INTRODUCTION
India’s pharmaceutical and healthcare regulatory landscape continued to evolve during the first half of 2026, with authorities introducing measures aimed at simplifying regulatory processes, strengthening regulatory oversight and improving post-market surveillance. Key developments included the operationalisation of the framework for compounding of offences, prior intimation mechanisms under the New Drugs and Clinical Trials Rules, 2019, regulatory guidelines for sampling and measures relating to pharmacovigilance, medical devices, drug regulation and pricing framework. These developments reflect continued efforts to promote regulatory efficiency and risk-based oversight while maintaining safeguards for product quality, patient safety and compliance.
COMPOUNDING OF OFFENCES UNDER THE DRUGS AND COSMETICS ACT, 1940
The Central Drugs Standard Control Organisation (“CDSCO”), through a Public Notice dated January 1, 2026, informed stakeholders of the procedure for submitting applications under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 (“Compounding Rules”)1. The CDSCO also issued Frequently Asked Questions (“FAQs”)2, a Standard Operating Procedure (“SOP”)3 and Guidelines4 to facilitate implementation of the framework.
These documents collectively clarify the scope of compoundable offences, eligibility criteria and the application procedure. The offences eligible for compounding include specified contraventions relating to the manufacture, sale, stocking, exhibition or distribution of drugs and cosmetics, as prescribed under Section 32B of the DCA and the Compounding Rules. Applications are submitted to the Central Compounding Authority, which considers the application based on a report furnished by the Reporting Authority5. The Compounding Authority may determine the compounding amount or reject the application after providing the applicant an opportunity of being heard. Where an application is allowed, the prescribed amount must be paid within thirty (30) days.
It also provides for immunity from prosecution where the applicant cooperates in the proceedings and makes a full and true disclosure of relevant facts. However, this immunity may be withdrawn in cases including non-payment, non-compliance with applicable conditions, concealment of material particulars or provision of false evidence.
The framework enables regulated entities to resolve eligible contraventions through compounding in lieu of prosecution, subject to payment of the prescribed amount and compliance with applicable conditions and is likely to ease the enforcement of the provisions under the DCA for offences committed by entities.
IMPLEMENTATION OF PHARMACOVIGILANCE REQUIREMENTS UNDER SCHEDULE M
The MoHFW, through the Drugs (Amendment) Rules, 2023 notified on December 28, 2023, revised Schedule M to the Drugs Rules, 1945 (“Drugs Rules”) to strengthen Good Manufacturing Practices (“GMP”) and quality management requirements for pharmaceutical products. The revised framework was introduced to align domestic manufacturing standards more closely with global standards and strengthen systems for ensuring the quality, safety and efficacy of pharmaceutical products. Among other requirements, Paragraph 6.11 of Schedule M requires manufacturers to establish and maintain an effective pharmacovigilance (“PV”) system.
The CDSCO, through a Circular dated June 3, 2026, directed stakeholders to establish and maintain an effective PV system in accordance with requirements under Schedule M to the Drugs Rules.6
The PV system is required to facilitate the collection, processing and reporting of adverse drug reactions associated with drugs manufactured or marketed by a licensee. Compliance with these requirements may be verified by the CDSCO, State Licensing Authorities and Union Territory administrations during routine inspections and other regulatory activities.
The Circular reinforces the importance of pharmacovigilance as an integral part of manufacturers’ quality management and post-market safety obligations. Pharmaceutical manufacturers and licensees will need to ensure that adequate systems for collecting, processing and reporting adverse drug reactions are operational and appropriately documented, as compliance with these requirements may be specifically examined during regulatory inspections and other activities.
IMPLEMENTATION OF PROVISIONS UNDER THE JAN VISHWAS (AMENDMENT OF PROVISIONS) ACT, 2026
The MoHFW, through a Notification dated June 22, 2026, appointed June 30, 2027 as the date on which the provisions of the Jan Vishwas (Amendment of Provisions) Act, 2026 (“Jan Vishwas Act”), insofar as they relate to Schedule concerning the DCA, will come into force.7
Serial No. 8 of the Schedule to the Jan Vishwas Act pertains to the DCA and provides for the amendment of Section 28A, which prescribes the penalty for failure to disclose the place where certain Ayurvedic, Siddha and Unani drugs are manufactured or stored. The amendment replaces the existing punishment of imprisonment of up to six months along with a fine with a higher monetary penalty. The Notification does not itself introduce additional substantive changes but appoints the date on which the relevant amendment to the DCA will come into force.
The amendment reflects the broader objective of decriminalising minor regulatory contraventions and replacing criminal sanctions with monetary penalties to enable better enforcement. For regulated entities, the change reduces exposure to imprisonment for the relevant contravention while retaining financial consequences for non-compliance.
