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CDSCO Advisory on GLP-1 Drug Promotions : What Changes Now?

The Central Drugs Standard Control Organisation (CDSCO) has recently issued an Advisory that has the effect of re-shaping the legal landscape around disease awareness campaigns, surrogate promotion, and other communications for an entire class of medicines popularly known as GLP-1 receptor agonists or GLP-1 drugs (such as Semaglutide, Liraglutide, and Tirzepatide).

Informing patients about a medical condition and spreading awareness in terms of prevention or cure has never been the same as advertising a drug. For decades, disease awareness campaigns that made no product claim, named no drug, and directed patients to registered medical practitioners were understood to fall within that permitted space. That is the status quo that the Advisory has now broken, not just for GLP-1 drugs but for all kinds of prescription drugs.

I. What the existing law already says (What cannot be done)
The Indian law currently prohibits (i) any person making or participating in the publication of communication which claims to cure diabetes or obesity; (ii) any manufacturer or importer of drugs from advertising any prescription drug; and (iii) making a claim on the label to the effect that a drug can cure diabetes and obesity. Violation of any of the aforementioned can result in criminal prosecution and cancellation of the manufacturing and import license.
Importers and manufacturers build their market strategy around educating about the disease, which are popularly known as disease awareness campaigns. For instance, in the context of GLP-1 drugs, companies have started conducting educational campaigns to highlight obesity as a medical condition and urge people to consult a doctor, without directly naming a drug or making any efficacy claim, in compliance with applicable drug law frameworks.

II. What does the advisory change
The Advisory has, for the first time, brought disease awareness campaigns under the purview of advertisement. However, if the disease awareness campaign seeks to indirectly (i) promote prescription-only medicines to the general public, or (ii) exaggerate therapeutic efficacy, or (iii) suggest assured or guaranteed weight loss outcomes, or (iv) downplay lifestyle modification measures (diet, exercise, behavioural interventions), or (v) induce demand for pharmacological therapy, then it would amount to ‘surrogate advertisement’, then the regulator may take action against erring manufacturers, importers and marketers. In the paragraph below, we have given examples for each of these situations:

(i) Promotion of Prescription Drugs: A paid Instagram reel by a manufacturer depicting that consumption of a GLP-1 drug has led to weight loss would amount to promotion of a prescription-only drug to the general public.

(ii) Exaggeration of Therapeutic Effect: Statements such as “Works even without diet or exercise”, where the drug’s own prescribing information mandates lifestyle modification, would constitute an exaggeration of therapeutic effect.

(iii) Assured Outcome Claims: Claims such as “Guaranteed 10 kg loss in 8 weeks or your money back” would amount to a claim of assured outcome.

(iv) Downplaying Diet, Exercise, and Lifestyle Modification: Any communication where diet, exercise, is shown as ineffective, or unnecessary, may be construed as downplaying lifestyle modification.

(v) Inducement of Pharmacological Therapy: An educational or awareness campaign in which individuals are shown, encouraging or directing an overweight person to consult a doctor in a manner that suggests that medical or pharmacological intervention is the only and necessary solution.

The Advisory does not define what constitutes “inducement”, nor does it prescribe any objective threshold. This creates a zone of significant interpretational uncertainty. A script that never mentions a drug may still be found to create an impression of pharmacological inducement if the overall communication suggests that medical intervention is the primary or natural solution to the condition. In such cases, even in the absence of any product reference, the communication may be treated as a surrogate advertisement based on the impression it creates rather than the words it uses.

For example, if an influencer publicly discusses her medically supervised GLP-1 treatment journey without promoting any specific product, but emphasises the need to consult a doctor, could this be said to induce demand for pharmacological therapy? The Advisory leaves this question open, even when it extends its ambit to influencer engagements and collaborations.

It is important to note that while the drug regulatory framework under Drugs and Cosmetics Act, 1940 and the rules thereunder, primarily governs manufacturers, importers and marketers, advertisements by celebrities and influencers are independently regulated under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMRA”). The DMRA prohibits any person, including manufacturers, importers, marketers, influencers and even doctors, from publishing or participating in advertisements that directly or indirectly claim that a drug can be used for the treatment, cure, prevention, or mitigation of obesity and diabetes.

Therefore, in a scenario where a manufacturer engages or pays an influencer to create content documenting or promoting a GLP-1 treatment journey, the manufacturer may be exposed to liability under the Drugs and Cosmetics Act, 1940 and the rules governing prescription drug advertising, as well as under the DMRA. The influencer, on the other hand, while not directly regulated under the drug approval and marketing framework, would nevertheless fall within the scope of the DMRA, which applies to “any person” participating in such advertisements.

