Introduction
Welcome to our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry. This month, we explore a range of significant legal and regulatory updates. We also examine recent judicial decisions and government initiatives that impact the pharmaceutical, medical device and healthcare sectors. Stay informed on the evolving landscape with our comprehensive analysis and expert insights.
Pharmaceuticals
Legal and Regulatory
1. National Regulatory Authority of India meets WHO international standards for vaccine regulations.
On October 11, 2024, The Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, was found to meet the World Health Organization (WHO) published indicators for a functional vaccine regulatory system. This acknowledgment came after an evaluation by international experts, focusing on essential aspects such as safety, efficacy, and quality. The assessment utilized the WHO's Global Benchmarking Tool (GBT) Version VI, which incorporates stricter standards than previous versions. India achieved a maturity level of 3, indicating strong performance in key regulatory functions. This recognition enhances India's role in global health and its capacity to produce affordable vaccines, with ongoing support from the WHO for further strengthening regulatory capabilities.
2. Drugs (Fifth Amendment) Rules, 2024
Ministry of Ayush has introduced changes to the licensing and manufacturing processes for Ayurveda, Siddha, Sowa-Rigpa, Unani, Homeopathic medicines in India under the Drugs Rules, 1945. The rules now have introduced the definition of "New Homeopathic Medicines" and have established a process for their import and approval. It also requires evidence of safety, therapeutic efficacy, and minimum homoeopathic standards for new medicines. New Homeopathic Medicines will be considered "new" for five years after initial approval, post which these medicines will be considered as homoeopathy medicines.
The rules mandate online applications via the e-AUSHADHI portal for selling, stocking, and distributing Homoeopathic medicines. They establish standardized fees for license applications. Retail and wholesale licenses for Homoeopathic medicines will be perpetual, requiring a self-declaration of compliance with regulations every five years.
A Good Manufacturing Practices (GMP) certificate is mandatory for obtaining a manufacturing license. The rules specify the required qualifications for personnel overseeing the manufacture of Homoeopathic medicines. Manufacturing facilities must undergo regular inspections at least once every five years. The GMP certificate will have perpetual validity, subject to renewal fees every five years.
These rules seek to enhance the quality, safety, and accessibility of Homoeopathic medicines in India. The introduction of an online application system and perpetual licenses is designed to streamline the process for legitimate manufacturers and sellers. By emphasizing New Homoeopathic Medicines and enforcing stricter quality control measures, the regulations aim to ensure the efficacy and safety of these products.
The gazette notification for the said amendment can be accessed through the link below.
3. Draft Proposal for Comments and Inclusion in The Indian Pharmacopoeia
The Indian Pharmacopoeia Commission (IPC) released a draft known as "Disinfectants and Antiseptics (Version-3.0)" on October 24, 2024, for a new general chapter on disinfectants and antiseptics to improve guidelines in healthcare settings. The draft guidelines aim to clarify the classification, testing, and use of disinfectants and antiseptics in hospitals and clinics. The IPC encourages feedback from healthcare professionals, manufacturers, and the public to ensure the guidelines are effective and practical. Once finalized, these updated standards will be included in the next edition of the Indian Pharmacopoeia, set for release in 2026, helping to enhance patient safety and infection control in healthcare environments.
4. NPPA has reduced the maximum retail price (MRP) and Goods and Services Tax (GST) rate of three anti-cancer drugs
The National Pharmaceutical Pricing Authority (NPPA) issued an office memorandum on October 28, 2024, directing the reduction of the MRP of three anti-cancer medications, namely, Trastuzumab, Osimertinib, and Durvalumab, in accordance with the government's commitment to guarantee the availability of medications at reasonable prices. This action was taken in response to the Union Budget's statement in 2024–2025 that stated that these three anti-cancer medications would not be subject to customs duties. Additionally, the GST rates for these three medications were decreased from 12% to 5%.
