INTRODUCTION
Over the past couple of months, the Central Drugs Standard Control Organisation has been actively streamlining licensing and approval requirements for pharmaceutical companies, with the aim of enhancing the ease of doing business in India. In addition, the Indian Council of Medical Research has further amended the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 to ensure that research involving traditional and modern medicine adheres to rigorous ethical and scientific standards. Other key developments such as the long-awaited ban by the Ministry of Health and Family Welfare on the use of drugs chloramphenicol and nitrofurans in food-producing animal rearing systems and the decision by the High Court of Delhi to facilitate affordable treatment of Spinal Muscular Atrophy disease have dominated headlines in the space.
In this edition of 'Checking the Pulse', we delve into key updates from February 2025 to March 2025 in the healthcare and pharmaceutical sectors, while also tapping on notable deals that have gained interest from the industry.
LEGAL & REGULATORY DEVELOPMENTS
Department of Pharmaceuticals Mandates the display of drug price list for all pharmacies in India
On February 4, 2025, the Department of Pharmaceuticals ("DoP") issued an office memorandum ("OM") directing all pharmacies to display the current drug price list as per the requirements prescribed under the Drugs (Prices Control) Order, 2013 ("DPCO").1 In this regard, DoP referred to paragraphs 24 and 25 of the DPCO to reiterate the requirement for every retailer and dealer engaged in the business of purchase or sale of drugs to display the price list, as furnished by the manufacturer, in a conspicuous part of the premises from where the business is carried out in a manner so as to be easily accessible to any person wishing to consult the same.
In the OM, DoP has expounded on the ambit of "conspicuous part of the premises" as appearing in the afore-mentioned paragraphs to mean not only the physical premises from where the retailer or dealer carries on business but also virtual/ online/ electronic premises, thereby clarifying that online pharmacies are covered within the framework. Accordingly, all retailers and dealers engaging in the business of purchase or sale of drugs either through physical mode or online mode (i.e., through website, online portal, mobile application, e-commerce platforms etc.) are required to display the current price list as per the provisions of DPCO.
In the event of violation of the afore-mentioned requirement, the retailer or dealer shall be punishable under Section 7 of the Essential Commodities Act, 1955, which stipulates imprisonment for a term extending up to 7 (seven) years along with fine for such contravention.
Central Drugs Standard Control Organisation classifies gastro-resistant and delayed-release drugs under 'new drug' category under the New Drugs and Clinical Trials Rules, 2019
On February 24, 2025, the Central Drugs Standard Control Organisation ("CDSCO") issued a circular directing all State and Union Territory drug controllers to uniformly classify gastro-restraint tablets/ capsules and delayed-release tablets/ capsules as 'new drugs' under Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019 ("NDCT Rules").2 The circular was issued pursuant to discussions during the 64th (sixty-fourth) meeting of the Drugs Consultative Committee held in July last year, where concerns were raised regarding the inconsistent classification of the afore-mentioned drugs in different parts of the country.
CDSCO cited the broad definition of the term 'new drug' under the NDCT Rules, which inter alia includes modified or sustained release form of any drug previously approved by the Central Licensing Authority ("CLA"), as the primary reason for the uniform classification of drugs. As a result, drugs such as enteric coated tablets/ capsules, gastro-resistant dosage forms as well as delayed-release dosage forms will get classified as 'new drug' under the ambit of the NDCT Rules.
In view of this clarification, pharmaceutical companies seeking approval for formulations containing these drugs will be mandatorily required to comply with all regulations applicable to 'new drug' under the NDCT Rules. These requirements include conducting additional clinical trials, providing bioequivalence studies, and obtaining fresh approval from CLA prior to marketing the formulations, among others. Accordingly, the clarification is intended to ensure clarity and standardisation in regulatory enforcement.
Food Safety and Standards Authority of India mandates strict adherence to accreditation accorded by the National Accreditation Board for Testing and Calibration Laboratories for referral sample testing
On February 25, 2025, the Food Safety and Standards Authority of India ("FSSAI") issued an order mandating all FSSAI-notified referral laboratories to strictly adhere to their National Accreditation Board for Testing and Calibration Laboratories ("NABL") scope of accreditation as per ISO 17025, while testing referral samples.3 The laboratories are only permitted to test food products explicitly covered under their NABL scope of accreditation.
Additionally, all FSSAI-notified referral laboratories have been instructed to only test such parameters as specified by the designated officers/ authorized officers.
