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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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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Government of India has in the Union Budget 2026–27, removed basic customs duty on 17 cancer drugs to reduce treatment costs. The move aims to ease the financial burden on patients, particularly for high-cost imported therapies, and improve access to essential cancer medicines across the country.
Source: h7.cl/1nZbu
#Drugs #Cancer #CustomDuty #Slashed #Budget2026

2. The Supreme Court of India has held that administering stem cell therapy for Autism Spectrum Disorder (ASD) outside an approved clinical trial setting is unethical and amounts to medical malpractice. The Court clarified that such therapy is not recognised as a sound and established medical practice due to the lack of scientific validation of safety and efficacy. The same is permissible only for an approved and monitored clinical trial with the intent to advance science.
Source: h7.cl/1nZbb

3. Maharashtra’s State Blood Transfusion Council has reportedly warned blood banks against collecting excess blood and transferring it to other states for profit. Violations, including commercial supply to plasma fractionation companies, may invite licence cancellation, as centres are directed to collect only patient-linked requirements to protect voluntary donation ethics.
Source: h7.cl/1iYh-

4. The Enforcement Directorate reportedly conducted searches at twenty six locations across multiple states as part of a probe into illegal international narcotics trafficking and money laundering. Investigations revealed a structured interstate drug network, leading to seizure of cash, narcotic substances, contraband, and incriminating documents indicating organised distribution and laundering activities.
Source: h7.cl/1nZbD

5. The Government of India has proposed amending the Drugs Rules, 1945 to designate Navi Mumbai International Airport (NMIA) as an authorised drug import entry point, making it a 12th approved airport, improving logistics and reducing congestion at existing ports. Stakeholders have been requested to submit comments withing 30 days.
Source: h7.cl/1nZbN

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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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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Food Safety and Standards Authority of India has issued draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Central Government has issued draft amendments to the Drugs Rules, 1945, proposing mandatory blue vertical strip on the left side running throughout the body of the label on all antimicrobial drugs and their preparations. The move aims to enhance identification and promote responsible antimicrobial use, with stakeholder comments invited within thirty days.
Source: h7.cl/1iBM0

2. The Kerala High Court has ruled that the title “Doctor” is not exclusive to medical doctors and can be used by physiotherapists and occupational therapists. The Court held that neither the NMC Act nor state law grants doctors an exclusive right over the “Dr.” prefix, which traditionally denotes advanced learning.
Source: h7.cl/1nBW7

3. India’s ministry of consumer affairs has notified amendments to the Legal Metrology Rules, tightening standards for manual blood pressure devices. Effective January 7, 2026, the rules set stricter accuracy limits, ban unsafe connectors, and mandate durability, safety, and environmental stress testing. Manufacturers must update design, labelling, and documentation, and obtain fresh model approvals to continue selling these devices in the Indian market.
Source: h7.cl/1nBWi

4. India’s Bombay High Court has quashed a prosecution after finding serious delays in drug sample analysis beyond the mandatory 60-day limit prescribed under the Drugs Rules. The Court made strong observations regarding the laxity of the Drugs Department, holding that such lapses endanger public health by allowing sub-standard drugs to circulate.
Source: h7.cl/1iBMQ

5. The Tamil Nadu Chemists and Druggists Association has formally complained to the Pharmaceuticals and Medical Devices Bureau of India (PMBI) alleging that Jan Aushadi Kendras across the state are violating scheme guidelines by selling locally procured patented and generic medicines and operating multiple licences per individual. PMBI has confirmed such local sourcing is prohibited and attracts disciplinary action.
Source: h7.cl/1nBWD

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Drug Controller General of India (DCGI) has directed all State and UT Drug Controllers to regularly sample kumkum and colour powders at religious sites for testing for synthetic ingredients due to public health concerns. Kumkum is regulated as a cosmetic in Indian law and must meet BIS standards covering heavy metal limits, microbial safety, prescribed testing methods, and mandatory packaging and labelling requirements.
Source: h7.cl/1nnwz

2. India’s Ministry of Agriculture & Farmers Welfare has released the draft Pesticides Management Bill, 2025 to replace the Insecticides Act, 1968. The farmer-centric bill proposes stronger regulation of spurious pesticides, higher penalties, digital processes, mandatory lab accreditation, and promotion of biopesticides and indigenous manufacturing. Stakeholders can submit comments in the prescribed format by 4 February 2026.
Source: h7.cl/1inPA

3. The Tea Board of India has issued revised guidelines for registration of manufacturers of flavoured tea, reaffirming that every factory manufacturing flavoured tea must be registered as a bonafide manufacturer with the Tea Board. This makes the registration process for flavoured tea manufacturers clearer and more structured.
Source: h7.cl/1nnx8

4. The European Parliament has approved measures to strengthen EU supply of essential medicines by reducing dependence on non-EU countries. The proposals support domestic manufacturing through strategic projects, priority funding, EU-favoured procurement, joint purchasing, and coordinated stockpiles to prevent shortages of critical medicines such as antibiotics, insulin and vaccines.
Source: h7.cl/1nnwI

5. India’s Central Drug regulator has given approval to manufacture and sell a generic version of Ozempic (semaglutide) for diabetes, ahead of its patent expiry in March 2026. The company plans to launch 12 million injectable pens in the first year and partner locally for distribution. The company is also awaiting similar approval for the obesity drug Wegovy.
Source: h7.cl/1nnwM

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Central Government has amended the New Drugs and Clinical Trials Rules, 2019 to streamline manufacture of new and investigational drugs for testing purposes. The amendment permits limited manufacturing for analytical and non-clinical testing based on prior intimation, except for specified high-risk categories, and reduce timelines from ninety to forty-five working days.
Source: h7.cl/1iiiB

2. India’s Food Safety and Standards Authority (FSSAI) has proposed amendments to its licensing regulations to tighten compliance. Delayed filing of the annual Food Safety Compliance Return beyond 31 May will attract graded penalties, and non-filing beyond 180 days will lead to deemed licence suspension. The draft also clarifies storage practice and record-keeping requirements for manufacturers, with exemptions for non-manufacturers and retailers. Public comments are invited latest by 19th March 2026.
Source: h7.cl/1nhPE

3. India’s Central Insecticides Board and Registration Committee has decided that pesticides highly sensitive to acidic or alkaline water must carry specific label and leaflet instructions on optimal water pH. Applicants and registrants have been advised to ensure compliance while seeking registration and finalising labels.
Source: h7.cl/1iiiN

4. India’s Health Ministry has asked the National Medical Commission (NMC) to examine and take appropriate action regarding appeals filed by individuals who are not registered medical practitioners against decisions made by State Medical Councils. This could affect rights of patients and the public to seek redress against decisions affecting healthcare practice and professionals.
Source: h7.cl/1iiiS

5. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has issued a structured inspection schedule and standard operating procedures for animal facilities of Clinical Research Organisations and research and development laboratories. It mandates three inspections over a year, clarifies roles of IAEC nominees, and introduces standard feedback and confidentiality requirements.
Source: h7.cl/1nhPP

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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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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