5. DGFT Aligns Pharma Export Rules with New Tariff Codes for Streamlined Process
The Directorate General of Foreign Trade (DGFT) has issued a trade notice to harmonize and streamline pharma export process and bring in line Schedule-II (Export Policy) with the latest tariff codes under the Finance Act, 2024. A draft of Schedule-II covering Chapters 01 – 98 of the ITC (HS) codes has been released for public feedback and comments.
6. Draft Regulations for Non-Invasive Automated Sphygmomanometers Proposed by Consumer Affairs Ministry
The Ministry of Consumer Affairs proposed draft regulations on November 29, 2024, to govern non-invasive automated sphygmomanometers and their accessories, which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure, and has sought feedback from stakeholders, in order to foster the collaborative development of these critical regulations. These regulations are intended to establish clear guidelines for the accuracy, design, and functionality of these devices, thereby guaranteeing their dependability in clinical settings. Furthermore, the draft specifies the testing procedures that manufacturers are required to implement in order to preserve the reliability and consistency of the devices' functionality.
7. The Ministry of Health and Family Welfare Prohibits Nimesulide and its formulation for animal use
This Central Government has found that the use of the drug formulations containing Nimesulide are likely to involve risk to animals. Further safer alternatives of the said drugs are available. In view of the same and in public interest, the Ministry of Health and Family Welfare vide notification dated December 30, 2024, prohibited the manufacture, sale and distribution of the drug, Nimesulide and its formulation for animal use.
8. India Set to Introduce Indigenous Antibiotic 'Nafithromycin' for Community-Acquired Pneumonia
India is set to introduce "nafithromycin", the first indigenous macrolide antibiotic, pending final approval from the Central Drugs Standard Control Organization (CDSCO). This innovative antibiotic, which is ten times more effective than azithromycin, offers a rapid three-day treatment for community-acquired bacterial pneumonia caused by drug-resistant bacteria, marking a significant advancement in the fight against antimicrobial resistance (AMR).
Government Initiatives
9. Joint Working Group Meeting Held to Strengthen Pharmacopeial Cooperation
A Joint Working Group meeting was held between officials from the IPC, and representatives from the national regulatory authorities of Bhutan, Mauritius, Mozambique, Nepal, the Solomon Islands, and Sri Lanka on October 16, 2024. The meeting focused on strengthening pharmacopeial cooperation and establishing an annual forum for ongoing collaboration.
During the meeting, IPC provided an overview of recent IPC developments, including the launch of the IP online portal and its growing international recognition. Partner countries shared their expectations, discussed mutual interests, and made various requests, such as additional subscriptions to the IP Online portal, training programs, and access to reference standards. The discussions concluded with all sides agreeing on the importance of organizing an annual pharmacopeial cooperation meeting to facilitate continued engagement and collaboration.
10. Food Safety and Standards Authority of India (FSSAI) Reduces Sample Size for Vitamin D2 Analysis to Cut Costs
FSSAI has directed to reduce the sample size of Vitamin D2 for analysis as it is an expensive ingredient. Earlier a sample of 500g was drawn for analysis, however now a sample of at least 50g is to be drawn i.e., two samples of 25g each, from the imported consignment and after the analysis, the remaining 25g should be returned to the importer making the sample collection process more cost-effective.
11. CDSCO streamlines procedure for updating Clinical Trial Sites online over SUGAM Portal
To streamline regulatory submissions, the Central Drugs Standard Control Organization (CDSCO) has enabled online applications for Clinical Trial Site Addition and Change of Principal Investigator via the SUGAM Portal (www.cdscoonline.gov.in). The notice was released on December 26, 2024. Applicants must submit the required documents, including Ethics Committee approval, through the portal. The proposed site addition is deemed approved if no objections are raised within 30 days, while the change of Principal Investigator is approved upon receipt of a complete application. This digital process enhances efficiency, transparency, and compliance for clinical trials, including global studies, new drugs, and bioavailability studies, supporting faster approvals and smoother trial operations.
