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Introduction
Welcome to the July 2025 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry and its impact on the various stakeholders.
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. Discontinuation of term "Paramedical" and adoption of the term "Allied and Healthcare"
The Ministry of Health and Family Welfare issued a Circular dated July 01, 2025, directing all State Governments, Union Territories and relevant Universities/Institutions to discontinue the use of term "Paramedical". The term "Allied and Healthcare" defined under Section 2(b), (c), (d), (e) and (j) of the National Commission for Allied and Healthcare Professions Act, 2021 ("NCAHP Act"), shall be used henceforth in place of "Paramedical" in all forms of usage i.e., in all official correspondence, communications, policies, advertisements, training programs, institutional titles, recruitment notifications, educational materials and any other Government-related documents or portals etc. - in all forms—written, verbal, or electronic.
This measure aims to ensure uniformity in terminology, alignment with the legislative framework under the NCAHP Act and promote the formal recognition and standardization of the professions categorized under "Allied and Healthcare".
2. CDSCO releases the Subject Expert Committees Guidance Document
On July 17, 2025, the CDSCO released the 'Subject Expert Committees Guidance Document'. The Subject Expert Committee (SEC) experts examine and advice Drugs Controller General (India) (DGCI) on the proposals related to new drugs, clinical trials, new Investigational medical devices for regulatory approvals in the country. The SEC gives recommendations to CDSCO which are advisory in nature. CDSCO takes final decision under the applicable regulatory provisions considering all aspects including the recommendations of the SECs.
Given the importance of the SECs, this Guidance Document provides a framework for the operation, composition, responsibilities, and decision-making processes of the SECs, elaborating the role of SEC and its members, the step-by-step process involved in the SECs review and recommendation processes, and the roles and responsibilities of the applicant stakeholder in the evaluation process, to ensure transparency and consistency across applications.
3. CDSCO publishes the Guidance Document for Issuance of No Objection Certificate (NOC) for Manufacture of Unapproved/Approved New Drugs for Export Purpose
On July 17, 2025, the CDSCO published the 'Guidance Document for Issuance of No Objection Certificate (NOC) for Manufacture of Unapproved/Approved New Drugs for Export Purpose.' These guidelines mandate that the export NOC for manufacture of unapproved or approved new drugs for export purpose may be obtained from the zonal offices of the CDSCO through a two-step process.
The first step comprises of registration at zonal office, including one-time online registration, submission of export NOC or the Integrated Registration Form, submission of legal undertaking and manufacturing license, reconciliation data, NRA approval status of importing country. In case the NRA approval is not available a separate set of documents for Active Pharmaceutical Ingredient (APIs) must be submitted, finished formulations, R&D and new chemical entity batches. The second step includes the procedure for releasing consignment at the port office, including submission of documents online.
Health and wellness
Government initiatives
4. CDSCO Mandates Online Submission of Clinical Trial Applications for Cell and Gene Therapeutic Products
The Central Drugs Standard Control Organization (CDSCO) has announced a key regulatory update requiring all clinical trial applications (Phase I, II, and III) for Cell and Gene Therapeutic Products (CGTP) to be submitted exclusively through the SUGAM Online portal (www.cdscoonline.gov.in). Effective 10th July 2025, offline submissions will no longer be accepted. The initiative aims to streamline regulatory procedures, improve transparency, and enhance efficiency for all stakeholders involved in CGTP clinical trials. Comprehensive user manuals and video tutorials for the online application process are now available on the CDSCO portal to assist applicants.
5. India's Ayush Innovations Featured in WHO's Landmark Brief on AI in Traditional Medicine
The World Health Organization (WHO) has released a technical brief titled "Mapping the Application of Artificial Intelligence in Traditional Medicine", acknowledging India's pioneering efforts in integrating Artificial Intelligence (AI) with traditional medicine systems, particularly Ayush systems. The release follows India's proposal on the subject, leading to the development of WHO's first-ever roadmap for applying AI in traditional medicine.
Medical devices
Legal and regulatory
6. Price Hike on Non-Scheduled Drugs and Devices Capped at ten per cent
The National Pharmaceutical Pricing Authority (NPPA) has instructed all manufacturers, importers, and marketers of non-scheduled drugs and medical devices to limit MRP increases to 10% over the preceding 12-month period. This directive, issued under the Drugs Price Control Order, 2013, warns of penal action for non-compliance.
