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 licensing authority, CDSCO has issued an alert on the theft of Lantus® SoloStar® insulin (Batch No. 5F0347B) belonging to Sanofi India during transit in Odisha. As the product requires cold-chain storage at 2–8°C, quality risks exist. CDSCO has issued an advisory to healthcare professionals, patients and regulators.
Source: short-url.org/1qgYH

2. India’s central drug regulator reportedly circulated a proposal from the Ministry of Cooperation that would allow Primary Agricultural Credit Societies (PACS) to operate Jan Aushadhi Kendras without registered pharmacists through restricted drug licences, aiming to expand access in underserved areas. The pharmacist community has raised serious concerns, arguing this move could weaken professional standards and patient safety.
Source: short-url.org/1qgYM

3. The Food Safety and Standards Authority of India has issued draft amendments to the Food Products Standards and Food Additives Regulations, 2011 proposing several changes. Stakeholders may submit objections or suggestions within sixty days from publication of the notification. The authority will consider all representations before finalising the proposed regulatory amendments.
Source: short-url.org/1qgYz

4. A court has granted interim relief in a trademark dispute involving the shape of a toilet cleaner bottle. It held that product shape can receive trademark protection even after design registration expires. Observing strong similarity between competing bottles, the court restrained sale of the allegedly infringing product pending further proceedings.
Source: short-url.org/1qgZN

5. The Madras High Court has stayed a single judge’s observation declaring the term “Vapo” as public property in a trademark dispute concerning vapour-based medicinal rubs. The Division Bench held that the finding requires further examination, while allowing continued use of the contested registered mark pending adjudication of the appeals.
Source: short-url.org/1l8DX

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 Delhi high court granted ex-parte interim injunction to major manufacturer of toothpaste, directing social media platforms to take down the defamatory content pending further proceedings which is falsely claiming that Dant Kanti toothpaste causes cancer. The court found the claims prima facie malicious and unsubstantiated.
Source: short-url.org/1l8us

2. The High Court of Bombay has granted permanent injunction protecting registered mark ZERODOL against use of ZEKODOL-P for identical pharma products. Court found strong phonetic and visual similarity, holding confusion in medicines unacceptable. Defendant restrained and directed to pay directed to pay costs.
Source: short-url.org/1qgQf

3. The CDSCO is reportedly set to formally involve Quality Council of India-certified notified bodies in its drug regulatory audit framework to boost coverage and compliance monitoring, addressing capacity constraints in current inspections. The reform, aligned with global standards, would expand third-party audit participation alongside plans to grow internal scientific review teams.
Source: short-url.org/1qgQx

4. The Central Drugs Standard Control Organization will reportedly replace its existing SUGAM regulatory portal with a modern open-architecture digital platform, following approval by the Department of Expenditure. The new system aims to integrate the entire drug regulatory value chain, improve transparency and efficiency, and streamline licence, import/export and regulatory approval processes across India.
Source: short-url.org/1l8uE

5. The National Medical Commission has directed all medical colleges to integrate the HMIS of their attached hospitals with the Ayushman Bharat Digital Mission (ABDM-HMIS) portal within 15 days. Issued under UGMSR 2023 compliance, the move aims to enhance transparency, objective assessments and digital monitoring of medical education standards.
Source: short-url.org/1qgSQ

Posted on

Braille labelling on medicines in India for Visually Impaired Persons: Recent Developments

Ensuring that all citizens can safely access and use medicines is a fundamental marker of an inclusive and progressive society. Many countries recognize that equitable healthcare requires not only affordable medicines but also accessible information about them. While several jurisdictions have made notable progress in mandating Braille labelling and accessible formats on medicines, India is steadily advancing along a similar path.

Legal and policy context in India:
The Indian law which governs labelling of medicines is the Drugs and Cosmetics Act, 1940. It focuses on the safety and authenticity of medicines but is silent on the specific accessibility needs of persons with disabilities. The Indian law which protects rights of disabled persons, The Rights of Persons with Disabilities (RPWD) Act, 2016, mandates equality, non-discrimination, and accessible information in audio, print, and electronic formats. However, these rights have not yet been translated into compulsory standards for accessible drug labelling.