Healthcare and Allied Sector
Legal and Regulatory
12. Pharmacy Council of India issues Guidelines for verifying Pharmacists Profile
The Pharmacy Council of India vide notification dated November 20, 2024, has issued guidelines regarding verification of Pharmacists Profile with the Ayushman Bharat Health Account ("ABHA") Number to integrate Pharmacists with the Healthcare Professional Registry ("HPR").
As per the guidelines, the Council is in the process of verification of all registered Pharmacists on the DIGI-PHARMed portal in order to integrate Pharmacists with the HPR. Further, this verification has to be done to verify DIGI-PHARMed profile with ABHA number within 45 days from issuance of circular. In case of new registrations Pharmacists must ensure to verify their account with ABHA number at the time of registration only.
13. ASUDTAB proposes New Rules for regulating retail sales of AYUSH Medicines
In its recent meeting, the Ayurveda Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) has proposed to amend the Drugs Rules, 1945, and regulate the retail sale of AYUSH medicine, which would empower drug inspectors to inspect these premises and collect and examine samples. The amendment is aimed to regulate the sale of ASU drugs from retail outlets which will require prior approval and also submitting the formulations of the ingredients to the e-AUSHADHI portal.
14. NMC Issues Medical Assessment and Rating Board (MARB) Guidelines – For Assessment of Medical Colleges/Institutions, 2024
National Medical Commission (NMC) has released comprehensive guidelines for the purpose of implementation of NMC regulations to fulfil functions of MARB as per the National Medical Commission Act, 2019 (NMC Act). As per Section 26 (b) of NMC Act, MARB shall grant permission for the establishment of a new medical institution, or to start any postgraduate course or to increase number of seats. To carry out the aforementioned functions the NMC has released the Guidelines – For Assessment of Medical Colleges/Institutions, 2024. The portal for application was open from 5th December 2024 till 4th Jan 2025.
Government Initiatives
15. National Accreditation Board for Hospitals and Healthcare Providers (NABH) announces certification programme for HIS/EMR Systems.
The NABH has started a certification program for Hospital Information Systems (HIS) and Electronic Medical Record (EMR) systems. This program follows the introduction of new standards for HIS/EMR at the National Patient Safety Conference on September 17, 2024. The goal is to ensure that these systems work well together and meet the requirements of the National Health Authority's Ayushman Bharat Digital Mission (ABDM) platform. NABH will offer two levels of certification, Basic and Advanced, each valid for two years. Registrations will open on December 1, 2024. Applicants need to prepare documents like ABDM and WASA certificates. This initiative aims to improve the quality of HIS/EMR products and enhance healthcare services in India.
General Updates
16. Ministry of Chemicals and Fertilizers Launches INR 500 Crore Scheme to Boost India's Medical Device Industry
On November 8, 2024, the Union Minister for Chemicals and Fertilizers, Jagat Prakash Nadda, has launched a new initiative worth INR 500 crores titled "Scheme for Strengthening the Medical Device Industry," to enhance manufacturing, skill development, clinical studies, and infrastructure in the medical device sector. It includes five sub-schemes designed to reduce import dependence and promote domestic production, ultimately supporting India's goal of self-reliance in healthcare.
17. Ayushman Bharat: Vay Vandana Cards achieves Milestone
On October 29, 2024, Prime Minister Shri Narendra Modi inaugurated multiple health sector projects worth approximately INR 12,850 crore at the All India Institute of Ayurveda (AIIA) in New Delhi. Marking a transformative step in healthcare, the Prime Minister announced that every senior citizen aged 70 and above would receive free treatment in hospitals. Such elderly individuals will be provided with the Ayushman Vay Vandana Card. This initiative has already seen significant participation, with over 10 lakh senior citizens enrolling for the Ayushman Vay Vandana Card, ensuring themselves of free treatment and support under the scheme.
18. Expansion of Ayushman Bharat Coverage to include Senior Citizens aged 70 and above
The Government of India expanded Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) to provide free treatment benefits of up to 5 lakh per year on a family basis to all senior citizens aged 70 years and above, irrespective of their socio-economic status. Also, approximately 1,961 procedures across 27 medical specialties, including General Medicine, General Surgery, Orthopaedics, Cardiology, Oncology, and more, can now be availed by different age groups.
