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Introduction
Welcome to the August 2025 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry. This month, we explored a range of significant legal and regulatory updates, including the introduction of an enhanced online Dual Use System on the SUGAM portal by CDSCO, initiative by The Food Safety and Standards Authority of India towards customer empowerment, and introduction of SHRESTH - the State Health Regulatory Excellence Index, for strengthening State drug regulatory systems.
In addition, we examine recent judicial decisions and government initiatives that impact the pharmaceutical and healthcare sectors. Stay informed on the evolving landscape with our comprehensive analysis and expert insights.
Pharmaceuticals
Legal and regulatory
1. Central Drugs Standard Control Organization (“CDSCO”) Launches Online Dual Use System for Bulk Drug Imports
CDSCO has introduced an enhanced online Dual Use System on the SUGAM portal, effective from August 31, 2025, streamlining the application and approval process for drugs imported in bulk for non-medicinal use. Stakeholders are required to complete a fresh registration, submit mandatory documents including government-issued address proof, a notarized undertaking, and authorized person ID, and follow a two-step NOC procedure for both zonal and port offices. The new system ensures greater transparency, security via OTP verification, and digital reconciliation of supply chain data. No Objection Certificate are valid for one year, with applications requiring technical literature and prior quantity justification. This modernization is aimed at reducing compliance burdens, expediting approvals, and strengthening regulatory oversight for all eligible industries.
2. Food Safety and Standards Authority of India (“FSSAI”) Mandates 'Food Safety Connect' App, QR Code at Food Outlets
The Food Safety and Standards Authority of India (“FSSAI”) issued a press release dated August 1, 2025, which requires all Food Business Operators, including restaurants, cafes, and eateries etc., to prominently display their FSSAI License or Registration certificate featuring the QR code for the 'Food Safety Connect' app at key customer-facing areas. This directive is aimed at enhancing consumer empowerment by enabling direct, user-friendly grievance redressal on food safety and hygiene. The QR code is now available on the front page of FSSAI licenses and registrations, and FBOs must also display it, or app download links, on their websites and online ordering platforms. Complaints registered through the app are quickly routed to jurisdictional authorities for expedited resolution, reinforcing FSSAI's commitment to a safer food environment nationwide.
3. The Ministry of Health and Family Welfare notified the Drugs (2nd Amendment) Rules, 2025
The Ministry of Health and Family Welfare notified the Drugs (2nd Amendment) Rules, 2025 (“Amendment Rules”). The Amendment Rules will come in force from March 1, 2026. As per the Drug Rules, 1945, manufacturers of drug formulation products as specified in Schedule H2 are required to print or affix Bar Code or Quick Response Code on its packaging that store data or information legible with software application to facilitate authentication. The Amendment Rules mandate the inclusion of qualitative details of excipients as part of the data stored in the label of drug formulation products as bar code or Quick Response (QR) code.
Health and wellness
Legal and Regulatory
4. Food Safety and Standards Authority of India in Consultation with Ministry of Ayush Releases Definitive List of Ayurveda Aahara Products under Category A
The FSSAI in consultation with the Ministry of Ayush, has released a definitive list of Ayurvedic food preparations under the category of “Ayurveda Aahara.” The list, provided under Note (1) of Schedule B of the Food Safety and Standards (Ayurveda Aahara) Regulations in 2022, is derived directly from the classical Ayurvedic texts mentioned in Schedule A, ensuring the authenticity and traditional foundation of these food formulations. This initiative is intended to support Food Business Operators (FBOs) by offering a clear and reliable reference for manufacturing Ayurveda Aahara products.
5. The Central Mental Health Authority notified the Mental Healthcare (Central Mental Health Authority) Amendment Regulations, 2025
The Central Mental Health Authority notified the Mental Healthcare (Central Mental Health Authority) Amendment Regulations, 2025 on August 12, 2025, vide which a new Chapter VII was included. The said chapter relates to ‘Classification and Categories of Mental Health Establishments.' The mental health establishments shall consist of the following classifications and categories: (i) Standalone Mental Health Establishments; (ii) Psychiatric Department of Medical Colleges; (iii) Psychiatric Wards of Multi-specialty Hospitals; (iv) Standalone De-addiction Centres; and (v) Centres for Psychosocial Rehabilitation. The aforementioned categories of mental health establishments are required to be registered with the respective Authority.
