Pharma & Healthcare Update: Regulatory Wrap 2025: Pharmaceutical Industry in India

Regulatory Wrap 2025: Pharmaceutical Industry in India

The most significant regulatory developments in the Indian pharmaceutical industry in 2025 are:

• The Drugs and Cosmetics (Compounding of Offences) Rules, 2025 notified.
• DOP issued circular clarifying pharmaceutical marketing practices.
• CDSCO reiterates mandatory testing of raw materials and finished formulations.
• CDSCO issued guidance document on disposal of expired and unused drugs.
• Digital Personal Data Protection Rules, 2025 notified to implement the Digital Personal Data Protection Act, 2023.

INTRODUCTION

India’s pharmaceutical industry reaffirmed its role as the ‘Pharmacy of the World’ in 2025 by supplying affordable, high-quality medicines to more than 200 countries and meeting a significant share of global demand for generics. Innovation and digitisation emerged as defining themes for the pharmaceutical industry in 2025, as companies sought to future-proof their business models beyond traditional generics. India’s capacity to deliver at scale, with reliability and cost efficiency, continued to be vital for global healthcare systems.

DRUGS AND COSMETICS (COMPOUNDING OF OFFENCES) RULES, 2025 NOTIFIED

The Ministry of Health and Family Welfare (“MoHFW”) notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025¹ (“Compounding Rules”) on April 24, 2025, formally operationalising the statutory framework for compounding of offences under the Drugs and Cosmetics Act, 1940 (“DCA”).

The Compounding Rules lay down a structured mechanism through which a company or individual involved in manufacturing, import, sale, or distribution of pharmaceutical products may apply for compounding of an offence, either before or after the institution of prosecution.

Immunity granted under the Compounding Rules is conditional upon full and true disclosure of facts and cooperation in the proceedings. The compounding amount must be paid within thirty days (30) and the amount is non-refundable except where a court rejects the grant of immunity. It also sets out the circumstances in which immunity may be withdrawn such as failure to pay the compounding amount within the stipulated period or non-compliance with conditions attached to the immunity.

The notification of the Compounding Rules is expected to streamline enforcement, provide regulatory certainty, and reduce litigation by offering a definitive statutory pathway for settlement of specified offences under the DCA.

DOP ISSUED CIRCULAR CLARIFYING PHARMACEUTICAL MARKETING PRACTICES

Through a circular issued on September 1, 2025, (“UCPMP Circular”)² by the Department of Pharmaceuticals (“DoP”), disclosure framework has been updated and the process for companies to file disclosures was clarified, along with imposition of additional compliance requirements on industry associations under the Uniform Code for Pharmaceutical Marketing Practices, 2024 (“UCPMP”).

The UCPMP Circular provides specific guidance on the valuation of free samples distributed to HCPs and updated the disclosure requirements where companies must file their disclosures with the relevant industry associations of which they are members, and the disclosure format has been updated to make reporting more straightforward. The UCPMP Circular introduces an additional responsibility for industry associations to put in place robust mechanisms for the secure storage and protection of data received from their member companies. Associations are also obligated to furnish such data to these bodies upon request. These changes are expected to encourage more efficient and effective compliance with the UCPMP by pharmaceutical companies.

A detailed analysis of this update is provided in our hotline.

DIGITAL PERSONAL DATA PROTECTION (DPDP) RULES, 2025 NOTIFIED

The Ministry of Electronics and Information Technology (“MeitY”) notified the Digital Personal Data Protection Rules, 2025³ (“DPDP Rules”) on November 13, 2025, thereby operationalising the Digital Personal Data Protection Act, 2023 (“DPDP Act”). The DPDP Rules introduce a phased compliance framework, becoming effective after an 18-month transition period ending on May 13, 2027, requiring companies to put in place compliance mechanisms over the transition period.

The Data Protection Rules prescribe minimum security standards which, among others, include implementing data security measures including encryption, obfuscation, masking or use of virtual tokens; retention of logs and personal data for 1 year to detect unauthorized access; and inclusion of appropriate contractual provisions in the contract between the Data Fiduciary and the Data Processor to adopt reasonable security safeguards.

If the Data Protection Board determines that a person has breached any provision of the DPDP Act, it may impose monetary penalties after conducting an inquiry and the fines can go up to INR 2,500,000,000.

