The regulatory landscape in August 2026 was marked by significant developments across pharmaceuticals, medical devices, clinical research, medical education, food safety and public health. Key developments included amendments to the Medical Devices Rules, 2017 focusing on Quality Management Systems and testing fees, restrictions on certain cough-and-cold formulations for young children, CDSCO's enforcement against unapproved Enclomiphene products, proposed reforms to medical practitioner registration, and developments in food safety and pharmaceutical innovation. This Newsletter highlights key regulatory and policy developments relevant to pharmaceutical, biotechnology, medical device, clinical research, and healthcare sector stakeholders operating in India.
Key Takeaways
- CDSCO amended the Medical Devices Rules, 2017 to introduce a revised testing-fee framework, strengthen QMS oversight, and expand recognition of EU notified bodies. It also mandated disclosure of outsourced sterilization facilities on product labels.
- CDSCO directed states to take enforcement action against unapproved Enclomiphene products, clarifying that Enclomiphene is a New Drug requiring prior regulatory approval under the NDCT Rules, 2019.
- The Ministry of Health and Family Welfare (MoHFW) prohibited the use of Chlorpheniramine, Maleate and Phenylephrine HCl FDCs in children below four years and mandated prominent safety warnings on product labels.
- A draft amendment to Schedule H1 proposes adding Flupentixol, Zopiclone, Gabapentin, and Carisoprodol, expanding the list of prescription medicines subject to stricter sale and record-keeping requirements.
- The MoHFW notified the Drugs (Twelfth Amendment) Rules, 2026, expanding the forms referenced under Rule 89 of the Drugs Rules, 1945.
- DHR invited proposals for Medical College-Level Viral Research and Diagnosis Laboratories, providing financial support to strengthen infectious disease surveillance capacity with the last day for submission of the proposal being September 30, 2026.
- CDSCO initiated stakeholder consultations on implementing single ethics committee review for multi-centre research studies under the ICMR Addendum, 2026.
- CDSCO clarified that global Phase III IND applications involving Indian participants for drugs not approved anywhere in the world must be filed directly with its IND Division.
- NMC proposed reforms to medical practitioner registration through a centralized UID system, enhanced portability, and revised temporary registration norms for foreign practitioners.
- FSSAI proposed thresholds for identifying foods high in added fat, added sugar and salt under the school-food framework and notified packaging requirements for pan masala. FSSAI mandated the use of the “NFG” qualifier for non-food-grade imports in the ICEGATE/SWIFT system to facilitate streamlined customs processing and regulatory compliance.
Pharmaceuticals & Drug Regulation
CDSCO Bars All FDC Formulations of Chlorpheniramine Maleate and Phenylephrine HCl in Children Below Four Years
By a notification dated 18 August 2026 issued under Section 26A of the Drugs and Cosmetics Act, 1940, and pursuant to recommendations of the Expert Committee and the Drugs Technical Advisory Board ("DTAB"), the Central Government has imposed regulatory restrictions on the manufacture, sale or distribution of all fixed-dose combination ("FDC") formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The notification mandates all manufacturers, importers and marketers of such FDCs to prominently display the warning "This fixed-dose combination shall not be used in children below four years of age" on the product label, package insert and all promotional material, with immediate effect from the date of publication of the notification.
Why this matters: The restriction prohibits use of these FDCs in children below four years and requires manufacturers, importers and marketers to promptly update labelling, package inserts and promotional materials.
CDSCO Classifies Enclomiphene as a New Drug; Mandates Suspension of Unapproved Product Manufacturing
By a regulatory directive dated August 11, 2026, issued to all State/UT Drugs Controllers, CDSCO has clarified that Enclomiphene and its combinations qualify as a "New Drug" under Rule 2(1)(w) and Rule 19 of the New Drugs and Clinical Trials Rules, 2019, and that manufacture/marketing/distribution of drug products containing Enclomiphene and its combinations without prior Central Licensing Authority approval via Form CT-21 under Rule 80 would constitute a violation of the Drugs and Cosmetics Act, 1940. All State/UT Drug Controllers are required to identify non-compliant manufacturers, suspend or cancel manufacturing licences, and submit an Action Taken Report to CDSCO.
Why this matters: The CDSCO action represents a significant enforcement measure against unapproved Enclomiphene products, reinforcing the requirement for prior regulatory approval under the NDCT Rules. Companies should reassess regulatory pathways for Enclomiphene-containing products and review existing stock and distribution channels.
