SUGAM portal for export of Active Pharmaceutical Ingredients (API) to EU for human use. The move aims to improve efficiency aligning with EU GMP compliance requirements under Article 46(2)(b) of Directive 2001/83/EC.
Source: shortlink.uk/1sbyd

4. The National Medical Commission (NMC), following a Supreme Court of India ruling, now limits stem cell therapy to approved conditions only, so far there are 32 approved conditions. Unproven uses outside clinical trials are banned, with strict ethical rules and legal action to prevent misuse and protect patients.
Source: shortlink.uk/1mYsV

5. The Central Consumer Protection Authority (CCPA) has directed hotels and restaurants to stop adding charges such as “LPG charges” and “fuel cost recovery” to customer bills, terming the practice an unfair trade practice, and warning of strict action. The CCPA clarified LPG and electricity, are part of running a business and should be factored into final menu prices.
Source: shortlink.uk/1mYt2

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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 extended the deadline for registered Producers, Importers and Brand Owners (PIBOs) to file Annual Returns for FY 2024–25 under the Plastic Waste Management Rules, 2016 until March 31, 2026. Non-compliance may attract environmental compensation.
Source: shortlink.uk/1rAfG

2. The Central Pollution Control Board has issued show cause notices to PIBOs for failing to meet EPR obligations and not submitting Annual Returns for FY 2022–23 under the Plastic Waste Management Rules, 2016. Defaulters will face environmental compensation and tighter enforcement from authorities
Source: shortlink.uk/1rAg8
Source: shortlink.uk/1rAga

3. The Central Pollution Control Board (CPCB) has issued show cause notices to producers, importers, and brand owners (PIBOs) for failing to meet Extended Producer Responsibility obligations, fulfil targets, and file annual returns under the Plastic Waste Management Rules, 2016 for FY 2022–23. Non-compliant entities may have to pay environmental compensation, face penalties, and higher future targets. Entities must respond latest by 26.03.2026or face further regulatory and legal action.
Source: shortlink.uk/1mol6

4. The Karnataka government has released a draft policy promoting responsible digital use among students, focusing on curbing screen addiction, cyber risks, and mental health impacts. The move aligns with its broader push to restrict social media access for minors and regulate device usage.
Source: shortlink.uk/1mol8

5. Parliamentary panel has reportedly urged the Department of Pharmaceuticals to address administrative delays affecting the Promotion of Research and Innovation in Pharma MedTech Sector scheme after significant underutilisation of funds. Despite increased allocations, spending remained low. Revised guidelines and stronger monitoring are expected to improve execution and outcomes.
Source: shortlink.uk/1rAgj

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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 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 Central Pollution Control Board (CPCB) has extended the deadline for registered Producers, Importers, Brand Owners (PIBOs) and Plastic Waste Processors (PWPs) for filing annual returns under the Plastic Waste Management Rules, 2016 until 31st January 2026. The previous deadline for filing of annual returns was November 30, 2025.
Source: h7.cl/1iapl

2. India’s Central Pollution Control Board (CPCB) has issued a notice clarifying implementation of Extended Producer Responsibility (EPR) guidelines for plastic packaging, permitting regulated inter-category certificate purchases only until FY 2025–26. Producers, importers, and brand owners will then be prohibited from cross-category adjustment of surplus EPR certificates and barred from using end-of-life certificates for recycling targets.
Source: h7.cl/1n9HG

3. The Union Health Minister has directed CDSCO and the Department of Pharmaceuticals to find a workable solution to industry concerns over revised Schedule M GMP norms. The revised guidelines necessitate structural and layout changes to facilities, setting up rigorous quality control systems, and training personnel. The Ministry is considering deadline extensions or relaxations following consultations with industry bodies, particularly for small and medium manufacturers facing compliance issues.
Source: h7.cl/1n9HM

4. The High Court of Allahabad has dismissed petitions by directors and officials of a major drug manufacturer challenging summons for alleged violations under the Drugs and Cosmetics Act after a test analysis found samples to be of substandard quality. The analysis found the presence of ethylene glycol in cough syrup, a toxic industrial chemical. The Court found the summons lawful, as the officials were responsible for the company’s business conduct.
Source: h7.cl/1n9HR

5. India’s Delhi High Court has upheld the rejection of a foreign drug manufacturer’s patent application for a nematode-based cancer detection method, ruling it a non-patentable diagnostic process under the Patents Act, 1970. The court said the invention performs essential diagnostic steps and cannot bypass exclusion by being labelled as screening or in-vitro testing.
Source: h7.cl/1iar0

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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 Delhi High Court restored the Central government’s 2018 ban on fixed-dose combinations (FDCs) of three different drugs used to treat Type-2 diabetes, overturning a lower court’s order. The bench ruled that such combinations must independently prove safety and that regulatory action can be taken based on the likelihood of risk, without proof of actual harm.
Source: h7.cl/1hWHD