III. Surrogate Advertisement Problem
Further, this Advisory also sweeps all educational activity as a surrogate advertisement if it is “under the pretext of disease awareness” that creates “brand recall or product visibility”. The Advisory’s twin tests (the inducement standard and brand recall test) are both impression- and output-based, not content- or intention-based.

In simple terms, brand recall would include any element that reminds the viewer of a particular drug or brand, such as brand colours, taglines, packaging style, or any visual identity associated with a product. Product visibility or product placement would include showing a product, its packaging, or any identifiable brand element, even if it appears only in the background.

This gives rise to two important questions in light of the Advisory. (i) Is corporate branding allowed in disease awareness campaigns? Can disclaimers include product references or directions to product information?

In our view, corporate branding is permitted so long as it does not create an association with a specific prescription drug or product brand. Similarly, if a disclaimer mentions a product name, directs viewers to a product website, or provides product-related information, or if any scientific reference contains a product name or information, such communication may no longer remain a disease awareness campaign and may instead be treated as product promotion or surrogate advertisement. Furthermore, if a brand makes a tagline that strikingly resembles the product brand name, it would again be termed a violation.

IV. Way forward after the Advisory
Going forward, all drug and medical manufacturers and importers who invest in disease awareness campaigns would now need to ensure that such campaigns meet the requirements of the Advisory. From a visual standpoint, the standard imposed by the Advisory would effectively require zero product appearance. Beyond the visuals, the scripts will need to be vetted at every stage, not only for what they explicitly state, but also for what they may imply. How a disease awareness campaign is structured, including positioning of the elements such as doctor’s consultation, pharmacological treatment, efficacy claims, etc., in compliance with the Advisory, will be of critical importance to keep companies outside the risk of violation.

For obesity disease awareness campaigns specifically, it will be important to have a balanced and holistic approach in the advertisement, providing equal emphasis on lifestyle and diet, without medical consultation being shown as the only option. Further, medical consultation, if shown at all, would have to be framed generally as one of the options.

On a separate note, all drug and medical manufacturers and importers may proactively undertake a comprehensive review of their websites, creating disease awareness, containing educational materials, as well as their social media content and strategy, to not be caught off guard in light of the sweeping nature of the Advisory.

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Blood, Bodies and Personal Data: How Period Tracking Apps approach privacy rights of menstruating individuals, from the lens of Digital Personal Data Protection Act, 2023 and Digital Personal Data Protection Rules, 2025

Digital health technologies are repositories of some of our most intimate personal data. Most menstruating individuals who use menstrual and fertility tracking apps (referred to as “period tracking apps” hereafter) regularly record the most private aspects of their life, such as cycle dates, symptoms, mood, sexual activity, and fertility patterns (referred to as “menstrual data”) on these apps while looking for predictability and awareness of their own body and its functioning. Implicit in this use is an assumption that the app will protect their sensitive personal information and that it will not be disclosed or shared with anyone, especially without their informed consent.

However, investigations and regulatory findings in various countries have revealed that period tracking apps collect sensitive personal data beyond what is necessary for service delivery, retain such data for extended periods of time and share it with third-party advertisers or analytics platforms without the knowledge of unsuspecting users.

Law to protect privacy in India
A privacy-focused law called the Digital Personal Data Protection Act, 2023 (“DPDP Act” or “Act”) was passed in 2023. The Act introduces a definitive legal framework for the protection of digital personal data, but it has been largely ineffective thus far, owing to the absence of rules which can translate the legal framework into concrete obligations with accountability.

The Indian Government has notified the Digital Personal Data Protection (DPDP) Rules, 2025 (“DPDP Rules”) under the DPDP Act on November 14, 2025. Before the enactment of the DPDP Act, the collection, storage, processing, disclosure and transfer of health-related personal information and data was regulated in a limited manner under the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011 (“SPDI Rules”). However, with the introduction of the DPDP Act and DPDP Rules, the SPDI Rules are set to be replaced by May 13, 2027. The DPDP Rules are expected to give teeth to the DPDP Act since they enumerate real obligations on entities that process personal data.

This article will critically examine whether the protections put in place by the DPDP Act and DPDP Rules are sufficient to protect the personal data of menstruating individuals which is being collected and stored in period tracking apps.

Data processed by period tracking apps
Menstrual data is not just informational. Unlike most health data, which is often a record of isolated medical facts, menstrual data is inherently derivative and inferential in nature. From seemingly simple menstrual cycle logs, it is possible to predict pregnancy, miscarriage, or abortion; indicate underlying conditions such as Polycystic Ovary Syndrome (PCOS) or endometriosis; and enable profiling relating to marital status, sexual behaviour, fertility preferences, and broader reproductive choices. The misuse of such data can result in stigma, discrimination, coercion, or even physical risk. Therefore, menstrual data is not merely sensitive; it is sacrosanct and private.

