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Introduction
Welcome to the September 2025 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry. This month, we explored a range of significant legal and regulatory updates, including Department of Pharmaceuticals amendments to marketing codes, National Pharmaceutical Pricing Authority's GST-linked pricing directions, and Department of Biotechnology's launch of the SAHAJ research-equipment portal. We have also covered multiple CDSCO initiatives streamlining medical device labelling, evaluation, and import processes.
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
Department of Pharmaceuticals releases Amendment to Uniform Code for Pharmaceutical Marketing Practices
The Department of Pharmaceuticals ("DoP") issued an amendment to the Uniform Code for Pharmaceutical Marketing Practices, 2024 ("UCPMP"), on September 1, 2025. The amendment establishes standardized methodology for valuing free samples and focuses on shifting disclosure of marketing expenditure from the DoP's UCPMP portal to industry associations. Companies are now permitted to submit marketing expenditure declarations within 2 (two) months of the financial year end or make the disclosure to a single association of which they are members and have it uploaded on their website. Further amendment mandate that associations must implement secure systems to store and protect member data, retain such data for a minimum of 5 (five) years, extendable for investigations or legal proceedings, and share data with relevant authorities upon request. The requirement on pharmaceutical associations to upload complaint details and their resolutions on the DoP's UCPMP portal has been removed, with associations now solely responsible for displaying such information on their websites.
NPPA releases directions on implementation of revision in Maximum Retail Price due to reduction in GST rates
The National Pharmaceuticals Pricing Authority ("NPPA") issued a revision in directions for the implementation of the new maximum retail price ("MRP") following the reduction in the Goods and Service Tax ("GST") rates. The revisions clarify that manufacturer/ marketing companies shall issue a revised price list or supplementary price list to dealers and retailers for display to consumers as well as the State Drug Controllers and the Government reflecting the revised GST rates and revised MRP.
The Directions clarify that recalling, re-labelling, or re-stickering of stock released in the market prior to September 22, 2025, is not mandatory, provided price compliance is ensured at the retailer level through revised price lists and sensitization of consumers and the supply chain. Manufacturers may voluntarily undertake re-labelling or re-stickering in a phased manner to avoid supply shortages. The directions operate in conjunction with the Central Drugs Standard Control Organization ("CDSCO") Order dated September 11, 2025, with respect to Medical Devices.
Biotechnology
Department of Biotechnology implements DBT-SAHAJ Unified Portal for Optimal Utilization of High-End Equipment supported by the Government of India
The Department of Biotechnology ("DBT") issued an Office Memorandum dated September 23, 2025, implementing the DBT-SAHAJ Unified Portal as a centralized digital platform to facilitate seamless access to high-end equipment installed across various Government-funded research institutions and universities. The portal is designed to promote efficient resource utilization, enhance research collaboration, and avoid duplication of infrastructure by enabling researchers, scientists, and industry professionals to locate, book, and utilize advanced scientific instruments. Implementation will be carried out in a phased manner, with Phase 1 providing initial access to DBT-Biotechnology Research and Innovation Council Institutes, and Phase 2 onboarding all DBT-supported SAHAJ facilities across institutions and universities, and the portal will be made accessible to researchers nationwide.
Healthcare and Allied Sector
Office of the Controller General of Patents, Designs and Trade Marks releases Guidelines for examination of AYUSH inventions
The Office of the Controller General of Patents, Designs and Trade Marks released the Guidelines for the Examination of Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy ("AYUSH")-Related Inventions on September 23, 2025. These guidelines provide clarity on filing and examining patent applications for AYUSH-related inventions, ensuring alignment with the Patents Act, 1970, and the Biological Diversity Act, 2002. The guidelines establish six guiding principles for assessing patentability with respect to novelty, inventive step, and synergistic effect. This initiative strengthens India's intellectual property regime for AYUSH while safeguarding heritage knowledge systems.
NCAHP notifies Draft Registration of Allied and Healthcare Professionals Regulations, 2025
The National Commission for Allied and Healthcare Professions ("NCAHP") has released draft "Registration of Allied and Healthcare Professionals Regulations, 2025", for public consultation. The draft outlines procedures for registration, renewal, and removal of allied and healthcare professionals in both State and Central Registers, in accordance with the National Commission for Allied and Healthcare Professions Act, 2021. It also introduces a Unique Identification system for registered professionals and prescribes a 5 (five) year validity for registration, renewal contingent upon meeting Continuous Professional Development requirements. The draft also details registration mechanisms for foreign-qualified and sponsored foreign allied and healthcare professionals, establishing eligibility through equivalency credential evaluation, exit examinations, and provisions for temporary registration for pursuing education, clinical research, training, fellowship, expert visits, or voluntary service. Stakeholder comments are invited until October 25, 2025.
