INTRODUCTION
With 2024 coming to a close and 2025 starting to take shape, the healthcare and pharmaceutical sectors appear set to build on the positive momentum accumulated in the last year. The seismic developments that characterized 2024 have emboldened these sectors to embrace emerging technologies, tackle pressing global health challenges and further solidify the ever-evolving regulatory landscape in the new year. In this regard, continued efforts to bring uniformity in the regulation of medical devices, introduction of a novel framework for evaluating the validity and accuracy of rapid diagnostic tests and further streamlining of the application procedure for clinical trials serve as cases in point which highlight the upward trajectory that the healthcare and pharmaceutical sectors have been on lately.
In this edition of 'Checking the Pulse', we delve into key updates from December 2024 to January 2025 in the healthcare and pharmaceutical sectors, while also tapping on notable deals that have gained interest from the industry.
LEGAL & REGULATORY DEVELOPMENTS
The Ministry of Health and Family Welfare issues notification to amend the Cigarettes and other Tobacco Products (Packaging and Labelling) Rules, 2008
On December 2, 2024, the Ministry of Health and Family Welfare ("MoH&FW") issued the Cigarettes and other Tobacco Products (Packaging and Labelling) Amendment Rules, 2024 ("Amendment Rules") to amend the Cigarettes and other Tobacco Products (Packaging and Labelling) Rules, 2008.1
As per the Amendment Rules, with effect from June 1, 2025, cigarette and other tobacco product packaging must feature updated health warning, including the message "TOBACCO CAUSES PAINFUL DEATH" printed in white on a bright red background with a quit line number (1800-11-2356) printed in white on a black background. Additionally, the Amendment Rules prescribe the inclusion of 2 (two) new pictorial health warnings, to be displayed on tobacco product packaging in a phased manner. The first image shall be valid for a period of 12 (twelve) months starting from June 1, 2025, with the second image replacing it for the subsequent 12 (twelve) months.
To facilitate smooth implementation, MoH&FW shall make the digital versions of all specified health warnings available on its official platforms, ensuring that manufacturers and packagers have access to accurate and standardized materials.
The Amendment Rules aligns with the global best practices recommended by the World Health Organisation Framework Convention on Tobacco Control and reflects the Central Government's commitment towards safeguarding public health by raising awareness of the dangers of tobacco, encouraging cessation and deterring new users.
The Food Safety and Standards Authority of India issues advisory for e-commerce food business operators
On December 3, 2024, the Food Safety and Standards Authority of India ("FSSAI") issued an advisory for e-commerce food business operators ("FBOs") with the aim of strengthening the food safety compliance framework in India.2 FSSAI cited the growing influence of e-commerce platforms in the food sector as the primary reason for issuing the advisory and highlighted the need for transparency and trust by customers as key to the overall strengthening of the food safety ecosystem in the country.
In pursuance of these objectives, the advisory requires FBOs to ensure that:
- their delivery staff are well trained in food safety and hygiene practices. The training should focus on safe handling and transportation of food to prevent contamination, as well as personal hygiene and proper sanitization procedures.
- food and non-food items are delivered separately in order to avoid the risk of cross-contamination.
- product claims made on e-commerce platforms are fully aligned with the information provided on the physical label of the product. In this regard, FBOs are required to have mechanisms in place to ensure that products listed on their platforms are in compliance with the Food Safety and Standards (Labelling and Display) Regulations, 2020.
- the food products being delivered to customers have sufficient remaining shelf life. In this regard, FSSAI has mandated that products must have a shelf life of 30% (thirty percent) or at least 45 (forty-five) days before expiry, at the time of delivery.
- they prominently display FSSAI license/ registration numbers of the sellers, and hygiene ratings obtained by them on the e-commerce platforms. FBOs shall be required to adhere to this requirement as a pre requisite to listing the products of any seller on their platform.