Consent, purpose and necessity framework for processing personal data
Under the DPDP Act, owners and operators of period tracking apps are known as “data fiduciaries”. The DPDP Act has imposed an obligation on data fiduciaries to obtain valid consent from users who come under the definition of “data principals” before any collection, storing and processing of data principals’ personal data. The consent given by a data principal has to be free, specific, informed, unconditional and unambiguous, with a clear affirmative action. Further, any processing of such personal data must be limited, i.e., as is necessary for performing the specified purpose that was informed before or at the time of taking consent.

For period tracking apps, a bundled consent mechanism and ambiguous privacy policies will now turn out to be unlawful. Such apps must explicitly disclose (i) what menstrual data is collected with a description; (ii) the specified purpose of such collection (including whether it is shared, with whom, and for what purpose); (iii) a mechanism for withdrawal of consent, exercise of rights, including making complaints to the Data Protection Board.

As stated above, before requesting specific consent, the data fiduciary is required to describe the specified purpose for processing personal data. However, there is currently no guidance on the standards a data fiduciary should follow while describing a specified purpose, which begs the following question: Should the specified purpose be left to be determined by data fiduciaries who are running businesses and would be inclined to expand the specified purpose as much as possible? If the data fiduciaries who runs period tracking apps decides to include “use of menstrual data for recommendation of health services and health service providers” as another specified purpose in addition to access to period tracking service, and start sharing the personal data of menstruating individuals users to doctors and hospitals in form of leads, it won’t be unlawful, if the unsuspecting user has granted their consent to such “specified use”.

Therefore, in the context of period tracking applications, the ability of a data fiduciary to define a specified purpose in broad or unrelated terms and seek specific consent from unsuspecting users creates a systemic vulnerability for menstruating individuals who use period tracking app. A period tracking app may lawfully define its specified purpose to include targeted advertising, behavioural analytics, or commercial use of such data, provided such purposes are disclosed and consented to. The Act does not impose an independent test of necessity, proportionality, or contextual legitimacy of the specified purpose, nor does it prohibit certain uses of menstrual data outright. In this way, the current privacy framework under the DPDP Act and DPDP Rules risks reducing consent to a mere formality, insufficient to protect menstruating individuals from exploitative or intrusive uses of their most intimate menstrual data.

Derivative and Anonymised Data: Limits of the Right to Erasur
Pursuant to the DPDP Act, the users have an explicit right to access their stored (menstrual) data, correct inaccuracies, seek erasure where the specified purpose they consented to is served or when they withdraw consent. Hence, among the rights conferred on data principals under the DPDP Act, the right to erasure is particularly significant in the context of period tracking apps. Historically, such apps have relied on indefinite and discretionary retention of menstrual data and have thrived on years of cycle history that make their predictions more “accurate” by training their models, as well as to benefit from the economic value of such data by selling it to third parties. The DPDP Act makes it unlawful to do so now.

However, a challenge remains in the context of derivative and AI-generated data because the DPDP Act does not distinguish between original personal data and inferences drawn from it, i.e., derivative personal data. In other words, derivative menstrual data remains “personal data” so long as it relates to an identifiable individual. Therefore, when it comes to erasure of such personal derivative menstrual data, the right of erasure turns out to be ineffective as once an individual’s menstrual data has been incorporated into a trained (AI) model, the underlying data cannot be extracted, separated and deleted in any meaningful sense. Even after a user requests deletion of their personal data, the model may continue to draw on patterns derived from that data to infer or predict similar outcomes.

Another risk is that of anonymisation, which is often presented as a solution to privacy concerns. Yet menstrual data, even when stripped of personal information, can be re-identified when combined with other datasets. It can also enable group-level profiling (e.g., fertility trends in a region, age group, or socio-economic class). Further, the DPDP Act does not specify standards for what level of anonymisation is sufficient, or who bears the burden of proving irreversibility.

This gap becomes particularly consequential when such menstrual (derivative or anonymised) data is retained indefinitely, perhaps even monetised, or used to train predictive or AI-driven systems.

Minors, Consent, and Menstrual Privacy
It is worth noting that a substantial number of period tracking app users include teenagers. The DPDP Act introduces strict “verifiable parental consent” for those under the age of 18. Verifiable consent entails that the individual who has provided parental consent – his/her identity is checked, age is confirmed, using reliable or government-backed identity verification methods. While intended as a protective measure, this requirement may unintentionally undermine the privacy of minors.

In many social contexts, young users may not feel safe or comfortable discussing menstrual health or sexual activity with their parents. Mandatory parental consent could therefore discourage minors from using digital tools that help them manage their reproductive health, effectively denying them confidential access to essential health information.

