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Welcome to the October 2025 edition of our Life Sciences and Healthcare Newsletter, where we highlight the latest developments shaping the industry. This month, we cover significant legal and regulatory updates, including Central Drugs Standard Control Organization's ("CDSCO") amendments to the Drugs & Cosmetics Rules, 1945 ("Drugs Rules"); the launch of a digital monitoring system for high-risk solvents; stakeholder consultations on new drug approvals; guidelines on medical device software under the Medical Devices Rules, 2017 ("MD Rules"); the Department of Pharmaceuticals' ("DoP") Promotion of Research and Innovation in Pharma MedTech Sector ("PRIP") Scheme; and National Accreditation Board for Testing and Calibration Laboratories ("NABL") expanded accreditation scope to include biobanks, among other updates.
In addition, we examine a recent judicial decision that impacted the pharmaceutical and healthcare sectors. Stay informed on the evolving landscape with our comprehensive analysis and expert insights.
Pharmaceuticals
Ministry of Health and Family Welfare amends Schedule K of the Drugs Rules
The Ministry of Health and Family Welfare ("MoHFW") has proposed a draft amendment to Schedule K of the Drug Rules, introducing specific labeling requirements to categorize liquid antiseptics as "for household use" or "for hospital and other than household use". The move seeks to clearly distinguish the two categories to ensure appropriate licensing, labeling, and safe distribution based on intended use. Household-use antiseptics may be sold without a sale license under specified conditions, whereas hospital-use products require a sale license.
The MoHFW amends the Drugs Rules to include recombinant DNA and stem cell procedures
The MoHFW has released a draft amendment seeking to update the Drugs Rules, proposing to expand the categories covered under the existing provisions for recombinant DNA derived drugs. The draft adds "Cell or Stem Cell derived products, Gene therapeutic products and Xenografts" to Rules 75(3), 75A(1A), 76, and 76A, as well as related forms (27D, 27DA, 28D, 28DA). The change broadens the existing licensing and compliance framework to include cell-based therapies, gene therapies and xenografts products.
CDSCO inserts Table 2 under Schedule H2 of the Drugs Rules
The MoHFW has proposed a draft amendment to the Drugs Rules, introducing a new Table 2 to Schedule H2, covering all vaccines, antimicrobials, narcotic and psychotropic substances covered by the Narcotic Drugs and Psychotropic Substances Act, 1985, and anticancer drugs. By expanding Schedule H2, whose drugs are subject to barcode or QR code requirements under Rule 96(6) and (7), the draft extends traceability and authentication for these additional high-risk drug categories. The proposed amendment aims to improve patient safety and combat counterfeiting.
CDSCO introduces a drug monitoring system to track formulations with high-risk solvents
CDSCO has launched a Digital Monitoring System on the Online National Drug Licensing System ("ONDLS") portal to track the manufacture, quality, and distribution of high-risk pharmaceutical solvents used in pharmaceutical manufacturing, in response to diethylene glycol ("DEG") contamination concerns in cough syrups. As per the notification, pharmaceutical grade solvent manufacturers must obtain or register their manufacturing license through the ONDLS and need to upload batch-wise quantity, Certificate of Analysis, and vendor data on the portal. State and Union Territory Drug Controllers must ensure no non-compliant batch is released into the market.
The notification lists ten high-risk solvents that need monitoring: Glycerin, Propylene Glycol, Maltitol and Maltitol Solution, Sorbitol and Sorbitol Solution, Hydrogenated Starch Hydrolysate, Polyethylene Glycol (MW<1000), DEG Stearates, Polysorbate variants, and Ethyl alcohol.
CDSCO introduces new SUGAM module for Post Approval Changes
CDSCO has made provision for filing Post Approval Changes for clinical trials ("Form CT-06") for Cell and Gene Therapeutic Products ("CGTPs") through a new module on the SUGAM online portal. To streamline the regulatory process for filing Form CT-06 Applications, CDSCO had published a notice in July 2025, that provision is now functional, and the applicant's seeking permission, acknowledgment, or for notification purpose must now submit their applications through the SUGAM online portal using the prescribed checklist. CDSCO shall not accept offline submissions of CGTPs related Form CT-06 applications after October 24, 2025.
CDSCO releases comprehensive list of Bureau of Indian Standards relating to the Medical Equipment and Hospital Planning division
CDSCO has published a consolidated document compiling 1,700 Bureau of Indian Standards specifications under its Medical Equipment and Hospital Planning division, which aims to streamline regulatory compliance for device manufacturers by providing easy access to applicable technical standards. The document classifies the standards into roughly 20 product categories, including surgical instruments, implants, diagnostic imaging systems, dental products, hospital disposables, health informatics, rehabilitation and assistive devices, and hospital planning, with Indian Standard reference numbers for each.
CDSCO issues notifications citing measures to increase awareness about GST reforms
CDSCO has issued a circular directing all State/ Union Territories Drug Licensing Authorities, industry and pharmacy associations to undertake a 100-day nationwide awareness campaign on the Government of India's revised Goods & Services Tax ("GST") rates for medicines, pharmaceuticals, medical devices, and cosmetics, effective from September 22, 2025. The circular instructs stakeholders to widely disseminate information on the GST reductions through print and electronic media, social media campaigns, website banners, and the display of posters, and banners at manufacturing sites, offices, pharmacies and public locations.
