19 Aug 2025
In this update:
Partners: Kosturi Ghosh, Kirti Balasubramanian, Senior Associate: Ajeya BG, Associates: Rimjhim Mishra and Paarth Samdani
The Central Government notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 under the Drugs and Cosmetics Act, 1940 (DCA) on 25 April 2025. These rules create a structured framework for settling minor regulatory offences through a compounding process to avoid protracted litigation. Designated officers at central (Central Licensing Authority) and state levels oversee the process, and companies may submit applications before or after prosecution is initiated. Compounding may be granted within a month based on a compliance report submitted by the relevant authority. Immunity from prosecution is not automatic and may be withdrawn if material facts are concealed or payment directions not complied with. Repeat offences will attract stricter penalties, including imprisonment. Internal standard operating procedures must be updated to track compoundable offences, ensure timely and transparent disclosures, and maintain proof of payment to reduce litigation exposure and safeguard immunity.
A joint office memorandum (OM) from Central Drugs Standard Organisation (CDSCO) and Directorate General of Health Services (DGHS) on 26 May 2025 tightens compliance for importers and licensees handling overprinting or stickering of drug packaging under Rule 104A of the Drugs Rules, 1945. The OM mandates that all labelling activities be carried out at licensed premises only, under a valid manufacturing licence in the importer’s name, and in the presence of qualified quality assurance personnel. The original label should not be concealed, and any alterations to the label must be clearly marked with the licence number and specific purpose of the labelling.
The OM also clarifies the scope of Rule 104A of the Drugs Rules, 1945, which prohibits tampering with any markings made by the original manufacturer on drug containers, labels, or wrappers, except with the specific permission of the licensing authority. Previously, importers were required to apply for such permission separately for each product. In 2020, to simplify the process, the CDSCO and DGHS had permitted importers to obtain comprehensive permission for limited purposes such as government supply. The OM has clarified that even with the permission obtained for such limited purposes, the original label of the manufacturer cannot be concealed.
Under the DCA, importing any misbranded drug is punishable with imprisonment for up to six months, or a fine of up to INR 500, or both. The OM aims to strengthen regulatory compliance while enabling targeted drug supply to, for instance, central government health schemes, without compromising public safety. Importers should review their current labelling practices and licensing status to ensure full compliance.
The Department of Pharmaceuticals (DoP) introduced the Uniform Code for Pharmaceutical Marketing Practices 2024 (UCPMP) in early 2024, encouraging voluntary compliance by the pharmaceutical and medical device industry. The DoP initially asked companies to submit self-declarations and details of marketing expenditures by 31 July 2025. This deadline was extended to 31 August 2025.
Companies must now publicly disclose event-related expenses and selection processes for speakers and participants. The disclosure form1 requires detailed information, including monetary value of packs, the number of healthcare professionals involved, and domestic sales revenue with respect to free samples distributed. It also requires disclosure of all expenses incurred on continuing medical education activities (CME), and continuing professional development (CPD) – sponsorship, travel, lodging, hospitality, advertisements, stalls, souvenirs, etc.
This has significantly increased emphasis on real-time documentation of samples, sponsorships, speaker engagements, CME/CPD events, and any third-party collaborations. To ensure accurate tracking across business functions, pharma and medical device companies will need to streamline internal reporting systems to monitor marketing-related expenditures. Companies should conduct a comprehensive gap analysis to assess current practices against UCPMP requirements, especially if they have previously taken a less rigorous approach to voluntary compliance.
A similar code introduced by the DoP for medical devices, i.e., the Uniform Code for Marketing Practices in Medical Devices 2024 (UCMPMD) has similar requirements for medical device companies. However, while the deadline under the UCMPMD was extended until 31 July 2025, it does not appear to have been extended further.
On 28 May 2025, the DGHS issued a directive prohibiting medical representatives from entering central government hospitals and engaging directly with doctors. This is aimed at eliminating undue influence in hospitals and enhancing patient care standards.