Conclusion
It is undeniable that the DPDP Act and DPDP Rules provide a legal framework for protecting the privacy of users of period tracking apps in India. However, when applied to menstrual data, certain limitations become evident where clearer guidance and interpretation are needed.

The current framework does not fully account for the unique sensitivity of menstrual information, the realities of AI-driven processing, the risks of derivative and anonymised data, and the potential inadvertent exclusion of minors from period tracking apps. Without clearer restrictions on permissible uses and stronger safeguards, the law risks treating deeply intimate bodily data as ordinary consumer information.

To fill the gap, one potential solutions could be that the schema of the DPDP Act itself be tweaked to treat menstrual and other sensitive health data as a special category or sensitive form of data requiring higher standards of protection, much like the outgoing SPDI Rules which categorically labelled health data as sensitive data and EU General Data Protection Regulation (GDPR) that treats menstrual data as “Special Category Data”.

Adopting a comparable approach under the DPDP Act and DPDP Rules would ensure that menstrual data receives the heightened protection it deserves. Without such reforms, the privacy of millions of menstruating individuals using period tracking apps will remain unsecured and exposed to potential misuse.

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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.

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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

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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.

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India’s Cosmetic Regulator Cancels Import Registration On Discovering Inconsistencies Between Label Claims and Website Claims

India’s central cosmetics regulator, The Central Drug Standard Control Organization (“CDSCO”), has recently passed an order cancelling the registration of an importer of a cosmetic product after it discovered inconsistency between the claims made on label of the product and claims made on the product website. The order is relevant because it evidences a new trend that the Indian regulator is scrutinizing not just claims made on product label at the time of grant of registration but is also scrutinizing claims made on the product marketing materials and product website after grant of import registration certificate.

In this article, we have summarized the reasons for cancellation of the order and contextualized the cancellation in background of sensitivity of the regulator to cosmetic products that make drug-type claims.

Legal Background

In order to import cosmetics into India, a registration is required to be taken by the importer under The Cosmetics Rules, 2020 (“Cosmetics Rules”). The registration entitles the importer to import cosmetics mentioned in the registration certificate for the term of certificate. However, during the term, the importer has to ensure compliance with conditions of the registration as well as the Cosmetics Rules in order to maintain the registration.

Under Indian law, there is a separate regulatory pathway for import of drugs, and a separate license is required under The Drugs Rules, 1945 (“Drug Rules”) to import drugs in India. The definition of “drug” is very broad, and any substance which makes any claim that it may diagnose, treat, mitigate or prevent any disease or disorder is regulated as a drug.

In other words, a cosmetic product will be regulated as a drug and would require license under Drugs Rules (separate than the registration certificate under Cosmetics Rules), if the importer of cosmetic product makes a claim which qualifies the product to be a drug under Indian laws.

    The CDSCO cancelled the registration certificate of M/s. Esthetic Centers lnternational Pvt. Ltd. for the following reasons:

    a) Inconsistency between the claims made on the label which was submitted to CDSCO at the time of application of registration certificate and the claims made on the website of the product.

    Claims on the approved label Claims on the website
    Anti-hair loss solutionTreatment for Post-Chemotherapy hair loss, Androgenetic alopecia, Seborrhoeic dermatitis of scalp etc.

    b) Nature of the claims being ‘drug’ claim owing to the use of the word “treatment” and reference to human diseases and conditions.

      Key takeaways


    a) It is now evident that CDSCO is scrutinising marketing claims of a cosmetic product including claims made on the product website. The CDSCO appears to be especially sensitive to products which are registered as cosmetics but are found to be making drug claims after receiving registration to import.

    b) CDSCO is taking serious action against registration holders despite the registration holder undertaking to comply with directions and undertaking to remove all inconsistent and drug-type claims from the product website. In this case, the importer had removed all the references to disease conditions from the website, but the CDSCO still cancelled the registration certificate.

    In fact, the CDSCO does not have powers under Cosmetic Rules to cancel registration if the importer of cosmetic product makes a misleading claim in violation of Rule 36 of Cosmetic Rules. Such power is only available against domestic manufacturers of cosmetics due a lacunae in the existing law. However, CDSCO has overlooked the shortcoming and still chosen to cancel the registration, which shows the seriousness with which CDSCO views such violations.

      Conclusion


    It is important for importers, marketers and manufacturers of cosmetics product to ensure that the claims made by them on the label of cosmetics at the time of receipt of registration or license are consistent with the marketing claims made by them after import or manufacture of cosmetic product into India. Any inconsistency, especially with reference to overlap with drug-type claims, can invite serious action including cancellation of import registration are manufacturing license, as the case maybe.

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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.