19. IMA Launches AMR Smart Hospital Project to Combat Antimicrobial Resistance
The Indian Medical Association (IMA) has launched the IMA AMR Smart Hospital Project, an initiative aimed at combating Antimicrobial Resistance (AMR) through advanced Antimicrobial Stewardship (AMS) and Infection Prevention and Control (IPC) practices.
Health and Wellness
Legal and Regulatory
20. Public notice was published by the Ministry of Ayush for the public to be aware of misleading advertisements.
The Union AYUSH Ministry has banned the advertising of Ayurveda, Siddha, Unani, and Homeopathy drugs that make claims of "miraculous or supernatural effects." This move is intended to protect the public from misleading information about these products. To promote safety, the ministry requires that these drugs carry a label warning that they should only be used under medical supervision. Additionally, the ministry clarified that it does not certify or approve any companies for manufacturing these traditional medicines; instead, licensing is managed by State authorities. This initiative is part of a broader effort to ensure consumers receive accurate information about alternative medicines and to prevent unverified claims that could endanger public health.
21. Central Government releases Draft Liquid Waste Management Rules, 2024
The Ministry of Environment, Forest and Climate Change published the Draft Liquid Waste Management Rules, 2024, which shall come into force on October 1, 2025. These Draft rules were published on October 7, 2024. These new rules aim to address the management of liquid waste as a whole and each of its aspects individually. These aspects are: Liquid waste minimization; managing the collection of liquid waste; treatment of liquid waste; reuse/utilization of treated wastewater or sludge/faecal sludge; discharge/disposal of the remaining treated wastewater or sludge/faecal sludge. This initiative is designed to promote better waste management practices and protect our environment as India faces increasing challenges with wastewater.
Objections or suggestions on the proposals contained in the draft notification, if any may be sent to the designated authority within a period of sixty days of its publication.
22. Department of Consumer Affairs publishes the Guidelines for Prevention and Regulation of Greenwashing or Misleading Environmental Claims, 2024
The Department of Consumer Affairs issued the Guidelines on October 15, 2024, for the Prevention and Regulation of Greenwashing and Misleading Environmental Claims, 2024. These guidelines regulate the nature of technical terms that can be used in these claims and prescribe requirements for substantiation of the claims. These guidelines are operating in accordance with the Guidelines for Prevention and Regulation of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022, and have laid down the conditions that must be followed when using environmental claims in any kind of advertising that are outlined in the Greenwashing Guidelines.
23. Department of Health Research and the Indian Council of Medical Research host the DHR-ICMR Health Research Excellence Summit 2024
The Department of Health Research and the Indian Council of Medical Research (DHR-ICMR) hosted the DHR-ICMR Health Research Excellence Summit 2024 at Sushma Swaraj Bhawan, New Delhi. The event witnessed the launch of several significant initiatives designed to bolster ICMR's contributions to healthcare innovation. Notable among them was the Research Infrastructure Sharing Ecosystem (I-RISE) Policy which is a collaborative platform for expanding access to ICMR's extensive laboratory and research network to foster healthcare innovation.
24. FSSAI Issues Advisory on Preventing Misleading Food Advertisements
The Food Safety and Standards Authority of India ("FSSAI") issued an advisory dated November 11, 2024, urging Food Business Operators ("FBOs") to ensure compliance with the Supreme Court's decision in Indian Medical Association v. Union of India to curb misleading advertisements and protect consumer interest. The Supreme Court held that before an advertisement is printed/ aired/ displayed, a self-declaration must be submitted by the advertiser/ advertising agency on the designated portal.
Subsequently, the Ministry of Information and Broadcasting introduced a new feature on Broadcast Seva Portal for TV and Radio, and the Press Council of India's portal for print/ digital/ internet to upload and generate the said self-certification prior to telecast/ publishing of the advertisement. The portal has been operational since June 4, 2024. The FSSAI has advised that all FBO's should comply with the given directives.
