Introduction
Welcome to the September 2024 edition of 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, including the introduction of a new Chapter in New Drugs and Clinical Trials Rules, 2019 ("NDCT Rules") to specifically govern clinical research organizations; introduction of draft guidelines on Good Clinical Practices by Central Drugs Standard Control Organization ("CDSCO"); introduction of the Uniform Code for Marketing Practices in Medical Devices, 2024 by Department of Pharmaceuticals ("DoP"). 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. New Drugs and Clinical Trials (Amendment) Rules, 2024
On September 19, 2024, the Ministry of Health and Family Welfare ("MoHFW") introduced amendments to the NDCT Rules, by incorporating provisions for "Clinical Research Organisations" ("CROs") and adding a new Chapter VA. The newly inserted rules will govern the registration process, validity, inspection, and cancellation of CROs involved in clinical trials.
The MoHFW released the draft amendment rules vide notification issued on May 11, 2023, inviting feedback from the public. Objections and suggestions received were duly considered by the Central Government. Following consultations with the Drugs Technical Advisory Board, the rules were finalized and named the New Drugs and Clinical Trials (Amendment) Rules, 2024 and the same shall come into force on and from April 1, 2025.
2. The National Pharmaceutical Pricing Authority (NPPA) extends ceiling price for orthopaedic knee implant systems until September 2025.
On September 10, 2024, the NPPA has issued a notification under the Drug Price Control Order, 2013 ("DPCO 2013"), extending the current ceiling price for orthopaedic knee implant systems until September 15, 2025. This extension follows a series of previous notifications dated August 16, 2017, August 13, 2018, and September 15, 2022, all of which pertain to the fixation and revision of ceiling prices for orthopaedic knee implants used in knee replacement systems. In continuance of these prior directives, the ceiling prices will remain effective until September 15, 2025, unless an earlier revision is issued.
3. The NPPA has revised ceiling price of 1 Scheduled Formulation
On September 10, 2024, the NPPA has issued a review order under the DPCO 2013, fixing / revising the ceiling price of malaria drug chloroquine 150 mg, following a direction from the DoP to recalculate the price observing that the pricing authority has erred in calculation. This revision, which includes a Wholesale Price Index (WPI) impact of 0.00551% for the year 2024, is based on various regulatory provisions and supersedes previous orders.
4. Researchers at the Institute of Advanced Study in Science and Technology ("IASST") have discovered Antidepressant drug can be repurposed for treating breast cancer
Researchers at IASST, Guwahati have discovered that Selegiline (L-deprenyl), an antidepressant drug, has potential of being a cost-effective solution for treatment for breast cancer. This drug, classified as a monoamine oxidase inhibitor, was shown to interact with 10 genes intricately linked to various types of cancer with a significant number of nodes. Selegiline was found effective in killing estrogen and progesterone-positive (ER+ & PR+) as well as triple-negative breast cancer. Notably, Selegiline induces cell death in breast cancer cells through a mechanism that does not depend on reactive oxygen species and inhibits a process called protein kinase C phosphorylation in breast cancer cells. This pioneering research, published in "Medical Oncology," could help biomedical scientists explore this area further. The research is the first of its kind and holds great significance in the field of cancer research. It deserves further investigation in terms of in vivo efficacy study, dose optimization, contraindications, and associated adverse side effects in the near future.
5. Indian Pharmacopoeia Commission ("IPC") and CDSCO have released revised 'Pharmacovigilance Guidance Document for Marketing Authorization Holders ("MAHs") of Pharmaceutical Products' ("Pharmacovigilance Guidelines"), extending non-serious adverse event reporting timeline to 90 days.
On September 17, 2024 the IPC and the CDSCO have released version 2.0 of the Pharmacovigilance Guidelines. This updated Pharmacovigilance Guidelines extends the reporting timeline for non-serious adverse events to 90 calendar days, up from the previously proposed 30 days.
This Pharmacovigilance Guidelines aligns with the objectives and revised Schedule M of Drugs and Cosmetics Rules, 1945 and the NDCT Rules. Developed by the National Coordination Centre -Pharmacovigilance Programme of India in collaboration with CDSCO, it aims to facilitate the submission of safety profiles by MAHs, which refer to the manufacturers, marketers, or importers with valid licenses in India. It also emphasizes the establishment of a robust Pharmacovigilance System to monitor the safety profile of marketed pharmaceutical products.