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RECENT NPPA NOTICES AND THEIR IMPACT ON THE MEDICAL DEVICE INDUSTRY

Several medical devices companies have recently received an official letter (“Letter”) from the National Pharmaceutical Pricing authority (“NPPA”) directing them to register on the Integrated Pharmaceutical Database Management System (“IPDMS”) portal and file applicable forms under the Drugs (Prices Control) Order, 2013 (“DPCO”) within 15 (fifteen) days of issue of the Letter.

In this article, we have explained the legal background to these Letters, the consequences of non-compliance with NPPA directions, and the common issues faced by industry while complying with these requirements.

What is IPDMS?

IPDMS is an online platform developed by the NPPA to enable importers, manufacturers and marketers of drugs and medical devices to submit product pricing and related data in accordance with the requirements of the DPCO.

The pricing data submitted to NPPA through the IPDMS forms the basis for monitoring and enforcement activities carried out by NPPA against importers, manufacturers and marketers of medical devices under the DPCO.

Powers of NPPA to direct submission of product pricing and related data

Paragraph 29 of the DPCO mandates importers, manufacturers and marketers of medical devices to maintain such records as may be directed by the NPPA, including sale records, and empowers NPPA to call for and inspect such records at the premises of the manufacturer, importer and marketer of medical devices. Paragraph 30 of DPCO, empowers NPPA to enter and search any place, seize any medical device and records of purchase or sale of medical device.

The Letter has been issued in exercise of powers to call for records under Paragraph 29 and 30 of DPCO read with the Essential Commodities Act, 1955.

Consequences of non-compliance

Failure to comply with directions issued by NPPA may trigger enforcement actions under paragraphs 29 and 30 of the DPCO.

More critically, non-compliance has serious personal liability implications. Under Section 7(1)(a) of the Essential Commodities Act, any contravention of orders issued under Section 3 of the Act, including the DPCO, constitutes a criminal offence. In such cases, directors, key managerial personnel, and individuals responsible for the conduct of the business of the company may be proceeded against and can face severe penal consequences, including imprisonment and substantial fines.

It is important for company leadership to recognise that non-compliance with NPPA directions is not a routine regulatory lapse, but a matter that can expose senior management and directors to potential criminal prosecution.

How to ensure compliance of directions issued by NPPA under the Letter?

As indicated above, medical device companies that have received the Letter are required to undertake mandatory registration on the IPDMS portal and to file the applicable forms as prescribed under the DPCO within 15 (fifteen) days of the date of issue of the Letter. From compliance perspective, the companies receiving the Letter are required to undertake the following actions:

a) Registration of the company (corporate entity)

b) Registration of manufacturing plants (foreign and / or domestic)

c) Registration of products (medical devices and their model numbers)

d) Filing of applicable forms on the IPDMS portal, as directed by NPPA.

These requirements apply regardless of whether the devices are presently subject to price control (scheduled formulations) or are only covered under price monitoring (non-scheduled formulations) provisions.

Key concerns faced by medical devices companies:

Medical device manufacturers, importers, and marketers are currently grappling with several practical challenges while implementing DPCO compliance, including the following:

  • Uncertainty on the applicability of DPCO to medical devices intended for institutional sale.

  • Retrospective exposure concerns, as NPPA communications often require submission of historical pricing and sales data, potentially triggering past non-compliance scrutiny.

  • Challenges in maintaining prices due to volatile raw material and import costs.

  • Complexity in price reporting arising from differential pricing across distributors and supply chains.

  • MRP declaration on package despite the package being intended for institutional sale (not invoiced to end users)

  • Multiple model numbers for a single product, resulting in lengthy product lines and bulky data uploads on the IPDMS portal.

These operational issues underscore the need for a structured internal compliance mechanism and careful regulatory assessment.

Conclusion

Compliance with the provisions of DPCO and the directions issued by the NPPA is mandatory for all medical device importers, manufacturers, and marketers operating in India. Companies must urgently assess their DPCO applicability, ensure timely registration on the IPDMS portal, and file the prescribed forms in accordance with regulatory requirements. Failure to do so may result in regulatory scrutiny, potential financial exposure, and personal liability for directors and senior management under the provisions of DPCO and the Essential Commodities Act.

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

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Frequently Asked Questions (FAQ’s) on regulatory compliances associated with GST rate reduction for retailers of medicines in India

On September 03, 2025, The Goods & Services Tax Council announced the revision in Goods and Services Tax (GST) rates for medicines. The revised GST rates came into effect on September 22, 2025. In this article, we have answered frequently asked questions (FAQs) by retailers about the sale of medicines with revised MRP due to revision of GST.

