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The Life Sciences and Healthcare industry in India continues to evolve through regulatory and policy developments. In June 2026, key developments included pharmacovigilance mandates, prohibition of irrational drug combinations, expanded QR code authentication requirements, cosmetics compliance directions, ART and surrogacy clinic renewal frameworks, safe injection practice mandates, drug price control reforms, and new ambulance service guidelines.
This newsletter aims to highlight key regulatory and policy developments relevant to pharmaceutical, biotechnology, medical devices, and healthcare sector stakeholders operating in India.
Key Takeaways
- CDSCO has directed drug manufacturers and marketers to implement pharmacovigilance systems under Schedule M for ADR reporting.
- MoHFW has prohibited manufacture, sale and distribution of 16 irrational fixed dose combination drugs under Section 26A of the D&C Act.
- The Drugs (Seventh Amendment) Rules, 2026 extends Schedule h3 barcode/QR authentication requirements to entire therapeutic categories (vaccines, antimicrobials, NDPS, and anticancer drugs).
- MoHFW has notified the commencement date for Jan Vishwas Act, 2026 amendments to the D&C Act, which decriminalize minor violations by replacing imprisonment with departmental adjudication.
- CDSCO has directed hair colour cosmetic manufacturers/importers to comply with BIS standards IS 4707 and IS 8481 and labelling requirements under the Cosmetics Rules, 2020.
- The ART Amendment Rules, 2026 establish a fee utilization framework and a five-year renewal regime for ART clinics/banks.
- The Surrogacy Amendment Rules mandates a fee-based renewal process for surrogacy clinic registrations and grants renewed certificates a validity of three years.
- NMC has directed medical colleges to enforce safe injection practices and sharps disposal to prevent blood-borne infections like HIV, HBV and HCV.
- The DPCO Amendment, 2026 expands the Government's price-fixing powers, eases prior approval requirements for new drug launches, limits overcharging exposure with proof of price dissemination, and extends record retention to seven years.
- NABL has extended the accreditation cycle to four years with a new Surveillance-1, Midcycle, and Surveillance-2 assessment schedule.
- NABH has launched the MITRA Empanelment Programme to empanel individuals/organisations supporting hospitals, especially in Tier 2-4 cities, in achieving NABH accreditation and digital health compliance, with final empanelment valid for three years.
- MoHFW has launched National Ambulance Services Guidelines, 2026, creating India's first standardized framework for ambulance operations for equitable emergency coverage.
- FSSAI has withdrawn the method used for determining fruit content in fruit juices, directing labs to use validated internationally recognised methods until a revised official method is notified.
- FSSAI has directed all FBOs to immediately stop using metallic pins, staples and wires in food packaging across all categories.
Pharmaceuticals
CDSCO Directs Implementation of PV Systems under Schedule M
The Central Drugs Standard Control Organization (CDSCO) has (vide circular dated June 3, 2026) directed all drug manufacturers and marketers to implement effective pharmacovigilance (PV) system in accordance with Para 6.11 of Schedule M of the Drugs & Cosmetics Act, 1940 (D&C Act) and the rules made thereunder. The PV system is required to facilitate the collection, processing and reporting of adverse drug reactions (ADRs) to the relevant licensing authorities. CDSCO has further clarified that compliance with these requirements may be assessed by CDSCO, State Licensing Authorities (SLA) and Union Territory authorities during inspections and other regulatory activities.
Why this matters: This direction strengthens post-market surveillance obligations and underscores the increasing regulatory focus on drug safety monitoring, adverse event reporting and compliance with revised Schedule M requirements.
Mandatory Online Submission of PAC Applications for Human Vaccines and Anti-sera through SUGAM Portal
The CDSCO has (vide circular dated June 24, 2026) mandated for all Post Approval Changes (PAC) applications for Registration Certificates and Import License of Human Vaccines and Anti-sera to be submitted through the SUGAM online portal (under the ‘other section checklist module of Post approval changes’ section) and that from July 1, 2026, such applications submitted in hard copy via CRU or via e-mail will not be accepted for processing. This is in alignment to CDSCO’s Guidance for Industry on PAC in Biological Products released on May 16, 2024.
Why this matters: This circular eliminates offline submission of PAC applications for vaccines and anti-sera, making SUGAM portal submission mandatory for regulatory processing to continue.
CDSCO Clarifies Licensing Jurisdiction for Formulation Intermediates (Granules/Pellets)
CDSCO has (vide circular dated June 24, 2026) clarified the regulatory pathway for formulation intermediates such as directly compressible granules, taste-masked granules, and modified-release granules/pellets. It has clarified that since all modified-release dosage forms of a drug including SR/ER/PR/DR formulations will deemed to be a ‘new drug’” under Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules), such modified-release dosage forms (including the formulation intermediates intended to be used in such dosage forms) will require CDSCO approval. It has further clarified that the application (for permission to manufacture for sale or distribution) to be submitted by the manufacturers of such formulations should include application for manufacture of the formulation intermediates as well. It has also clarified that for other formulation intermediates that are not new drugs, manufacturers may approach the State Licensing Authority (SLA) for a manufacturing license, unless the formulation or intermediate contains a new or novel excipient, in which case CDSCO approval is required.
Why this matters: The circular clarifies that manufacturers may approach the SLA for a manufacturing license for formulation intermediaries that are not new drugs and that CDSCO approval is required where the formulation or intermediate to be used in the formulation contains a new or novel excipient.
Drugs Rules Amendment to Correct Unit for Folic Acid
Pursuant to the Drugs (Fourth Amendment) Rules, 2026 (published on June 1, 2026), the unit for Folic acid in Paragraph 2 of Schedule V of the Drugs Rules, 1945 (Drug Rules) has been corrected to "mcg" (micrograms) (which is currently mentioned as “mg” (milligram)). It comes into force six months after publication in the Official Gazette.
Why this matters: This amendment corrects a potentially significant unit error for folic acid by replacing “mg” with “mcg”, thereby aligning the rule with standard scientific usage and reducing the risk of dosage misinterpretation, labelling inconsistencies, and compliance issues for manufacturers.