A detailed analysis of this update is provided in our hotline.

CDSCO LAUNCHES ONLINE REGISTRATION OF CLINICAL RESEARCH ORGANISATIONS THROUGH SUGAM PORTAL

The Central Drugs Standard Control Organisation (“CDSCO”) vide public notice dated March 4, 2025, launched the online system for submission and processing of applications for registration and renewal of Clinical Research Organisations (“CROs”) through the SUGAM Portal.⁴ It facilitates the mandatory registration of CROs, which became effective from April 1, 2025, as per the Ministry of Health and Family Welfare’s G.S.R. 581(E) notification dated September 19, 2024.

The move represents a significant shift toward digitisation of regulatory workflows relating to clinical research oversight. New users may register on the SUGAM Portal by selecting “Clinical Research Organisation” as the registration purpose, following which the account request will be reviewed and approved by CDSCO. Existing users can request the CRO role through their user profile. The online system standardises the CRO registration workflow by requiring applicants to provide correspondence address details, accreditation information, and supporting documentation, followed by payment of the prescribed fee of INR 5,00,000 for registration or renewal.

The transition to the digital interface is aimed at reducing administrative burden and supporting more efficient processing of CRO applications by CDSCO, in line with broader policy measures towards e-governance in the regulatory landscape.

CDSCO ISSUES GUIDANCE DOCUMENT ON DISPOSAL OF EXPIRED AND UNUSED DRUGS

The CDSCO has released a comprehensive Guidance Document on disposal of expired and unused drugs (“Guidance Document”) dated May 26, 2025, outlining the procedures for the safe and compliant disposal of expired and unused drugs.⁵

This Guidance Document has been developed pursuant to the concerns raised by State Licensing Authorities (“SLAs”) regarding improper methods employed by manufacturers, wholesalers, and retailers for disposing expired stock, which risk non-compliance with environmental and drug regulatory norms. It requires licence holders across the manufacturing and distribution chain to adopt documented, verifiable disposal practices in accordance with the DCA and other laws as applicable for the safe disposal of expired and unused drugs. Licensees are required to maintain detailed records of stocks destroyed, including product particulars, batch numbers, quantities, reasons for disposal, and certification from the authorised waste disposal agency.

The Guidance Document also instructs SLAs and CDSCO officers to verify compliance during inspections and to ensure that destruction protocols are consistent with Good Manufacturing Practices (“GMP”) and Good Distribution Practices (“GDP”).

CDSCO CLARIFIES PROCESS FOR COPP/WHO-GMP APPLICATIONS FOR PRODUCTS AWAITING STATE LICENSE APPROVAL

The CDSCO has issued a clarification dated September 36, 2025, permitting applicants to submit applications for Certificates of Pharmaceutical Product (“COPP”) and WHO-GMP certification even in cases where the corresponding product licence application is still under examination by the concerned SLA.⁶ This clarification aims to streamline regulatory timelines, particularly for manufacturers seeking timely export facilitation while product approvals remain under review.

WHO-GMP certificate facilitates international market access to manufacturers for their products indicating that products are consistently produced and controlled according to quality standards determined by the World Health Organization (WHO). COPP is an official document issued by CDSCO that certifies a specific pharmaceutical product is authorized for sale or distribution within that country and that the manufacturer complies with GMP.

Applicants must first submit a complete product licence application with all requisite data to the SLA. While the licence application remains under consideration, the applicant may simultaneously apply for COPP/WHO-GMP certification for the same product. CDSCO will process these COPP/WHO-GMP applications in parallel with the product licence application, allowing for early initiation of assessment and reducing overall processing delays. However, the CDSCO has emphasised that no COPP or WHO-GMP certificate will be issued until the SLA confirms that the product licence has been duly approved and that the underlying license data has been verified and accepted. Thus, while parallel processing is permitted, grant of certification remains strictly contingent upon final product licence approval.

The move is expected to optimise timelines for export-oriented manufacturers while maintaining regulatory safeguards over product licensing and quality assurance.

CDSCO REITERATES MANDATORY TESTING OF RAW MATERIALS AND FINISHED FORMULATIONS

The CDSCO vide its directive dated October 7, 2025, has reiterated the mandatory requirement of testing raw materials, including excipients, and finished pharmaceutical formulations under the Drugs Rules, 1945 (“Drugs Rules”).⁷ The directive follows recent reports of quality lapses in the manufacturing process for certain pharmaceutical products.