6. The CDSCO releases draft guidelines on Good Clinical Practices in line with the NDCT Rules
The CDSCO published draft guidelines on Good Clinical Practices vide circular dated September 12, 2024. The CDSCO constituted a committee under the chairmanship of Dr. Bikas Medhi, Prof. Department of Pharmacology, PGIMER, Chandigarh for the revision of India Good Clinical Practices Guidelines and related guidelines in-line with the NDCT Rules and currently available international guidelines.
These guidelines have been evolved in consideration of various national and global guidelines and in line with NDCT Rules, World Health Organization, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, U.S. Food and Drug Administration and European Good Clinical Practices guidelines as well as the Ethical Guidelines for Biomedical research on Human Participants issued by the Indian Council of Medical Research. They should be followed for carrying out all biomedical research in India at all stages of drug development, whether prior or subsequent to product registration in India.
The committee has prepared the draft guidelines after detailed discussions and is now to be circulated to various stakeholders for comments before finalization for a period of 30 days.
7. Deadline for registration of companies that are dealing with psychotropic substances on Central Bureau of Narcotics ("CBN") Online Portal extended
The Narcotics Commissioner of India, CBN has extended the deadline for registration of companies that are dealing with psychotropic substances and registered with the Narcotics Commissioner under Rule 65 of the Narcotics Drugs & Psychotropic Substances Rules, 1985 ("NDPS Rules"), on the CBN Online Portal. As a onetime relaxation the deadline has been extended till December 31, 2024.
Accordingly, all such previously registered companies yet to be registered on CBN Online Portal are advised to register themselves on the said portal latest by December 31, 2024. The previous registrations of the companies who fail to register themselves on the CBN Online Portal by December 31, 2024, are deemed to be cancelled.
Further, the format of quarterly returns prescribed vide the Public Notices dated 05.08.2024 and 22.08.2024 are kept on hold till further notice. Therefore, all the companies registered under Rule 65 of NDPS Rules are advised to submit quarterly returns as earlier by adhering to timelines.
8. Online Application in Form-44 for issuance of new drug permission of Bulk (API) drugs/ vaccines in Form 45A/ 46A and finished formulation in Form 45/46 and Field Trial Permission is now functional on SUGAM portal
In order to streamline the process of regulatory submissions, the CDSCO vide circular dated September 12, 2024 has mandated that the submission of application for issuance of New Drug permission of Vaccines/ Drugs for Bulk (API) in Form 45A/ 46A and finished formulation in Form 45/46 and Field Trial Permission is now functional on online system of SUGAM portal. Applicants seeking such certificates/ approvals/ permissions shall apply through the online portal as per the checklist in the development modules.
Further, the facility of online submission of applications in Form- 44 in hard copy / through e-office has been retroactively paused from August 16, 2024.
Government initiatives
9. Health Ministry Releases "Health Dynamics of India (Infrastructure and Human Resources) 2022-23"
The Union Health Secretary, Shri Apurva Chandra, released the annual publication "Health Dynamics of India (Infrastructure and Human Resources) 2022-23," previously known as "Rural Health Statistics." This document provides essential information on manpower and infrastructure within the National Health Mission (NHM), aiding policy-making and problem-solving.
The publication includes comprehensive data on India's healthcare system, highlighting the availability and deficiencies of health infrastructure across states, which is crucial for effective planning and management.
General Updates
10. Goods and Services Tax ("GST") Council cuts tax rate on key cancer drugs to 5%, plans further reductions for health insurance premiums.
The GST Council has decided to reduce the tax rate on certain cancer drugs, including Trastuzumab Deruxtecan, Osimertinib, and Durvalumab, from 12% to 5%. Additionally, the GST Council is expected to finalize tax rate reductions for life and health insurance premiums in its upcoming meeting in November 2024. In its broader agenda, the GST Council has made several recommendations aimed at providing relief to individuals, facilitating trade, and streamlining compliance under the GST regime.
One of the significant changes includes the reduction of GST rates on extruded or expanded savory food products from 18% to 12%, aligning them with rates applicable to namkeens and similar snacks.
Healthcare and Allied Sector
Legal and Regulatory
11. National Exit Test (NExT) for Ayush to be Effective from 2021-2022 Batch: Union Minister of Ayush Shri Prataprao Jadhav
Union Minister of State for Ayush (Independent Charge) Shri Prataprao Jadhav, on September 5, 2024, announced that the NExT for Ayush will be effective from 2021-2022 batch onwards.
This decision was taken on the recommendation of the committee setup in this regard to review the concerns of students in this matter. The test is mandatory for licensing and enrolment in State or National Registers after completing a one-year internship, and the structure is problem-based examination featuring clinical case scenarios, images, and videos to evaluate practical skills.