2. India’s Ministry of Consumer Affairs has issued show cause notices to major edible oil companies for non-compliance with the amended VOPPA Order, 2025, after inspections of return filings. The Order mandates monthly reporting of production, stocks, imports, dispatches, sales, and consumption of notified edible oil products. Authorities have warned that similar action will be taken against all unregistered units or those failing to file mandatory returns to ensure uniform compliance across the sector.
Source: h7.cl/1mUuB

3. The Indian Pharmaceutical Association-Community Pharmacy Division (IPA-CPD) has urged the Union Health Ministry to amend the Drugs & Cosmetics Rules to re-mandate the red line on antibiotic labels, reinforcing prescription-only status and combating antimicrobial resistance. The request aims to align regulatory provisions with public health communication and discourage self-medication misuse.
Source: h7.cl/1mUuE

4. India’s Ministry of Tourism is promoting medical tourism by easing international patient access through e-Medical visas for modern healthcare and e-Ayush visas for traditional treatments. The initiative supports seamless digital entry, coordinated care, and longer stays, reinforcing government’s efforts to position the country as a global destination for affordable, quality medical and wellness services.
Source: h7.cl/1hWHM

5. The U.S. Food and Drug Administration has requested manufacturers to remove suicidal behaviour and ideation warnings from the labels of GLP-1 receptor agonist drugs after reviewing clinical and real-world data showing no increased risk. This action aligns labels across the class and reflects current evidence from extensive clinical and retrospective analyses.
Source: h7.cl/1mUuJ

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FAQs for subsequent importer license of medical devices in India

On September 15, 2025, the Central Drugs Standards Control Organization (“CDSCO”) which issues import license for medical devices and In-vitro diagnostic medical devices (“IVD”) in India, announced that it had introduced a new regulatory pathway for importers of medical devices which are already approved for marketing in India. Such importers may obtain license as a ‘subsequent importer’ by submitting limited set of information and documents as opposed to the original importers who received the first import license for import of specific medical device in India.
After the announcement, several questions and issues remain arose, which are yet to be addressed by CDSCO. In this article, we have attempted to collate the questions and issues in form of frequently asked questions (FAQs) and address them to the best of our current understanding.
Please note that our answers are based on our good faith understanding of the current law and industry practice and should not be construed as official responses of CDSCO or professional advice.

1. Who qualifies as a “Subsequent Importer”?
Any entity/person who intends to import into India a medical device or IVDS that is already licensed by the CDSCO under the Medical Devices Rules, 2017 (MDR) to be imported into India by another importer, may apply as a subsequent importer.

2. Who cannot be a subsequent importer in India?
Importers of medical devices which are not already licensed to be imported into India, and importers who do not have direct access to foreign manufacturer of the medical device sought to be imported, cannot become subsequent importers in India.

3. Is there a similar regulatory pathway available for subsequent manufacturers of medical devices?
No. Unlike the concept of a subsequent importer, there is no provision that allows an entity in India to act as a subsequent manufacturer. Domestic manufacturers who are desirous of claiming the title of ‘manufacturer’ without manufacturing the medical device may explore the loan license route.

4. Where should applications to obtain a license as a Subsequent Importer be submitted?
The application for obtaining a license as a subsequent importer has to be filed through the CDSCO MD online portal.

5. In which form is the application for obtaining a license as a subsequent importer to be filed?
The application will be submitted in Form MD-14. The license will be issued in Form MD-15.

6. Is the subsequent importer route available to importers of IVDs?
Yes. The subsequent importer route is available to both importers of medical devices and IVD.

7. Is a wholesale drug license prerequisite for applying for a subsequent importer license?
In order to import and sell medical devices in India, the applicant who wishes to obtain subsequent importer license must first obtain wholesale drug License or registration certificate under Form MD-42.

8. Is submission of a fresh Power of Attorney (POA) required for subsequent importer application?
Yes. A fresh POA has to be submitted at the time of application.

9. What is the role of foreign manufacturer in obtaining subsequent importer license?
The person making an application for obtaining a license as subsequent importer has to obtain original documents from foreign manufacturer. The documents include POA, labels, regulatory certificates like free sales certificate, quality management certificate, undertaking etc.

10. Does an applicant have to submit Plant Master File (PMF) and Device Master File (DMF) for obtaining subsequent importer license?
No. There is no requirement to submit the actual PMF and DMF. However, the foreign manufacturer is required to submit an undertaking confirming that there have been no major changes to the PMF and DMF of the previously approved device since its primary submission and approval.

11. Is it mandatory for the subsequent import license holder to comply with the labelling requirements prescribed under MDR?
Yes. The subsequent importer has the mandatory obligation to comply with the labelling requirements prescribed under the rules.

12. Is a separate government fee payable for obtaining a subsequent importer license?
Yes. The applicant is required to pay both manufacturing site fee and product fee to obtain a fresh license as a subsequent importer.

13. What are the timelines for obtaining a subsequent importer license?
The Medical Devices Rules, 2017 do not prescribe specific timelines for obtaining a subsequent importer licence. The typical timelines to obtain an import license under Form MD-14 is nine months from the date of application. In practice, the timeline for obtaining a subsequent importer license may be similar or shorter than the primary import license, since the approval relies on the primary import licence already granted for the same device.