Global practices and Indian judicial activism
In the European Union, medicine name labelling in Braille on outer cartons is legally required for most patients handled prescription medicines under Directive 2001/83/EC (as amended), enabling many visually impaired people to manage medicines more independently.

India has shown forward movement through judicial activism. Notably, the Supreme Court of India, in response to a public interest petition (W.P.(Civil) No. 516 of 2024), issued a notice via its order dated 27 August 2024, seeking responses from government on guidelines for implementing a Braille Integration System on medicine prescriptions, strips, labels, consumer products, and currency notes. The petition detailed the serious barriers faced by visually impaired people: difficulty in identifying currency notes, reading product labels, and managing prescriptions independently. These issues, the plea argued, constitute violations of the constitutional rights to equality and dignity under Articles 14, 16, 19, and 21 of the Indian Constitution. It also emphasized how the absence of Braille on key everyday items forces visually impaired citizens to depend on others for essential information in public and private settings.

Separately, Indian courts have directed platforms like Netflix and other OTT services to make their user interfaces more accessible, including audio descriptions for the visually impaired. These examples show courts stepping in to advance accessibility where government policy has lagged.

Current regulatory efforts and their limitations:
India’s central drug regulatory authority, the Central Drugs Standards Control Organization (CDSCO), has recently acknowledged these longstanding issues and on 9th September 2025, it invited stakeholder comments on proposals to address the challenges faced by blind and visually impaired individuals when reading tablet and capsule strips. Key recommendations included:

  • Introducing Braille labelling on medicines supplied in mono-carton packs on a voluntary basis initially, prioritizing products like eye drops that are frequently used by visually impaired patients.
  • Including Braille cards with secondary packaging for medicines supplied in bulk quantities exceeding ten units.
  • Adding QR codes on packaging linked to voice assistance technology to provide audio-based medicine information.
  • Ensuring that Braille labels are validated by recognized institutions such as the National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID), in conjunction with the Braille Council of India.
  • Exempting medicines administered solely by healthcare professionals (injectables, vaccines), although concerns remain around the exclusion of certain self-administered devices like prefilled injection pens.
  • Making available patient information leaflets in accessible formats such as Braille, large print, and audio versions upon request.
  • Advising pharmacists and retailers to provide verbal guidance to visually impaired patients concerning medicine names, dosages, expiry dates, and usage instructions.

However, these initiatives have so far only been offered for stakeholder comment and feedback, with no clear timetable for adoption or any mandatory framework for implementation. As a result, there remains significant uncertainty about when these measures will become legally binding and uniformly enforced across the pharmaceutical industry. This leaves millions in continued limbo, dependent on voluntary compliance rather than assured rights, and underscores the urgent need for the government to move from consultation to concrete action.

The human impact and need for urgency:
For visually impaired individuals, inaccessible drug labelling creates daily challenges and safety risks. The inability to read medicine names, expiry dates, and dosage instructions often leads to dependence on caregivers and undermines autonomy and dignity. Prolonged consultations and voluntary measures have repeatedly failed to address these realities.

What is expected versus what is realistically doable
There is a clear gap between regulatory ambition and on-ground feasibility. Expecting full Braille labelling on every primary strip or blister pack presents technical, spatial, and cost challenges, particularly for medicines with small packaging or high-volume generic production. At the same time, doing nothing perpetuates risk and dependence.

The critical question, therefore, is not whether accessibility should be provided, but how it can be implemented in a manner that is practical, scalable, and enforceable across India’s diverse pharmaceutical and retail ecosystem.

Practical alternatives and pharmacist-led solutions
A more workable approach may lie in standardized yet flexible solutions. Instead of attempting to place complete Braille information on every label, manufacturers could be required to maintain one standardized Braille specimen for each product, covering information required on drugs label as per the Drugs Rules, 1945. This specimen could apply to both the label content and the patient information leaflet.

Retail pharmacists could then play a central role by keeping these Braille specimens or accessible leaflets available at the point of sale and providing them on request, alongside verbal counselling. QR codes linked to verified audio instructions could further complement this system, allowing patients to access information privately and independently.

Such an approach recognizes operational realities while still advancing accessibility in a meaningful way that pharmacists and retailers can realistically manage.

Conclusion:
Millions of visually impaired Indians continue to face significant barriers because medicine labels remain inaccessible. This is not merely an inconvenience, it directly affects safety, independence, and dignity. When people cannot read labels, they are forced to rely on others to manage their health.

