TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. India’s Directorate General of Foreign Trade (DGFT), has extended the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Returns filing deadline for FY 2023-24 from November 30, 2025 to March 31, 2026, with a ₹15,000 composition fee. Missing the extended deadline may lead to denial of RoDTEP benefits or scrip cancellations.
Source: h7.cl/1p1E2

2. The National Pharmaceuticals Pricing Authority (NPPA) has directed manufacturers and marketing companies to revise the Maximum Retail Prices (MRP) of 17 life-saving cancer drugs following their exemption from Customs Duty. Downward change in Duties/taxes should be passed on to consumers at the retail level, Form V must be submitted along with issue of to dealers and NPPA.
Source: h7.cl/1jXJ8

3. The Tea Board of India has issued updated guidelines for tea warehouse licence applications and renewals. The specifications that a warehouse must meet have been specified in the guidelines. Modifications of warehouse license is allowed only for floor area changes, and renewals can be auto-processed. Non-submission of requisite documents may lead to rejection without fee refund.
Source: h7.cl/1p1DR

4. Indian Council of Medical Research (ICMR) has reportedly directed that clinical trials in India focus on local genetics, diets, and lifestyles rather than rely on Western research. The move addresses rising lifestyle diseases and aims to produce more relevant evidence. Multicentre trials with government funding will study therapies suited for Indian patients, potentially improving effectiveness and access.
Source: h7.cl/1p1Ef

5. The Department of Pharmaceuticals has reportedly invited stakeholder comments on the amended list of 354 medical devices exempted from restrictions on global tender enquiries. The exemption, valid until March 31, 2027, allows public procurement agencies to source these devices internationally, subject to review of adequate domestic manufacturing capacity.
Source: h7.cl/1jXJk

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. India’s Supreme Court has directed the Food Safety and Standards Authority of India (FSSAI) to consider mandatory front-of-pack warning labels on packaged foods. This move aims to inform consumers about high levels of sugar, salt, and saturated fats, addressing rising health concerns like obesity and diabetes. The court emphasized prioritizing public health over industry resistance.
Source: h7.cl/1jEhc

2. The Indian government has tightened the IT intermediary law, by an amendment that defines synthetic media, and require social media platforms to remove flagged harmful content within three hours, enhancing accountability and curbing misuse of AI online. The amendment also obliges intermediaries offering AI tools to deploy technical (including automated) measures blocking unlawful deepfake and synthetic content.
Source: h7.cl/1jEgT

3. India’s Supreme Court has issued notices to the Central Government and National Medical Commission on a PIL seeking exemption of medical professionals from the Consumer Protection Act. The petition argues consumer law undermines doctor-patient trust and promotes defensive medicine. The Court’s decision remains pending.
Source: h7.cl/1jEhX

4. The Supreme Court reportedly directed the Gujarat Pollution Control Board to decide within a week on Pharma company’s plea to reopen its Dahej plant, producing hexafluoro-methoxypropane, a key sevoflurane intermediate. It was shut over alleged hazardous waste discharge into the Narmada River. The court denied interim relief, advising remedies via statutory authorities and the National Green Tribunal.
Source: h7.cl/1jEh-

5. United States Food and Drug Administration reportedly issued a warning that a major pharma company’s Television advertisement for its obesity pill is false or misleading as it suggested unproven superiority and benefits over other GLP one medicines. The regulator directed corrective action to ensure accuracy and protect patients.
Source: h7.cl/1oHAn

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. India’s central drug authority (CDSCO) reportedly flagged 35 drugs manufactured in Telangana as Not of Standard Quality (NSQ), including painkillers, antacids and antibiotics. These medicines, failed quality or labelling standards, resulting in regulatory and manufacturing oversight gaps. Affected batches are reportedly recalled, and show-cause notices are issued.
Source: h7.cl/1oCiU

2. The Indian Pharmacopoeia Commission (IPC) has entered into three strategic Memoranda of Understanding (MoUs) with the Goa State Pharmacy Council (GSPC), Quality Council of India (QCI), and HLL Infra Tech Services Limited. These collaborations aim to strengthen pharmacovigilance systems, enhance professional competencies, and promote uniform standards for medicine quality and patient safety across India.
Source: h7.cl/1oCj1

3. India and United States has agreed under an interim trade framework to address long-standing barriers for US medical devices, eliminate restrictive import licensing procedures, and review adoption of US or international standards within six months to boost market access. The move is part of broader efforts to improve MedTech trade and bilateral economic cooperation
Source: h7.cl/1jzb3