Link to the Notification for Pharma, Med-tech and Cosmetics Industry Associations here
CDSCO invites stakeholder feedback on ensuring a level playing field for new drug approvals
The CDSCO issued a notice on October 8, 2025, inviting stakeholder comments to address the regulatory disparity in new drug approvals. The CDSCO has noted that when multiple applicants receive permission for clinical trials of the same new drug, typically only the first applicant completes the full clinical trial. Later applicants often receive approval based solely on chemical and pharmaceutical data and bioequivalence studies. This situation creates an unequal regulatory burden, the first applicant faces significantly higher costs for clinical trials, while the later applicants avoid this requirement. The CDSCO is sought feedback and comments from stakeholders to help formulate a balanced policy that ensures a level playing field and promotes new drug development in India.
Government Initiatives
DoP notifies Guidelines for PRIP Scheme
The DoP launched the PRIP Scheme and its Guidelines on 1 October 2025 to boost high-priority research and development ("R&D") in India's pharmaceutical and MedTech sectors. The Scheme supports both long-term institutional infrastructure and project-level research. Under Component A, Centres of Excellence will be established at National Institutes of Pharmaceutical Education and Research, through government-industry collaboration to build specialized research capabilities. Under Component B, the DoP will provide funding to companies, with or without academic partners, to develop nationally important technologies, platforms, products and processes that can be commercialized. Funding support will be scaled to size and stage of the applicant, from early-stage startups to large firms. Overall, PRIP Scheme aims to strengthen India's R&D ecosystem, promote commercialization of innovations, and enhance the country's scientific and technological capabilities.
Medical Devices
CDSCO has released a draft guidance document on conduct of Medical Device Software under the MD Rules
CDSCO has released a draft guidance document under the MD Rules for the regulation of Medical Device Software, covering both software built into medical devices and standalone health software. The draft provides a structured regulatory framework clarifying what types of software qualify as medical devices, defining key terms, introducing a risk-based classification system, and detailed documentation and compliance requirements (including applicable safety and performance principles) centered on the software's output in a clinical context.
It mandates a Quality Management System and submission of a Device Master File (or equivalent technical documentation) for software-based medical devices. It encourages use of internationally accepted standards like international standard ("ISO") 13485, ISO 14971, International Electrotechnical Commission ("IEC") 62304, clarifies which software qualifies as medical devices, and outlines licensing routes for manufacturing or import.
CDSCO introduces new class of Non-Sterile Non-Measuring Medical Devices within MD Rules
CDSCO has announced an updated classification list in Appendix A under the MD Rules, specifying a set of medical devices classified as Class A- non-sterile and non-measuring ("NS-NM"). The notification follows the framework introduced by G.S.R. 777(E) dated October 14, 2022. Under this classification, Class A devices are exempt from licensing requirements under Rule 4(3) of the MD Rules, manufacturers/ importers must register them under Chapter IIIB. The "intended use" mentioned in the list is provided is only for guidance; manufacturers may register variants with their own intended use provided the device remains NS-NM. The classification list is dynamic and may be revised by CDSCO over time.
The Department of Consumer Affairs exempts Medical Devices from the application of Legal Metrology (Packaged Commodities) Rules, 2011
The Department of Consumer Affairs has notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025 ("LMPC Rules"), which for packages containing medical devices assigns packaging and labelling regulation exclusively to MD Rules. Under the amendment, typographical and dimension-related packaging requirements (e.g. height and width of letters and numerals) under LMPC Rules will no longer apply to medical device packages; instead, MD Rules specified labelling norm will govern them. Relaxations available under Rule 33 of the LMPC Rules will no longer apply in cases where MD Rules is applicable. This harmonization resolves overlapping compliance obligations, giving medical-device manufacturers and importers a single regulatory framework for packaging and labeling of medical devices.
Diagnostics
NABL expands its Accreditation Scope to Include Biobanks
The NABL has issued an updated General Information Brochure on 22 October 2025 to expand its accreditation scope to include biobanks under ISO 20387:2018 - "Biotechnology - Biobanking - General requirements for biobanking." The scope covers biobanks handling human, animal, plant, microbial, fungi and worm-seed specimens.
The brochure delineates required documentation including application and assessment forms, checklists, accreditation criteria, and pre-assessment guidelines aligned with ISO 20387. Under the new fee structure for biobank accreditation, NABL charges INR 25,000 for three activities, and INR 11,000 for each additional activity. NABL's accreditation framework provides for scope expansion or amendments (e.g. name or premises change) through reassessment and certificate change procedure, enabling accredited organizations to update or extend their credentials as their operations evolve.