All promotional communications, including updates on new drugs, treatments, diagnostics and procedures, must now be conducted exclusively through email or digital platforms. Heads of central government hospitals have been instructed to enforce the ban and report compliance to the DGHS.
Pharmaceutical and healthcare companies must re-evaluate their outreach and engagement strategies, particularly for sample distribution and in-person detailing in government hospitals. In particular, companies must ensure that medical representatives have the necessary digital tools and training for effective and compliant engagement.
On 6 May 2025, the CDSCO published the Draft Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2025 (Draft SB Guidelines), which aim to replace the 2016 version. This aligns with global best practices and accounts for scientific advancements and has sought to incorporate major updates from other internal guidelines on similar biologics, particularly from the WHO TRS 1043: 19 Guidelines for evaluation of biosimilars. The Draft SB Guidelines propose a step-wise framework for demonstrating bio-similarity to a Reference Biological Product (RBP). If implemented, the guidelines are likely to have significant implications for biologics manufacturers, especially clinical trial requirements and product development timelines.
Key highlights include:
The CDSCO is expected to present a revised version of the guidelines based on feedback received from stakeholders.
On 9 April 2025, the CDSCO launched an automated system for issuing Neutral Codes, Market Standing Certificates (MSC),2 and Non-Conviction Certificates (NCC)3 through its online medical devices portal. This aligns with the National Medical Devices Policy, 2023, aiming to reduce administrative delays, streamline documentation, and enhance regulatory efficiency and export preparedness.
Under the new system, MSCs and NCCs are issued automatically, based on the manufacturer’s licence validity and compliance record. Neutral Codes, which allow export without disclosing company-specific identity, can be directly downloaded from the portal.
Applications submitted under the previous workflow may be auto-rejected, and manufacturers and importers must submit fresh applications under the revised system to maintain continuity. Businesses should review their application status and ensure resubmission through the portal to avoid disruptions in obtaining regulatory approvals. This marks a significant step toward digitising regulatory processes.
On 3 April 2025, the Food Safety and Standards Authority of India (FSSAI) updated its inspection checklists to classify food-grade packaging as essential to food safety across sectors, including general manufacturing, dairy, meat, fish, and catering. This builds on the Food Safety and Standards (Packaging) Regulations, 2018 and requires packaging materials to be backed by a certificate of conformity from NABL-accredited labs, significantly raising the compliance threshold. Food business operators must re-evaluate vendor certifications, maintain comprehensive records, and ensure internal teams are audit ready.
On 7 April 2025, the Advertising Standards Council of India issued Addendum 2 to its Guidelines for Influencer Advertising, introducing stricter norms for posts related to health, nutrition, and financial services. Addendum 2 now differentiates between general promotions and the endorsement of technical aspects of products and services, which consumers may perceive as expert advice.
Influencers offering technical or expert advice must now possess relevant qualifications (such as medical degrees or certifications in nutrition or psychology) and must disclose these credentials prominently – either superimposed on visuals or stated upfront. Influencers without such credentials may continue with non-technical promotions but must avoid providing advice related to treatment, cure or prevention, or financial decision making.
Brands and agencies should vet and verify influencer qualifications, review contracts, and ensure appropriate disclosures are in place to avoid regulatory risks.
[1] Standing Order – Circular No. 2 of 2024_0.pdf
[2] An MSC is issued by the drug regulatory authority to confirm that a manufacturer or importer holds a valid license for medical devices.
[3] The NCC provides formal assurance that the medical device company possesses a valid manufacturing license and has not been convicted under any Indian laws.
If you require any further information about the material contained in this newsletter, please get in touch with your Trilegal relationship partner or send an email to alerts@trilegal.com. The contents of this newsletter are intended for informational purposes only and are not in the nature of a legal opinion. Readers are encouraged to seek legal counsel prior to acting upon any of the information provided herein.
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