Government initiatives
6. CDSCO Final Deadline Announced for WHO-GMP COPP Applications via ONDLS Portal
CDSCO has reaffirmed that all applications for WHO-GMP Certificate of Pharmaceutical Product (“COPP”) must be submitted exclusively through the Online National Drug Licensing System portal, with the final deadline for physical submissions closing on August 15, 2025. This follows an extended transition period and comprehensive training sessions with state officials and industry stakeholders to ensure seamless adoption of the digital process. After this date, no hard-copy (i.e., physical) applications will be accepted by CDSCO or its zonal offices. All State/UT Drugs Controllers and pharmaceutical manufacturing units are directed to ensure proper mapping, verification, and online submission of applications to support regulatory compliance. For technical assistance, applicants may contact CDSCO IT Cell as specified in the official circular.
Medical devices
Legal and regulatory
7. Draft Rules Released for Clinical Electrical Thermometers Rules
The Ministry of Consumer Affairs has published draft rules amending the Legal Metrology (General) Rules, 2011, on July 31, 2025, and introduce comprehensive standards for clinical electrical thermometers used in continuous body temperature measurement. These draft rules envisaged the metrological and technical requirements—including permissible errors, probe and display specifications, and test procedures—for instruments used in critical care and surgical settings. This initiative aims to enhance patient safety, device reliability, and regulatory clarity within India's healthcare and medical device sector.
8. Union Health Ministry Launches SHRESTH for Strengthening State Drug Regulatory Systems
The Ministry of Health and Family Welfare, through CDSCO, has launched SHRESTH - the State Health Regulatory Excellence Index, a pioneering initiative to benchmark and enhance State drug regulatory systems via a transparent, data-driven framework. SHRESTH divides States into Manufacturing and Distribution categories, assessing them on key parameters such as human resources, infrastructure, licensing, surveillance, and grievance responsiveness. The index aims to promote uniform drug safety standards, facilitate capacity building, and encourage cross-learning of best practices among states. This virtual gap assessment tool supports maturity certification and the consistent delivery of safe and effective medicines across India, reinforcing the Government's commitment to safeguarding public health nationwide.
9. Updated Regulatory Protocols for In-Vitro Diagnostic Kits
The Ministry of Health and Family Welfare, in collaboration with the Indian Council of Medical Research (“ICMR”), CDSCO, Department of Health Research and Drugs Controller General of India, have issued updated protocols for evaluating In-Vitro Diagnostic (IVD) kits targeting critical pathogens including Influenza, SARS-CoV-2, Respiratory Syncytial Virus (RSV), Malaria, and Nipah virus. These protocols establish rigorous scientific standards to assess sensitivity, specificity, cross-reactivity, and reproducibility, ensuring the delivery of high-quality diagnostics for clinical use. The guidelines include detailed requirements for sample sizes, evaluation procedures, and ethical considerations, reflecting inputs from stakeholder consultations to enhance practical applicability and regulatory oversight. These standardized measures are vital to reinforcing India's diagnostic capabilities and readiness against infectious diseases. Manufacturers and laboratories are urged to comply with the protocols to guarantee diagnostic reliability and public health safety.
Healthcare and Allied Sector
Government initiatives
10. South & Southeast Asian Nations unite to strengthen health research systems through collaboration
The ICMR and DHR, convened representatives from Bhutan, Nepal, Sri Lanka, Timor-Leste, and India on August 23, 2025, for a high-level regional dialogue on strengthening health research systems. The meeting marked an important milestone in fostering collaboration across South and Southeast Asia to ensure that health research directly informs policy, addresses regional priorities, and builds sustainable systems for the future.
The representatives reached a consensus on several fronts such as:
• South–South Collaboration: Regional cooperation is essential to tackle common challenges such as antimicrobial resistance (AMR), non-communicable diseases (NCDs), and One Health.
• Pooling Resources & Expertise: Joint efforts in medical technology innovation, field epidemiology training, ethics, and quality assurance were identified as priority areas.
• Bridging Research & Policy: Participants committed to formal mechanisms for research–policy dialogue, ensuring that scientific evidence is translated into effective programmes.
Key judgements
Noteworthy judgement in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
Uvais Muhammad K.C vs State of Kerala, WP (C) No. 45300 of 2024
A recent decision by the High Court of Kerala has shed important light on the complex legal landscape surrounding altruistic organ donation in India. The case has brought attention to the challenges faced by individuals who wish to donate organs selflessly under the Transplantation of Human Organs and Tissues Act, 1994 (THOT Act).