Draft Amendment to Schedule H1 of the Drug Rules, 1945: Flupentixol, Zopiclone, Gabapentin, and Carisoprodol
By a draft gazette notification dated 19th August 2026 under the Drugs and Cosmetics Act, 1940 following consultation with the Drugs Technical Advisory Board, the MoHFW has proposed amendments to Schedule H1 of the Drugs Rules, 1945 adding four new substances after entry 52: Flupentixol (entry 53), Zopiclone (entry 54), Gabapentin (entry 55), and Carisoprodol (entry 56). A 30-day comment window applies; once finalized and notified, the amendment rules will have a 180-day deferred commencement period.
Why this matters: The proposed additions to Schedule H1 would subject these CNS-active products to stricter prescription, record-keeping and dispensing requirements. The move is likely to increase compliance obligations across the supply chain and may particularly affect existing distribution practices for Gabapentin-containing products.
Drugs (Twelfth Amendment) Rules, 2026 - Expanded Form References in Rule 89
By notification G.S.R. 713(E) dated 6th August 2026, in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the MoHFW has substituted "Form 25 or Form 28" in Rule 89 of the Drugs Rules, 1945 with an expanded enumeration: "Form 25, 25A, 25F, 28, 28A, 28B, 28D, 28DA, 28E, or 28F". The afore-stated amendment shall come into force from the date of publication of the said notification in the Official Gazette.
Why this matters: The amendment expressly expands the manufacturing-license forms referenced under Rule 89, clarifying its application across the additional license categories.
Medical Devices
CDSCO Notifies Medical Devices (Third Amendment) Rules, 2026 - Quality Management System Realignment
By a notification dated 14th August 2026, in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board, the MoHFW has notified the Medical Devices (Third Amendment) Rules, 2026 amending the Medical Devices Rules, 2017. The amendment (i) inserts "and Quality Management System" after "standards" in Rule 19H(2)(v) and Rule 19J(2)(v) (audit/inspection language), (ii) substitutes the marginal heading for Rule 19 with "Government Medical Device Testing laboratories", and (iii) extends Rule 63(1) Proviso (iv) by adding "or European Union countries" after "or Japan". In force from the date of publication in the Official Gazette.
Why this matters: The amendment adds Quality Management System language to specified audit and inspection provisions and extends the stated Rule 63(1) proviso (iv) reference to European Union countries.
CDSCO Notifies Medical Devices (Second Amendment) Rules, 2026 - Ninth Schedule Testing Fees and Outsourcing Disclosures
By notification dated 14th August 2026, in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board and consideration of public feedback on the prior April 2026 draft, the MoHFW has notified the Medical Devices (Second Amendment) Rules, 2026, amending the Medical Devices Rules, 2017. Key changes include inter alia defining "Certificate of Registration" under Rule 3; a mandatory requirement under Rule 44 for manufacturers who outsource sterilization processes to display the license number of the outsourced sterilization site on device labels, effective six months from notification; Insertion of the Ninth Schedule prescribing fee structures for sterility, implantation, and bacterial endotoxin tests, etc.; fee structures to automatically increase by 5% annually; and unspecified test charges to be determined by the relevant laboratory director or testing officer.
Why this matters: The new Ninth Schedule provides a prescribed testing-fee framework, while manufacturers outsourcing sterilization will need to ensure compliance with the new labelling requirement within the six-month transition period.
Clinical Trials
CDSCO Stakeholder Consultation on Single Ethics Committee Review for Multi-Centre Research
By a public notice dated 6th August 2026 the CDSCO, Directorate General of Health Services, MoHFW has announced a stakeholder consultation (scheduled for August 25, 2026, in hybrid mode at CDSCO HQ, New Delhi) on operationalizing the ICMR Addendum (2026) to the National Ethical Guidelines (2017), introducing Single Ethics Review for Multi-Centre Research in India. Sponsors and CROs have been invited to nominate participants via email. The consultation is intended to align Single Ethics Committee Review with the New Drugs and Clinical Trials Rules (NDCTR), 2019.
Why this matters: The consultation is an important step towards operationalizing single ethics review for multi-centre research and could, if implemented, reduce duplication in ethics review and facilitate more efficient study initiation.
