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, policy, and judicial developments aimed at strengthening regulatory oversight, enhancing patient safety, and promoting export competitiveness.

Key developments include the revision of the regulatory framework governing the sampling of drugs, cosmetics, and medical devices, and strengthening of the pharmacovigilance obligations under the Drugs and Cosmetics Act, 1940. Policymakers have also proposed comprehensive reforms to pharmacy education and regulation, introduced measures to strengthen pharmaceutical supply chain integrity, and operationalised schemes to support the domestic medical devices industry.

Judicial developments have further clarified the scope of compliance obligations under healthcare and pharmaceutical laws, including statutory record-keeping requirements under the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, the protection of pharmaceutical trademarks, patentability of pharmaceutical combination therapies, and issues relating to access to patented life-saving medicines.

In this edition of ‘Checking the Pulse’, we examine key policy, regulatory, and judicial developments in India's healthcare, pharmaceutical, and medical devices sectors from June 2026 to July 2026.

1. CDSCO mandates strengthening of pharmacovigilance systems under revised Schedule M for enhanced drug safety compliance

On June 3, 2026, the Central Drugs Standard Control Organisation (“CDSCO”), under the Directorate General of Health Services, has issued a circular, mandating the establishment and maintenance of robust pharmacovigilance systems by all pharmaceutical manufacturers and stakeholders under Schedule M of the Drugs and Cosmetics Act, 1940 (“D&C Act”). [1]

Pursuant to paragraph 6.11 of Schedule M of the D&C Act, licensees are required to collect, process, evaluate and forward adverse drug reaction reports to the competent licensing authorities in a timely manner. Compliance with the aforesaid provision will be verified during routine and for-cause inspections conducted by CDSCO, State Licensing Authorities (“SLA”) and Union Territory administrations, ensuring continuous regulatory oversight and enforcement of pharmacovigilance obligations. 

These measures reinforce India’s commitment to strengthening post-marketing drug safety surveillance, enhancing accountability among manufacturers, and safeguarding public health through systematic adverse event reporting and vigilance systems. 

2. CDSCO revises guideline for sampling of drugs, cosmetics and medical devices

On June 24, 2026, CDSCO issued the ‘Revised Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices by Drugs Inspectors of Central & State Drug Authorities’ (“Revised Guidelines”), updating the ‘Not of Standard Quality’ (“NSQ”) and spurious reporting formats.

The revised NSQ format now includes separate fields for product type, name, brand, dosage form, route, manufacturer, manufacturing state, dates, reporting source, batch number, NSQ result, and the modified dosage form. Annexure 6 of the Revised Guidelines requires reports from state and central laboratories to be submitted in excel format on the CDSCO portal, along with the relevant test reports. 

Additionally, the Revised Guidelines require that, where a drug is identified as spurious due to a break in the distribution chain or is reported as spurious by the manufacturer, the case must be reported in the prescribed format provided in Annexure 7, accompanied by the Drugs Inspector’s report and the manufacturer’s response identifying the distinguishing features of the genuine product.

By enhancing the granularity of information captured and streamlining reporting requirements, the Revised Guidelines are expected to strengthen regulatory oversight, improve traceability across the pharmaceutical supply chain, and enable more timely and effective enforcement action in relation to quality and safety.

1. MoHFW releases Draft National Pharmacy Commission Bill, 2026 for stakeholder consultation

On July 1, 2026, the Ministry of Health and Family Welfare (“MoHFW”) released the second draft of the National Pharmacy Commission Bill, 2026 (“Bill”) for public consultation. [2]  The Bill seeks to repeal the Pharmacy Act, 1948, and establish the National Pharmacy Commission (“NPC”) as the apex regulatory body for pharmacy education and professional regulation in India. 