25. FSSAI Designates Packaged Drinking and Mineral Water as High-Risk Food Categories
India's food regulator, the Food Safety and Standards Authority of India (FSSAI) has designated packaged drinking water and mineral water as "High-Risk Food Categories" after the removal of mandatory Bureau of Indian Standards (BIS) certification for these products. This decision will now require the manufacturers to undergo annual risk-based inspections and third-party audits before obtaining licenses or registrations.
26. FSSAI Updates List of Accredited Food Testing Laboratories
FSSAI has released an updated list of recognized food testing laboratories, detailing their National Accreditation Board for testing and Calibration Laboratories (NABL) accreditation validity as of December 12, 2024. These laboratories are authorized to analyze food samples under the Food Safety and Standards Act, 2006. The list includes validity details and contact information for laboratories in the Northern Region, with recognition guidelines governed by FSSAI's directives.
27. Draft Rules for Extended Producer Responsibility to manage post-consumer waste
India's Ministry of Environment, Forest, and Climate Change has released draft rules under the Environment Protection Act, 1986, which aims to introduce Extended Producer Responsibility (EPR) for managing post-consumer waste generated from paper, glass, metal packaging, and sanitary products. These draft regulations are designed to ensure that producers, importers, and brand owners take accountability for recycling and reusing materials, aligning with the broader goal of reducing environmental pollution. By enforcing EPR targets starting in April 2026, the rules promote a circular economy through initiatives like recycling, reuse, and waste-to-energy programs, ultimately supporting sustainable waste management practices.
28. FBOs to submit quarterly details on rejected/ expired food items over FoSCoS portal
Under Sections 26 and 27 of the Food Safety and Standards Act, 2006, Food Business Operators (FBOs) are mandated to ensure food safety and proper storage practices. As per FSS (Licensing and Registration of Food Business) Regulations, 2011, raw, processed, rejected, recalled, or returned materials must be segregated, marked, and stored securely, following FIFO (First in, First Out)/ FEFO (First Expire First Out) systems. To prevent rejected/expired food items from being rebranded or misused, FSSAI has introduced a new provision in FoSCoS requiring FBOs to submit quarterly details on rejected/expired quantities and action taken with rejected/expired Items. FBOs must maintain accurate records for timely submissions once the provision is activated.
General Updates
29. Government's Intensified Efforts to Eliminate Tuberculosis by 2025
The Indian government is intensifying efforts to eliminate tuberculosis (TB) by 2025, targeting 347 high-focus districts across 33 states and Union territories. A 100-day TB elimination campaign will be launched by the Union Health Ministry in this regard to enhance case detection, reduce diagnostic delays, and improve treatment outcomes, particularly among vulnerable populations.
30. AYUSH Ministry to Launch 'Trinetra' Portal for Pharmacovigilance and Misleading Advertisements Prevention
The Union Ministry of AYUSH will reportedly launch a national portal, 'Trinetra', for pharmacovigilance in Indian Systems of Medicine (ISM) to curb misleading advertisements. Announced at the World Ayurveda Congress in Dehradun, the portal will ensure quicker reporting of misleading advertisements thereby improving consumer safety. Experts emphasized the need to protect Ayurveda's reputation and address false claims of "magic cures" and "side-effect-free" treatments.
Medical Devices
Legal and Regulatory
31. CDSCO has introduced reporting mechanism for Medical Device Adverse Events
On October 8, 2024, CDSCO introduced an updated Medical Device Adverse Event Reporting Form under the Materiovigilance Program of India (MvPI), i.e. version 1.2 to make it easier to report Medical Device Adverse Events (MDAEs). The form is designed to be used by Manufacturers/Importers/ Distributors of Medical Devices and Healthcare Professionals with direct/indirect knowledge of Medical Devices Adverse Events. Individuals/patients who report these instances will not face legal consequences, according to the new form, and their identities will be kept anonymous. This aims to encourage more healthcare professionals and stakeholders to exchange information regarding adverse incidents, hence increasing patient safety and medical device monitoring in India.