With binding regulations, clear timelines, and thorough enforcement, the Indian Government has the ability give every individual the confidence and freedom to manage his or her health safely and independently.

Posted on

Pre-filing consultation for medical device risk classification now possible in India

India’s central medical device regulator, The Central Drugs Standard Control Organization (“CDSCO”), has introduced a facility that allows importers and manufacturers of medical devices who are desirous of ascertaining the risk classification of their medical devices to receive an official confirmation on risk classification from the CDSCO.

Regulatory context
India’s medical device regulatory framework differs from most other jurisdictions. In India, risk classification of medical devices is determined by CDSCO and is not self-declared by manufacturers and importers who are making the product license application.
Additional complexity arises from the fact that manufacturing licenses for Class A and Class B devices are issued by State authorities. This has resulted in inconsistent application of risk classification thresholds, with similar products receiving different risk classifications across states. Although CDSCO has issued directions to address this issue, practical challenges continue.

Why does risk classification matter?
The risk classification determines documents and data required, government fees and timelines for obtaining the product license. Therefore, risk classification is a key commercial and strategic factor.

Pre-filing consultation facility
To align risk classification and bring regulatory certainty, CDSCO has introduced a voluntary pre-filing consultation facility to confirm medical device risk classification. The facility is only available to manufacturers and importers of medical devices other than in-vitro diagnostic medical devices (IVDs).

Consultation fee
Please note that there is no consultation fee for availing the facility to determine risk classification of medical devices.

Documents required
In order to avail the facility, the manufacturer or importer is required to submit existing device labels, instructions for use, and the regulatory status of the device in other jurisdictions (like USA, UK, EU, Australia, Canada, or Japan), etc.

Timeline for receiving response on risk classification of medical device from CDSCO
There is no prescribed timeline, and the consultation is best undertaken in parallel with preparation of the main regulatory dossier of medical devices.

Key take-aways for industry
It is pragmatic to undertake pre-consultation when the risk classification of the medical device is unclear.
Early confirmation of risk classification allows companies to plan approval pathways with greater certainty, align licensing strategy at an early stage, and reduce regulatory friction. It also supports better coordination between India-specific regulatory requirements and global product positioning.

Disclaimer: This article is intended for general information purposes only and does not constitute legal advice

Posted on

The 90 Day Rule: Indian Drug and Medical Device Regulator (CDSCO) tightens query response timelines on applications 

India’s Central Drug and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has made it clear that it will reject product applications if the official queries to the applications are not responded within 90 days from the date of receipt of the first official reminder.

Background
On January 16, 2026, CDSCO issued a public notice informing the general public that it has initiated a time-bound reminder and rejection mechanism to ensure timely disposal of the pending applications. As per CDSCO, a large number of product applications across categories such as new drugs, cosmetics, biologics, medical devices and IVDs are pending since 8 to 10 years because of non- submission of responses to queries on product application raised on the official electronic submission portal (SUGAM portal).

In the notice, CDSCO issued a final warning to applicants whose application has been pending for more than two years for want of response to queries and who have received three reminders from CDSCO requesting submission of response to query. If such applicants fail to respond to queries within 30 days from date of public notice i.e. by 14 February 2026, it will result in rejection of the application.

The CDSCO also used the opportunity to inform the public that it has instituted a structured reminder mechanism for queries to applications under which it was going to issue three reminders to applicants in relation to unresponded queries. This structured reminder system and consequences of failing to respond to queries are discussed in the paragraphs below.

CDSCO’s Structured reminder mechanism
Under the structured reminder mechanism, CDSCO has decided that it will issue reminders at fixed intervals to applicants who do not respond to the official queries to an application in the following manner:

  • First Reminder- CDSCO will issue the first reminder if it does not receive response to query. The time-period that CDSCO will wait for response to queries before it issues the first reminder has not been specified.
  • Second reminder – If no response to queries is received within 30 days of first reminder, a second reminder will be issued o.
  • Third reminder – If no response to queries is received within 30 days of second reminder, a third and final reminder will be issued.
  • Disposal Notice – If no response to queries is received within 30 days of issuance of third reminder, CDSCO will issue dispose the application.