Syrups Removed from Household Remedies Exemption List Under Drugs Rules
Pursuant to the Drugs (Fifth Amendment) Rules, 2026 (published on June 9, 2026), ‘Syrups’ have been removed from S.No. 13 in Schedule K of the Drug Rules. This amendment follows a draft notification published for public comments in December 2025.
Why this matters: Earlier syrups (by virtue of being listed in Schedule K of the Drug Rules) were permitted to be sold under the category of household remedies which enjoy a limited exemption in certain underserved rural areas. The amendment tightens the regulatory position and brings ’syrups’ back within the ordinary licensing regime.
MoHFW Prohibits Sale of 16 Irrational Fixed Dose Combination Drugs
The Ministry of Health and Family Welfare (MoHFW) has (vide notifications each dated June 11, 2026 and issued under Section 26A of the D&C Act) prohibited, with immediate effect, the manufacture, sale and distribution for human use of 16 fixed dose combinations (FDCs) found to be irrational / lacking therapeutic justification. These include combinations such as Acetyl Salicylic Acid + Ethoheptazine, Amoxicillin + Serratiopeptidase, Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes, Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase, Dicyclomine + Paracetamol + Clidinium Bromide (with and without Chlordiazepoxide), Gliclazide + Chromium Picolinate, Paracetamol + Lignocaine, Cefadroxyl + Probenecid, Cefuroxime + Serratiopeptidase, and multiple Aloe Vera / Aloe Extract -based topical combinations.
In each case, the matter was examined by an Expert Committee in 2021, then by the Drugs Technical Advisory Board (DTAB) and its Sub-Committee, whose report dated December 28, 2024, concluded that there was no scientific justification for the FDCs. Consequently, the Central Government held that prohibition was necessary in the public interest, as safer alternatives exist.
Why this matters: These notifications reflect the Central Government’s evidence-based crackdown on irrational FDCs, prioritizing patient safety by removing formulations with no proven therapeutic benefit.
Drugs Rules Amendment Expands Schedule h3 Authentication Mandates to Broad Therapeutic Categories
Pursuant to the Drugs (Seventh Amendment) Rules, 2026 (published on June 22, 2026), the ambit of Schedule h3 of the Drugs Rules has been expanded. That is, the existing 300-item brand-name list has been re-organized as "Table 1" and a new "Table 2" has been added, extending the barcode/Quick Response (QR)-code authentication requirement, under Rule 96(6)-(7) of the Drug Rules, to entire therapeutic categories (all vaccines, all antimicrobials, all narcotic drugs & psychotropic substances (NDPS) and all anticancer drugs, rather than just named brands. This expanded scope will be effective from July 1, 2027, except the antimicrobials entry, which will be effective from July 1, 2028.
Why this matters: It significantly widens India’s mandatory anti-counterfeiting track-and-trace net from named brands to entire high-risk drug categories, strengthening patient safety and supply-chain traceability nationwide.
Amendment Notification (Link Here)
Draft Drugs Rules Amendment for Residual Shelf-Life Norms for Imported Drugs
The MoHFW has published draft amendment to the Drugs Rules, which proposes replacing the second proviso to Rule 31 of the Drug Rules with a stipulation that the licensing authority shall not permit the import of any drug with a residual shelf-life of less than one year as on the date of import. An exception is carved out for Biological drugs and Radiopharmaceuticals, where up to 60% of the labelled shelf-life may be allowed. The draft amendment is open for public objections/suggestions for 30 days before final consideration.
Why this matters: If notified in its present form, the amendment would safeguard patients from near-expiry imported drugs by mandating a minimum one-year shelf-life, while allowing a practical exception for biologics and radiopharmaceuticals due to their shorter stability.
Commencement Date Notified for D&C Act Amendments Under Jan Vishwas Act
The MoHFW has notified the provisions of the Jan Vishwas (Amendment of Provisions) Act, 2026 (Jan Vishwas 2026 Act) relating to Serial No. 8 of Schedule to the Jan Vishwas 2026 Act (the entry which specifically amends the D&C Act) to come into effect from June 30, 2027. While the notification primarily establishes the commencement timeline, the substantive legal changes are detailed within the Schedule to the Jan Vishwas Act, 2026. These reforms focus on decriminalizing technical or minor violations by replacing imprisonment-based penalties with a departmental adjudication framework or omitting them entirely.
Why this matters: By notifying June 30, 2027, as the commencement date, the MoHFW has set the timeline for operationalizing Jan Vishwas Act reforms that decriminalize technical offences under the D&C Act in favor of administrative penalties.
Draft Amendment to Drugs Rules Proposes Prior Intimation Route for Drug Import for Testing
The MoHFW published a draft amendment to the Drugs Rules proposing a new proviso to be added to Rule 34 of the Drug Rules: for import of drugs meant for analytical and non-clinical testing (excluding sex hormones, cytotoxic drugs, beta lactams, live-microorganism biologics, and narcotics and psychotropic drugs), applicants can now submit an online "prior intimation" Form 12 to the Central Licensing Authority instead of obtaining a full import license, and import based on the acknowledgement of that intimation. Rules 33, 35, and Form 12 (in Schedule A) are consequentially amended throughout to recognize this "acknowledgement of prior intimation" as an alternative to a license, including for appeals against cancellation. The draft amendment is open for public objections/suggestions for 30 days.
Why this matters: If notified in its present form, the amendment would create a lighter-touch, faster notification-based route for importing test/research-quantity drugs in place of the standard licensing process, for a defined set of lower-risk drug categories.
Drugs Rules Amendment Brings Cell, Gene & Xenograft Products Under r-DNA Framework
Pursuant to the Drugs (Eighth Amendment) Rules, 2026 (published on June 29, 2026), the Drugs the regulatory scope of provisions covering ‘Recombinant DNA (r-DNA) derived drugs’ has been expanded. Specifically, Rules 75, 75A, 76, and 76A of the Drug Rules, along with Forms 27D, 27DA, 28D, and 28DA in Schedule A of the Drug Rules have been amended to also explicitly include "Cell or Stem Cell derived products, Gene therapeutic products or Xenografts," thereby bringing these newer categories of biologics under the same licensing and approval framework that previously applied only to r-DNA derived drugs.
