Checking the Pulse – Recent Legal Developments in the Indian Healthcare and Pharma Sector

In recent months, India’s healthcare, pharmaceutical, and medical devices sectors have witnessed continued regulatory and policy activity aimed at strengthening healthcare delivery, enhancing patient safety, and promoting digital health innovation.

Key developments include the nationwide expansion of mental healthcare services under the National Mental Health Programme, the launch of the JANANI platform to support maternal and child healthcare, and initiatives to advance the responsible adoption of artificial intelligence in healthcare. Policymakers have also proposed amendments to the Medical Devices Rules, 2017, reforms for regulation of healthcare establishments, and measures to strengthen oversight of medical devices and cosmetic products.

Judicial developments have further clarified the scope of regulatory oversight under healthcare and pharmaceutical laws, including matters relating to pharmaceutical price controls, compliance obligations under the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994, and the limits of sectoral regulatory jurisdiction.

In this edition of ‘Checking the Pulse’, we examine key policy, regulatory, and judicial developments in the Indian healthcare, pharmaceutical, and medical devices sectors from April 2026 to May 2026.

1. Central Government announces implementation of National Mental Health Programme across 767 districts to strengthen mental health services

On April 1, 2026, the Central Government announced the implementation of the National Mental Health Programme (“NMHP”) with the objective of strengthening mental health services across the country, including support and care for postpartum mothers. The District Mental Health Programme (“DMHP”), which serves as the primary implementation mechanism under the NMHP, has been approved for rollout across 767 (seven hundred and sixty-seven) districts. [1]

Facilities available under the DMHP at the community health centre and primary health centre levels include:

a. outpatient services;

b. assessment services;

c. counselling and psychosocial interventions;

d. continuing care and support to persons with severe mental disorders;

e. provision of medicinal drugs, outreach services, and ambulance services; and 

f. 10 (ten) bed inpatient facility at the district level. 

Additionally, more than 183,000 (one hundred and eighty-three thousand) sub-health centres and primary health centres have been upgraded to Ayushman Arogya Mandirs, with mental health services incorporated under the Comprehensive Primary Health Care initiative. Further, under the tertiary care component of the NMHP, 25 (twenty-five) centres of excellence have been sanctioned with the objective of increasing the intake capacity for postgraduate students in mental health specialisations.

The expansion of mental healthcare services across the primary, secondary and tertiary healthcare systems underscores the Central Government’s continued focus on improving access to mental healthcare and strengthening the overall mental healthcare framework in India.

2. DGHS reiterates mandate for generic medicine prescriptions at all Central Government hospitals and CGHS facilities

On April 7, 2026, the Directorate General of Health Services (“DGHS”) issued an office order (“DGHS Order”), reiterating that prescription of generic medicines must be strictly followed in all Central Government hospitals, Central Government Health Scheme (“CGHS”), wellness centres, and polyclinics. [2]

In furtherance of an earlier circular dated May 12, 2023 [3] , the DGHS Order directs all heads of Central Government hospitals, CGHS, wellness centres, and polyclinics to:

a. monitor prescriptions periodically to promote and adhere to 100% (one hundred percent) generic medicine prescription compliance; and 

b. share a brief quarterly compliance update with the DGHS. Heads of departments have been designated as the primary points of contact for monitoring and facilitating smooth implementation.

The DGHS Order signals the intent to strengthen enforcement of the requirement to prescribe generic medicines and is likely to have implications for pharmaceutical companies, hospital procurement practices, and patients availing healthcare services through Central Government health facilities.

3. Union Health Ministry launches JANANI platform at National Summit on Innovation and Inclusivity to strengthen maternal and child healthcare 

On May 7, 2026, the Ministry of Health and Family Welfare (“MoHFW”) launched the Journey of Antenatal, Natal and Neonatal Integrated Care (“JANANI”) platform at the National Summit on Innovation and Inclusivity. [4]

JANANI is a service-oriented digital platform designed to comprehensively monitor and maintain digital health records of women during their reproductive years. Developed as an upgraded version of the existing Reproductive and Child Health ("RCH") portal, the platform seeks to create a longitudinal health record by capturing key service-delivery events across the continuum of care, including antenatal care, birth preparedness, childbirth, postnatal care, newborn care, home-based newborn and young childcare, and family planning services.