One of the key reforms proposed under the Bill is the introduction of a National Exit Test (Pharmacy) (“NExT-Pharmacy”) as a common final-year examination for diploma and bachelor-level pharmacy education. The NExT-Pharmacy is proposed to serve as the qualifying examination for obtaining a licence to practise pharmacy and for enrolment in the National or State Register of Pharmacy Professionals. NExT-Pharmacy is also intended to serve as the basis for admissions to postgraduate pharmacy programmes once operationalised. Further, the Bill proposes that individuals possessing foreign pharmacy qualifications would also be required to qualify the NExT-Pharmacy before becoming eligible to practise in India. 

Additionally, the Bill proposes a significant restructuring of the regulatory framework by establishing 4 (four) specialised statutory boards for pharmacy education under the NPC: (a) Pharmacy Education Board for Modern System of Medicine; (b) Pharmacy Education Board for Indian System of Medicine and Homoeopathy; (c) Pharmacy Assessment and Rating Board; and (d) Pharmacy Ethics and Registration Board. These boards would collectively oversee pharmacy education standards, institutional assessment and ratings, registration of pharmacy professionals, and enforcement of professional ethics, replacing the existing regulatory structure with a more specialised and function-based governance model. 

The Bill represents a significant step towards overhauling India’s pharmacy regulatory framework and if enacted in its present form, the Bill is expected to have far-reaching implications for pharmacy education, professional licensing, institutional regulation and the governance of the pharmacy profession in India.

2. DCC recommends measures to strengthen pharmaceutical supply chain oversight and regulatory transparency

On June 24, 2026, the Drugs Consultative Committee (“DCC”) convened its 69^th meeting chaired by the Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi. [3]  During the meeting, DCC deliberated on several proposals aimed at strengthening India’s drug regulatory framework and made a number of recommendations for considerations by central and state regulators. Among the notable recommendations were measures to regulate manufacturers and suppliers of printed pharmaceutical packaging materials and to enhance transparency through public disclosure of regulatory enforcement actions. 

To prevent the circulation of spurious and counterfeit drugs, DCC recommended constitution of a sub-committee, which is proposed to be tasked with evaluating the necessity and feasibility of an appropriate regulatory mechanism under Drug Rules, 1945, and recommending additional measures to curb the diversion and misuse of pharmaceutical packaging materials within the drug supply chain. 

DCC also recommended measures to improve regulatory transparency by requiring SLAs to publicly disclose details of license suspensions, cancellations, stop orders and recall alerts on their official website. Additionally, DCC recommended that such information be shared with CDSCO on a monthly basis to facilitate coordinated regulatory oversight and monitoring. 

The recommendations of DCC reflect a continued regulatory focus on strengthening pharmaceutical supply chain integrity and enhancing transparency in enforcement actions. If implemented, these measures are expected to reinforce regulatory oversight while supporting efforts to combat the manufacture and circulation of spurious and counterfeit drugs. 

1. MoHFW proposes amendments to Medical Devices Rules, 2017 to expedite licensing approvals for manufacturers

On June 23, 2026, MoHFW, published the draft Medical Devices (Amendment) Rules, 2026 [4]  (“Draft Amendment Rules”), thereby proposing to amend the Medical Devices Rules, 2017 (“MDR”),in exercise of the powers conferred under Section 12(1) and Section 33(1) of the D&C Act, in consultation with the Drugs Technical Advisory Board (“DTAB”). These amendments primarily aim to speed up the timeline of licensing approvals for manufacturers of class B, C and D medical devices prescribed under Rules 20, 21, 23 and 25 of MDR. 

Under the existing regulatory framework, application for license for manufacturing class B medical devices are processed within an overall timeline of approximately 140 (one hundred and forty) days, while applications for class C and class D medical devices are processed within 105 (one hundred and five) days. The Draft Amendment Rules propose to reduce these timelines to 115 (one hundred and fifteen) days and 90 (ninety) days, respectively, by revising the timeline of individual stages involved in the approval process, thereby effectively reducing the total time of the process. These stages include scrutiny of applications, audits and inspections, verification of non-conformities with quality management systems, submission of audit reports and grant of approvals or rejection of application.