Why this matters: The amendment modernizes India's regulatory framework by bringing advanced therapy medicinal products, such as gene therapies and stem cell products under the same rigorous licensing and manufacturing oversight previously reserved for r-DNA derived drugs.
IPC Issues Errata 01 and Amendment List 01 to IP 2026
The Indian Pharmacopoeia Commission (IPC) issued two notices relating to the 10th Edition of the Indian Pharmacopoeia 2026 (IP 2026), which becomes effective from July 1, 2026. Errata 01 to IP 2026 sets out minor corrections to general chapters and monographs for effective implementation. Amendment List 01 to IP 2026 sets out revisions/amendments to certain monographs, generally effective from July 1, 2026, except for the amendments concerning Dapagliflozin and Metformin Hydrochloride Prolonged-release Tablets and Vildagliptin and Metformin Prolonged-release Tablets, which are effective from December 1, 2026.
Errata 01 to IP 2026 (Link Here)
Amendment List 01 to IP 2026 (Link Here)
Medical Devices
Draft MD Rules Amendment Proposes Streamlined Licensing Timelines and Enhanced QMS Compliance Verification
The MoHFW has published a draft amendment to the Medical Devices Rules, 2017 (MD Rules). The amendment proposes tighter timelines for processing medical device license applications. For Class B devices, the SLA must complete scrutiny and assign the application to a notified body within 30 days of online submission and where rectifiable deficiencies are pointed out within that period, the timeline will run from the date such deficiencies are removed. The notified body audit must be carried out within 30 days of such assignment, and the notified body must submit its final report with recommendations within 15 days of completion of the audit.
The draft also shortens several timelines. In Rule 21(4), the time period for scrutinizing applications for Class C or Class D medical devices is reduced from 45 days to 30 days. In Rule 23(1), the timeframe for inspecting the manufacturing site before granting a license to manufacture for sale for Class C or D medical devices has been decreased from 60 days to 55 days. Additionally, the timeline for CLA to either grant or reject a license or loan license under Rule 25(1) has been reduced from 45 days to 20 days.
It further introduces an express requirement that the manufacturing site conform to the Fifth Schedule Quality Management System (QMS) requirements and applicable standards before grant of license, with such conformity to be verified by audit. Where QMS non-conformances are identified, compliance verification is proposed within 20 days in the case of notified body audits and within 15 days in the case of inspection-team inspections. The draft amendment is open for public comments for 30 days.
Why this matters: The amendment proposes changes that aim to streamline and expedite the medical device licensing process while strengthening quality compliance follow-up.
Amendments Proposed to GTE Exemption List for Medical Devices
The Department of Pharmaceuticals (DoP) issued a public notice inviting stakeholder comments on proposed amendments to the Global Tender Enquiry (GTE) Exemption List of Medical Devices. The notice follows a prior Public Notice dated February 11, 2026, pursuant to which representations were received from various stakeholders seeking additions, deletions, and/or modifications to the existing GTE Exemption List.
Annexure-I covers existing devices proposed for deletion/modification, while Annexure-II lists new devices proposed for inclusion. All concerned stakeholders, including domestic manufacturers, importers, industry associations, procurement agencies, and healthcare institutions are invited to submit their comments/objections with supporting justification, covering domestic manufacturing capacity, import dependence, applicable standards, procurement impact, and patient access considerations, among others, in the prescribed format by July 15, 2026.
Why this matters: The DoP’s public notice allowsc domestic manufacturers, importers, and healthcare stakeholders to comment on which medical devices should be exempted from mandatory local sourcing preference under government procurement, directly affecting market access, competition, and pricing for those devices.
DoP Invites Proposals Under Medical Device Industry Scheme
The DoP issued a notice inviting proposals under the Scheme for Strengthening of Medical Device Industry, covering two sub-schemes: the Marginal Investment Scheme for Reducing Import Dependence and the Medical Device Clinical Studies Support Scheme. The broad intent of these two sub-schemes is to strengthen the Indian medical devices sector by, on the one hand, incentivizing incremental domestic investment to reduce import dependence, and on the other, supporting clinical studies necessary for regulatory approval and market adoption of medical devices. Applications must be submitted via the online portal July 23, 2026.
Clinical Trials
Revised PSUR Timelines in the Draft Amendment to NDCT Rules
The MoHFW has published draft amendment to the NDCT Rules, proposing insertion of a proviso in Paragraph 1(5)(C)(iii) of the Fifth Schedule to the NDCT Rules, to prescribe revised timelines for submission of Periodic Safety Update Reports (PSURs) for new drugs. For new drugs falling under Rule 2(1)(w)(iv), PSURs are required to be submitted every six months for the first two years after drug approval, annually for the subsequent two years, and thereafter once every three years until the drug is marketed. For new drugs falling under Rule 2(1)(w)(v), PSURs are required to be submitted every six months for the first two years after approval and annually thereafter until the drug product is marketed. Objections and suggestions on the draft amendment will be considered if received within 30 days of publication.
Why this matters: The draft amendment introduces a clear, graduated PSUR reporting schedule, easing the long-term compliance burden on drug applicants while still ensuring close safety monitoring in the critical early years after a drug's approval.
Cosmetics
CDSCO Issues Compliance Reminder for Hair Colour Cosmetic Products
The CDSCO has (vide circular dated June 10, 2026) mandated importers/manufacturers of hair color cosmetics to comply with Bureau of Indian Standards (BIS) standards IS 4707 (Parts 1 & 2) and IS 8481, along with labelling requirements under Rules 34 and 37 of the Cosmetics Rules, 2020 (Cosmetics Rules). IS 4707 Part 1 lists ‘Generally Recognized as Safe’ list of colourants, while Part 2 lists ‘Generally Not Recognized as Safe’ and Restricted Ingredients. The requirements relating to permissible hair dye ingredients, restrictions on use of hair dye substances, declaration of ingredients, directions for use, warnings statements, patch test instructions and other labelling requirements are prescribed under the Cosmetics Rules and applicable BIS standards and must be complied with by the manufacturers/ importers. Changes to the label, product composition and product quality specifications shall be reported to CDSCO/ SLA as per Rules 15(2) and 26(k) of the Cosmetics Rules, 2020.