The key features of the JANANI platform include:

a. quick response (“QR”) code-enabled digital mother and child health (“MCH”) cards, facilitating portability and seamless access to health records;

b. automated alerts for high-risk pregnancies, real-time dashboards for supervisory review, and due-list generation for timely targeted interventions;

c. interoperability with national platforms such as the universal immunisation programme WIN (Winning against Immunisation Needs) (“U-WIN”) and Prime Minister's Overarching Scheme for Holistic Nutrition (“POSHAN”), enabling seamless data exchange and integrated monitoring;

d. registration using unique identifiers such as Ayushman Bharat Health Account ("ABHA"), Aadhaar (through one-time password and biometric authentication), and mobile number, coupled with pan-India search functionality to ensure continuity of care for migratory populations; and

e. self-registration facilities through web and mobile platforms, empowering beneficiaries to actively engage with their healthcare journey.

As of the date of launch, JANANI had recorded 13,400,000 (thirteen million four hundred thousand) beneficiary registrations, over 3,000,000 (three million) registrations of pregnant women, more than 3,000,000 (three million) MCH cards generated, and over 100,000 (one hundred thousand) biometric verifications.

 The launch of JANANI marks a structured digital reform in maternal and child health administration by integrating digital authentication, real-time monitoring, and inter-sectoral convergence; thereby contributing to improved service coverage, accountability, and long-term reductions in maternal and child mortality indicators.

4. CDSCO issues public notice prohibiting use of cosmetics as injectable preparations

On May 18, 2026, the Central Drugs Standard Control Organisation ("CDSCO") issued a public notice under the Drugs and Cosmetics Act, 1940 (“D&C Act”), explicitly prohibiting the use of cosmetics as injectable preparations by consumers, healthcare professionals, aesthetic practitioners, and clinics. [5]

The notice reiterates that cosmetics, as defined under the D&C Act, are products intended for external application to the human body, primarily for the purpose of cleansing, beautifying or altering the appearance, and are neither formulated, tested, nor approved for injectable use. The CDSCO has further clarified that the administration of cosmetic products through intravenous, intramuscular, subcutaneous, or intradermal routes constitutes a violation of the D&C Act.

Since such practices carry serious risks to patient safety, including systemic toxicity, anaphylaxis, and infection, due to the absence of sterility standards and pharmacological safety testing for injectable use in these products, the notice is specifically directed at aesthetic clinics and beauty practitioners who have reportedly been using certain cosmetic preparations (such as skin-brightening solutions, glutathione, and vitamins) as injectables. 

This development is significant for aesthetic medicine practitioners, dermatology clinics, and cosmetic product manufacturers, as it reinforces the strict regulatory distinction between drug-classified injectables and cosmetic products intended solely for external application. It also signals heightened regulatory scrutiny of the rapidly expanding aesthetic medicine sector.

1. MoHFW proposes key amendments to the Medical Devices Rules, 2017

On April 10, 2026, the MoHFW published draft amendments (“Draft MD Amendment Rules”) to the Medical Devices Rules, 2017 (“MDR”). The Draft MD Amendment Rules have been proposed by the Central Government under Section 12(1) and Section 33(1) of the D&C Act, following consultation with the Drugs Technical Advisory Board (“DTAB”). [6]

The Draft MD Amendment Rules proposed several key amendments including:

a. Clarification of the concept of Certificate of Registration: A new definitional clause (ya) is proposed to be inserted after clause (y) of Rule 3 of MDR, to formally define ‘Certificate of Registration’ as a registration certificate granted by the State Licensing Authority or the Central Licensing Authority in Form MD-2, Form MD-40, or Form MD-42. 

b. Introduction of sterilization site labelling requirements: A new clause (p) is proposed to be inserted after clause (o) of Rule 44 of MDR, mandating manufacturers who outsource sterilization of their devices to third-party facilities to display the sterilization site’s license number on the device label. The license number must be preceded by one of the following designations: ‘Sterilization sites Manufacturing License Number,’ or its abbreviated forms ‘Ster.Mfg.Lic.No.’ or ‘S.M.L’. Presently, no such mandatory requirement to disclose the identity of the outsourced sterilisation facility exists under the MDR.

c. Introduction of standardised testing and evaluation fees: A new Schedule titled ‘Fee for test or evaluation’ is proposed to be inserted to the MDR, establishing for the first time, a standardised fee structure for medical device testing at government laboratories between INR 150 (Indian Rupees One Hundred Fifty) and INR 5,000 (Indian Rupees Five Thousand). To account for the rising costs, the framework also proposes a 5% (five per cent) annual increase in fees. This is a departure from the earlier approach, under which testing charges were determined by individual testing laboratories based on their internal fee structure on a case-by-case basis.

