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Welcome to the November 2025 edition of our Life Sciences and Healthcare Newsletter, featuring key regulatory and policy developments across the sector. Highlights include revised procurement and licensing requirements, updated medical device classifications, strengthened pharmacist database accuracy, and broader international acceptance of Indian standards. These reforms are designed to reinforce domestic manufacturing, enhance public health systems, and ensure smoother compliance transitions for industry stakeholders. In addition, we examine a recent judicial decision that impacted the life sciences and healthcare sectors.
Pharmaceuticals
DoP Proposes GTE Exemption for Patented Drug Formulations
The Department of Pharmaceuticals ("DoP") has issued a public notice on November 21, 2025, inviting objections from local manufacturers against the proposed inclusion of certain patented and proprietary drug formulations in the Global Tender Enquiry ("GTE") exemption list under Rule 161(iv) of the General Financial Rules, 2017. This proposal prompted by requests from central procuring agencies including the Directorate General of Armed Forces Medical Services, Indian Council of Medical Research, as well as Central Government procuring agencies, and the pharmaceutical industry for inclusion of patented or proprietary formulations in the GTE exemption list, citing absence of domestic manufacturing. Under the Department of Expenditure's decision, these drugs are exempted from the rule that GTEs are required only for procurements above INR 200 crore, allowing them to be procured through global tenders.
DoP Invites Applications Under PLI Scheme for Meropenem and Ritonavir
The DoP has invited fresh applications for the manufacture of Meropenem and Ritonavir under the Production Linked Incentive Scheme for Promotion of Domestic Manufacturing of Critical Key Starting Materials, Drug Intermediates, and Active Pharmaceutical Ingredients in the country. The application window is open till December 26, 2025. Only new applicants (those who have not earlier applied for these products) are eligible; firms whose earlier approvals were withdrawn or cancelled are excluded from applying again for the same products. The total available production capacity for Meropenem is 16 Metric Tonne ("MT") and for Ritonavir is 20 MT and the minimum annual production capacity per applicant as per scheme guidelines is 4 MT and 5 MT respectively.
NPPA Fixes Ceiling Prices for Six Scheduled Formulations Under DPCO, 2013
The National Pharmaceutical Pricing Authority ("NPPA") under the Drugs (Prices Control) Order, 2013 ("DPCO, 2013"), has issued an order on November 6, 2025, fixing ceiling prices for six scheduled formulations, including 10 mg riboflavin tablets, denatured ethyl alcohol (70% solution), peritoneal dialysis solution, and various strengths of human normal immunoglobulin infusions. Under the order, any manufacturer selling these drugs above the notified ceiling must revise the maximum retail price downwards, while those already priced below the ceiling may continue at existing prices. This move reinforces price control of essential medicines, aiming to ensure critical, life‑saving formulations remain affordable and accessible across India.
CDSCO Directs Pharmacies to Display QR Code for Adverse Drug Reaction Reporting
Central Drugs Standard Control Organization ("CDSCO") has directed all State Licensing Authorities and Union Territory Licensing Authorities ("SLAs") to mandate retail and wholesale pharmacy stores to display designated QR code, along with the Pharmacovigilance Program of India's ("PvPI") toll-free number at every pharmacy premises across the country. This measure will facilitate seamless reporting of adverse events/ adverse reactions by the consumers and healthcare professionals through the indigenous PvPI Adverse Drug Reaction Monitoring System.
IPC Publishes Updated List of Countries Recognizing the Indian Pharmacopoeia
The Indian Pharmacopoeia Commission ("IPC") has published an update reporting that the Indian Pharmacopoeia ("IP") is now formally recognized as an official pharmacopoeia standard for medicines in a growing list of foreign countries. The list of foreign countries includes Afghanistan, Ghana, Nepal, Mauritius, Suriname, Nicaragua, Bhutan, Mozambique, Solomon Islands, Sri Lanka, Nauru, Malawi, Guyana, Fiji, Cuba, Trinidad & Tobago, Maldives, and Botswana. This recognition enables these countries to accept IP-based drug quality standards for medicines imported from or manufactured in India, reflecting IPC's ongoing diplomatic and regulatory efforts to globalize the IP as a trusted reference across international markets.
Medical Devices
CDSCO Releases Risk Classification of Medical Devices for Interventional Radiology and Radiotherapy
CDSCO has classified various medical devices pertaining to Interventional Radiology and Radiotherapy in separate notifications. The general intended use given against each of the devices is for guidance of the applicants who intend to furnish applications for manufacturing or import of medical devices under the Medical Devices Rules, 2017 ("MDR Rules"). However, a device may have a specified intended use as specified by its manufacturer. The risk classification lists are placed in Appendix A of each notification and place the notified devices under Class A, B, C, or D, as per the MDR Rules.