32. Revised List of High-End, High-Value Used Medical Equipment other than critical care medical equipment.
The Revised List of High-End, High-Value Used Medical Equipment in India now permits the import of 38 types of refurbished medical devices, excluding critical care items. This initiative, issued by the Ministry of Environment, Forest, and Climate Change (MoEFCC), aims to enhance access to advanced medical technologies, especially in smaller cities. The list includes essential devices like MRI, CT scans, PET-CT machines, and robotic surgical systems. To ensure safety and reliability, the imported equipment must have a minimum residual life of seven years and be certified by a Chartered Engineer. Importers are also required to comply with hazardous waste management regulations and provide a one-year warranty along with a three-year Comprehensive Maintenance Contract (CMC).
33. IPC Implements New Pharmacovigilance Guidelines for Marketing Authorization Holders
The Indian Pharmacopoeia Commission (IPC) has announced the implementation of the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) Version 2.0, via a notice released on November 11, 2024, and will be effective from February 1, 2025. The document aims to strengthen the pharmacovigilance systems of MAHs in India. This is brought to the attention of all concerned that National Coordination Centre Pharmacovigilance Programme of India (NCC- PvPI), IPC and CDSCO released the Pharmacovigilance Guidelines for pharmaceutical products.
34. ICMR Calls for Proposals to Evaluate High-Priority Medical Device Technologies
ICMR is inviting proposals from government and nongovernment organization under Centre for Advanced Research (CAR) scheme, currently advertised on ICMR website, for carrying out clinical evaluation studies of high priority medical device & diagnostic technologies. Some of the technologies recommended for innovation mapping are as follows: AI enabled portable platform for cervical cancer screening, Electrochemotherapy for soft Tissues, Paper based point of care device –PrePAP QR etc.
35. BIS Develops Standards for Assistive Medical Devices to Enhance Accessibility
The Bureau for Indian Standards (BIS) is currently addressing the need for medical assistive technology that is reliable and affordable. The Bureau is developing standards for innovative products such as therapeutic footwear, portable ramps, braille displays, and fall detectors, which support individuals with disabilities and enhance their quality of life. Aligning with the agenda laid down in National Medical Device Policy, 2023, BIS has been prioritizing developing standards for 214 critical medical devices, identified in consultation with Department of Pharmaceuticals. It includes septal closure devices, plasma sterilizers, and phototherapy machines. The initiative was notified vide a press release dated November 25, 2024, and is set for phased completion by December 2025.
36. Amendment to Medical Devices Rules for Laboratory Designation and Testing
Ministry of Health and Family Welfare has issued an amendment to the Medical Devices Rules, specifying laboratories, and the Medical Devices that the laboratories are designated to test.
Government Initiatives
37. Prime Minister inaugurates five projects under the PLI scheme for medical devices and bulk drugs.
In a major boost to Make in India initiative in the healthcare sector, the Prime Minister on October 29, 2024, inaugurated five projects under the Production Linked Incentive (PLI) scheme for medical devices and bulk drugs at Vapi in Gujarat, Hyderabad in Telangana, Bengaluru in Karnataka, Kakinada in Andhra Pradesh and Nalagarh in Himachal Pradesh. These units will manufacture high-end medical devices, such as body implants and critical care equipment, along with important bulk drugs.
38. CPCB issues Show Cause Notice to Producers, Importers, and Brand Owners
The Central Pollution Control Board (CPCB) has issued a Show Cause Notice under Section 5 of the Environment (Protection) Act, 1986, for non-compliance with the Plastic Waste Management (PWM) Rules, 2016, as amended. The notice highlights the failure of Producers, Importers, and Brand Owners (PIBOs) to meet Extended Producer Responsibility (EPR) targets for FY 2022-23 and/or FY 2023-24, including non-submission or shortfall in annual returns. As per the EPR Guidelines, environmental compensation (EC) will be levied at INR 2,900/T (Cat I), INR 5,000/T (Cat II), and INR 7,900/T (Cat III & IV) for unfulfilled targets. Additionally, EPR targets for FY 2024-25 will be increased by 25% as a penalty.