EXPANSION OF CATEGORIES COVERED UNDER SCHEDULE H2 OF THE DRUGS RULES
The MoHFW, through a notification dated June 22, 2026, notified the Drugs (Seventh Amendment) Rules, 2026, expanding the categories of drugs covered under Schedule H2 of the Drugs Rules.8
Schedule H2 to the Drugs Rules prescribes labelling requirements for specified drugs, including the display of a unique identification code on the primary packaging label to facilitate authentication and traceability. The expansion of Schedule H2 will require manufacturers of the newly covered categories to comply with the applicable labelling and traceability requirements, requiring changes to packaging and compliance systems. The phased implementation timeline provides manufacturers with additional time to undertake the necessary operational changes, particularly in relation to antimicrobials.
The amendment renumbers the existing table as Table 1 and inserts a new Table 2 covering all vaccines, all antimicrobials, all narcotic drugs and psychotropic substances listed under the Narcotic Drugs and Psychotropic Substances Act, 1985, and all anticancer drugs.
The amendment will come into force on July 1, 2027, except for the provisions relating to antimicrobials, which will take effect on July 1, 2028.
AMENDMENT TO THE DRUGS (PRICES CONTROL) ORDER, 2013
The Department of Pharmaceuticals (“DoP”), through the Drugs (Prices Control) Amendment Order, 2026, amended the Drugs (Prices Control) Order, 2013 (“DPCO”) to introduce changes relating to differential pricing, overcharging liability, implementation of price revisions, launch requirements for follow-on products and record retention obligations9.
The amendments, inter alia, permit separate ceiling or retail prices for the same drug based on factors such as pack size, dosage form, strength or content characteristics; restrict manufacturers’ exposure to downstream overcharging subject to compliance with prescribed dissemination requirements; and permit subsequent manufacturers launching the same new drug within twelve (12) months of the first retail price fixation to proceed without obtaining fresh approval, subject to prescribed intimation requirements. The amendment order also requires manufacturers to retain production and sales records for at least seven financial years.
The amendments seek to reduce procedural requirements and provide greater flexibility to pharmaceutical manufacturers while linking regulatory protections more closely to compliance with price dissemination and record-keeping obligations. Manufacturers will therefore need to strengthen documentation, pricing compliance and supply-chain oversight to benefit from the protections introduced under the revised framework.
Please find our detailed analysis of the amendments here.
CHANGES TO REQUIREMENTS OF TEST LICENCE UNDER THE CLINICAL TRIAL RULES, 2019
The Ministry of Health and Family Welfare (“MoHFW”) notified the New Drugs and Clinical Trials (Amendment) Rules, 2026 on January 20, 2026,10 amending the New Drugs and Clinical Trial Rules, 2019 (“NDCTR”). This amendment came into force on March 6, 2026, and introduced a prior intimation mechanism to obtain test licenses for the manufacture of new drugs and investigational new drugs for analytical and non-clinical testing purposes.
Under the amended framework, eligible applicants may submit Form CT-10 to the Central Licensing Authority (“CLA”) as prior intimation and commence manufacture on the basis of an acknowledgement. Specified categories of drugs, including sex hormones, cytotoxic drugs, beta-lactams, biologics containing live microorganisms and narcotic and psychotropic drugs are exempt from this amendment and remain subject to previously existing requirements to obtain prior permission from the Central Licensing Authority.
This amendment also introduced a prior intimation mechanism for certain unapproved active pharmaceutical ingredients (“APIs”) required for analytical and non-clinical testing under a test license. The pharmaceutical formulation manufacturer and API manufacturer are required to submit Forms CT-12 and CT-13, respectively, as prior intimation to the CLA. The amendment further reduced the prescribed timelines for processing certain applications from ninety (90) to forty-five (45) working days and prescribed conditions relating to manufacture, use, record-keeping and disposal.
The prior intimation mechanism is expected to reduce regulatory waiting periods and facilitate faster commencement of eligible analytical and non-clinical testing activities, while the excluded categories will continue to require prior permission from the Central Licensing Authority.
ONLINE PRIOR INTIMATION MECHANISM FOR BA/BE STUDIES FOR EXPORT PURPOSES
The MoHFW notified the New Drugs and Clinical Trials (Second Amendment) Rules, 2026 on January 21, 2026,11 amending the NDCTR by inserting a proviso to introduce a prior intimation mechanism for specified bioavailability (“BA”) and bioequivalence (“BE”) studies for export purposes. It came into force on April 21, 202612.
The mechanism applies to eligible BA/BE studies involving oral dosage forms of drugs approved in India or specified reference jurisdictions, and conducted in normal healthy adult human volunteers. Specified categories, including cytotoxic drugs, hormones, narcotic and psychotropic substances, drugs with a narrow therapeutic index and drugs having highly variable pharmacokinetics, remain excluded.