Overall, the Draft MD Amendment Rules seek to strengthen the medical device regulatory framework by enhancing traceability, improving regulatory clarity, and introducing a structured fee mechanism for testing and evaluation. The Draft MD Amendment Rules may require manufacturers and other stakeholders to align their compliance and labelling practices with the revised requirements once notified.

2. IndiaAI Mission and ICMR sign MoU to advance artificial intelligence in healthcare 

On May 7, 2026, India’s National Artificial Intelligence (“IndiaAI”) mission, an initiative of the Ministry of Electronics and Information Technology (“MeitY”), through the Digital India Corporation entered into a memorandum of understanding (“MoU”) with the Indian Council of Medical Research (“ICMR”) to advance healthcare outcomes through the responsible and scalable application of artificial intelligence (“AI”). [7]

The collaboration seeks to catalyse innovation at the intersection of technology and public health while ensuring compliance with ethical standards, data privacy requirements, and applicable regulatory frameworks. The collaboration will combine IndiaAI's computing infrastructure, datasets, and AI capacity-building initiatives with ICMR's biomedical research expertise and its ‘Medical Information Data for AI Solutions’ (“MIDAS”) framework to accelerate the development and deployment of AI-driven healthcare solutions.

Specifically, the MoU provides for the following, among other things: 

a. ICMR will contribute anonymised and ethics-approved health research datasets, AI models, and toolkits developed under the MIDAS framework to the AIKosh platform, thereby enabling wider access to high-quality biomedical datasets for researchers, startups, and innovators across India; 

b. IndiaAI will provide ICMR with access to graphics processing unit based, high-performance computing infrastructure at subsidised rates, subject to agreed service-level agreements, with the objective of addressing infrastructure gap in scaling advanced AI research in healthcare; and

c. as per the MoU, the parties will support co-development of AI-powered solutions addressing priority public health challenges in India, by leveraging ICMR's disease burden data and IndiaAI's technology stack.

The MoU is expected to contribute to establishing a nationally coherent and interoperable AI ecosystem for healthcare in India.

3. Maharashtra proposes clinical establishments law to replace Bombay Nursing Homes Act, 1949 

Maharashtra Government is proposing to enact the Maharashtra Clinical Establishment (Registration and Regulation) Act, 2025 (“Maharashtra CE Act”), which would make registration mandatory for all clinical establishments in the state and prescribe penalties of up to INR 5,00,000 (Indian Rupees Five Hundred Thousand) and a 6 (six) month term of imprisonment for non-compliance. [8]

 The proposed legislation aims to replace the Bombay Nursing Homes Registration Act, 1949, which currently applies only to nursing homes and residential healthcare facilities and has been widely regarded as outdated and inadequate. 

By bringing hospitals, clinics, diagnostic centres, and a wide range of healthcare facilities under a unified regulatory framework, the Maharashtra CE Act intends to establish a comprehensive system for registration, regulation, inspection, and standardisation of healthcare institutions across the state. 

Key features of the proposed Maharashtra CE Act include: 

a. a mandatory requirement that all registered clinical establishments provide immediate stabilisation treatment in emergency medical situations. For this, the term ‘emergency medical condition’ is proposed to be broadly defined to include circumstances in which the lack of prompt treatment could seriously endanger a person's health, bodily functions, or organs;

b. the formation of a State Council for Clinical Establishments (“Proposed Council”), headed by the Health Minister, to set standards, supervise implementation, and maintain the state register of healthcare facilities. The Proposed Council would include representation from medical, dental, nursing, and pharmacy councils, Indian systems of medicine, paramedical professionals, the Indian Medical Association, and consumer groups;

c. requirements for proper disclosure of treatment charges and maintenance of standards of rates and treatment protocols; and 

d. coverage of all recognised systems of medicine, including Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy (collectively, “AYUSH”). 

The Maharashtra CE Act is currently proposed to be submitted for cabinet approval and tabling in the state legislature. If enacted, this would have significant implications for all healthcare facility operators, healthcare professionals, and patients across Maharashtra.