The directive has been issued for the strict enforcement of Clause 9.1(a) of the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2018 which places an obligation on food laboratories to perform all tests in the approved premises as per the valid scope of recognition. The move intends to ensure compliance with quality and regulatory standards.
CDSCO mandates online registration for clinical research organisations through the SUGAM Portal
In line with the directive of the Ministry of Health and Family Welfare ("MoH&FW") to make the registration of clinical research organisations ("CROs") mandatory effective from April 1, 2025, CDSCO, through a public notice dated March 4, 2025 ("Public Notice"), intimated industry stakeholders regarding the initiation of the registration process via the SUGAM portal.4
In September last year, MoH&FW had notified amendments to the NDCT Rules to the effect of defining CROs and mandating their registration with CLA under the NDCT Rules as a pre-requisite to undertaking clinical trials, and bio-availability and bio-equivalence studies of new drugs, or investigational new drugs in humans.
As per the Public Notice, CROs will be required to make an application in Form CT-07B to the CLA for the purpose of obtaining registration. In case registration is granted, such registration shall be valid for a period of 5 (five) years from the date of its grant, unless it is suspended or cancelled earlier by CLA. However, in the event the application is rejected, the applicant may request CLA to reconsider the application within a period of 60 (sixty) days from the date of rejection of the application. Further, the applicant has also been vested with the right to file an appeal within 45 (forty-five) days from the date of the decision made by CLA.
The initiative is intended to streamline the registration process, enhance transparency and efficiency in regulatory oversight, help ensure compliance with the mandatory registration requirements, and provide a central location for records.
Supreme Court of India directs State Governments to formulate policies for protecting patients from exploitative practices of private hospitals
The Supreme Court of India ("Supreme Court") urged all State Governments to devise adequate policies to prevent private hospitals from exploiting their patients by compelling them to purchase medicines, implants, and consumables exclusively from in-house pharmacies at inflated rates.5
In response to a public interest litigation, the two-judge bench comprising Justices Surya Kant and N Kotiswar Singh observed that: (a) the right to avail medical facilities flows from the broad ambit of Article 21 of the Constitution of India; and (b) the subjects of public health and sanitation, hospitals and dispensaries fall in List II (state list), and therefore, relevant measures should be taken by State Governments to protect the right of patients keeping their local conditions in view.
The Supreme Court, while emphasising the need to take swift action, acknowledged that the over-regulation of the private healthcare industry may have a deterrent effect on the investment that the sector has the potential to attract. Accordingly, it advised State Governments to strike a fine balance between the protection of patient's rights and the creation of a conducive environment for growth of the healthcare sector, in their policy-making endeavours.
CDSCO revamps the procedure for grant of no-objection certificates for export of unapproved and approved new drugs
In an effort towards enhancing the ease of doing business in India, CDSCO issued a public notice on March 10, 2025, to revamp the procedure for grant of no-objection certificates for export of unapproved or approved new drugs ("Export NOC").6 Manufacturers holding valid license in Form 25, Form 28 and Form 28-D of the Drugs and Cosmetics Act, 1940 ("D&C Act") have now been allowed to obtain a one-time Export NOC based on their track record of exporting such drugs, provided that the drug is approved in the importing country. Previously, manufacturers were required to apply for a customer and quantity specific NOC for each order received from the customer.
Under the new framework, the manufacturer intending to export drugs is required to file a one-time Integrated Registration Form through the SUGAM portal for grant of the Export NOC. Subject to the verification of the application by the concerned zonal office of CDSCO, the Export NOC shall be granted to the manufacturer for the applied products within 7 (seven) working days from the date of application. In the event the Export NOC is granted, the same shall remain valid for a period of 1 (one) year.
The new framework has only been formulated for manufacturers of unapproved and approved new drugs in India, and thus, manufacturers of drugs falling under the ambit of the Narcotic Drugs and Psychotropic Substances Act, 1985 shall still be required to obtain case-specific NOCs in line with the erstwhile framework.