Why this matters: The circular serves as a reminder for cosmetic manufacturers and importers to review product formulations, labelling and regulatory filings to ensure continued compliance and mitigate potential enforcement risks.
Reproductive Rights
CDSCO Mandates Restricted Supply of IVF Media and Reagents to Registered ART Centres Only
The CDSCO has (vide circular dated June 23, 2026) clarified that In-Vitro Fertilization (IVF) media and reagents used in Assisted Reproductive Technology (ART) procedures are regulated as medical devices requiring a license under the MD Rules. These products are being used by ART clinics and banks registered under the Assisted Reproductive Technology (Regulations) Act, 2021 (ART Act) and the Surrogacy (Regulation) Act, 2021 (Surrogacy Act) for the regulations of safe and ethical practice of ART services and for the regulation of practice and process of surrogacy. The CDSCO noted that such products are being supplied to facilities not registered under the ART Act and Surrogacy Act, posing risk to patient health and welfare, and directed all stakeholders to supply these products only to registered centres.
Why this matters: The circular aims to prevent unregistered clinics from accessing IVF media and reagents, thereby curbing unethical or unsafe fertility practices and protecting patient health under India's ART and Surrogacy regulatory framework.
ART Amendment Rules Prescribes Registration Fee Utilisation and Renewal Framework
Pursuant to the Assisted Reproductive Technology (Regulation) Amendment Rules, 2026 (ART Amendment Rules), Rule 7A has been introduced and added to the Assisted Reproductive Technology (Regulation) Rules, 2022 (ART Rules) which requires registration fees for ART clinics and banks to be deposited into a bank account opened in the name of the appropriate authority concerned and permits their use for implementation of the ART Act and the ART Rules.
Further, Rule 8A has also been introduced and added to the ART Rules which establishes the renewal regime for registration certificates. ART clinics and banks must apply through the National Registry portal in Form 1 and Form 2 respectively, at least 60 days before expiry, with prescribed renewal fees; delayed applications attract the initial registration fee; Government-run institutes are exempt from renewal fees.
It also requires submission of a signed PDF printout of the filled-in application form to the appropriate authority, mandates disposal of the renewal application within 60 days, requires an opportunity of hearing before rejection, allows fee-free re-submission of a rejected renewal application once brought into compliance, requires intimation to the State Board, and provides that renewed registration remains valid for five years from expiry of the earlier certificate.
Why this matters: The amendment introduces a formal renewal mechanism for ART clinic/bank registrations, previously absent in the ART Rules and mandates stricter financial accountability for registration fees collected by authorities.
Surrogacy Amendment Rules Introduces Renewal Framework for Clinic Registration
Pursuant to the Surrogacy (Regulation) Amendment Rules, 2026 (Surrogacy Amendment Rules),Rules 10A and 11A have been introduced and added into the Surrogacy (Regulation) Rules, 2022 (Surrogacy Rules). Rule 10A provides that registration fees for surrogacy clinics must be deposited in a bank account opened in the name of the official designation of the appropriate authority concerned and utilized for activities connected with implementation of the Surrogacy Act and Surrogacy Rules.
Rule 11A prescribes the manner of renewal of a surrogacy clinic’s certificate of registration under section 12(3) of the Surrogacy Act, the clinic must apply in Form 3 through the National Registry portal at least 60 days before expiry, with a non-refundable fee; if the application is not made within that 60-day period, the initial registration fee becomes payable, though government-run institutes are exempt from renewal fees.
After online filing, a duly signed PDF printout must also be submitted to the relevant appropriate authority, which must decide the application within 60 days by either renewing the certificate in Form 4 after inspection and satisfaction of compliance, or rejecting it by a reasoned order after giving the applicant an opportunity of hearing. The renewed certificate remains valid for a further three years, must be displayed at the clinic, and the result of renewal or rejection must be intimated to the State Board.
Why this matters: The amendment is important because it closes a gap in the Surrogacy Rules by establishing a clear and structured process for renewing a surrogacy clinic's registration, ensuring continuity of regulatory oversight and preventing clinics from operating in a legal vacuum once their initial certificate expires.
Animal Health
CDSCO Calls for Stricter Enforcement of Ban on Chloramphenicol and Nitrofurans in Food-Producing Animals
CDSCO has issued a follow-up letter to all State and Union Territory Drug Controllers in continuation of its earlier communication dated April 2, 2025, seeking stronger enforcement action in relation to Chloramphenicol and Nitrofuran drugs and their formulations in food-producing animal rearing systems. CDSCO’s letter refers to Notification S.O. 1158 dated March 12, 2025, under which Chloramphenicol, Nitrofurans and their formulations were already banned, and notes that despite the ban, residues continue to be detected in shrimp export consignments.
The letter records that the Marine Products Export Development Authority (MPEDA), by its communication dated January 27, 2026, flagged continued residue detections leading to 43% rejections in 2025 by the EU, USA and Japan, linked to more than 40 farms across various States, predominantly Andhra Pradesh, Odisha, West Bengal and Gujarat. In that context, CDSCO has asked States to provide information on: (i) the current mechanism for implementation of the notification across States; (ii) the number of inspections conducted in veterinary medical shops and related establishments and their outcomes; and (iii) punitive action initiated or completed against violators, if any.
CDSCO has further requested States to ensure that these drugs and formulations are sold only to licensed manufacturers (bulk and formulation), through licensed premises, only for the intended purpose, with proper reconciliation, and that appropriate regulatory action is taken in case of violations under the D&C Act and the Drug Rules. The letter also asks for the information sought by MPEDA to be furnished in a time-bound manner.
Why this matters: This is not a fresh ban, but an enforcement-focused follow-up from CDSCO highlighting continued non-compliance despite the earlier prohibition, with a particular emphasis on State-level inspections, traceability of sale channels, and regulatory action in light of export rejections and residue findings in the seafood supply chain.