1. India-New Zealand FTA to boost pharmaceutical and medical device exports

On April 27, 2026, India and New Zealand signed the India-New Zealand Trade Agreement (“IN-NZ FTA”). The IN-NZ FTA grants 100% (one hundred percent) duty-free access to all Indian export products from the date IN-NZ FTA comes into effect. India, in turn, has offered tariff liberalisation on 70.03% (seventy point zero three percent) of tariff lines, covering approximately 95% (ninety-five percent) of bilateral trade value. IN-NZ FTA is presently subject to ratification by the New Zealand Parliament. [9]

The IN-NZ FTA includes several provisions of significance for India’s pharmaceutical and medical devices sector:

a. Regulatory recognition: New Zealand will accept Good Manufacturing Practice (“GMP”) and Good Clinical Practice (“GCP”) inspection reports issued by comparable international regulators, such as US Food Drug Administration, European Medicine Agency, UK Medicines and Healthcare Products Regulatory Agency, and Health Canada. This is expected to eliminate duplicative inspections, reduce compliance costs, and accelerate product approvals for Indian pharmaceutical and device exporters entering the New Zealand market. 

b. Dedicated chapter on AYUSH and traditional medicine: The IN-NZ FTA includes a dedicated chapter addressing health and traditional medicine, thereby marking the first formal recognition of India’s AYUSH in any bilateral trade agreement for both countries.

c. Geographic Indications:New Zealand has committed to amending its domestic geographic indications (“GI”) legislation within 18 (eighteen) months of the commencement of IN-NZ FTA, to permit registration of Indian GIs for goods other than wines and spirits. This commitment is expected to place India on a footing comparable to that enjoyed by the European Union under New Zealand’s GI Framework.

The IN-NZ FTA is expected to strengthen export opportunities for India’s pharmaceutical and medical devices sectors through duty-free market access, streamlined regulatory approvals, and enhanced protection for Indian geographical indications. It also marks the first formal recognition of AYUSH and traditional medicine in a bilateral trade agreement.

2. Government of India plans to introduce a National Implant Registry to monitor high-risk medical devices and track patient outcomes

The Government of India is reportedly planning to introduce a National Implant Registry (“NIR”) to strengthen oversight of high-risk medical devices and track long-term patient outcomes. [10]

The proposed NIR is envisaged as a centralised database that will longitudinally track patients implanted with high-risk devices such as cardiac stents, orthopaedic implants, cochlear devices, and spinal fixation systems, from the point of implantation to post-operative outcomes. The initiative is intended to address a significant and longstanding gap in India's post-market surveillance infrastructure for medical devices. 

Presently, India does not have a comprehensive tracking system for implantable devices. Consequently, in the event of a global product recall or safety alert concerning an implant, there is no centralised reliable mechanism to identify and notify affected patients. The NIR is intended to address these challenges by enabling identification of patients implanted with recalled or flagged devices, facilitate timely post-market safety monitoring and generate Indian-specific clinical evidence on device performance.

The NIR is also expected to support procurement policy under Government healthcare schemes such as Pradhan Mantri Jan Arogya Yojana, where implant costs have been a persistent area of regulatory attention. 

If implemented, the NIR could have significant implications for medical device manufacturers (both domestic and international), hospitals performing implant surgeries, and insurers operating in the health insurance space, as it may introduce mandatory device-tracking, patient-reporting, and data-submission obligations across the healthcare ecosystem.

1. Delhi HC rules FSS Act does not extend to animal feed

On April 7, 2026, the Delhi High Court (“Delhi HC”) struck down regulatory amendments and directives issued by the Food Safety and Standards Authority of India (“FSSAI”) that sought the certification of commercial animal feed, holding that the FSSAI’s jurisdiction is limited to food for humans and accordingly, does not prescribe standards for food meant for animal consumption. [11]

The challenge was directed against Note (c) appended to Regulation 2.5.2 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. The impugned provision prohibited the use of meat and bone meal in feed for animals raised for milk and meat (except poultry, pigs and fish), and mandated compliance with Bureau of Indian Standards (“BIS”) certification requirements for commercial and animal feed. 

Allowing the writ petition, the Delhi HC held that the Food Safety and Standards Act, 2006 (“FSS Act”) is concerned exclusively with ‘food’ intended for human consumption. The Delhi HC observed that the definition of ‘food’ under Section 3(1)(j) of the FSS Act expressly excludes animal feed, and therefore, the functions and duties vested in the FSSAI under Section 16 of the FSS Act cannot extend to regulation of animal or cattle feed. The Delhi HC held that, in the absence of any express inclusion of animal feed within the statutory definition of food, the FSSAI lacked jurisdiction to regulate the same.