Key Judgements
Noteworthy judgement in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
Neeraj Sud & Anr vs Jaswinder Singh (Minor) & Anr, 2024 SCC Online SC 3069
In a recent order passed by the Hon'ble Supreme Court on 25th October 2024, the Hon'ble Supreme Court clarified the principles of medical negligence. The judgment underscored the need for evidence to establish negligence and observed that a patient not responding favorably to a surgery or treatment would not by itself amount to negligence.
Background of the Case
The Complainants, a father, and his minor son, alleged negligence against Dr. Neeraj Sud and the Post Graduate Institute of Medical Education & Research, Chandigarh following a surgery performed by Dr. Sud to cure the minor son's congenital disorder in the left eye called "PTOSIS" (also known as drooping eyelid). The Complainants claimed that the condition of the minor son deteriorated post-surgery, due to negligence leading to severe ptosis and double vision. The Hon'ble State Commission dismissed the complaint in 2005 holding that there was no negligence on the part of the Respondents.
Aggrieved by the said order, the Complaints preferred an appeal before the Hon'ble NCDRC. Hon'ble NCDRC reversed the decision of the State Commission, holding Dr. Sud and PGIMER jointly and severally liable for compensation of INR 3,00,000, with interest, and costs of INR 50,000.
Hon'ble NCDRC in its finding held that the minor son had proper 6/9 vision in both eyes before the surgery. However, post-surgery, the condition of ptosis deteriorated from moderate to severe and the vision of the patient also fell down from 6/9 in both eyes to 6/18. Accordingly, NCDRC held Dr. Sudd was negligent in giving proper treatment.
Both parties appealed to the Supreme Court. The Complainants appealed for enhancement of compensation and the Respondents appealed to challenge the finding of negligence.
Supreme Court's Analysis
The Court reiterated that actionable medical negligence requires proof of:
1. Duty of Care: Failure on the part of the doctor to demonstrate the exercise of requisite skill and competence while giving treatment.
2. Breach of Duty: Failure to meet the expected standard of care.
3. Consequential Damage: A direct link between the breach and the harm caused.
In the present case, the Complainants failed to establish any breach of duty or deviation from standard medical practices. The Hon'ble Supreme Court observed that mere dissatisfaction with surgical outcomes or post-surgical complications does not automatically imply negligence.
Key Legal Principles Affirmed
1. Bolam's Test: The Hon'ble Supreme Court reaffirmed the standard laid down in Bolam v. Friern Hospital Management Committee (1957), holding that a doctor is not negligent if they act in accordance with practices accepted by a responsible body of medical professionals.
2. Jacob Mathew Case: The Court emphasized its earlier ruling in Jacob Mathew v. State of Punjab (2005) 6 SCC 1, which protects medical professionals who exercise reasonable skill and care in their practice.
3. Complications vs. Negligence: It is not uncommon for surgeries to result in complications, but this does not amount to negligence unless there is evidence of a lack of reasonable care or skill.
Observations on NCDRC's Findings
The Hon'ble Supreme Court criticized Hon'ble NCDRC for its reliance on medical records alone, without expert evidence. Hon'ble Supreme Court found no proof that Dr. Sud failed to exercise due care or skill. The deterioration in the patient's condition, while unfortunate, was not conclusive evidence of negligence.
Conclusion
The Hon'ble Supreme Court's decision to restore the State Commission's judgment is a balanced application of the law laid down to deal with medical negligence cases. It reinforces the importance of evidence-based adjudication while ensuring that the medical profession is not unfairly penalized for unavoidable complications. This ruling should reassure doctors and hospitals that genuine efforts to provide care, even when unsuccessful, will not expose them to liability without evidence of negligence.
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