AYUSH
Corrigendum on Revised Benchmark Rates for AYUSH Treatments Under Insurance Coverage, 2026
The Ministry of Ayush has issued a corrigendum dated June 5, 2026 to its letter dated April 13, 2026 on revised benchmark insurance rates for Ayurveda, Siddha, Unani, and Yoga & Naturopathy treatments. Pursuant to the corrigendum, it has made certain revisions to the annexures, including rate additions and nomenclature changes in Annexure-1 (Ayurveda), new procedure codes for Shalya, Shalakya, and Prasuti Tantra & Stree Roga in Annexure-2, corrections to Yoga codes YG14-YG19 and PT16 in Annexure-3, and realigned Siddha rates in Annexure-5.
Professionals
National Medical Commission Mandates Safe Injection Practices in Medical Colleges
The National Medical Commission (NMC) has (vide advisory dated May 31, 2026) directed all medical colleges to strictly implement safe injection practices to prevent blood-borne infections such as HIV, HBV and HCV, in compliance with the National Guidelines for Infection Prevention and Control. It mandates the exclusive use of sterile, single-use needles and syringes with a strict prohibition on reuse, proper segregation and disposal of sharps as per the Biomedical Waste Management Rules, 2016, and periodic staff training. Colleges are also encouraged to adopt auto-disable syringes and must report needle-stick injuries or infection clusters, ensure post-exposure prophylaxis per National AIDS Control Organization (NACO) guidelines, and conduct regular audits.
Why this matters: The advisory calls for zero tolerance towards breaches like reuse, unsafe vial sharing, recapping, and improper sharps disposal, treating safe injection practices as a non-negotiable patient safety mandate.
Pricing Control
NPPA Directs Mandatory Quarterly Submission of Form III under DPCO, 2013
The NPPA has (vide Office Memorandum dated June 23, 2026) directed all ‘manufacturers’ under Drugs (Prices Control) Order, 2013 (DPCO, 2013) to comply with Para 21(1) of the DPCO, 2013 by submitting Form III of Schedule II, covering production/availability of scheduled formulations and active pharmaceutical ingredients, every quarter via the Integrated Pharmaceutical Database Management System (IPDMS) 2.0 portal. The NPPA noted that many manufacturers have not been submitting regularly, causing monitoring gaps and directed all entities to immediately clear pending Form III returns for missed quarters and maintain timely quarterly compliance going forward, with a warning that non-submission or delays may invite regulatory action.
NPPA Integrates Pharma Jan Samadhan & Pharma Sahi Daam Portals
The NPPA has (vide Office Memorandum dated June 23, 2026) announced integration of the Pharma Jan Samadhan portal (for medicine pricing grievance redressal) with the Pharma Sahi Daam portal (for medicine price information) into a single, unified citizen-centric digital platform. The move aligns with the Government of India's ‘Minimum Government, Maximum Governance’ vision, aiming to improve accessibility, reduce duplication, and enhance user experience. The integrated portal is operational immediately from the date of issue, and all services will now be accessed through the unified ‘Pharma Sahi Daam’ app/portal.
DoP Notifies DPCO Amendment, 2026
Pursuant to the Drugs (Prices Control) Amendment Order, 2026 (DPCO Amendment, 2026), the following material amendments have been introduced to the DPCO, 2013. First, amended paragraph 11(3) of the DPCO, 2013 broadens the Government’s power to fix separate ceiling or retail prices for any drug whose ceiling or retail price has already been fixed, having regard to specified therapeutic rationale, packaging type, pack size, dosage compliance, or pack content, instead of the earlier narrower position mainly covering injections, inhalation and cases where dosage form/strength was not specified.
Second, under amended paragraph 15(2) of the DPCO, 2013, other existing manufacturers launching the same “new drug” within 12 months of retail price fixation no longer require prior price approval but must file a Form-IA intimation within one month of launch. Third, amended paragraphs 14(2) and 24(1) of the DPCO, 2013 limit manufacturer overcharging exposure in respect of scheduled formulations already produced or available in the market before ceiling price notification, provided the manufacturer proves adequate dissemination of revised prices through dealer/retailer circulation, newspaper advertisements, revised price lists, website disclosure, and batch-wise production and stock details. Fourth, amended paragraph 29 of the DPCO, 2013 now requires record retention for at least seven financial years, with continued preservation until final disposal of any pending proceedings.
Why it matters: The amendment eases new-drug launch and overcharge-liability compliance for manufacturers while tightening record-keeping and price-transparency obligations under DPCO, 2013.
Accreditation
NABL's Four-Year Assessment Programme for Accredited CABs
National Accreditation Board for Testing and Calibration Laboratories (NABL) has extended the accreditation cycle from two to four years and introduced a revised assessment schedule comprising Surveillance-1 (within 12 months), Midcycle Assessment (13-24 months), and Surveillance-2 (25–36 months). Onsite assessment is mandatory for all Conformity Assessment Bodies (CABs), except that Surveillance-1 and Surveillance-2 may be conducted via desktop review for CABs with 10+ years of continuous, unblemished accreditation history, though the Midcycle Assessment must always be onsite. NABL retains discretion to increase surveillance frequency (up to four assessments per year) or conduct unannounced assessments (onsite/remote) if concerns arise. Assessment teams (Lead Assessor and Technical Assessors as needed) are deputed based on scope complexity, past findings, and risk factors, with full-scope coverage required at every stage for Biobanks.
Why this matters: It reduces the assessment burden on well-performing CABs while still safeguarding quality through mandatory midcycle onsite checks and NABL's ability to step up scrutiny when needed.