4. Delhi High Court disposed of a trademark infringement suit after parties reached an amicable settlement. The defendant acknowledged superior trademark rights of the plaintiff in trademark “Blue Heaven”, agreed to permanent injunction, withdrew trademark applications, paid damages and costs, removed online listings, and enabled refund of court fees as ordered.
Source: h7.cl/1oCj9

5. Indian Council of Medical Research is reportedly rolling out an AI-based surveillance system under the National One Health Mission to detect zoonotic diseases early. By integrating human, animal, and environmental data, it will identify unusual patterns, provide real-time decision support, and help prevent local outbreaks from escalating into pandemics.
Source: h7.cl/1jzeb

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. India has reportedly agreed to reduce tariffs on a broad range of U.S. exports, including medical devices, manufactured goods and chemicals from about 13.5% to zero. Lower tariffs on medical devices from the US would help hospitals and clinics in India to procure advanced equipment more cheaply, improving healthcare delivery and access.
Source: h7.cl/1ow26

2. US FDA has shut down over 200 illegal online pharmacy websites linked to an India-based criminal network. The sites allegedly sold unapproved and counterfeit medicines to U.S. consumers, raising serious public health concerns and highlighting the need for stronger regulation and cross-border cooperation.
Source: h7.cl/1ow29

3. The Indian government is reportedly examining a proposal to mandate pharmaceutical companies to allocate at least 1% of their net profits for free medicines during health emergencies by amending the Drugs Rules, 1945. However, the move faces legal constraints, as CSR spending is governed by the Companies Act, 2013. The central drugs regulator, CDSCO, is reassessing the proposal’s feasibility.
Source: h7.cl/1ow2c

4. The Association of Indian Medical Device Industry (AiMEd) has reportedly opposed any reconsideration or easing of policy restrictions on importing refurbished or pre-owned medical equipment. Association has urged the government to uphold the ban on imports, enforce stricter regulations by emphasizing the strengthening of indigenous innovation like Make in India.
Source: h7.cl/1ow2i

5. A leading fast moving consumer goods manufacturer has filed a suit in the Calcutta High Court, alleging deceptive imitation of its biscuit packaging and trade dress by a rival. The suit seeks injunction against sale and distribution, claiming consumer confusion and unfair competition. The court has taken the matter on record and scheduled further hearing shortly.
Source: h7.cl/1jt71

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. The Ministry of Health has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, proposing to remove the provision dealing with the provisional registration of Ethics Committees. The designated authority will now directly grant final registration in Form CT-03 after scrutiny of Form CT-01, or reject with written reasons.
Source: h7.cl/1oifC

2. Bulk Drug Manufacturers Association of India has launched a marketing portal enabling Indian pharmaceutical companies to promote and source active pharmaceutical ingredients, intermediates, pallets, and contract development and manufacturing services, supporting both domestic and international markets through an integrated vendor management system with no cost registration for buyers.
Source: h7.cl/1oifJ

3. The Department of Pharmaceuticals has extended the deadline for submitting applications under the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme to 15 February 2026. The scheme supports shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, imaging equipment, and Class B, C, and D IVDs.
Source: h7.cl/1jfLz

4. The Maharashtra government has issued a resolution by introducing a new fee structure at state-run hospitals from effective from January 16, 2026. ₹5 for OPD registration, ₹10/day for inpatient admission, and up to ₹40,000 for major surgeries like joint replacements. Diagnostic services, ICU care, and ambulance services also have updated charges. Implementation across hospitals is pending.
Source: h7.cl/1oiwW

5. The Indian Pharmacopoeia Commission is reportedly taking efforts to develop more biosimilar in alignment with governments Biopharma Shakti initiative. This move aims to align Indian quality standards with global benchmarks and strengthen the country’s biologics and biosimilars ecosystem.
Source: h7.cl/1jfLU

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. India’s Ministry of Health has issued draft amendments to the New Drugs & Clinical Trials Rules, 2019 introducing a framework for filing of post-approval changes in new drugs. Manufacturers of new drugs may have to take prior approval from the authorities for major and moderate quality changes while minor quality changes might be implemented without prior approval and changes which might have a minimal effect can be implemented with annual submission by 1st quarter of every calendar year to the authorities.
Source: h7.cl/1odSN