7. 100% Inspection Mandated for Packaged Drinking Water Units
The Food Safety and Standards Authority of India (FSSAI) has mandated comprehensive inspections of all packaged drinking water units in Hyderabad and Maharashtra. Using RAFT kits and mobile labs, the move categorizes bottled water as a "high-risk" product, requiring annual or bi-annual audits, enhanced quality checks, and immediate corrective measures to ensure safety and compliance.
8. New Standards Introduced for Automated Blood Pressure Monitors
The Indian Government has notified the Legal Metrology (General) Third Amendment Rules, 2025, aimed at regulating non-invasive automated sphygmomanometers and related accessories. The rules establish standards for accuracy, safety, and labeling to ensure the reliable monitoring of blood pressure at the arm, wrist, or thigh.
Healthcare and Allied Sector
9. The National Medical Commission (NMC) issued Public Notice on establishment of Grievance Redressal Mechanism for Medical Students, parents, and stakeholders
The National Medical Commission (NMC) has issued an important advisory to establish a structured Grievance Redressal Mechanism for medical students, parents, and stakeholders. Recognizing rising concerns related to fees, stipends, ragging, academic issues, and others, the NMC emphasizes resolving grievances at three levels—Medical College/Institute, University, and State/UT Health & Medical Education Departments.
Colleges and universities are advised to constitute dedicated committees, publish contact details online, and maintain records of grievances and their resolution. An online portal (https://nmc.org.in/ActivitiWebClient/open/initiateComplaint) has been activated for escalation of unresolved cases to the NMC. All stakeholders are encouraged to use these channels for prompt and transparent resolution of concerns.
10. National Medical Commission (NMC) issued Medical Institutions (Qualifications of Faculty) Regulations, 2025
NMC has released the Medical Institutions (Qualifications of Faculty) Regulations, 2025 — a significant step towards strengthening India's medical education ecosystem. These forward-looking reforms broaden eligibility criteria for faculty positions, now allowing experienced specialists from non-teaching government hospitals and diploma holders with adequate service to join medical colleges as professors and assistant professors.
Key highlights include - recognizing teaching and research experience from various government organizations; permitting the launch of simultaneous MBBS and postgraduate courses in new medical colleges; rationalizing faculty and infrastructure requirements for starting PG programs; and expanding the scope for faculty with MSc-PhD qualifications. The regulations also raise the upper age limit for Senior Residents in pre- and para-clinical fields and facilitate internal mobility of faculty across specialties.
11. NMC Takes Strict Action Against Corruption in Medical College Assessment
The National Medical Commission (NMC) has issued a strong press release following the arrest of a senior assessor for accepting a bribe in connection with the assessment of a private medical college in Karnataka. The NMC has blacklisted the assessor and imposed stringent sanctions on the implicated college, including denial of seat renewals and cancellation of new course applications for 2025-26. The Commission reiterated its zero-tolerance policy towards corruption, affirming that any violations by assessors or institutions will attract severe penalties as per the NMC Act and regulations. All stakeholders are urged to strictly comply with NMC norms and uphold the highest standards of integrity in medical education.
12. Ethical Guidelines Issued for Live Surgical Demonstrations
The National Medical Commission has released official guidelines for the ethical conduct and broadcast of live surgeries. Key requirements include explicit patient consent, data anonymization, oversight by ethics boards, clear educational intent, and strict limits on commercialization. The guidelines were introduced in response to Supreme Court concerns and aim to protect patient safety and dignity.
Key judgement(s)
Noteworthy judgement in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
Sukdeb Saha v. State of Andhra Pradesh, 2025 SCC Online SC 1515
In a recent judgment passed by the Supreme Court on 25th July 2025, the Supreme Court in a bid to make urgent social reform, has formulated measures in addressing mental health crisis among students. While the appeal stemmed from the tragic death of a NEET aspirant, the Court utilized the matter to recognize mental health as an inseparable part of the right to life under Article 21 and laid down binding guidelines under Articles 32 and 141, for educational institutions across the country.
The Court observed that mental health is a core component of a dignified life. Relying on the judgments passed in the matter of Shatrughan Chauhan v. Union of India and Navtej Singh Johar v. Union of India, the Court reiterated that mental integrity, psychological autonomy, and freedom from degrading treatment are essential to human dignity and thereby protected by Article 21.
The Court also placed significant reliance on the Mental Healthcare Act, 2017 ("Act"), particularly Section 18 of the Act, which guarantees the right to access mental health services for all individuals. In addition, the Court highlighted Section 115 of the Act, which explicitly decriminalizes attempted suicide, thereby recognizing that individuals who attempt suicide require care, compassion, and medical assistance, rather than punishment. The Supreme Court held that these provisions read with judicial precedents reflect a broader constitutional vision that mandates a responsive legal framework to prevent self-harm and promote well-being, particularly among vulnerable populations such as students and youth.