CDSCO Clarifies Application Process for Import-and-Marketing of Unapproved Global Phase III New Drugs Involving Indian Subjects
By a CDSCO circular dated 10th August 2026, following internal technical committee deliberations, the regulator has clarified that investigational new drug (IND) applications under foreign review, i.e., new drugs not yet approved anywhere globally but with ongoing/completed Phase III Global Clinical Trials (GCT) involving Indian subjects must be submitted directly to the IND Division at CDSCO (HQ), New Delhi. Comprehensive non-clinical and clinical data evaluation will be undertaken under the New Drugs and Clinical Trials (NDCT) Rules, 2019.
Why this matters: The circular provides clarity on the appropriate CDSCO division for global Phase III IND applications involving Indian participants.
Medical Education & Professional Regulation
NMC Drafts Amendments to the Registration of Medical Practitioners and Licence to Practice Medicine Regulations, 2023By a gazette notification dated August 14, 2026, the NMC through its Ethics and Medical Registration Board (EMRB) has issued draft amendments proposing modifications to the 2023 regulations regarding: (i) updates to definitions of "Additional Qualifications", "Foreign Medical Graduate (FMG)" and "Person"; (ii) formalized architecture and operation of the National Medical Register (NMR); (iii) Unique Identification (UID) generation and assignment; (iv) centralized online procedures via the EMRB Unified Registration portal; (v) synchronization between State Medical Registers (SMRs) and the NMR; (vi) confirmation that NMR-registered practitioners may practice across India without separate State licences; (vii) jurisdictional rules under Regulation 9A for professional misconduct or medical negligence; (viii) appeal mechanisms before the EMRB against license rejections; and (ix) temporary registration rules for foreign medical trainees capped at 24 months. Public comments and objections were invited within 30 days of publication.
Why this matters: If finalized, the proposed amendments would further centralize practitioner registration through the NMR and UID framework and could facilitate greater portability of registration across States, while also clarifying temporary registration and disciplinary jurisdiction.
Government Initiatives
Second Call Under ₹5,000 Crore PRIP Scheme Announced for Pharma & MedTech Innovation
On August 28, 2026, the Department of Pharmaceuticals announced the second call for applications under the Promotion of Research and Innovation in Pharma & MedTech (PRIP) Scheme, with a financial outlay of ₹5,000 crore. The scheme provides financial assistance across two tracks. Early-stage projects by startups and MSMEs at TRLs 1-3 may receive assistance of up to ₹5 crore per project to progress to higher TRLs not exceeding TRL 5. Later-stage projects by industry, startups and MSMEs at TRLs 4-6 may receive assistance of up to ₹100 crore per project, subject to a maximum of 35% of the approved total project cost. The identified priority areas include new medicines, complex generics and biosimilars, and novel medical devices, including AI/ML-based medical devices, SaMD and SiMD, genetic diagnostic and screening devices, robotic medical devices, telemedicine-enabled devices and novel IVDs supporting precision medicine.
Why this matters: The second call provides funding opportunities for pharmaceutical and MedTech innovation across different technology-readiness levels.
DHR Invites Proposals for Medical College-Level Viral Research and Diagnosis Laboratories
On August 18, 2026, DHR invited proposals from eligible medical colleges, hospitals and research institutions for establishing Medical College & Research Institute-level VRDLs. Eligible laboratories may receive non-recurring financial assistance of up to ₹1.55 crore for civil works and laboratory equipment, while recurring expenditure is to be borne by the host institution. Applications are due by September 30, 2026.
Why this matters: The call provides eligible medical institutions an opportunity to access government support for strengthening infectious-disease diagnostic and surveillance infrastructure.
Food Laws (Select Regulatory Developments)
FSSAI Proposes Thresholds for Foods High in Added Fat, Sugar and Salt in Schools
On August 11, 2026, the Food Safety and Standards Authority of India (FSSAI) published draft regulations proposing amendments to the Food Safety and Standards (Safe food and balanced diets for children in school) Regulations, 2020. The proposal introduces thresholds for identifying food products high in added fat, added sugar or salt, based on the Dietary Guidelines for Indians, 2024 issued by ICMR. Food containing more than 4.2 g/100 g of added fat in solid form or 1.5 g/100 ml in liquid form would be considered high in fat; food containing more than 3 g/100 g of added sugar in solid form or 2 g/100 ml in liquid form would be considered high in sugar; and food containing more than 0.625 g/100 g of salt in solid form or 0.175 g/100 ml in liquid form would be considered high in salt.