The Draft Amendment Rules reflect the government’s continued emphasis on improving regulatory efficiency within India’s medical devices sector by reducing procedural timelines for manufacturing license approvals while retaining quality assurance safeguards thereby making the industry more attractive and reliable for the market.  

2. DoP invites applications under Strengthening of Medical Devices Industry Scheme 

On June 23, 2026, the Department of Pharmaceuticals (“DoP”) invited applications from eligible entities vide a notice published on its website under the Strengthening of Medical Devices Industry Scheme (“SMDI Scheme”). [5]  The SMDI scheme seeks to strengthen domestic manufacturing capabilities and promote innovation within India’s medical devices sector through targeted financial assistance. 

The SMDI Scheme provides financial assistance under 2 (two) sub-schemes:

a. Marginal Investment Scheme for Reducing Import Dependence

This sub-scheme seeks to incentivise domestic manufacturing of medical devices, key components, raw materials, accessories, and other upstream products with the objective of reducing India’s dependence on imports. Under the sub-scheme, eligible entities may receive financial assistance of up to INR 100,000,000 (Indian Rupees One Hundred Million) on a reimbursement basis, while Central and State Government organisations may receive grants up to INR 100,000,000 (Indian Rupees One Hundred Million). 

b. Medical Device Clinical Studies Support Scheme 

The Medical Device Clinical Studies Support Scheme (“MDCSS”) aims to encourage research and innovation by supporting clinical investigations and performance evaluation of medical devices. Financial assistance available on a reimbursement basis is as follows: 

1. Up to INR 50,000,000 (Indian Rupees Fifty Million) for clinical investigations;
2. Up to INR 20,000,000 (Indian Rupees Twenty Million) for pre-clinical animal studies;
3. Up to INR 10,000,000 (Indian Rupees Ten Million) for post-market clinical follow-up studies; and 
4. Up to INR 10,000,000 (Indian Rupees Ten Million) for performance evaluation of new in-vitro diagnostic medical devices.

The opening of applications under the SMDI Scheme reflects the government’s continued policy focus on strengthening domestic manufacturing and fostering innovation in the medical devices sector. By extending financial support across both manufacturing and clinical research activities, the SMDI Scheme is expected to support capacity creation while encouraging the development and commercialisation of indigenous medical technologies. 

3. DoP invites stakeholder comments on proposed amendments to the Global Tender Enquiry Exemption List

On June 22, 2026, the DoP issued a public notice [6]  inviting comments and objections from stakeholders on proposals seeking the addition, deletion and modification of entries in the Global Tender Enquiry (“GTE”) exemption list.

The GTE exemption list identifies medical devices that are exempt from restrictions on global tender enquiries in public procurement owing to the absence of adequate domestic manufacturing capacity. The GTE exemption list seeks to ensure the continued availability of medical devices that cannot presently be sourced in sufficient quantity or quality from domestic manufacturers. 

To facilitate an evidence-based review, the DoP has requested stakeholders to provide supporting information relating to inter alia, domestic manufacturing capacity, production and supply capability, import dependence, applicable standards and certifications. 

The ongoing review of the GTE exemption list reflects the government’s continued assessment of domestic manufacturing capabilities within the medical devices sector.

1. Supreme Court rules Form F compliance mandatory under PCPNDT Act and treats record deficiencies as serious violations

On June 14, 2026, the Supreme Court in the case of Dr. Ramesh v. State of Maharashtra and Another, dismissed a petition filed by a medical practitioner challenging the initiation of criminal proceedings under the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (“PCPNDT Act”), reaffirming strict compliance with statutory record-keeping requirements. [7]

The Supreme Court held that deficiencies in Form F records as prescribed under the PCPNDT Act cannot be treated as mere clerical or technical errors but constitute substantive violations going to the root of the PCPNDT Act’s enforcement framework. 

Emphasising the object of the legislation, the Supreme Court reiterated that accurate documentation is central to preventing sex-selective practices and female foeticide, as such records form the primary evidentiary basis for monitoring ultrasound clinics and ensuring compliance. 