Link for the Interventional Radiology Classification Notification here.
Link for The Radiotherapy Classification Notification here.
CDSCO Directs Procurement Agencies to Mandate Indian Licensing for Medical Devices
CDSCO has issued a circular noting that various procurement agencies, including hospitals, are requiring US Food and Drug Administration / Conformité Européenne certification as one of the requirements for technical bids for medical device procurement. The circular clarifies that all medical devices in India are regulated under the MDR Rules and therefore must have a valid license obtained from Concerned Licensing Authorities (such as CDSCO or SLAs) for import, manufacture, sale or distribution. Procurement agencies have been directed to recognize CDSCO or SLAs licenses issued under the MDR Rules as a mandatory requirement for sourcing medical devices, while any other certifications may be considered only as supplementary.
Accreditation
NABL Amends Terms and Conditions for Obtaining and Maintaining Accreditation
The National Accreditation Board for Testing and Calibration Laboratories ("NABL") has issued an amended version of its Terms & Conditions for Obtaining and Maintaining NABL Accreditation, which serves as a binding accreditation agreement with Conformity Assessment Bodies ("CABs"). The amendment brings biobanks within the scope of the accreditation framework and introduces requirements for CABs to conform to ISO 20387, which sets out general standards for biobanking activities involving biological material from multicellular organisms (e.g. humans, animals, plants and fungi) as well as microorganisms for research and development.
NABH Releases Second Edition of Entry-Level Certification Standards For Hospitals
The National Accreditation Board for Hospitals & Healthcare Providers ("NABH") has released the Second Edition of its Entry-Level Certification Standards for Hospitals, which will come into effect on January 1, 2026. Hospitals submitting fresh or renewal applications by 31 December 2025 may still follow the First Edition, after which only the Second Edition standards will apply. The revised standards introduce strengthened requirements on patient safety, quality of care, regulatory compliance, and institutional governance. The implementation plan clearly outlines transition timelines and protocols for phasing out the earlier edition and initiating assessments under the new standards.
Government Initiatives
MOHFW Eases Corneal Transplantation Requirements
The Ministry of Health and Family Welfare ("MoHFW") has notified the Transplantation of Human Organs and Tissues (Amendment) Rules, 2025, removing the mandatory requirement of a clinical Specular microscope for Corneal Transplantation Centres under Form 15 of the Transplantation of Human Organs and Tissues Rules, 2014. The change is intended to ease infrastructure and operational burdens, particularly for smaller and rural or semi-urban eye-care facilities, thereby supporting the expansion of the corneal transplant network. This amendment forms part of broader efforts under the National Organ Transplant Programme to simplify corneal transplant norms and enhance equitable access to transplant services across India.
MOHFW Launches National Action Plan on Antimicrobial Resistance 2.0
The MoHFW has launched the National Action Plan on Antimicrobial Resistance 2.0 (2025-2029) ("NAP-AMR 2.0"), which adopts a One Health approach through coordinated actions across human health, animal husbandry, agriculture, and environmental sectors. The plan sets out national priorities and defines sector specific roles for relevant ministries and departments with goals, timelines and budgetary provisions to support implementation and monitoring. Key priorities include strengthening awareness, education, and antimicrobial stewardship to curb irrational antibiotic use, improving infection prevention and control practices in healthcare facilities, enhancing laboratory and surveillance systems, and promoting data sharing. NAP-AMR 2.0 also focuses on research and innovation, including the development of new diagnostics, vaccines, and alternative therapies to address the growing antimicrobial resistance threat.
PCI Mandates Integration with Healthcare Professional Registry and Update of Pharmacist Databases
The Pharmacy Council of India ("PCI") has directed all State Pharmacy Councils and Registration Tribunals to submit consolidated, verified data of all registered pharmacists in their databases under Section 15 (A) of the Pharmacy Act, 1948, as part of an initiative to integrate state-level records with the national Healthcare Professional Registry managed by the National Health Authority. The circular mandates that each record must include valid registration details, including the correct pharmacist's details (name, date of birth, contact number, email ID, state registration number, basic qualification, contact information, and registration certificate validity dates), with no invalid or placeholder entries.
Launch of SIDDHI 2.0 to Strengthen Research-Driven Innovation in Ayurveda Sector
The Central Council for Research in Ayurvedic Sciences ("CCRAS"), Ministry of Ayush, has launched SIDDHI 2.0- Scientific Innovation in Drug Development, Healthcare & Integration. It is a national industry-research interface platform to strengthen evidence-based Ayurvedic product development. The initiative aims to foster collaboration among industry, academia, and regulators to scale up the commercialization and wider adoption of CCRAS-validated Ayurvedic formulations; strengthen institutional linkages; promote innovation; support intellectual property rights-sharing for research outputs; and enhance regulatory frameworks to build globally competitive, evidence-based Ayurvedic pharmaceuticals.