Key Updates to NABL General Information Brochure
The NABL amended its General Information Brochure, specifically introducing a Midcycle Fee payable by the CAB at the end of the 2nd year during the 4-year accreditation cycle, increased the accreditation cycle from 2 years to 4 years, recorded the formation of Global Accreditation Cooperation Incorporated with effect from January 1, 2026 as the new body bringing together the work of International Laboratory Accreditation Cooperation and the International Accreditation Forum, added the Coconut Development Board to the Integrated Assessment framework, and removed the reference to ISO/IEC 17043:2010 as part of the transition to ISO/IEC 17043:2023. The amendment also corrected the honorarium for Technical Assessor. Together, these amendments update the fee structure, extend the accreditation cycle, and align the brochure with current international accreditation architecture and updated ISO standards.
NABH Launches MITRA Empanelment Programme
The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has launched the NABH MITRA Empanelment Programme (MEP), a structured scheme to empanel qualified individuals and organizations to support hospitals, particularly in Tier 2, 3, and 4 cities in achieving NABH accreditation, certification, and digital health transformation, including through a separate Digital MITRA track for implementation of digital health tools and compliance with NABH Digital Health Standards (DHS). The programme creates two categories, Organisational MITRAs and Individual MITRAs, and prescribes detailed eligibility criteria relating to legal status, professional qualifications/experience, and prior accreditation/certification support.
The process involves online application, committee review and shortlisting, virtual interaction, mandatory paid training, provisional empanelment upon successful completion, and final empanelment after supporting at least one health organisation/ small healthcare organisation through NABH certification/accreditation. Final empanelment is valid for three years, subject to ongoing compliance and ethical requirements, applications close on July 15, 2026.
Why this matters: It creates a voluntary, credentialed pathway for consultants supporting hospital accreditation, aiming to bring verified, ethical, and accountable expertise to an otherwise unregulated space.
Legal Metrology
DoCA Issues Advisory on Standard Pack Sizes for Edible Oils
The Department of Consumer Affairs (DoCA) has (vide Advisory dated June 5, 2026) amended the Standard Operating Protocol (SOP) December 29, 2023 on determination of net quantity for packaged edible oils and fats under the Legal Metrology framework. The Advisory introduces standard pack size guidance for major edible oils, prescribes corresponding volume-based sizes, and requires that where quantity is declared in volume, the package must also declare the equivalent quantity by weight in the same size of letters/numerals in accordance with the Legal Metrology (Packaged Commodities) Rules, 2011. Minor edible oils remain exempt from the standard pack size requirement, though existing unit sale price declaration requirements continue to apply. The Advisory also clarifies that the framework applies to both domestic and imported edible oils, preserves the existing SOP procedures for determination of net quantity, sampling, testing and error evaluation, and provides a three-month transition period for compliance.
Why this matters: The advisory standardizes edible oil pack sizes to curb quantity proliferation, making it easier for consumers to compare prices and prevent deceptive packaging practices.
DoCA’s Improvement Notice Mechanism Under LM Act
DoCA has launched an Improvement Notice mechanism under the Legal Metrology Act, 2009 (LM Act), through the Jan Vishwas 2026 Act, allowing businesses to correct specified first-time procedural and regulatory non-compliances (covering areas like registration requirements, documentation maintenance, model approval, and packaged commodities) before facing penal action. The reform aims to promote Ease of Doing Business and trust-based governance by encouraging voluntary compliance and reducing unnecessary litigation, while applying to manufacturers, importers, dealers, traders, and MSMEs. However, the mechanism does not extend to fraud, repeated violations, or tampering, and strict enforcement continues for such acts to safeguard consumer interests.
Why this matters: The Improvement Notice mechanism shifts regulatory approach from punitive-first to correction-first for genuine first-time lapses, cutting compliance costs and litigation for honest businesses while still preserving strict enforcement against fraud and repeat offenders.
Government Initiatives
Aarogya Setu Relaunched as Personal Health Record App Under ABDM
Aarogya Setu 2.0 was launched was launched by Union Health Minister, transforming the former COVID-era contact-tracing app into a Personal Health Record (PHR) platform under the Ayushman Bharat Digital Mission (ABDM). It offers features like Ayushman Bharat Health Account (ABHA) creation, AI-based digitization of medical records, Pradhan Mantri Jan Arogya Yojana (PM-JAY) wallet tracking, medication reminders, family health management, nearby hospital and blood-availability search via e-RakhtKosh, and consent-based data sharing, leveraging its existing user-base of nearly 20 crore to drive wider ABDM adoption.
Why this matters: It repurposes a dormant pandemic-tracking app with a large existing user base into a mainstream, citizen-facing gateway to India's national digital health infrastructure, potentially accelerating adoption of digital health services at scale.
SUMAN Roadmap 2030 Launched to Strengthen Maternal and Newborn Health
The SUMAN Roadmap 2030 was released by the Union Health Minister at the 16th Conference of the Central Council of Health and Family Welfare. It is a strategic framework to accelerate progress on maternal and newborn mortality targets through customised, life-cycle interventions across the continuum of care, covering pre-pregnancy, antenatal, intrapartum and postnatal care. It focuses special attention on 130 districts across 13 high-focus States with measures like Accredited Social Health Activist (ASHA) home visits, referral transport, birth waiting homes, and high-dependency units, while also rolling out nationwide initiatives such as SUMAN Panchayats, digital monitoring via the JANANI portal, and climate-responsive action planning. The overarching goal is to cut India's Maternal Mortality Ratio below 70 per 100,000 live births by 2030 and realize the goal of zero preventable maternal and newborn deaths.
Why this matters: It lays out a concrete, targeted plan to cut preventable maternal and newborn deaths across India's most vulnerable regions, directly advancing the country's Sustainable Development Goals targets for reducing maternal and newborn mortality by 2030.
MoHFW Unveils National Guidelines for Ambulance Services
The MoHFW launched the Operational Guidelines on National Ambulance Services (NAS), 2026, creating India's first national framework to standardize ambulance planning, operations, and monitoring across all States and UTs, with all ambulances required to meet AIS-125 standards.
The guidelines push for tech-driven emergency response through Integrated Command and Dispatch Centres with GPS tracking, digital call management, and real-time monitoring dashboards, alongside eventual integration with the unified '112' emergency number.
They also emphasize Geographic Information System (GIS)-based mapping and data-driven fleet deployment (based on call trends, referral patterns, traffic density, accident hotspots, and population distribution) to improve response times and ensure equitable emergency medical coverage, especially in rural and remote areas.