Why this matters: The proposed thresholds provide greater clarity on foods considered high in added fat, sugar and salt under the school-food framework.
FSSAI Notifies Packaging Requirements for Pan Masala
On August 10, 2026, FSSAI notified the Food Safety and Standards (Packaging) Amendment Regulations, 2026, amending the Food Safety and Standards (Packaging) Regulations, 2018. The amendment introduces a new entry in Schedule IV for pan masala and permits paper, paper board, cellulose and other naturally derived materials that are free from plastic, synthetic polymers, copolymers, laminates, aluminium foil and metallised layers. Tin or glass containers are also permitted, and specified provisions of the Plastic Waste Management Rules, 2016 are made applicable.
Why this matters: The amendment establishes specific packaging requirements for pan masala manufacturers.
FSSAI Clarifies Declaration of Non-Food Grade Items in Bills of Entry
On August 10, 2026, FSSAI issued a public notice concerning the declaration of non-food grade items in Bills of Entry. The notice addresses the routing of Bills of Entry relating to non-food grade items, particularly goods having dual food/non-food use under the same HSN code, to FSSAI for clearance. Importers and customs brokers have been advised to use the qualifier “NFG” in ICEGATE to indicate non-food end use. The use of the qualifier in the SWIFT system is intended to enable appropriate PGA routing and prevent non-applicable Bills of Entry from being referred to FSSAI.
Why this matters: The clarification aims to facilitate appropriate routing of non-food-grade imports and reduce unnecessary FSSAI referrals.
Key Judicial Developments
Albert David Limited v. State of J&K (Jammu & Kashmir and Ladakh High Court, August 2026) (CRM(M) No. 618/2024)
The Jammu & Kashmir and Ladakh High Court quashed criminal proceedings against Albert David Limited after finding that the company had been deprived of its statutory right to have the sample (declared “Not of Standard Quality” by the Government Analyst) re-tested by the Central Drugs Laboratory. The Court held that since the sample expired before it could be re-tested by the Central Drugs Laboratory, the company was denied a valuable statutory safeguard and the prosecution could not continue solely on the original analyst's report.
Why this matters: The ruling reinforces pharmaceutical companies' statutory right to re-testing and underscores the obligation of regulatory authorities to ensure timely preservation and transmission of drug samples.
Dr Reddy's Laboratories Limited v. M/s Razenta Pharmaceuticals Private Limited (Delhi High Court, 17 August 2026)
On 17 August 2026, the Delhi High Court considered a petition under Section 57 of the Trade Marks Act, 1999 seeking cancellation of the registration of 'DAPLOGIN' in Class 5. The Court held that the registration fell foul of Sections 9(1)(a), 9(2)(a), and 11(1)(b) of the Trade Marks Act, 1999 and directed cancellation of the registration and rectification of the Register of Trade Marks. The Court examined the similarity between the pharmaceutical marks DAPLO and DAPLOGIN and the likelihood of confusion.
Why this matters: The decision illustrates the strict approach applied to pharmaceutical trademarks where similarity may create a risk of confusion, and highlights the relevance of absolute and relative grounds under Sections 9 and 11 of the Trade Marks Act, 1999 in cancellation proceedings.
Editor's Insight
The August 2026 developments reveal a continued focus on strengthening regulatory oversight, patient safety, compliance and innovation across India's life sciences and healthcare sector. Amendments to the Medical Devices Rules, enforcement against unapproved Enclomiphene products, restrictions on paediatric FDCs and the proposed expansion of Schedule H1 indicate increased regulatory scrutiny of product safety, market access and supply-chain compliance.
Clinical research and medical regulation also remained key areas of policy focus, with CDSCO consulting on Single Ethics Committee Review, clarifying the processing of global Phase III IND applications, and the NMC proposing a more centralized framework for medical practitioner registration through the NMR and UID system. At the same time, the PRIP Scheme reflects continued Government support for pharmaceutical and MedTech innovation, while FSSAI's developments demonstrate an emphasis on food safety and import compliance.
The judicial developments further underscore the importance of regulatory safeguards and intellectual property protection in the sector, particularly in relation to statutory re-testing rights and pharmaceutical trademark protection. Companies operating in the sector should closely monitor these developments, as they may affect regulatory strategy, compliance, and product lifecycle management in India.
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.
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