The Delhi HC further held that the FSSAI could not mandate BIS certification for animal feed, since standards under the Bureau of Indian Standards Act, 2016, are voluntary unless specifically made mandatory by the Central Government through a statutory notification. The Delhi HC clarified that such power could not be independently exercised by the FSSAI.

Accordingly, the Delhi HC quashed the impugned regulation and directions, holding them to be beyond the statutory jurisdiction of FSSAI. The ruling is significant for animal nutrition, agri-pharma, and livestock sectors, as it clarifies the limits of the FSSAI’s regulatory jurisdiction over animal feed and related products.

2. Bombay High Court holds that NPPA cannot impose price ceilings on pharmaceutical formulations not expressly listed in the First Schedule of DPCO 2013

On April 10, 2026, the Bombay High Court (“Bombay HC”) set aside overcharging demands and price ceiling actions initiated by the National Pharmaceutical Pricing Authority (“NPPA”) against certain pharmaceutical formulations not specifically listed in the First Schedule to the Drugs (Prices Control) Order, 2013 (“DPCO 2013”), holding that the NPPA cannot impose ceiling prices on formulations that are not expressly included in the Schedule. [12]

The dispute arose in relation to ‘Glyciphage SR 500 mg’, a sustained-release (“SR”) formulation of Metformin manufactured by Franco Indian Pharmaceuticals Private Limited. While conventional Metformin 500 (five hundred) mg tablets were specifically included in the First Schedule to DPCO 2013 with a notified ceiling price, the SR formulation was not separately listed. Despite this, the NPPA imposed a price ceiling on the SR formulation and issued overcharging notices and recovery demands against the manufacturer.

Allowing the writ petitions, the Bombay HC held that a plain reading of DPCO 2013 and the First Schedule appended thereto demonstrates that unless a specific formulation, together with its drug delivery system, is expressly included in the Schedule, the NPPA cannot impose a ceiling price upon it. 

The Bombay HC further held that sustained-release, controlled-release, or other modified drug delivery system variants cannot automatically be treated as equivalent to conventional formulations merely because they contain the same active pharmaceutical ingredient. In the absence of specific inclusion within the First Schedule, the NPPA lacked authority to issue overcharging notices or recovery demands in respect of such formulations.

Accordingly, the Bombay HC quashed the impugned overcharging notices and recovery demands issued by the NPPA. The ruling clarifies the limits of the NPPA’s pricing powers under DPCO 2013 and is likely to impact manufacturers of modified-release and other specialised formulations.

3. Punjab and Haryana HC rules that Form F lapses are not mere procedural defects

On April 10, 2026, the Punjab and Haryana High Court (“Punjab and Haryana HC”) upheld the conviction of a Barnala-based clinic owner for violating mandatory record-keeping requirements under the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994 (“PCPNDT Act”), categorically holding that deficiencies in maintaining Form F records under the PCPNDT Act cannot be treated as mere procedural irregularities. The Punjab and Haryana HC held that such documentation lies at the heart of the legislative mechanism designed to prevent female foeticide and sex-selective practices. [13]

The proceedings were initiated following an inspection of the petitioner’s clinic during which authorities recovered several Form F records that were incomplete and lacked the mandatory signatures of the concerned doctor. Criminal proceedings were initiated under Section 29 of the PCPNDT Act, punishable under Section 23 thereof, resulting in concurrent conviction by the trial court and appellate court. 

The Punjab and Haryana HC dismissed the revision petition and upheld both the conviction and the sentence of 1 (one) year rigorous imprisonment (as already reduced by the appellate court) along with the applicable fine. The Punjab and Haryana HC held that:

a. Form F is not an empty procedural formality but a substantive statutory safeguard, and any deficiency in its maintenance strikes directly at the object of the PCPNDT Act;

b. the prosecution had successfully established that multiple Form F records recovered from the petitioner’s clinic lacked mandatory signatures of the concerned doctor, thereby constituting a clear violation of statutory requirements under the PCPNDT Act and the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996;

c. even assuming procedural irregularities existed in the search and seizure process, such irregularities would not by themselves render otherwise admissible and relevant evidence inadmissible; and

d. leniency based on old age was not warranted given the nature and seriousness of violations under the PCPNDT Act, which have far-reaching societal implications concerning the prevention of gender discrimination and female foeticide.

This judgment reinforces the judiciary’s consistent and strict approach to compliance under the PCPNDT Act and serves as a significant reminder to all practitioners operating diagnostic and clinical facilities involving prenatal diagnostic procedures that documentary obligations under the PCPNDT Act are non-negotiable and attract penal consequences.