Why it matters: It sets a uniform, technology-enabled standard for ambulance services across India, aiming to cut emergency response times and reduce disparities in access to emergency care between urban and rural areas.
Food Laws (Selective Developments)
FSSAI Directs Immediate Discontinuation of Metallic Pins and Wires in Food Packaging
The Food Safety and Standards Authority of India (FSSAI) has directed all Food Business Operators (FBOs) to immediately discontinue the use of metallic pins, staple pins, wires and similar materials for sealing, fastening or packaging food products. The direction follows reports of metallic objects being found in cakes and packaged food items, posing a significant risk of injury and adverse health consequences to consumers. The prohibition applies across all food categories and packaging formats, including cake boxes, sweet boxes, snack packets, takeaway meals and food parcels. FSSAI has clarified that non-compliance may attract penal action under the Food Safety and Standards Act, 2006 (FSS Act) and the Regulations framed thereunder.
Why this matters: This direction turns a widespread, previously unregulated safety hazard, metal pins in food, into a legally enforceable violation, protecting consumers from injury while forcing FBOs nationwide to change packaging practices.
FSSAI Notifies Amendments to Vegan Foods Regulations
The FSSAI has notified the Food Safety and Standards (Vegan Foods) Amendment Regulations, 2026, amending the Food Safety and Standards (Vegan Foods) Regulations, 2022. The amendment replaces sub-regulation 4(2) to prescribe revised logo requirements applicable to approved vegan food products and mandates the use of the prescribed vegan logo in the specified format and dimensions on product packaging. The amended regulations will come into force on July 1, 2027, providing FBOs with adequate time to align their packaging and labelling practices with the revised requirements.
Why this matters: It gives vegan food packaging in India a standardized, legally mandated logo with specifications, helping consumers instantly identify certified vegan products and curbing mislabeling.
FSSAI Withdraws Method for Determination of Fruit Content in Fruit Juices
FSSAI through an order has withdrawn Method No. 2.11 for the determination of fruit content in fruit juices from the Manual of Methods of Analysis of Foods - Fruit and Vegetable Products. Pending notification of a revised official method, food testing laboratories may utilize validated testing methods prescribed by internationally recognized bodies such as AOAC, International Organization of Standardization, Pearson’s, Jacob, Food Chemicals CODEX, Bureau of Indian Standards (BIS) and other international recognized regulatory agencies. All FSSAI notified food testing laboratories are directed to comply with immediate effect.
Why this matters: The order affects how fruit juice manufacturers, importers, and testing labs across India verify compliance and label claims, since there's now no single mandated method for a key quality parameter until a replacement is notified.
FSSAI Eases Compliance for Non-Manufacturers and Retailers
FSSAI notified the Food Safety and Standards (Licensing and Registration of Food Businesses) Second Amendment Regulations, 2026. The amendment makes two targeted changes to the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011: first, non-manufacturing food businesses no longer need to maintain separate daily records of production and raw material usage. Second, retailers are now exempt from following FIFO (First In, First Out) and FEFO (First Expire, First Out) stock rotation practices when storing raw materials, ingredients, work-in-progress, or packaged food products.
Why this matters: This amendment reduces the operational compliance burden on non-manufacturing food businesses and retailers by exempting them from detailed production record-keeping and FIFO/FEFO stock rotation requirements, respectively.
FSSAI Mandates Use of Food-Grade and Corrosion-Resistant Cutting Equipment
FSSAI in exercise of requirements under Schedule 4 of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, has directed all FBOs to use only food-grade, non-toxic and corrosion-resistant knives, blades and cutting equipment in food handling, preparation and packaging operations. This direction was issued in response to reports of food businesses using rusted, corroded, chipped, painted, damaged or otherwise unsuitable cutting equipment during food handling, preparation and packaging operations.
Food businesses must ensure all cutting equipment is maintained in a sound and hygienic condition, free from rust, corrosion, cracks, chipping or any other defect that may contaminate food. Damaged or unsuitable equipment must be immediately removed and replaced with adequate cleaning, sanitization and sterilization procedures implemented at prescribed intervals. Non-compliance shall attract enforcement action under the FSS Act and Regulations made thereunder.
Why this matters: The FSSAI directive is signaling active enforcement of an existing but often-ignored hygiene requirement, putting food businesses on notice that using rusted or damaged cutting equipment can now trigger inspections and penalties.
Key Judicial Development
Pharmadude Pharmacy Vannappuram v. State of Kerala and Ors. (MANU/KE/1409/2026)
The Hon’ble High Court of Kerala considered three connected writ petitions arising from a Circular dated September 4, 2024, issued by the Office of Drugs Controller requiring applicants for grant/renewal of drug licences to furnish an affidavit undertaking not to display discount boards at pharmacies.
Two pharmacy-owner petitioners challenged the Circular, arguing that neither the D&C Act, Drugs Rules, nor the DPCO, 2013 prohibits sale of medicines below maximum retail price (MRP) or transparent disclosure of discounts, while a third petitioner sought enforcement of the Circular against allegedly misleading discount advertisements. The State clarified that it did not oppose discounts per se but objected to vague or misleading discount boards that could deceive customers.
The Court held that while drugs cannot be sold above MRP, there is no bar on selling below MRP; however, the licensing authority has incidental regulatory power to impose conditions to prevent the public from being misled. Taking note of the Drugs Controller’s revised undertaking, restricting only “discount boards containing misleading or vague claims regarding the price of drugs”, the Court found no unconstitutional restriction on the right to carry on business. The Court dismissed the writ petitions challenging the Circular and allowed the writ petition seeking implementation of the Circular.
Why this matters: The case affirms that drug licensing authorities may impose licence-related conditions to curb misleading or vague discount advertising by pharmacies, without infringing the right to carry on business, provided that pharmacies remain free to offer genuine discounts below MRP.