[If you are short on time, please read response to Q. 4 and 8]

1. Will the revised GST rates apply to stock of medicines already present in the market?

Yes. The reduced GST rates will apply to the stock of medicines already present in the market on or after September 22, 2025, irrespective of the fact that it was manufactured, imported or packed prior to September 22, 2025.

The price of the medicines available in the market on or after September 22, 2025 will have to be reduced to reflect the reduction in GST rates.

2. How will a retailer find out the revised price of medicines on and after September 22, 2025?

The retailer should receive a revised price list in Form V of the DPCO from the manufacturer, importer, or marketer of the medicines, reflecting the reduced MRP due to the revision in GST rates. The Form V contains reduced GST rate applicable to medicine and revised MRP.

3. What if the retailer has not received revised price list (Form V) from the manufacturer or importer of medicines?

If a retailer of medicine has not received revised price list in Form V of DPCO from manufacturer or importer of the medicine, then retailer should sell the medicine at a reduced price, after applying revised GST rate. Please refer to response to Q. 4 for calculation of price at which the retailer should sell the medicine.

4. Can the retailers sell medicines at the same MRP without revising GST rates?

No, retailers must comply with the revised GST rates from September 22, 2025, even if the old MRP printed on the pack of medicine has not changed.

There are two likely scenarios for the retailer:

  • If the retailer of medicines has received the revised price list (Form V):

    • The retailer cannot sell the medicine at old MRP and all medicines must be sold at the revised GST and reduced MRP as is mentioned in Form V.

  • If the retailer of medicines has not received the revised price list (Form V):

The medicine still cannot be sold at old MRP that is printed on the pack of the medicine. It will have to be sold at a GST-reduced price, which may be arrived at after applying reduced GST to sum of retailer’s procurement price and retailer’s standard margin for the medicine.

5. If a retailer sells stock of medicines at a price higher then revised MRP, what are the consequences for the retailer?

Retailers selling medicines at a price higher than the reduced MRP can be proceeded against under the applicable GST laws and Essential Commodities Act, 1955 for violation of said laws.

6. Is retailer legally obligated to return stock to manufacturer or importer of medicine for re-labelling with revised MRP?

No. Re-labelling with reduced MRP is not a mandatory legal obligation on the manufacturers and importers of medicines. Therefore, the retailer is not legally obligated to return the stock of medicine for re-labelling. However, if the retailer is returning the stock, it must be done in a phased manner to avoid any shortage of medicines in the market.

7. If the stock of medicine with a retailer has not been re-labelled, is the retailer required to display the revised price list of medicines to retail consumers?

Irrespective of whether the stock of medicines has been re-labelled with revised MRP or not, a retailer should display the revised price list received from the manufacturers or importers of medicines at a conspicuous part of its premises.

8. What are key compliances in relation to revision of GST rates for medicines that a retailer of medicines should be aware of?

A retailer of medicines should undertake the following compliances in relation to the revision of GST rates for medicines on or after September 22, 2025:

  • Sell medicines at reduced price after applying revised GST rates (refer to response to Q. 4 for details);
  • Verify the revised GST rate and reduced MRP against the revised price list in Form V received from the manufacturer or importer of medicines;
  • Display the revised price lists of medicines received from the manufacturers or importers on a conspicuous part of the premises where they carry on business;
  • Issue tax invoice with revised GST rates;
  • Not alter, tamper, over-sticker or re-label the existing product packaging;
  • If reduced MRP has been declared on the package, ensure that both original MRP and reduced MRP are visible and the reduced MRP declaration does not hide or alter other declarations on the package.
  • Ensure that there is no shortage of medicines, if stock of medicines is recalled by the manufacturer or importer for re-labelling of reduced MRP.
  • Ensure that reduced MRP declaration on the label (if any) has been made in the correct format.
  • Ensure that products manufactured or imported after September 22, 2025 declares reduced MRP on the package.
  • Do not refuse to sell available medicines to retail consumers.
  • Sell loose quantity of medicines at price which is pro-rated to GST reduced price (where Form V has not been received or stock has not been relabelled with reduced MRP) or pro-rated to reduced MRP known to the retailer.
  • Update billing systems, including online billing software with revised GST rates effective September 22, 2025.

9. What are the consequences of failure to display the revised price list in Form V of DPCO by the retailers on or after September 22, 2025?

The failure to display price list for medicines in Form V of DPCO will constitute a violation of DPCO and may lead to penal action under the Essential Commodities Act, 1955 resulting in fine and imprisonment.

Disclaimer: This article contains personal views of the authors and should not be considered as legal advice.

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Frequently Asked Questions (FAQ’s) on regulatory compliances associated with GST rate reduction of medicines in India

On September 03, 2025, The Goods & Services Tax Council has announced the reduction in Goods and Services Tax (GST) rates for medicines. The reduced GST rates will come into effect on September 22, 2025. In this article, we have answered frequently asked questions (FAQs) about compliance associated with the reduction in GST rates for medicines (other than ayurveda and homeopathy medicines).