Will the disposal of application due to non-response to queries be treated as rejection of the application effectively barring the applicant to make the same application again?
The disposal by CDSCO should not be treated as rejection of the application. This means that the applicant should be able to apply for license again for the same products, even if the application for same products has been rejected before for want of response to queries.

Whether the government fees paid be refunded or reused or adjusted in case of disposal of application of CDSCO on grounds of non-response to queries?
As per the public notice, the government fees paid will not be refunded or reused or adjusted once the underlying application is disposed by CDSCO due to non-receipt of response to queries despite three reminders.

What will happen to product applications that are pending for more than two years?
Where an application has remained pending for over two years, but no queries have been raised by CDSCO, there is currently no clarity on how such cases will be treated. Based on the language and intent of the public notice, such applications should not be disposed, because the structured reminder mechanism gets triggered only when queries raised by CDSCO are not responded to by the applicants.
Where queries have been raised in the application, but the applicant is yet to receive three reminders from CDSCO as described in the structured reminder mechanism, it is unclear what will happen because the public notice does not provide any guidance on this issue. In our view, such applications should not get disposed by CDSCO for want of response since the disposal of application under the structured reminder mechanism can happen only after issuance of three reminders by CDSCO. However, CDSCO is free to follow its own processes and cannot be blamed for disposal of application without notice on the ground that the applicant has not responded to queries and appears to have abandoned the application.

Is it possible to seek extension of the timeline?
It is unclear whether CDSCO will entertain extension of timeline beyond the timeline of 90 days prescribed under the structured reminder mechanism. The Public Notice leaves some flexibility for making an application for extension of timeline. However, the final decision on extension of timeline beyond the 90 day window under the structured reminder mechanism will rest with CDSCO.

Is it possible to partly respond to CDSCO’s queries and respond to remainder of the queries later?
It is unclear whether CDSCO will entertain partial response to queries as sufficient to stop the 90 day clock under its structured reminder mechanism. However, in the event of time-crunch, it may be pragmatic to submit a partial response to queries than to submit no response at all.

What is timeline for CDSCO to issue queries after submission of an application?
CDSCO has not committed to a timeline to review application and issue queries to applicants.

What is the timeline within which an applicant must respond to queries raised on the application to avoid receipt of first reminder from CDSCO?
CDSCO has not indicated any expectation on timeline within which applicants should respond to its queries to avoid receiving the first reminder.

Will State Drug and Medical Device Licensing Authorities also follow structured reminder mechanism and dispose applications due to non-response to queries?
The State Drug and Medical Device Licensing Authorities are not bound to follow the structured reminder mechanism as published by CDSCO in its public notice. For all practical purposes, the structured reminder mechanism should be assumed to be applicable to CDSCO only.

There is a statutory timeline prescribed for processing most product license applications. What happens to the statutory timeline is the impact of query on statutory timeline of processing of an application?
The statutory timelines prescribed for processing drug, medical device or cosmetic license by CDSCO or State Licensing Authority are considered to be suspended upon receipt of queries from the regulatory authority.

Take-away for industry
It may be pragmatic for manufacturers and importers of drugs and medical device manufacturers to respond official queries received to their product applications at the earliest opportunity and in the best possible way, to avoid repeat queries or reminders from CDSCO. It is possible that some queries may require more time to respond than other queries, at which time appropriate regulatory strategy should be formulated to address all queries so as to avoid disposal or rejection of application and consequent loss of valuable time and government fees.

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. Delhi High Court has held that English alphabets cannot be monopolised under trademarks law, refusing interim protection to the mark “A to Z” used for pharmaceutical products. The Court held the mark is descriptive, lacking distinctiveness, and cannot bar another company’s use of the letters A and Z, vacating an earlier injunction granted in favour of the company.
Source: h7.cl/1idmr

2. India’s Karnataka High Court has ruled that doctors with an MD in Anesthesiology do not require separate training to prescribe, possess, or dispense essential narcotic drugs for pain relief and palliative care, as Anaesthesiology comprises necessary training prescribed under NDPS Rule and no separate training is essential. The court directed authorities to grant certifications to hospitals designating such practitioners, allowing them to procure and prescribe narcotics.
Source: h7.cl/1idmx

