JSA Newsletter | Healthcare | July 2026 Edition

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Recent developments in the Indian healthcare and life sciences industry reflect a continued shift towards risk-based regulation, closer scrutiny of patient-facing practices, and greater accountability across the healthcare value chain.

This edition of the JSA Healthcare Newsletter focuses on the key developments undertaken in the Indian healthcare and life sciences ecosystem during July 2026.

Guidance document for medical device software released

The Central Drugs Standard Control Organisation (“CDSCO”), vide circular dated July 21, 2026, issued a guidance document on medical device software under the Medical Devices Rules, 2017 (“MDR 2017”). The guidance provides greater clarity on the regulatory treatment of software that falls within the definition of a medical device and is intended to assist stakeholders in applications for the manufacture or import of medical device software. It addresses key aspects including the scope and definition of medical device software, risk classification, applicable standards, technical documentation and quality management system requirements. It follows the draft guidance document which was released by the CDSCO in October 2025 for stakeholder comments.

Stricter regulation of high alcohol-containing medicinal formulations

In response to concerns regarding the potential misuse of certain medicinal preparations containing very high concentrations of alcohol, the Ministry of Health and Family Welfare (“MoHFW”), vide notification dated July 8, 2026, amended the Drugs Rules, 1945 to strengthen the regulatory framework applicable to medicinal formulations containing high concentrations of ethyl alcohol.

Under the amended framework, formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer benefit from the exemption from sales licensing requirements previously available under Schedule K. The products have also been brought within Schedule H1, which requires dispensation against a prescription and compliance with the enhanced record-keeping requirements applicable to Schedule H1 drugs.

CDSCO strengthens oversight of Ethics Committees conducting clinical research

CDSCO, vide regulatory alert dated July 13, 2026, announced the cancellation of registration certificates of certain Ethics Committees following risk-based inspections that identified significant regulatory non-compliances.

This action represents a notable escalation in the enforcement of regulatory requirements applicable to Ethics Committees under the New Drugs and Clinical Trials Rules, 2019 (“NDCTR”). The regulatory framework places responsibility on Ethics Committees not merely to review study documentation, but to independently safeguard the rights, safety and well-being of clinical trial participants.

The enforcement action is significant in the context of the increasing emphasis on risk-based regulatory inspections. It indicates that registration with CDSCO should not be viewed as a one-time procedural requirement and that continuing compliance with the requirements applicable to the constitution, functioning and oversight of Ethics Committees may be subject to regulatory scrutiny.

Sponsors, clinical research organisations and investigators may accordingly need to reassess their governance arrangements with Ethics Committees, including documentation of review processes, record maintenance, committee constitution, conflict management and continuing oversight of approved studies.

CDSCO clamps down on the use of brand name extensions

The CDSCO, vide public notice dated July 6, 2026, invited comments from stakeholders on the use of brand name extensions by pharmaceutical companies.

The issue arose from representations concerning the marketing of different drug formulations containing different active pharmaceutical ingredients under the same established brand name with different extensions. The matter was subsequently considered by during 67th meeting of the Drugs Consultative Committee held on November 17, 2025.

The concern underlying the consultation is that the use of a common parent brand name across products containing different active ingredients may create confusion for prescribers, pharmacists and patients and potentially increase the risk of medication errors.

Cell and gene therapies under the CLAA framework

The Ministry of Health and Family Welfare, vide notification dated June 29, 2026, has expanded the Central Licence Approving Authority (“CLAA”) framework under the Drugs Rules, 1945 to expressly cover cell or stem cell-derived products, gene therapeutic products and xenografts.

The amendment does not create an entirely new requirement for these products. Under the NDCTR, cell or stem cell-derived products, gene therapeutic products and xenografts intended to be used as drugs are included in the definition of a “new drug”. Further, unlike other categories of new drugs that cease to be treated as new drugs after four years, these products are always deemed to be new drugs. As a result, their manufacture was already subject to central permission under the NDCTR, followed by an application for a manufacturing licence under the Drugs Rules. The amendment therefore primarily aligns the existing framework by amending the provisions governing the procedure for applying for a manufacturing licence for these products and the corresponding forms.

NCW constitutes expert groups to review the ART and IVF regulatory framework

The National Commission for Women (“NCW”), on July 21, 2026, convened the first meeting of its Expert Committee on Assisted Reproductive Technology, IVF Clinics and Protection of Women’s Reproductive Rights.

The committee has constituted three specialised groups to examine: (a) ethical issues, including informed consent, reproductive autonomy, privacy, donor management and prevention of exploitation; (b) legislative and regulatory issues, including implementation gaps and potential legal and institutional reforms; and (c) medical and preventive issues, including clinical protocols, laboratory practices, patient safety, quality standards, record maintenance and biological traceability.

The initiative is significant because ART regulation involves multiple overlapping considerations extending beyond licensing and registration, including consent, reproductive autonomy, donor management, data and privacy, clinical quality and patient safety. The constitution of dedicated groups covering these separate dimensions suggests that future regulatory developments in the ART and IVF sector may increasingly address the governance of clinical practice, rather than focusing solely on registration and administrative compliance.

This Newsletter is prepared by:

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