These measures are intended to help mitigate risks associated with foodborne illnesses and fraudulent practices, safeguard consumer health and enhance consumer trust.
The Ministry of AYUSH notifies amendments to the Drugs and Cosmetics Act, 1940
On December 4, 2024, the Ministry of AYUSH ("AYUSH") issued a notification amending the First and Second Schedules of the Drugs and Cosmetics Act, 1940 ("D&C Act").3 Pursuant to the notification, the following changes have been brought to the D&C Act:
- in the First Schedule, a list of 20 (twenty) authoritative books on the Homeopathy system of medicine and 34 (thirty-four) authoritative books on the Sowa Rigpa system of medicine has been included. As a result of this inclusion, the definition of "Ayurvedic, Siddha and Unani drugs" under Section 3(a) of the D&C Act has significantly broadened. The D&C Act only recognizes Ayurvedic, Siddha and Unani drugs that have been manufactured in accordance with the formulae prescribed in the books that have been specified in the First Schedule.
- in the Second Schedule, the French Homeopathic Pharmacopoeia and the European Pharmacopoeia have been added as recognised standards based on which the import and manufacture of Homoeopathic medicines will be allowed in India. Accordingly, the forms of Homoeopathic medicines that can be imported or manufactured in India has increased as, prior to the amendment, only the drugs included in the Homoeopathic Pharmacopoeia of India, the United States of America ("USA"), United Kingdom and Germany could be manufactured or imported in the country.
Through this move, AYUSH aims to enhance the quality and accessibility of traditional medicines in India while aligning domestic standards with globally recognized benchmarks.
The Central Drugs Standard Control Organisation streamlines application procedure for clinical trials through SUGAM portal
The Central Drugs Standard Control Organisation ("CDSCO") has announced a streamlined procedure for submitting applications related to clinical trials by introducing an online system through the SUGAM portal. In this regard, CDSCO issued a notice on December 26, 2024, mandating applications for: (a) addition of clinical trial sites; and (b) changing principal investigators, to be made through the online portal.4 This requirement is applicable to various forms of clinical trials, including global clinical trials, trials for new drugs, subsequent new drugs, investigational new drugs, fixed-dose combinations, as well as bioavailability and bioequivalence studies.
As per the notice, each application must be accompanied by a checklist of required documents along with proof of approval from the ethics committee supervising the trial. The notice also sets out the timelines for approval of these applications by CDSCO:
- in relation to the proposed addition of clinical trial sites, the application shall be deemed to be approved if no objection is received from CDSCO within 30 (thirty) days of receipt of application; and
- in relation to the proposed change of principal investigator, the application shall be deemed to be approved from the date of receipt of application itself, subject to the condition that the application is complete as per the checklist.
The initiative to streamline the application procedure is in line with continued efforts by CDSCO to instil efficiency and transparency in clinical trial management, while minimizing administrative delays.
MoH&FW prohibits manufacture, sale and distribution of veterinary drug Nimesulide
On December 30, 2024, MoH&FW issued a notification to prohibit the manufacture, sale and distribution of all formulations of the drug Nimesulide for animal use, with immediate effect.5 The ministry cited the risk posed by the drug to animals and the availability of safer alternatives as primary reasons for issuing the ban in public interest, pursuant to its powers under Section 26A of the D&C Act.
The decision to prohibit the drug was taken based on the recommendation given by the Drugs Technical Advisory Board early last year, which was backed by a study conducted jointly by the Bombay Natural History Society and the Indian Veterinary Research Institute. The study found that vultures treated with Nimesulide died within 2 (two) days of treatment due to elevated uric acid levels and highlighted that the veterinary use of the drug to treat cattle posed a major risk to vulture populations in India.
Notably, in 2023, MoH&FW had issued a similar ban on all formulations of the drugs Ketoprofen and Aceclofenac, in an effort to protect the vulture population from going extinct in the country.