NABH invites applications for NABH MITRA Empanelment Programme
The National Accreditation Board for Hospitals & Healthcare Providers ("NABH") announced the launch of the NABH MITRA Empanelment Programme as a structured initiative to empanel individuals and organizations ("MITRA") who will support healthcare organizations in their journey towards NABH accreditation, certification, and digital health transformation. The programme establishes two categories of NABH MITRA: Organizational MITRAs- consulting organization supporting full accreditation and entry-level certification and Individual MITRAs- independent professionals primarily supporting entry-level certification. NABH is also inviting applications for Digital MITRA professionals who will help healthcare organizations implement digital health tools and comply with NABH Digital Health Standards. Applications are invited until October 24, 2025, with mandatory training programmes and empanelment fees applicable for three years.
National Medical Commission notifies Standard Treatment Workflows in collaboration with National Health Authority and World Health Organization
The Indian Council of Medical Research ("ICMR") in collaboration with the National Health Authority and the World Health Organization have developed 157 Standard Treatment Workflows ("STWs") across 28 medical specialties. The National Medical Commission issued a public notice dated September 15, 2025, requesting all medical colleges and institutions under its oversight, to actively support the dissemination and implementation of the STWs, among undergraduates, postgraduates, and physicians. Further, ICMR has initiated nation-wide training sessions for primary healthcare physicians for dissemination and implementation of these STWs.
Medical Devices
DoP releases Amendment to Uniform Code on Marketing Practices for Medical Devices
The DoP has issued a circular dated September 1, 2025, introducing the amendment to the Uniform Code for Marketing Practices in Medical Devices, 2024 ("UCMPMD"). The amendment establishes standardized methodology for valuing free evaluation samples distributed by medical device companies. Where the company is the manufacturer of such samples, valuation is based on per-unit price or the price charged to its stockists. Where the company has purchased such sample, valuation is based on the purchase price.
The amendment also designates the Chief Executive Officer as directly responsible for ensuring compliance with the UCMPMD, including the annual disclosure of all marketing expenditure either through submission to one industry association or by uploading the marketing expenditure via a dedicated UCMPMD portal incase the company is not a member of any association and the amendment also removes the requirement to upload marketing expenditure disclosure on the UCPMP portal. Furthermore, it mandates industry associations to retain data for a minimum period of 5 (five) years and ensure its secure storage.
CDSCO eases stickering requirements for Revised MRP on Medical Devices
The CDSCO has issued an Order on September 11, 2025, concerning the recent reduction in GST rates for drugs and formulations, effective from September 22, 2025. To implement the revised pricing, the Central Licensing Authority ("CLA") has no objection with importers and manufacturers of Class C and D medical devices affixing stickers showing the revised MRP. This permission allows for the stickering to be completed within 3 (three) months from the date of the Order i.e., December 11, 2025. The CDSCO also separately requested all State and Union Territories' Drugs Controller to expedite the process of issuing no objection for alteration of label (stickering) by the manufacturers under relevant Rules made under Drugs and Cosmetics Act, 1940, for implementation of revised GST.
ICMR and CDSCO release Standard Performance Evaluation Protocols
ICMR and CDSCO have jointly developed and released a compendium of 39 Standard In-Vitro Diagnostic ("IVD") Evaluation Protocols to assess the performance of IVD kits used for high-risk and critical infectious diseases. This streamlines the testing protocol by making it uniform and setting minimum standards and acceptance criteria for various critical disease markers. This compendium includes protocols for IVDs detecting Tuberculosis, Malaria, Dengue, Chikungunya, Zika Virus and Typhoid fever, among others. Developed under the ICMR-CDSCO MoU this initiative aims to streamline the testing and licensing pathway for IVD manufacturers and testing laboratories, strengthen quality assurance across in the IVD sector and promote faster access to reliable diagnostic tools.
CDSCO implements Subsequent Importer in Online System for Medical Devices
To simplify the regulatory approval procedure, CDSCO has initiated various steps to bring more transparency and accountability in the regulatory system. Several 'Tool tips' have been published on the CDSCO website to give more clarity on the technical requirements while making applications for regulatory approvals on the portal. The procedure for 'Brand Approval' has also been simplified with minimum requirements and separated from the routine endorsement application with the objective to reduce processing timelines and facilitate expedited approvals. In furtherance of the above, CDSCO has announced a new measure for 'Subsequent Importers' on the Online System for Medical Devices portal as of September 11, 2025. This feature is for applicants intending to import medical devices and IVDs that are already approved by the CLA for marketing under Medical Devices Rules, 2017. Those who intend to import such devices as subsequent importers can submit their applications on the Portal.