Heath-Tech, Hospitals and Healthcare Institutions
General Updates
12. National Health Authority ("NHA") and Indian Institutes of Technology ("IIT"), Kanpur sign Memorandum of Understanding ("MoU") for development of digital public goods for Artificial Intelligence ("AI") in Healthcare.
On September 11, 2024, NHA and IIT Kanpur have signed a MoU aimed at enhancing AI in healthcare under the Ayushman Bharat Digital Mission ("ABDM"). This collaboration will develop a federated learning platform across a variety of machine learning model pipelines, a quality-preserving database, an open benchmarking platform for comparing & validating AI models, and a consent management system for research under ABDM would be developed by IIT Kanpur.
Union Health Secretary Apurva Chandra emphasized the goal of using data to improve health outcomes, while Prof. Manindra Agrawal from IIT Kanpur highlighted the partnership's potential to democratize access to quality healthcare in India. Key benefits of the platform include fostering trust in AI healthcare models through validation and benchmarking, improving data access while maintaining data privacy, and preserving the statistical quality of healthcare data.
Medical Devices
Legal and Regulatory
13. The Department of Pharmaceuticals published the Uniform Code for Marketing Practices in Medical Devices, 2024
On September 6, 2024, DoP published the Uniform Code for Marketing Practices in Medical Devices, 2024 ("UCMPMD"). The UCMPMD comes after a long wait of the draft Uniform Code for Medical Device Marketing Practices ("Draft UCMDMP") published in March 2022. Unlike the voluntary Draft UCMDMP, Medical Device companies must strictly adhere to the provisions of the UCMPMD.
Under the new UCMPMD, all medical device associations are required to constitute an Ethics Committee for Marketing Practices in Medical Devices ("ECMPMD") and upload the UCMPMD on their website along with the detailed procedure for lodging complaints, which should be linked to the Uniform Code for Pharmaceutical Marketing Practices portal ("UCPMP Portal") of the DoP.
Additionally, Medical Device companies must mandatorily disclose, inter alia, particulars related to distribution of evaluation of samples and expenses incurred on continuing medical education/ continuing professional development/ conferences/ workshops / trainings / seminars in the prescribed format. These particulars must be filled on an ongoing basis and mandatorily within 2 months of the end of every financial year on the UCPMP Portal within the timeline fixed for submitting self-declaration as prescribed.
Health and Wellness
Legal and Regulatory Updates
14. Food Safety and Standards Authority of India ("FSSAI") Expands instant food license and registration nationwide
The FSSAI has extended the availability of the Instant (Tatkal) Food License/ Registration for specific categories of food businesses across the nation, excluding Chandigarh, Himachal Pradesh, and Meghalaya. This provision, which was previously confined to select states and Union Territories of Assam, Delhi, Gujarat, Jammu and Kashmir and Kerela, aims to streamline the process for food businesses seeking swift licensing. This extension of Instant (Tatkal) Food License and Registration provision took effect on August 31, 2024.
To facilitate ease of doing business, it has been decided by the FSSAI, to enable instant issuance of licenses/registrations for specific categories such as wholesalers, distributors, retailers, transporters, storage without atmospheric control, importers, food vending agencies, direct sellers, merchant-exporters, petty retailer of snack/tea shops and hawkers (itinerant/ mobile food venders).
15. Central Government mandates Anti-Tobacco Ads for online content publishers starting March 2025
The MoHFW published the draft Cigarette and other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Amendment Rules, 2024 on September 13, 2024. The new draft rules stipulate that all online curated content publishers include a non-skippable anti-tobacco audio-visual advertisement and display a static health warning regarding tobacco use during their content. This requirement, effective from March 2025, aims to deter tobacco consumption by providing critical information about its harmful effects.
Under the new draft rules, all films—certified or not by the Central Board of Film Certification, regardless of whether they are of Indian or foreign origin and released on or after September 1, 2023—must display anti-tobacco health spots at the beginning and middle of the film, along with prominent static health warnings during any tobacco product usage shown. Additionally, a non-skippable audio-visual disclaimer about the adverse effects of tobacco must be included upon accessing the online content platforms.
16. Ministry of Textiles introduces Quality Control Order for Medical Textiles to enhance Public Health and Safety
On September 25, 2024, the Ministry of Textiles in a landmark initiative to strengthen public health and safety, notified the Medical Textiles (Quality Control) Order, 2023 ("MTQCO"). The MTQCO is set to take effect on October 1, 2024. This regulation establishes stringent quality standards for critical medical textile products, including sanitary napkins, baby diapers, reusable sanitary pads, and dental bibs.