In its communication to all State and UT Drug Controllers, CDSCO noted that inspections and investigations of drugs have revealed systemic non-compliance by certain manufacturers who failed to test each batch of raw materials, including inactive and active ingredients, before their use in formulation. Such omissions are in direct violation of the Drugs Rules which mandate that licence holders must test each batch of raw materials as well as each batch of the final product, either in their in-house laboratory or through an approved external laboratory, and maintain complete records as specified in Schedule U.

The directive emphasises that manufacturers must procure raw materials, including excipients, only from reliable, approved vendors and ensure traceability and quality assurance at every stage of the supply chain to ensure curbing supply of Not of Standard Quality drugs. SLAs have been directed by the Central Licensing Authority (“CLA”) to report compliance actions taken pursuant to this directive.

DRAFT AMENDMENT TO DRUGS RULES PROPOSES DEBARMENT OF APPLICANTS SUBMITTING MISLEADING OR FORGED INFORMATION

The MoHFW released a draft amendment to the Drugs Rules (“Draft Rules”) proposing a uniform framework for debarment of applicants found to have submitted misleading, fake, or fabricated documents or information across multiple licensing pathways.⁸

Under the Draft Rules, if an applicant, or any person acting on their behalf, is found guilty of submitting misleading or falsified documents or information, the licensing authority may, after issuing a show-cause notice and recording reasons in writing, debar the applicant for a period deemed appropriate. The Draft Rules propose to insert provisions covering activities such as manufacturing, sale, distribution, clinical trials, new drug approvals, and testing laboratories.

The draft also provides a right of appeal by which an aggrieved applicant may, within thirty (30) days of receiving the debarment order, appeal to the Central or State Government (as applicable).

PROPOSED MANDATORY TRACKING MECHANISMS FOR VACCINES, ANTIMICROBIALS, CANCER AND N&P DRUGS

The MoHFW vide order dated October 7, 2025, has proposed amendments to the Drugs Rules requiring all vaccines, antimicrobials, narcotic and psychotropic substances covered under the Narcotic and Psychotropic Drugs Act, 1985, and all anti-cancer drugs to carry a quick response (QR) code on their labels.⁹

Under the proposal, the existing list of 300 brands currently included in Schedule H2 of the Drugs Rules medicines that are required to bear a barcode or QR code will be redesignated as Table I, and a new Table II will be added to Schedule H2 to cover the broader ambit of all vaccines, antimicrobials, narcotic and psychotropic drugs, and anti-cancer medicines.

The amendment further requires manufacturers of drug formulations listed under Schedule H2 to print or affix a barcode or QR code on the primary packaging label, or on the secondary packaging where space on the primary label is insufficient. These codes must store information readable through software applications to enable authentication.

This initiative represents another measure aimed at combating counterfeit medicines, enhancing supply chain transparency, and enabling consumers to verify the authenticity of drugs.

CONCLUSION

These developments reaffirmed the Indian pharmaceutical sector’s status as a strong and strategically essential industry, backed by rising domestic momentum and international need. Meanwhile, the regulatory initiatives undertaken throughout the year signal the emergence of a reformed framework that encourages innovation. As companies adapt to evolving compliance standards and invest in innovation, it sets the stage for sustained growth, higher innovation, and a stronger focus on quality and patient outcomes in the future.

Naveli Sharma, Shlok Siddhant, Tanya Kukade and Dr. Milind Antani
You can direct your queries or comments to the authors.

¹Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI4NTA=

²Accessible at: https://pharma-dept.gov.in/sites/default/files/Circular%20No.%203%20of%202025%20and%20UCPMP%202024%20as%20amended.pdf

³Accessible at: https://www.meity.gov.in/documents/act-and-policies/digital-personal-data-protection-rules-2025-gDOxUjMtQWa?pageTitle=Digital-Personal-Data-Protection-Rules-2025

⁴Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1NzU=

⁵Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI3NTI=

⁶Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM0NDc=

⁷Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM0NzI=

⁸Accessible at: https://egazette.gov.in/(S(n1rojmrprrk1dlf0sifcu0j1)

⁹Accessible at: https://egazette.gov.in/(S(n1rojmrprrk1dlf0sifcu0j1