The Indian Council of Medical Research releases addendum to Ethical Guidelines for Integrative Medicine Research
On March 5, 2025, the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy issued a press release to inform that the Indian Council of Medical Research has published an addendum to the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 ("Addendum").7 The Addendum establishes a structured ethical framework specifically for research in Integrative Medicine ("IM") by combining traditional Ayush systems with modern medical practices, and providing clear guidance for researchers, institutions, Ethics Committees ("EC"), and regulatory bodies involved in IM research.8
The initiative marks a significant step in strengthening the clinical trials landscape in India, particularly in the domain of traditional medicine. The key additions introduced by the Addendum include:
- An obligation on ECs overseeing IM research to include 2 (two) Ayush subject-matter experts, with at least 1 (one) expert being external to the institution in order to ensure well-rounded deliberations;
- The strengthening of informed consent standards, requiring researchers to provide research participants with clear and tailored information about IM interventions in line with India's standard ethical guidelines for biomedical and clinical research;
- The removal of requirement for Ayush-approved medicines used in integrative research to undergo extra safety trials or pre-clinical studies. However, noncodified traditional medicines will still be required to undergo the complete regulatory approval process prior to use; and
- The requirement for IM research to align with the standards prescribed under the D&C Act, the NDCT Rules and the Good Clinical Practice guidelines specific to Ayush systems.
With India being a global leader in Ayurveda, Yoga, Unani, Siddha, and Homoeopathy, these guidelines intend to ensure that research involving traditional and modern medicine adheres to rigorous ethical and scientific standards. By ensuring ethical rigor and regulatory compliance, the addendum shall aim to enhance the credibility and acceptance of IM research in the country.
MoH&FW bans use of Chloramphenicol and Nitrofurans in food producing animal rearing systems
On March 12, 2025, MoH&FW, in exercise of its powers conferred by Section 26A of the D&C Act, issued a nation-wide ban on the import, manufacture, sale and distribution of drug formulations containing: (a) chloramphenicol; and (b) nitrofurans, for use in any food-producing animal rearing systems. The decision comes in light of rising concerns regarding the potential risks associated with the use of these drugs in animals intended for food production as well as the availability of safer alternatives to these drugs.
Chloramphenicol, which inhibits bacterial protein production and growth, is used to treat various bacterial infections. Similarly, nitrofurans, a class of antibiotics used to treat urinary infections, are also employed as antibacterials in food-producing animals. However, recent studies have shown that the use of these drugs can cause side effects including bone marrow suppression and diarrhoea and result in the development of antibioticresistant bacteria.
The ban by MoH&FW follows the decision by FSSAI in 2018 to ban the use of several antibiotics and veterinary drugs, including chloramphenicol and nitrofurans, in processing meat, poultry, eggs, seafood, and fishery products.
High Court of Delhi facilitates access to affordable treatment for Spinal Muscular Atrophy disease
On March 24, 2025, the High Court of Delhi ("Delhi HC") issued a landmark decision, paving the way for Natco Pharma Limited ("Natco Pharma"), an Indian pharmaceutical company, to produce a generic version of Risdiplam, a crucial drug for curing Spinal Muscular Atrophy ("SMA").9 The decision to allow Natco Pharma to produce Risdiplam was made despite La Hoffman Roche, a Swiss-based pharmaceutical corporation, holding a patent on the formulae involved in the production of the concerned drug.
In reaching this decision, the Delhi HC emphasised the paramount importance of public health over commercial interests and noted that the availability of affordable medication is essential for patients in the country who are suffering from SMA. In this regard, Justice Mini Pushkarna highlighted that when a drug is the sole treatment available for a rare disease in India, its accessibility at economical prices becomes a significant factor for judicial consideration.
SMA is a severe genetic disorder affecting approximately 1 (one) in 7,000 (seven thousand) individuals in India, leading to progressive muscle weakness and high infant mortality rates. The exorbitant cost of Risdiplam – around INR 6.2 Lakhs (approximately Indian Rupees Six Lakhs Twenty Thousand) per bottle – serves as an impediment on the accessibility of this drug to many patients.
DSCO issues draft of the revised risk-based classification list for cardiovascular and neurological medical devices
On April 1, 2025, CDSCO issued a notice to revise the risk-based classifications for medical devices falling in the cardiovascular and neurological categories and sought feedback from industry stakeholders concerning the intended revision.10
The updated draft list annexed to the notice includes a total of 553 (five hundred and fifty-three) devices, out of which 351 (three hundred and fifty-one) devices belong to the cardiovascular category and 202 (two hundred and two) devices belong to the neurological category. Of the total devices, 372 (three hundred and seventy-two) devices, including aortic annuloplasty rings and biological heart valve implants, have been classified as high-risk, whereas the other 181 (one hundred and eighty-one) devices, including cardiac mapping system reference patches, have been classified as low-risk.