Eligible studies may proceed after submission of prior intimation and receipt of an acknowledgement from the CLA. The mechanism is subject to safeguards including approval by a registered Ethics Committee, a minimum sample size of eighteen (18) participants and compliance with applicable fees and documentation requirements. The acknowledgement generated upon submission may be treated as prior intimation for eligible studies, while the existing prior approval process continues to apply to other purposes and categories of BA/BE studies.
The mechanism is expected to reduce regulatory timelines for eligible BA/BE studies undertaken for export purposes and facilitate their faster commencement, while retaining the existing approval framework for other categories of BA/BE studies.
SALE OF IVF MEDIA, REAGENTS AND RELATED CONSUMABLES USED IN ART PROCEDURES
The CDSCO, through a Circular dated June 23, 2026, clarified that in-vitro fertilisation (“IVF”) media, reagents and related consumables used in Assisted Reproductive Technology (“ART”) procedures are regulated as medical devices under the Medical Devices Rules, 2017 (“MDR”).13
The Circular is expected to strengthen regulatory oversight of IVF-related products and prevent their supply to unregistered facilities. Manufacturers and suppliers may need to strengthen distribution controls and verification mechanisms to ensure that such products are supplied only to duly registered ART centres.
By prescribing specific timelines for these regulatory processes, the proposed amendments seek to reduce delays and provide greater certainty to applicants regarding the processing of manufacturing licence applications. The Circular directs stakeholders to ensure that such products are supplied only to centres registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021.
The clarification is significant as it reinforces the application of the regulatory framework under the MDR to IVF media, reagents and related consumables and seeks to strengthen oversight over their supply and use in ART procedures.
DRAFT AMENDMENTS TO THE MEDICAL DEVICES RULES, 2017
The MoHFW, through G.S.R. 269(E) dated April 10, 2026, issued draft amendments to the Medical Devices Rules, 201714 (“MDR”).
The proposed amendment would include European Union (“EU”) countries among the specified jurisdictions recognised under Rule 63(1) of the MDR. Rule 63(1) of the MDR governs the grant of import licences for medical devices. Under the existing framework, clinical investigation may be waived for medical devices that have been approved for marketing in specified reference jurisdictions and have been marketed in such jurisdictions for at least two years, subject to the prescribed conditions.
If finalised, the amendment could reduce the regulatory burden and time involved in obtaining import licences for eligible EU-approved medical devices by expanding the jurisdictions recognised under Rule 63(1) of the MDR. This may create additional market-entry opportunities for manufacturers and importers of medical devices approved in EU countries
DRAFT AMENDMENTS TO REDUCE TIMELINES FOR MANUFACTURING LICENCES
The MoHFW, through a notification dated June 23, 2026, published draft amendments to the MDR aimed at reducing regulatory timelines and facilitating ease of doing business.15 The draft amendments are open for public comments for a period of thirty (30) days from the date on which copies of the Official Gazette containing the notification are made available to the public.
The draft amendments propose to reduce timelines at various stages of the manufacturing licence process. The timeline for scrutiny of an application for grant of a manufacturing licence for Class C or Class D medical devices is proposed to be reduced from forty-five (45) to thirty (30) days. The timeline for inspection of the manufacturing site by the Central Licensing Authority is proposed to be reduced from sixty (60) to fifty-five (55) days, while the timeline for the grant or rejection of a manufacturing licence for Class C or Class D medical devices after receipt of the inspection report is proposed to be reduced from forty-five (45) to twenty (20) days. The Central Government will consider any objections or suggestions received during this period before finalising the amendments.
If finalised, the amendments could streamline the manufacturing licence process and reduce regulatory waiting periods for medical device manufacturers. Greater certainty in application processing and audit timelines may enable manufacturers to plan product launches more efficiently and facilitate faster market entry.
CONCLUSION
The regulatory developments introduced by the regulator during the first half of 2026 reflect continued efforts to improve regulatory efficiency and strengthen oversight across India’s pharmaceutical and healthcare sectors. The introduction of prior intimation mechanisms and revised regulatory timelines seeks to simplify compliance for eligible activities, while developments relating to pharmacovigilance, sampling, medical devices, drug regulation and price monitoring reinforce the focus on product quality and patient safety. Together, these measures demonstrate a continued shift towards risk-based regulation and streamlined procedures.
Shlok Siddhant, Naveli Sharma, Tanya Kukade and Dr. Milind Antani
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1Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM3NjA=
2Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM3NTk=
3Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM3NjI=
4Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM3NjE=
5‘Reporting Authority’ means the Drugs Controller General of lndia
6Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQyNzg=
7Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQzOTg=
8Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQ0MDU=
9Accessible here: https://nppa.gov.in/storage/uploads/tender/dpco-amend-2026-02-07-2026.pdf
10Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4MjE=
11Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4Mjk=
12Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQxMDM=
13Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQ0MDA=
14Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQwNTM=
15Accessible here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQ0MTU=