2. The Delhi High Court upheld the conviction of a sweet manufacturing unit for discharging untreated effluents into public sewers leading to the Yamuna River. However, citing the 2024 amendment to the Water Act, which replaces imprisonment with monetary penalties, the court set aside the jail term and imposed an ten lakh rupees penalty, underscoring strict environmental compliance.
Source: h7.cl/1jbwq

3. The National Biodiversity Authority has launched a digital portal for electronic issuance of Certificates of Origin for cultivated medicinal plants, enabling access and benefit sharing exemptions. The initiative operationalises the amended Biological Diversity framework, offering a single window online process for traditional medicine, seed and research sectors.
Source: h7.cl/1odSP

4. The Government has amended the Plant Quarantine Order to permit the import of dried Mitragyna speciosa (Kratom) leaves from Uganda for processing, subject to a phytosanitary certificate confirming the consignment is free from soil, quarantine weed seeds, and other plant debris.
Source: h7.cl/1jbwX

5. The Karnataka High Court has stayed a penalty imposed by the Central Consumer Protection Authority on an e-commerce platform for allowing the sale of walkie-talkies without mandatory licensing disclosures. The E-commerce platform had argued that its liability is limited owing to it being a mere intermediary.
Source: h7.cl/1jbx0

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.

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. The Ministry of Health and Family Welfare has constituted a committee to develop a policy governing refurbished medical devices. The committee will examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.
Source: h7.cl/1o8qd

2. Indian government has announced a tax holiday until 2047 for foreign companies that provide cloud services globally using data centres located in India. Further, there will be no risk of foreign firms’ global income being taxed in India solely because they use Indian data centres. This move is aimed at attracting long-term investment into India’s digital infrastructure.
Source: h7.cl/1o8qp

3. Indian Government has released first national evidence-based lung cancer treatment and palliation guidelines. It offers 15 recommendations to standardise diagnosis, treatment and palliative care, improve early detection, reduce treatment disparities and ensure consistent, patient-centred care across the country.
Source: h7.cl/1o8qA

4. India’s Ministry of Consumer Affairs issued show-cause notices to major edible oil companies for violating the amended Vegetable Oils Products, Production and Availability (VOPPA) Order, 2025. Companies failed to submit monthly production data and register on official portals. Authorities have warned that continued non-compliance could lead to inspections and confiscation under the Essential Commodities Act, 1955.
Source: h7.cl/1o8qN

5. The United States Food and Drug Administration has launched the PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. The initiative offers early regulatory engagement for new manufacturing facilities, improving predictability, streamlining facility assessments and accelerating readiness to supply medicines for the United States market.
Source: h7.cl/1o8qS

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. The Karnataka Health Department has proposed introducing QR codes on medicine strips and boxes to help visually impaired patients access key drug information via smartphone scanning under the IMPACT-VIP programme. Details such as dosage, composition, and expiry dates can be accessed, and the proposal may be sent to the Centre for wider implementation.
Source: h7.cl/1o2Wy

2. India’s central drugs regulatory authority (CDSCO) has released a draft guidance outlining regulatory requirements and online procedures for importing in-vitro diagnostic medical devices. The document aims to streamline approvals under Medical Devices Rules, 2017. Comments from stakeholders are invited within 15 days.
Source: h7.cl/1j0Wg

3. The Government of India has in the Union Budget 2026–27 announced measures to position India as a hub for medical tourism, biopharmaceutical manufacturing and traditional medicine. The government will establish five regional medical hubs, expand Ayurveda, Yoga, Unani, Siddha and Homeopathy infrastructure, and strengthen research, manufacturing capacity and employment across the healthcare value chain.
Source: h7.cl/1o2WE

4. The Government of India is planning to amend the Drugs and Cosmetics Act to tighten oversight of pharmaceutical opioids, proposing stricter penalties, higher fines, and enhanced monitoring of manufacturing and sales to curb misuse, diversion, and illegal distribution while strengthening regulatory enforcement.
Source: h7.cl/1j0Wr

5. Indian Pharmacopoeia Commission has issued a formal circular urging all Medical Device Marketing Authorisation Holders (MAHs) to strictly comply with adverse event reporting requirements under the Materiovigilance Programme of India (MvPI). The move is aimed at bolstering patient safety and enhancing the post-market surveillance ecosystem for medical devices across India.
Source: h7.cl/1o2WQ

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.