3. Reserve Bank of India (RBI) recently notified the Foreign Exchange Management (Export and Import of Goods and Services) Regulations, 2026, unifying goods and services trade under one FEMA framework. The regulation mandate services-export reporting, strengthen bank monitoring, tighten delayed-proceeds norms, and ease compliance for MSMEs, reflecting services’ role in India’s external sector.
Source: h7.cl/1ncIW

4. India’s Central Government has issued a new Drug Procurement Policy under the Central Government Health Scheme (CGHS), introducing demand-driven bulk purchasing, enhanced quality assurance, and transparent drug procurement processes. The policy aims to ensure uninterrupted medicine access, optimize resource utilization, and strengthen supply chain resilience across all CGHS establishments.
Source: h7.cl/1ncJh

5. India’s central drug regulator approved a record number of Recombinant DNA (r-DNA) origin drugs in 2025, granting permission for 28 new drugs for manufacture and 44 for import and marketing, the highest in five years. Approvals included insulin, oncology and immunology products.
Source: h7.cl/1ncJy

Posted on

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. The Pondicherry Drugs Control Department has mandated 100% batch-wise testing of all medicines sold in Pondicherry using Central Drugs Standard Control Organisation-accredited labs. The directive covers pharmacies, wholesalers, clinics, and public and private hospital stores, requiring immediate quality testing for every drug batch.
Source: h7.cl/1mwLy

2. The Central government told the Delhi High Court that judicial orders reducing GST on air purifiers would breach the Constitution’s separation of powers, asserting that GST rate decisions rest solely with the GST Council. It also labelled the PIL seeking medical-device status and tax cut as a “motivated attempt,” warning against judicial overreach.
Source: h7.cl/1hzJ2

3. The Delhi High Court has sought a response on a plea seeking revocation of a patent covering a widely used diabetes and anti-obesity medicine, ahead of its expiry in March. The petition alleges lack of novelty and attempts to extend exclusivity, amid growing interest from domestic manufacturers nationwide.
Source: h7.cl/1mwLG

4. The Medical Device Coordination Group (MDCG) has issued new guidance on post-market surveillance (PMS) for medical devices and IVDs under the EU regulations. The guidance outlines PMS system setup, data collection, analysis, and integration with quality management to ensure ongoing safety, performance, and regulatory compliance across the product lifecycle.
Source 1: h7.cl/1hzJ7
Source 2: h7.cl/1hzJ8

5. India’s central drug regulator, guided by a high-level DCC report, is reportedly launching the second phase of the National Action Plan on Antimicrobial Resistance (NAP-AMR) to combat antimicrobial resistance. Measures include banning OTC antibiotic sales, stamping prescriptions, real-time tracking, promoting new antibiotic R&D, stricter Schedule H/H1 controls, and extended producer responsibility for disposal.
Source: As essential antibiotics fail, regulator mulls R&D push, curbs on misuse
Source: h7.cl/1mwLP

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 Drugs Standard Control Organization has cancelled the import registration of a cosmetic product after finding misleading drug-related claims on its website, which were inconsistent with the approved product labels, including claims relating to treatment of medical conditions.
Source: h7.cl/1hoPv

2. CDSCO has issued guidelines and SOPs under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, detailing eligibility, application process, authorities, and conditions for compounding certain regulatory offences, enabling settlement through monetary penalties and compliance measures instead of prosecution, supporting ease of doing business while maintaining regulatory oversight.
Source: h7.cl/1mlwh

3. The Food Safety and Standards Authority of India has notified that all amendments to food labelling and display regulations will come into force from 1 July of the year of notification. It has also revised the compliance timeline, extending the mandatory transition period for industry from 180 days to 365 days.
Source: h7.cl/1mlvZ

4. The Union Health Ministry is reportedly in discussions with state drug authorities to consider granting a six-month, case-by-case extension for pharmaceutical companies to comply with revised GMP requirements. The updated Schedule M introduces stricter manufacturing quality standards to align India’s drug production framework with global norms.
Source: h7.cl/1mlw4

5. India’s pharma regulator reportedly plans to introduce a dedicated wholesale licensing regime for bulk drugs, APIs and key starting materials. The move, along with a national supplier database, aims to improve traceability of imported materials and strengthen accountability and supply-chain oversight amid rising quality concerns.
Source: h7.cl/1hoPC

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 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