Brief Background:
Uvais Muhammad, a 20-year-old with chronic kidney disease, desperately needed a kidney transplant. As none of his relatives could provide a donor kidney, Chippy S., an acquaintance with a motivation stemming from losing her younger brother to kidney disease, stepped forward to donate her kidney altruistically. Unfortunately, his application for approval was continuously rejected by the Authorization Committee, which is set up under the THOT Act, due to concerns that the donation might be financially motivated, mainly because of Chippy's economically vulnerable background.
Legal Framework:
Section 9(3) of the THOT Act requires that in cases where the organ donor and recipient are not related, the Authorization Committee must approve the donation. The Committee's role is to ensure that there are no commercial transactions involved and that the donation is voluntary and genuine.
To achieve the object of the THOT Act, the Transplantation of Human Organs and Tissues Rules, 2014 (“Rules”) were formulated. Sub-rule 3 of Rule 7 of the Rules set out the parameters which the Authorization Committee have to consider before issuing a Certificate under Form-18 of the Rules, granting permission for transplant.
Relying on the THOT Act and the Rules framed therein, the Court criticized the committee's mechanical rejection for issuing a certificate observing that it would be unpragmatic to assess every donation between non-relatives with scepticism in summary proceedings.
The Court relying on decisions of various Courts held that under the THOT Act altruistic intent is not limited to family members, people may feel genuine compassion for others, even strangers, and may wish to donate an organ purely out of humanitarian concern. The Court observed that such gestures must be viewed with an optimistic perspective. To presume that all non-relative donations are commercially tainted would be contrary to both the spirit of the law and the principles of fairness. The Court stressed that when a donor has clearly stated that the donation is voluntary and altruistic, the onus shifts to the Authorization Committee to prove otherwise. Unless the Authorization Committee can point to credible evidence of financial inducement, it must accept the donor's statement as genuine.
The Court also observed that denying permission on suspicion alone has grave consequences. For patients suffering from life-threatening conditions such as chronic kidney disease, the delay or denial of transplantation could amount to a denial of their right to life under Article 21 of the Constitution. Therefore, the scrutiny exercised by the Committee must be reasonable, proportionate, and evidence-based.
Court's Decision:
The Authorization Committee had rejected permission three times without producing any cogent material to demonstrate the presence of a commercial transaction. The only basis for rejection was suspicion arising from the absence of close familial ties between donor and recipient. Accordingly, responding to the delays that threatened the petitioner's life, the Court annulled earlier rejections and ordered the Authorization Committee to grant approval for the transplant within one week. It further stipulated that if the committee failed to act timely, permission would be deemed granted, thereby preventing further life-threatening delays.
This compassionate decision reflects a judicial willingness to adopt an empathetic and flexible approach toward organ donations, especially where procedural strictness could cost lives. The ruling aligns with other judicial rulings that urge recognition of genuine emotional connections between donors and recipients rather than blanket refusals based on non-relationship or economic status.
Conclusion:
This judgment is a crucial step toward reconciling ethical safeguards against organ commercialization with the need to respect genuine acts of altruism. Regulators and committees are encouraged to carry out detailed investigations based on facts instead of making decision based on income or background.
Organ donation in India faces many socio-economic challenges, and sometimes good intentions get caught up in bureaucratic red tape. Judgments like this restore faith in the legal framework, encouraging altruistic donations and providing hope to thousands in urgent need of transplants. In essence, the Kerala High Court's ruling marks an important advancement in protecting the constitutional right to life and health. By fostering a more just and timely organ donation approval process, it contributes to a more humane and effective organ donation system in India.
The Editor's Note
The August 2025 reforms reinforce a continuing trend toward digitalization, stricter traceability, and enhanced regulatory oversight seen in the previous month. For instance:
- July's online-only submission of cell and gene therapy trials on the SUGAM portal has now been mirrored by August's mandatory digital COPP applications and Dual Use import system, both of which increase compliance technology requirements.
- Similarly, July's standards for automated BP monitors anticipated the August draft standards for clinical electrical thermometers, signaling an incremental tightening of device metrology laws.
- Both months introduced reforms that disproportionately impact smaller players—from July's 100% inspection mandate for packaged water units to August's mandatory excipient disclosures on packaging.
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.