Key Judgment
Noteworthy judgement in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
Palsons Derma Pvt. Ltd. & Anr. Vs. Union of India & Ors., Writ Petition No. 20797 of 2015
In a recent decision, the Calcutta High Court held that Kancel-B gel falls within the ambit of the Drug (Prices Control) Order, 1995 ("DPCO"), as it contains the scheduled drug 'Betamethasone Dipropionate'. The Court held that the Petitioner was required to seek prior price fixation from the NPPA and upheld NPPA's demand for recovery of the price overcharge with interest.
Brief Background:
In 1997, the Petitioner began manufacturing Kancel-B gel, a gel formulation of Betamethasone Dipropionate. The Respondent issued a Standing Order dated February 14, 2007 ("Standing Order"), setting maximum prices for creams, ointments, and lotions of the scheduled bulk drug "Betamethasone Dipropionate" but did not mention gel formulations. The Petitioner continued selling Kancel-B gel without price restrictions. Between 2010 and 2013, the Respondent alleged illegal retailing, and in February 2015, raised a demand of ~ INR 1.15 Cr as an overcharge amount with interest. The Petitioner challenged this demand in a Writ Petition, which was disposed of by the Calcutta High Court, the court directed the Respondent to re-examine the issue and pass a reasoned order after hearing the Petitioner, keeping the previous demand in abeyance. Subsequently, the Respondent passed the Impugned Order, finding the Petitioner's representation "devoid of merit" and demanding ~ INR 1.19 Cr for price overcharge with interest. The main issue was whether gel formulations of Betamethasone Dipropionate fall under the Standing Order.
Petitioner's Contentions:
The Petitioner contended that gel formulations like Kancel-B gel differ significantly from creams and ointments in properties and applications, offering better drug dissolution, easier migration, faster drug release, and improved patient acceptability. They argued that Kancel-B gel is an entirely different medicine from its ointment or cream counterpart, with potentially higher efficacy in certain cases and different safety and potency profiles. The Petitioner also noted that the Respondent has recognized gel, cream, and ointment as distinct products in other notifications, and if gels were meant to be included in the Standing Order, it would have been explicitly stated.
Respondents Contentions:
The Respondent contended that gel formulation should be considered a special feature or a different packaging material and therefore should form part of the Standing Order. Further, the Respondent contended that the Petitioner remedy was to approach the Respondent using Form III under Clause 9(2) of the DPCO to obtain a specific price for Kancel-B gel.
Findings of the Court:
The Court acknowledged that Kancel-B gel is a formulation of Betamethasone Dipropionate, a scheduled drug under the DPCO. While the gel was not explicitly mentioned in the Standing Order and differs from ointment and cream formulations, it remains subject to price control regulations because it contains a scheduled drug. The Court further noted that under Clause 9 of DPCO, manufacturers or the appropriate authority can apply to fix a revised selling price for scheduled formulations. The Respondent had allowed the Petitioner to approach it for approval/fixation of specific prices, but the Petitioner did not follow this procedure and continued selling Kancel-B gel. Considering this, the Court held that the Respondent correctly demanded the overcharge amount and that the Impugned Order passed after hearing the Petitioner was legal.
Key Takeaway:
Even if a formulation, such as a gel, is not explicitly mentioned in the DPCO Standing Order, it remains subject to regulation if it contains a scheduled drug. Manufacturers must seek prior price approval for any such variants to avoid liability for overcharging.
The Editor's Note
The September 2025 reforms reflect India's ongoing shift toward digital governance, transparency, and executive accountability across the life sciences and healthcare sectors.
- The amendments to the UCPMP and UCMPMD extend ethical marketing and disclosure standards to both pharmaceutical and medical device companies, emphasizing data integrity and CEO-level accountability. NPPA's GST-linked pricing directions and CDSCO's procedural simplifications aim to ease compliance but still demand robust internal controls.
- It is interesting to note that CDSCO and ICMR jointly issued updated evaluation protocols for IVD kits targeting critical infectious diseases in August 2025. The collaboration expanded into a compendium of 39 standardized IVD performance evaluation protocols, covering a broader range of high-risk diseases. The two consecutive updates reflect a conscious phased strategy of the regulators toward implementing a uniform diagnostic evaluation and enhanced quality assurance.
- Collectively, these measures signal a move from enforcement to empowered self-regulation. For industry and legal professionals alike, the focus must now be on building digital readiness, strengthening compliance systems, and balancing regulatory expectations with operational feasibility.
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