Indian Council of Medical Research releases Guidance Document on Priority Pathogen Lists for Syndromic Surveillance of Infectious Diseases
The Indian Council of Medical Research has released a guidance document on syndromic surveillance that lists priority pathogens for testing across Indian clinical laboratories. It groups pathogens under major clinical syndromes such as acute febrile illness, acute encephalitis syndrome, acute respiratory illness and acute diarrheal disease. The document applies a four-tier priority classification ranging from commonly detected pathogens requiring prompt testing before treatment to rare or high-risk pathogens. Key examples include malaria parasites, dengue virus, typhoidal Salmonella, influenza viruses and major diarrheal pathogens. The Guidelines aim to standardize diagnostic practices, strengthen clinical management, and enhance public-health surveillance tailored to the Indian context.
Key Judgment
Noteworthy judgment in the realm of reproductive rights and healthcare regulation to increase awareness and knowledge.
Vijaya Kumari S. and Another v. Union of India; 2025 SCC OnLine SC 2195
The Supreme Court ruled that age limits under the Surrogacy (Regulation) Act, 2021 ("the Surrogacy Act"), cannot apply to intending couples who had already begun the surrogacy process before the Surrogacy Act came into force. Intending couples who created and froze embryos before January 25, 2022, retain a vested right to proceed with the surrogacy procedure, even if they later exceed the statutory age limits.
Brief Background
The petitioners were married couples who, between 2019 and early 2021, underwent In Vitro Fertilization ("IVF") cycles and successfully created cryopreserved embryos after being medically advised to pursue gestational surrogacy due to intending mother's advanced age, excessive bleeding during previous pregnancies and other medical conditions. Their attempts to proceed were further delayed due to COVID-19 pandemic. When the Surrogacy Act came into force on January 25, 2022, introducing age limits, the intending couple was denied eligibility as the wife had crossed 50 years of age and the husband had crossed 55 years of age, which are the age limits prescribed by law. They challenged the refusal, arguing they had already lawfully begun the surrogacy process and could not be retrospectively barred.
Petitioners' Contentions
The petitioners submitted that they had started the surrogacy process well before the Surrogacy Act came into force, and that embryo creation and freezing constituted a substantial step in the procedure, giving them a vested right to continue the process. They submitted that no age limits existed under the earlier legal framework and the Surrogacy Act did not disclose any intention to apply age restrictions retrospectively.
They further contended that right to make reproductive choice forms part of personal liberty which is protected under Article 21 of the Indian Constitution, relying on CIT v. Vatika Township (P) Ltd., (2015) 1 SCC 1, S.L. Srinivasa Jute Twine Mills (P) Ltd. v. Union of India, (2006) 2 SCC 740, and K. Gopinathan Nair v. State of Kerala, (1997) 10 SCC 1 to assert that vested rights cannot be taken away retrospectively without clear legislative intent. Citing Suchita Srivastava and X v. State (NCT of Delhi), (2023) 9 SCC 433, they also argued that the age bar lacks a rational connection to the stated object of the Surrogacy Act which is to prevent exploitation of surrogate mothers and protect the rights of children born via surrogacy.
Respondent's Contentions
The State contended that the Surrogacy Act aims to safeguard surrogate mothers and children born through surrogacy. Age limits were introduced after expert consultations due to concerns regarding the health of surrogate children, declining gamete quality, and the need for adequate guardianship. The State argued that surrogacy is a statutory right and not a fundamental right and cannot be equated with natural conception. They also stated that cryopreservation is not recognized under the Surrogacy Act as the commencement of a surrogacy procedure and that the transitional provision protects only existing surrogate mothers already pregnant at the time of enforcement. Hence, couples with only preserved embryos cannot claim exemption from age restrictions.
Findings of the Court
The Court observed that reproductive autonomy, including the decision to have children through surrogacy, forms part of Article 21 of the Indian Constitution. As no statutory age restrictions existed prior to January 25, 2022, intending couples who had created and preserved embryos before that date had validly exercised their decisional autonomy in accordance with the then prevailing regime. The Court held such couples retain a protected right to continue with the surrogacy process.
The Court observed that the Surrogacy Act contains no express provision giving retrospective effect to the age limits, and vested rights cannot be taken away without clear legislative intent. Concerns regarding health, gamete quality or parenting capacity could not justify a contrary interpretation, particularly when no comparable age restrictions apply to natural conception or adoption.
The Court concluded that although the age limits under the Surrogacy Act are valid prospectively, they cannot be applied to couples who had already begun the surrogacy process before the Surrogacy Act came into force. Such couples are entitled to proceed with embryo transfer and obtain certification, subject to compliance with all other statutory requirements.
The Editor's Note
Some key take aways from the October 2025 updates in the life sciences and health care space in India point to a regulatory landscape that is becoming more integrated, harmonized, technology-driven, and aligned with global best practices as India positions itself for the next phase of growth in pharma, med-tech, and healthcare delivery.
Removal of Medical Devices from within the ambit of the LMPC Rules is a welcome move which will provide manufacturers and importers with a single, streamlined labelling framework, reducing operational and compliance burdens and improving clarity on applicable obligations.
Notably, judicial intervention in the surrogacy judgment reinforces the judiciary's' role in protecting a couple's reproductive autonomy amid evolving statutory regimes.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