Draft evaluation protocols issued for establishing uniformity in performance evaluation of in-vitro diagnostic kits
On December 31, 2024, CDSCO and the Indian Council of Medical Research jointly released the draft standard evaluation protocols ("Protocol") in order to streamline the procedure for issuance of license for in vitro diagnostics under the Medical Devices Rules, 2017 ("MDR").6
The move intends to ensure the availability of high quality, standardized diagnostic kits in India by bridging critical gaps in the evaluation of diagnostic kits prior to their licensure. In this regard, the Protocol establishes clear guidelines for sensitivity and specificity, alongside defining standardized procedures for reproducibility and field evaluations. Furthermore, the Protocol places emphasis on ethical and transparent testing processes to maintain integrity in the evaluation framework.
The Protocol includes performance and field evaluation guidelines for diagnostic tests targeting critical arboviral infections, including Chikungunya, Dengue, and Zika virus. Pertinently, if any kit is found to be Not of Standard Quality (NSQ), no repeat testing of the same kit shall be entertained, until valid proof of change in the kit composition is submitted by the manufacturer.
MoH&FW extends deadline for compliance with revised Schedule M norms for small and medium manufacturers
On January 4, 2025, MoH&FW issued a draft notification, proposing extension of the deadline for implementation of the revised Schedule M manufacturing norms by micro, small and medium manufacturers having turnover of INR 250 crores (Indian Rupees Two Hundred and Fifty Crores) or less ("MSMEs"), subject to public consultation and feedback.7 Pertinently, on February 11, 2025, MoH&FW confirmed the decision to extend the deadline for compliance with Schedule M by issuing the Drugs Amendment Rules, 2025 ("DA Rules").8
Schedule M of the Drugs and Cosmetics Rules, 1945 outlines Good Manufacturing Practices (GMP) for pharmaceutical manufacturing premises in India. It provides guidelines for the layout, design and construction of manufacturing facilities, as well as standards for equipment, utilities and quality control systems. In December 2023, MoH&FW notified the revised Schedule M, with major changes in the manufacturing standards for drugs manufactured in India, in conformity with established global standards.
To facilitate smooth transition for manufacturers from the erstwhile paradigm to the revised one, large manufacturers i.e., manufacturers having turnover exceeding INR 250 crores (Indian Rupees Two Hundred and Fifty Crores) were given a period of 6 (six) months (i.e., till June 28, 2024) to implement changes while MSMEs were accorded a period of 12 (twelve) months (i.e., till December 28, 2024). However, MSMEs have repeatedly requested for an extension of this deadline due to not being in a position to comply with the requirements of the revised norms within a short timeframe.
In view of this, the DA Rules now enables MSMEs to apply to the Central Licensing Approving Authority in Form A for seeking an extension of the deadline, within a period of 3 (three) months from the date of publication of the DA Rules, along with a plan of upgradation. Pertinently, for such applicants, the timeline for implementation of revised Schedule M norms shall stand extended till December 31, 2025.
Footnotes
1.The Amendment Rules can be accessed here: https://www.legalitysimplified.com/wp-content/uploads/2024/12/Cigarettes-and-other-Tobacco-Products-Packaging-and-Labelling-Amendment-Rules-2024.pdf
2. The advisory can be accessed here: https://www.fssai.gov.in/upload/advisories/2024/12/674efa161d756Adobe%20Scan%203%20Dec%202024.Pdf
3. The notification can be accessed here: https://egazette.gov.in/WriteReadData/2024/259267.pdf
4. The notice can be accessed here: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/10171.pdf
5. The notification can be accessed here: https://www.legalitysimplified.com/central-government-prohibits-nimesulide-formulations-for-animal-use/
6. The Protocol can be accessed here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/
7. The draft notification can be accessed here: https://mohfw.gov.in/sites/default/files/Notification%20GSR%2010%28E%29_0001_0.pdf
8 The DA Rules can be accessed here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1MTk=
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