[If you are short on time, please read response to Q.3 and 4]

GST reduction and its impact on existing stock

1. Will the reduced GST rates apply to stock of medicines already present in the market, and if so, will the MRP of such medicines have to be reduced?

Yes. The reduced GST rates will apply to all the stock of medicines already present in the market on or after September 22, 2025, irrespective of the fact that it was manufactured, imported or packed prior to September 22, 2025.

The MRP of the medicines available in the market on or after September 22, 2025 will have to be reduced to reflect the reduction in GST rates, and the reduced MRP along with the revised GST rates applicable to medicines will have to be communicated by the manufacturers and importers of medicines to all wholesale and retail dealers. However, the MRP declared on the package of medicines need not be re-labelled or re-stickered. We have discussed this aspect in our response to Q. 5-9 below.

2. Is it possible to retain same MRP on medicines present in the market after reducing GST?

No. While it is generally permissible to increase MRP of medicines by up to 10% in India if they are not essential medicines (i.e. if they are not scheduled formulations under DPCO), doing so for stock of medicines which were manufactured or imported prior to September 22, 2025 may tantamount to denying trade and customers the benefit of reduction of GST, which is not permissible under India’s GST laws and is generally regarded as unlawful ‘profiteering’.
 
Compliances to be undertaken on account of reduction in GST rate

3. Which mandatory compliances should a manufacturer or importer of medicines undertake before September 22, 2025 to ensure compliance with applicable laws?

Manufacturers and importers of medicines should circulate a revised price list of medicines manufactured or imported or marketed by the company in Form V of DPCO to wholesale and retail dealers, State Drug Controllers, National Pharmaceutical Pricing Authority (NPPA) and Department of Pharmaceuticals (DoP), indicating revised GST rates and the revised MRP effective from September 22, 2025. The revised price list may be circulated through any suitable communication channel, including WhatsApp and email.

4. Which mandatory compliances should be undertaken by a manufacturer or importer of medicines on or after September 22, 2025 to ensure compliance with applicable laws?

Manufacturers and importers of medicines should undertake the following steps as soon as possible on or after September 22, 2025, in addition to declaring reduced MRP on package:

  • Submit the revised price list in Form V of DPCO on the IPDMS portal of NPPA, on or before October 6, 2025.
  • File Form II of DPCO to report a decrease in MRP on IPDMS Portal of NPPA, on or before October 6, 2025, applicable only if the medicine is part of list of scheduled formulations under DPCO.

    • Re-labelling of existing stock of medicines with revised MRP

5. Is it mandatory to declare reduced MRP on the label of medicines available with wholesale and retail dealers, which have been manufactured in India or imported into India before September 22, 2025?

No. It is not mandatory to declare reduced MRP on the label of medicines available with wholesale and retail dealers which are manufactured in India or imported into India before September 22, 2025.

However, all such medicines manufactured in India or imported into India on or after September 22, 2025 must declare reduced MRP on their label.

6. Is it mandatory to declare reduced MRP on the label of medicines stored at manufacturer’s or importer’s warehouse, which have been manufactured in India or imported into India before September 22, 2025?

No. It is not mandatory to declare reduced MRP on the label of medicines stored at manufacturer’s or importer’s warehouse, which have been manufactured in India or imported into India before September 22, 2025 provided the compliance described in response to Q. 3 have been taken.

However, if a manufacturer or importer of medicines wishes to voluntarily declare reduced MRP on the label of medicines, then the compliances described in response to Q. 7, 8 and 9 should be followed.

It is recommended that the unsold stock of medicines stored at manufacturers or importer’s warehouse should be re-labelled with reduced MRP before sale to trade, in order to reduce risk of allegation of overcharging or profiteering due to failure of retailer to sell at reduced MRP despite being notified by the manufacturer or importer about the reduction of MRP.

7. Is any permission required to re-label medicines with reduced MRP on account of reduction of GST?

Yes. While there is a prevailing understanding that all State Licensing Authorities (SLAs) in India have temporarily relaxed the requirement to obtain a manufacturing license or NOC by the manufacturers or importers for declaring reduced MRPs on medicines manufactured or imported by them before September 22, 2025, it may be pragmatic to confirm this understanding locally with the SLA of the State in which re-labelling is sought to be carried out before doing the re-labelling.

For example, in Delhi, it is mandatory for manufacturers and importers to obtain a No Objection Certificate (NOC) from the Delhi Drug Control Department prior to declaring reduced MRP on the label of medicines on account of revision of GST and no time-limit has been specified before which such re-labeling may be carried out on the label of medicines.