14. What is the validity of a subsequent importer license?
There is no clarity on it. However, in our view, the license for the applied device should be valid in perpetuity as long as the primary license stands.

15. Will the subsequent importer license remain valid if the primary import license is suspended or cancelled?
There is no clarity on it. However, in our view, if the primary import licence is suspended or cancelled due to issue with the medical device or foreign manufacturer, all subsequent importer licences linked to that device should be suspended or cancelled.

16. Does the applicant have to submit predicate analysis document for obtaining a subsequent importer license?
No. There is no requirement to submit the predicate analysis document at the time of application because the license as a subsequent importer is issued based on an already approved license.

17. Can a subsequent importer file an application for addition of models for the already approved device?
There is no clarity on it. However, in our view, the licensee should be able to add models.

18. What is the process to renew the subsequent importer license?
The license issued in Form MD-15 is valid in perpetuity. However, the subsequent impoter is required to pay the retention fee every 5 years from the date of its issuance in order to retain the license.

19. Can a person obtain a subsequent importer license for brand names different from those approved under the primary import license?
No. The subsequent import license can be issued only under the brand names approved in the primary license.

20. Does a subsequent importer have the responsibility to report the adverse events?
Yes. The subsequent importer has to report every adverse event to the authorities.

21. Does the subsequent importer have to comply with BIS standards?
Yes. All medical devices imported and sold in India shall conform to the standards laid down by the BIS, which are periodically notified by the Ministry of Health and Family Welfare (the Ministry). Where no such relevant standard of any medical device has been laid down either by BIS or by the Ministry, such device shall conform to the standards laid down by the International Organisation for Standardisation (ISO) or the International ElectroTechnical Commission (IEC), or by any other pharmacopeial standards. In case none of the above-mentioned standards exists, the device shall conform to the validated manufacturer’s standards.

22. Does subsequent importer have to fulfil the obligations prescribed under Drugs Price Control Order, 2013 (DPCO)?
Yes. The licensee has to comply with the obligations of declaring Maximum Retail Price (MRP) on the package of the device if the device is sold in retail packages. The licensee has to ensure that the MRP of the device is less than the prescribed price ceiling, where applicable, or does not increase beyond 10% in any 12-month period.

23. Is it mandatory for a subsequent importer to obtain IPDMS registration with National Pharmaceutical Pricing Authority (NPPA) under DPCO?
Yes. The licensee has to mandatorily obtain registration on IPDMS portal and file mandatory forms prescribed under DPCO.

24. Does the subsequent importer obliged to comply with Legal metrology (prepackaged commodities) rules, 2011 (LMPC Rules)?
Yes. The licensee has to obtain a registration under LMPC Rules and comply with the labelling requirements prescribed under the rules.

25. Is the subsequent importer required to fulfil the obligations under Plastic, E-waste and Battery Waste Management Rules?
Yes. The subsequent importer must comply with the Plastic, E-waste, and Battery Waste Management Rules where applicable. If the approved device is an electronic medical device, or it is an electronic medical device containing battery, and is imported with plastic packaging material, the importer must obtain the required Extended Producer Responsibility (EPR) registrations under the respective rules and fulfil all associated compliance obligations.

26. Can a subsequent importer transfer its license and rights to the third party?
No. The license issued in Form MD-15 is non-transferable.

27. Can an entity become a subsequent importer for Class A Non-sterile Non-measuring (NSNM) medical device?
No. The fresh registration under Class A NSNM category has to be obtained.

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 Pollution Control Board mandates real-time photographic monitoring of pharmaceutical effluent emissions, requiring automatic uploads to central portals. Non-compliance may trigger instant penalties and plant shutdowns forcing pharma CEOs and founders to implement on-site imaging systems immediately or risk regulatory sanctions.
Source: short-url.org/1beOU

2. The Indian Pharmacopoeia Commission has inaugurated the 5th National Pharmacovigilance Week (17–23 Sept 2025) themed “Your Safety, Just a Click Away: Report to PvPI”. The initiative aims to encourage broader participation in adverse drug reaction (ADR) reporting by healthcare professionals and patients to strengthen pharmacovigilance.
Source: short-url.org/1beP1

3. Telangana’s health department has sealed 115 pharmacies attached to corporate hospitals after discovering critical breaches such as no registered pharmacists on duty, absence of purchase-sale records, stocking expired drugs, and improper storage of thermolabile medicines. Authorities have issued notices to hospital managements and warned of strict legal action under pharmacy and drug laws.
Source: short-url.org/1fSXe

4. US President reportedly advised pregnant women to avoid paracetamol (Tylenol), citing suspected links to autism. The U.S. FDA has begun label-revision to reflect “possible association,” though causation isn’t proven. However, the WHO, EU regulators, and medical experts emphatically refute the claim, stating evidence remains inconsistent and insufficient to establish causality.
Source: short-url.org/1bePe

5. U.S. officials are reportedly exploring the launch of a branded web portal potentially called “TrumpRx” that enables consumers to search for prescription medicines and purchase them at discounted prices directly from manufacturers.
Source: short-url.org/1fSUh