The Supreme Court also placed reliance on India's obligations under international law. It referred to Article 12 of International Covenant on Economic, Social and Cultural Rights which recognizes the right to the highest attainable standard of physical and mental health. The Court also cited General Comment No. 14 issued by the United Nations Committee on Economic, Social and Cultural Rights, which mandates timely access to mental health care and proactive measures for preventing mental illness, including suicide. Additionally, the Court referred to WHO's Mental Health Action Plans such as the WHA66.8 Comprehensive Mental Health Action Plan 2013-2020 which identifies suicide prevention as a global public health priority, calling upon States to reduce suicide mortality rates through national strategies, school-based interventions, and community support mechanisms.
Taken together, these international norms and domestic legal standards underscore that suicide prevention is not merely a policy aspiration, but a binding constitutional and international obligation.
Acknowledging the regulatory vacuum, the Court drew a parallel from the matter of Vishaka v. State of Rajasthan, AIR 1997 SC 3011, where interim guidelines were issued against sexual harassment in the absence of a statutory framework. Here too, invoking its powers under Articles 32 and 141, the Court stepped in to create guidelines for all educational institutions, pending finalization of the National Task Force Report on student suicides.
The Supreme Court's Guidelines: A National Framework for Student Mental Health
Accordingly, the Court issued 15 detailed guidelines, applicable to all schools, colleges, universities, coaching centers, and hostels (both public and private), including:
1. Uniform Mental Health Policy: Institutions must adopt a publicly accessible mental health policy based on UMMEED, MANODARPAN, and the National Suicide Prevention Strategy.
2. Mandatory Counsellors: At least one trained mental health professional per 100 students, or formal referral mechanisms for smaller institutions.
3. Optimal Student–Counsellor Ratios: Especially during exam seasons, mentors should be available for informal and confidential support.
4. No Academic Segregation or Shaming: Performance-based batch segregation and unrealistic academic targets are strongly discouraged.
5. Crisis Protocols and Helpline Visibility: Clear protocols for emergency referrals and visible suicide helpline displays across campus.
6. Staff Sensitization Training: Bi-annual mental health first-aid training for all teaching and non-teaching staff.
7. Inclusive and Sensitive Campus Culture: Special emphasis on non-discriminatory practices for SC/ST/OBC, LGBTQ+, disabled, and marginalized students.
8. Redressal Against Abuse: Robust systems for complaints of sexual harassment, bullying, or caste/gender-based abuse—with institutional liability for failures.
9. Parental Involvement: Regular parent orientation on mental health and the dangers of academic pressure.
10. Monitoring and Reporting: Annual anonymized wellness reports to be submitted to education regulators like UGC, AICTE, CBSE, etc.
11. Promoting Extracurriculars: Institutions must reduce academic overburden by promoting arts, sports, and personal development.
12. Structured Career Counselling: To help students and parents make realistic and interest-based academic choices.
13. Safe Hostel Environments: Zero tolerance for harassment and substance abuse in residential facilities.
14. Suicide-Proof Infrastructure: Tamper-proof ceiling fans, restricted rooftop access, and other design-based interventions.
15. Heightened Safeguards in Coaching Hubs: Special protections in high-risk cities like Kota, Hyderabad, Delhi, and Visakhapatnam.
The Supreme Court held that the above guidelines shall apply to all educational institutions across India, including public and private schools, colleges, universities, training centres, coaching institutes, residential academies, and hostels, irrespective of their affiliation.
In a bid to implement these guidelines, the Court directed All States and Union Territories to frame rules within two months, for student protection norms, and grievance redressal mechanisms for all private coaching centres, and also directed the setting up of a District-level Monitoring Committees to be constituted under District Magistrates for enforcement. The Court also directed the Union of India to file a compliance affidavit in 90 days detailing actions taken by States and Union Territories and also on the progress made on the National Task Force's recommendations.
Conclusion:
The Supreme Court's judgment is not just a legal pronouncement; it is a call to rehumanize education. By declaring mental health, a constitutional right and prescribing a proactive institutional framework, the Court has responded to a grave societal crisis.
Like the Vishaka judgment which laid the groundwork for legal reform in workplace harassment, these ruling lays the foundation for mental health jurisprudence and policy in India's educational sector. The challenge now lies in implementation, requiring coordinated action by governments, regulators, and educational institutions to uphold the dignity and well-being of every student.
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.