Please note that the re-labelling to reflect reduced MRP on account of reduction in GST is subject to conditions which are discussed in response to Q. 8 and Q.9 below.

8. If a manufacturer or importer wishes to declare revised MRP on medicines which were manufactured in India or imported into India before September 22, 2025 and whose stock is available with wholesale and retail dealers or is present in manufacturer’s or importer’s warehouse, what are the legal compliances that such manufacturer or importer should be aware of?

Assuming the manufacturer or importer has complied with the mandatory requirements outlined in response to Q. 3 and 7 above, it may lawfully declare revised MRP by re-labeling medicines which have been manufactured in India or imported into India before September 22, 2025, after fulfilling the below-mentioned conditions:

  • The original MRP must remain visible, and the revised MRP must not be overwritten on it.
  • Other declarations on the label should not be affected.
  • The stocks should be re-called in a phased manner to avoid any shortage of the medicines in the market.

9. What are the permitted ways of declaring reduced MRP on the pack of medicines on account of reduction in GST?

Assuming the manufacturer or importer has complied with the mandatory requirements outlined in response to Q. 3, 7 and 8, the manufacturers and importers of medicines may declare reduced MRP on pack of medicines by stamping or affixing stickers or by printing.
Compliances applicable to wholesale and retail dealers

10. How are wholesale and retail dealers expected to know the revised GST rate and reduced MRP applicable to medicines stocked by them, if the stock of medicines available with them does not carry on the label a declaration of reduced MRP as of September 22, 2025?

As indicated in response to Q. 3, all manufacturers and importers of medicines are required to notify wholesale and retail dealers about revised GST rates and reduced MRP latest by September 21, 2025 by circulating a revised price list in Form V which is effective from September 22, 2025.

Accordingly, on or after September 22, 2025, all wholesale and retail dealers of the medicines must refer to the revised price list received from the manufacturer or importers of medicines before selling stock of medicines in their possession.

11. What are the compliances applicable to wholesale and retail dealers who have stock of medicines manufactured in India or imported into India prior to September 22, 2025?

On or after September 22, 2025, all wholesale and retail dealers must:

  • Sell medicines at reduced MRP after applying revised GST rates;
  • Verify the revised GST rate and reduced MRP against the revised price list in Form V received from the manufacturer or importer of medicines;
  • Display the revised price lists of medicines received from the manufacturers or importers on a conspicuous part of the premises where they carry on business; and
  • Not alter, tamper, over-sticker or re-label the existing product packaging.

    Penalties for non-compliance

    • 12. What are the consequences of failure to circulate revised price list in Form V to wholesale and retail dealers before September 22, 2025?

    The failure to circulate Form V before September 22, 2025 may result in recovery of the difference between old MRP and revised MRP from the manufacturer or importer of medicines as ‘overcharging’, along with interest and penalty, even though overcharged amount has been realized by the wholesale dealer or retail dealer.

    The failure to submit Form V on the IPDMS portal on or before October 6, 2025 will constitute a violation of DPCO and may lead to penal action under the Essential Commodities Act, 1955 including fine and imprisonment.

    13. What are the consequences of non-submission of Form II of DPCO before October 6, 2025?

    Non-submission of Form II of DPCO is deemed to be a failure to reduce MRP of medicines by the manufacturer or importer despite reduction in GST rates. The manufacturer or importer may be held liable for overcharging consumers and be required to pay the overcharged amount, along with interest and a penalty. It may also result in criminal prosecution under the Essential Commodities Act, 1955, inviting fine and imprisonment if convicted. Form II is required to be submitted only in case of reduction of MRP of medicines which are classified as scheduled formulations under DPCO.

    Requirement for obtaining a manufacturing license or NOC from State Licensing Authority for re-labelling

    14. Will declaration of reduced MRP on packages of medicines be considered to be “manufacturing” and require a manufacturing license or NOC from State Licensing Authority or CDSCO?

    The re-labelling of a medicine may be legally construed as manufacture of medicine under The Drugs and Cosmetics Act, 1940 (D&C Act), and such manufacturing activity requires a license from the Licensing Authority under D&C Act. The Licensing Authority in case of manufacturing of medicines in India is the respective State Licensing Authority i.e. SLA (for example – State Drug Control Department, State Food and Drug Administration). Such a license is require from SLA irrespective of whether the drug is manufactured in India or imported into India,

    As indicated in response to Q. 7, the possibility and time-limit for carrying out the re-labelling of medicines with reduced MRP should be checked locally with the respective SLA in each state where the re-labelling is sought to be carried out prior to undertaking re-labelling.

    Disclaimer: This article contains personal views of the authors and should not be considered as legal advice.