Food Laws
FSSAI Extends Alcoholic Beverages Labelling Deadline
The Food Safety and Standards Authority of India ("FSSAI") has extended the enforcement date for labelling requirements under the Food Safety and Standards (Alcoholic Beverages) First Amendment Regulations, 2025 ("AB Regulations") from January 1, 2026, to July 1, 2026. The AB Regulations prescribed standards for mead (honey wine), craft beer, Indian liquors, wine-based beverages, and alcoholic ready-to-drink products. The extension responds to stakeholder feedback highlighting that mid-year labelling changes could create operational difficulties, as alcoholic beverages are also regulated under State Excise Laws where label registration aligns with the commencement of the excise year (1st April or 1st July). The revised timeline aims to ensure a smooth transition and avoid business disruption or wastage of pre-printed labels.
Key Judgment
Techsync Vs. The Superintendent of Customs SIIB ACC Imports & Ors; 2025 SCC OnLine Del 8725
Background and Procedural History
The petitioners, namely Techsync and M/s. Debanjan Impex, had filed separate writ petitions before the Delhi High Court concerning the seizure of their respective imports of non-therapeutic electronic wellness massagers, such as body and personal massagers. The Customs Department detained their consignments, alleging (i) absence of Drug Controller General of India ("DCGI") approval (ii) absence of Extended Producer Responsibility ("EPR") certification for battery-operated items and (iii) that the products were "obscene" sex toys prohibited under 1964 Customs Notification.
An earlier order dated October 30, 2025, had directed provisional release of the imported goods and instructed Central Board of Indirect Taxes and Customs ("Customs Department") to frame a uniform policy for imports of body massagers and similar products due to inconsistent enforcement. The Customs Department subsequently filed a review petition before the Delhi High Court.
Petitioners' Submissions
The petitioners contended that the review was unwarranted, as the arguments relied upon by the Customs Department had already been considered and rejected in the order dated October 30, 2025. The petitioners referred to Frequently Asked Questions issued by the CDSCO, which clarify that non-therapeutic, general-wellness massagers do not fall under the MDR Rules and therefore do not require DCGI approval.
With respect to EPR compliance, they relied on a Customs Public Notice dated May 25, 2023, permitting importers to apply for EPR certification even after the release of goods. One of the petitioners had already filed such an application.
They further highlighted that similar goods imported by companies such as Reckitt Benckiser Healthcare India Private Limited (Durex) and Huha Care Private Limited (That Sassy Thing) were regularly cleared without objection. The petitioners argued that the selective detention of their consignment was arbitrary, discriminatory and in violative of Article 19(1)(g) of the Constitution of India, which guarantees the freedom to carry on trade and business. They also submitted that Customs' attempt to classify general-wellness massagers as "sex toys" or "obscene goods" was entirely baseless.
Respondents' Submissions
The Customs Department defended the detention on the grounds of lack of DCGI approval, absence of an EPR Certificate, and the prohibition purportedly imposed by the 1964 Customs Notification. However, they conceded that similar products had been routinely cleared for other importers and were unable to justify the differential treatment or their classification of the petitioners' goods as prohibited items.
Court's Findings and Directions
The Division Bench of the Delhi High Court held that non-therapeutic body massagers are not covered under MDR Rules and therefore do not require DCGI approval. It reaffirmed that EPR applications may validly be filled after the release of goods.
The Court rejected Customs' efforts to classify the items as "sex toys" or "obscene goods" under the 1964 Customs Notification, particularly because similar imports were being cleared without objection. The Court found that the petitioners were subjected to unjustified and discriminatory harassment.
The Court dismissed the review petitions and directed that the goods be released within two working days, subject to filing of the EPR application. It also imposed costs of INR 25,000 per petition on the Customs Department, recoverable from the salary of the concerned Assistant Commissioner of Customs.
Legal Determinations
The Delhi High Court held that non-therapeutic personal wellness products such as electronic body massagers, do not fall within the scope of the MDR Rules and therefore do not require approval from the DCGI. The Court further affirmed that importers may apply for an EPR Certificate under the Battery Waste Management Rules, 2022, even after the goods have been released.
The Court condemned the Customs Department's selective detention of the petitioners' consignment while allowing similar products of other importers to pass without objection. It also rejected Customs' attempt to classify the products as "sex toys" prohibited under the 1964 Customs Notification, finding no factual or legal basis for such classification.
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