Relying on earlier precedents, including Federation of Obstetrics and Gynaecological Societies of India v. Union of India (2019) and Voluntary Health Association of Punjab v. Union of India (2013), the Supreme Court underscored that strict enforcement is necessary to protect the constitutional right to life and dignity of the girl child under Article 21 of the Constitution of India. 

The Supreme Court accordingly dismissed the appeal, holding that the procedural lapses in Form F documentation amount to violations warranting prosecution, given their critical role in preventing sex selection practices nationwide under PCPNDT Act.

2. Delhi High Court remands refusal of pharmaceutical combination patent application for fresh consideration

On July 23, 2026, the Delhi High Court, in the case of Array Biopharma INC v. Deputy Controller of Patents and Designs, set aside the order of Deputy Controller of Patents and Designs (“Controller”) against Array Biopharma (“Petitioner”) refusing a patent application relating to pharmaceutical combination comprising of B-Raf inhibitor, EGFR inhibitor and Pl3K - αn inhibitor, and remanded the matter to the Controller for a fresh review. [8]  The application was rejected on the grounds of lack of inventive step under Section 2(1)(ja) and non-patentability under Sections 3(d) and 3(i) of the Patents Act, 1970. 

The Delhi High Court observed that pharmaceutical combination inventions cannot be rejected solely because they comprise previously known active pharmaceuticals ingredients. Further, the Delhi High Court held that the assessment of the claim must be made in view of the fact that even though the drugs already existed, it was the specific combination made by the Petitioner that demonstrated better results towards curing cancer. It further observed that a pharmaceutical combination claimed as a product cannot be regarded as a non-patentable method of treatment merely because the patent specification contains examples describing therapeutic administration or dosing schedules. 

The judgement is likely to be of particular significance for the pharmaceutical industry, where combination therapies increasingly form part of modern treatment strategies, particularly in oncology and other complex disease areas.

3. Supreme Court rules failure to maintain statutory records for pharmaceutical testing samples forfeits tax exemption claims

On July 16, 2026, Supreme Court, in the case of Hicure Pharmaceuticals Private Limited v. Commissioner of Central Excise, Karnataka, held that a pharmaceutical manufacturer who fails to maintain prescribed statutory records for drug samples drawn for quality testing cannot avoid tax duty by contending that the goods had not yet attained marketability. [9]

The Supreme Court clarified that while samples removed for bona fide internal quality control or testing by third-party laboratories may be eligible for exemption, such exemption is subject to compliance with the prescribed record-keeping requirements. In this regard, manufacturers are required to maintain records of the quantity, value and destruction of such samples. Where the prescribed records are not maintained, the manufacturer cannot establish that the samples were removed solely for testing purposes and, accordingly, cannot claim that the samples had not attained marketability.

The judgment underscores the imperative for pharmaceutical manufacturers to enforce rigorous, audit-ready record-keeping protocols for product sampling and quality assurance procedures.

4. Supreme Court takes suo motu cognisance of Kerala High Court plea on exorbitant pricing of patented cancer medicines

On July 17, 2026, the Supreme Court, in re: Access to Life-Saving Medicines and Judicial Expediency in Article 21 Matters, took suo motu cognisance of matters concerning the access to and affordability of life-saving patented cancer drugs, and directed the expeditious disposal of the related proceedings pending before the Kerala High Court. [10]

The proceedings originated from a writ petition filed before the Kerala High Court by a breast cancer patient challenging the prohibitively high costs of patented oncology treatments. Following the death of the original petitioner during the pendency of the suit, the Kerala High Court converted the matter into a public interest case to address systemic healthcare pricing concerns.

Directing the Kerala High Court to dispose of the matter expeditiously, the Supreme Court highlighted that judicial delays in resolving disputes concerning the pricing and availability of critical patented drugs impinge directly upon the right to health and life guaranteed under Article 21 of the Constitution of India. Supreme Court’s intervention underscores the increasing regulatory and policy scrutiny of drug pricing and access to patented medicines in India, with potential implications for global pharmaceutical patent holders.