The introduction of mandatory certifications under this MTQCO is aimed at ensuring that these products consistently meet essential quality benchmarks. Compliance with these standards will be legally required, with non-compliance potentially leading to fines and other penalties. Recognizing the challenges faced by small-scale enterprises, particularly Self-Help Groups, the government has exempted them from the requirements of this MTQCO.
Government Initiatives
17. Cabinet approves health coverage to all senior citizens of the age 70 years and above irrespective of income under Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY).
The Union Cabinet chaired by Prime Minister Narendra Modi, has approved health coverage for all senior citizens aged 70 years and above under the AB PM-JAY, regardless of income. This initiative will benefit approximately 4.5 crore families, providing a free health insurance cover of up to INR 5,00,000 per family annually.
The eligible senior citizens will receive a new distinct card under the scheme. Those already covered by AB PM-JAY will get an additional INR 5,00,000 top-up for their health expenses, while other seniors will have access to the same INR 5,00,000 cover on a family basis. has been clarified that senior citizens of 70 years and above who are under private health insurance policies or Employees' State Insurance scheme will be eligible to avail benefits under AB PM-JAY.
18. Department of Health and Family Welfare ("DoHFW") continues to conduct nationwide campaign on institutionalising Swachhata and minimising pendency in Government offices.
From November 2023 to August 2024, the DoHFW undertook a Special Campaign 3.0 focused on cleanliness and reducing backlog in government offices. During this period, 9,608 physical files were reviewed, leading to 505 files being weeded out.
The department also resolved 25,660 public grievances along with various appeals and references. Additionally, 817 cleanliness campaigns were organized, resulting in a revenue of INR 13,37,262 from the sale of scrap materials, which freed up 13,336 sq. ft. of office space. Furthermore, 23 rules were simplified to improve operational efficiency. These initiatives have significantly enhanced space management and created a healthier work environment. Looking ahead, DoHFW is preparing for Special Campaign 4.0, set to run from October 2 to October 31, 2024.
Key Judgements
Noteworthy judgement in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
Chief Medical Officer Nehru Satabdi Central Hospital vs. Puja Sahu (Revision Petition No. 1353 of 2022)
Background:
In a recent order passed by the National Consumer Disputes Redressal Commission ("NCDRC") on 16th August 2024, NCDRC emphasised on the importance of expert opinion to allege medical negligence. Accordingly, NCDRC overturned earlier judgments of the State and District Consumer Forums in a case involving the treatment of one Ms. Puja Sahu, who suffered a snake bite in 1999.
Case Overview
On May 23, 1999, Ms. Sahu was taken to the hospital after sustaining a snake bite on her right thumb. Admitted as a non-entitled patient on a payment basis, she was treated in the Pediatric Ward/ICU of the Appellant from 23rd May 1999 to 5th June 1999. Despite receiving anti-snake venom and supportive treatment, her right thumb developed gangrene, which required amputation on May 30, 1999. She later sought additional treatment at Sishu Bhawan, Cuttack. Accordingly, alleging medical negligence on the part of the Appellant, she demanded compensation of ₹5,00,000.
The Appellant argued that when Ms. Sahu was admitted, her thumb had already turned blue due to a tight black thread tied around it, likely by her parents to stop the spread of venom. They claimed that the gangrene resulted from the restricted blood flow caused by this thread and not from their negligent treatment. The Appellant emphasized that all necessary medical protocols were followed, and the amputation decision was taken after consulting with her father.
Lower Court Rulings
The District Forum initially ruled in favor of Ms. Sahu in 2000, holding the Appellant liable for negligence and awarding INR 3,00,000 as compensation. On appeal, the State Commission upheld the ruling in July 2022, increasing the compensation to INR 10,00,000 with 9% interest per annum, along with INR 25,000 for litigation costs.
NCDRC's Decision
The Appellant challenged the State Commission's order through a revision petition before the NCDRC.
In its observations, NCDRC relying on the decision of the Supreme Court in S.K. Jhunjhunwala v. Dhanwanti Kau & Anr held that in the absence of expert opinion to establish negligence, the Appellant cannot be held liable for medical negligence.
NCDRC also relied upon the landmark case of Jacob Mathew vs. State of Punjab, to establish that medical professionals are not liable for negligence if they follow acceptable practices at the time of treatment, even if alternate treatments exist
Conclusion
The NCDRC ruled in favor of the Appellant, dismissing the allegations of medical negligence. NCDRC emphasized that the hospital had provided appropriate care and that the gangrene was unrelated to the treatment. This judgment highlights the importance of expert medical evidence in medical negligence claims and reiterates that adherence to established medical protocols shields doctors from liability in such cases.
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.