H. Kusuma and Ors. v. Chief Secretary to Government and Ors. (MANU/KA/1754/2026)
The Hon’ble High Court of Karnataka considered a petition by the parents of a 23-year-old woman suffering from Global Developmental Delay associated with moderate permanent intellectual and developmental disability, along with cerebral palsy and seizure disorder, seeking permission for a Total Abdominal Hysterectomy.
The parents contended that she was incapable of independently managing menstrual hygiene, resulting in recurring infections, fever, and prolonged medical difficulties, and that they remained her sole caregivers. Given the invasive and irreversible nature of the procedure, the Court constituted a multidisciplinary Medical Board, which assessed her through specialists in psychology, psychiatry, neurology, obstetrics and gynaecology, radiology, and anaesthesiology. The Board found that she lacked the capacity to make an informed decision, was unable to independently manage menstrual hygiene, recorded no contraindication to surgery, and recommended the procedure.
Referring to the principles laid down by the Hon’ble Supreme Court in Suchita Srivastava case, the Court reaffirmed that reproductive autonomy and bodily integrity are protected under Article 21 of the Constitution, and that disability alone can never justify removal of a reproductive organ. However, since the patient lacked decision-making capacity, the Court exercised its parens patriae jurisdiction and, on a court-supervised best interests’ assessment, held that the procedure was intended to advance her health, dignity, and welfare.
The writ petition was accordingly allowed, permitting the hysterectomy procedure, with directions for pre-operative counselling, post-operative counselling, care, and rehabilitation services, monitoring post-operative recovery, and submission of a report to the Registrar General within eight weeks of the procedure.
Why this matters: It reaffirms that a hysterectomy for an intellectually disabled adult may be judicially authorised only under the Court’s parens patriae jurisdiction, on the basis of an independent multidisciplinary medical assessment and a genuine, best interests’ determination, and not merely because of disability.
Travancore-Cochin Medical Council v. Rajesh K. (2026:KER:42984)
This Writ Appeal before the Hon’ble High Court of Kerala arose from a challenge by the Travancore-Cochin Medical Council (Medical Council) against a Single Judge's judgment dated November 16, 2020. The original writ petition had been filed by Rajesh K., a self-described practitioner of Electro-Homeopathy, who held a diploma from the Council of Electro Homeopathic System of Medicine, Kanpur. He alleged that the Medical Council had wrongfully caused police interference with his practice without demonstrating any illegality.
The Single Judge had ruled in his favor, relying on a 2008 Division Bench precedent holding that police could not restrict Electropathy practice absent proof it was legally prohibited, reasoning that citizens may do anything not expressly barred by law.
On appeal, the Medical Council argued this assumption was incorrect, since the Travancore-Cochin Medical Practitioners Act, 1953 (MP Act, 1953), and its successor, the Kerala State Medical Practitioners Act, 2021 (MP Act, 2021), regulate homeopathic practice, requiring registration and inclusion in an official practitioners' list.
The Division Bench allowed the appeal, holding that the 2008 precedent was per incuriam for ignoring the MP Act, 1953, and rejected the notion of absolute citizen liberty as inconsistent with constitutional jurisprudence. Since Rajesh's qualification, even assuming it was recognised, fell within homeopathic medicine, his practice was subject to statutory regulation. The Court dismissed the writ petition, declared Electro-Homeopathy practice is regulated under both MP Act, 1953 and MP Act, 2021, and allowed the Writ Appeal.
Why this matters: This decision closes the argument that Electro-Homeopathy may be practised in Kerala as an unregulated alternative therapy. The Court has held that such practice is governed by the applicable medical practitioners statutes and has refused to treat the earlier contrary ruling as a valid precedent.
M/s Storia Foods and Beverages Private Limited (CCPA-2/71/2024-CCPA)
The Central Consumer Protection Authority (CCPA) took up a suo-moto case against Storia Foods and Beverages Private Limited (Storia) concerning claims made for its coconut water product and four juice variants. The CCPA found that Storia advertised its product as “100% Tender Coconut Water” and “100% Natural Tender Coconut Water” even though the label described it as water and coconut water concentrate (9.6%) (reconstituted), and marketed the juice variants as “100% Juice” although their ingredient panels showed compositions consisting largely of water, fruit pulp/concentrate, and apple juice concentrate.
Storia argued that its labelling and claims were permissible under the FSSAI framework governing reconstitution and labelling, and that disclosures such as “(Equivalent to 100% Coconut Water/Fruit Juice) (Reconstituted)” cured any ambiguity. It also relied on published literature to support claims including “Improves Metabolism,” “Kills Fatigue,” and “Rehydrates the Body Faster than Water” and (until December 2023) “Combats Virus”. The CCPA rejected these defenses, holding that compliance with food law does not displace its independent jurisdiction under the Consumer Protection Act, 2019 (CPA, 2019), especially in view of Section 100. It held that prominent front-of-pack and digital claims misled ordinary consumers, that disclaimers cannot correct inherently misleading principal claims, and that the health claims lacked product-specific substantiation.
Accordingly, the CCPA found violations of Sections 2(28) (i) [falsely describing a product or service] and (ii) [giving a false guarantee or advertisement likely to mislead consumers as to quantity or quality of such product], 2(47) [unfair trade practice], and 2(9) [Consumer rights] of the CPA, 2019, directed Storia to immediately discontinue the impugned claims across packaging, website, and e-commerce listings, required future health claims to be scientifically substantiated for the specific product advertised, imposed a penalty of INR 1,00,000, and directed submission of a compliance report within 15 days.
Why this matters: This Order matters because it confirms that even if a food product is argued to be FSSAI-compliant, the CCPA can still treat prominent packaging and online claims such as “100%” and unsubstantiated health benefits as misleading under the CPA, 2019.
Editor's Insight
Recent developments demonstrate a rise in regulatory focus on transparency, consumer protection, and process efficiency across India's life sciences and healthcare sector, spanning drug safety and pharmacovigilance, licensing and pricing reforms, cosmetics compliance, ART and surrogacy clinic governance, hospital and laboratory accreditation, and emergency healthcare infrastructure.
Companies operating in the pharmaceutical, biotechnology, medical device and healthcare sectors 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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