The decision to revise the risk-based classification list has been made with the intent of providing clarity and alignment to both regulators and manufacturers at the stage of review of licensing applications.
MAJOR DEALS IN INDIA IN THE PHARMA AND HEALTHCARE INDUSTRY
The following are the key deals announced during the months of February 2025 and March 2025, in the pharma and healthcare industry:11
Kotak Strategic Situations India Fund II and Kotak Alternate Asset Managers Limited invest INR 1,050 Crores in Tirupati Medicare Limited12
Kotak Strategic Situations India Fund II and Kotak Alternate Asset Managers (collectively, "Kotak"), the alternative asset management arms of Kotak Mahindra Bank, invested INR 1,050 Crores (Indian Rupees One Thousand and Fifty Crores) in Tirupati Medicare Limited ("TML"), a leading contract development and manufacturing organization (CDMO) specializing in nutraceuticals, pharmaceuticals, and Ayush products. In lieu of their investment, Kotak received compulsorily convertible preference shares from TML, along with equity shares transferred by the erstwhile existing shareholder Affirma Capital ("Affirma") and promoters of TML.
Through this investment, Kotak intends to support the expansion plans of TML, by allowing it to strengthen its presence in the domestic market and engage in export activities. The investment further facilitates a complete exit of Affirma.
KKR acquires majority stake in Healthcare Global Enterprises
On February 24, 2025, CVC Capital Partners plc, a leading global private markets manager, announced the signing of definitive agreements for the sale of 54% (fifty-four percent) stake in Healthcare Global Enterprises ("HCG") to Kohlberg Kravis Roberts & Co. ("KKR"), a leading global investment fund. KKR will acquire the stake in HCG at a purchase price of INR 445 (Indian Rupees Four Hundred and Forty-Five) per share.13
Founded in 1989, HCG is one of India's largest oncology hospital chains. HCG operates 25 (twenty-five) medical care centres across 19 (nineteen) cities with best-inclass infrastructure including 2,500 (two thousand and five hundred) beds, nearly 100 (one hundred) operating theatres and 40 (forty) linear accelerator machines. Through its investment, KKR intends to support HCG in the development of medical infrastructure and the delivery of critical oncology services and continue its foray in the healthcare sector of India.
Motilal Oswal Alternate Investment Advisors acquires majority stake in Mega Fine Pharma Private Limited
On February 25, 2025, Motilal Oswal Alternate Investment Advisors announced its investment of up to INR 460 Crores (Indian Rupees Four Hundred and Sixty Crores) in Mega Fine Pharma Private Limited ("Megafine"). A leading exporter of active pharmaceutical ingredients ("APIs"), Megafine specializes in producing highvalue, low-volume niche APIs for chronic therapies and maintains backward integration for its intermediates while also offering contract manufacturing services.
Through the investment, Megafine aims to strengthen its research and development capabilities while expanding its manufacturing infrastructure. As part of the transaction, the Sanghvi Family, one of the foundingpromoter groups, has also increased its stake in the company.14
Avendus Future Leaders Fund invests INR 160 Crores in La Renon Healthcare
Avendus Future Leaders Fund ("FLF"), the flagship private strategies fund of the Avendus Group, announced the acquisition of a minority stake worth INR 160 Crores (Indian Rupees One Hundred and Sixty Crores) in La Renon Healthcare ("La Renon"), one of the fastest growing domestic branded medicines company in India.15
La Renon holds 250 (two hundred and fifty) patents across India, the United States of America, European Union and Canada. It operates multiple manufacturing facilities and active pharmaceutical ingredients units, as well as a research and development centre. The investment is intended to aid La Renon in scaling its operations and further solidifying its presence in India.
Sun Pharma acquires Checkpoint Therapeutics for USD 355 Million
Sun Pharmaceuticals Industries Limited ("Sun Pharma") and Checkpoint Therapeutics ("Checkpoint") announced the execution of definitive agreements wherein Sun Pharma has undertaken to acquire Checkpoint, an immunotherapy and targeted oncology company, with upfront payment of USD 355 Million (United States Dollars Three Hundred and Fifty-Five Million).16 Through this acquisition, Sun Pharma aims to expand its immunotherapy and oncology portfolio in India.
Foonotes
1. The OM can be accessed here: https://www.nppaindia.nic.in/uploads/tender/c99b75820cf3e516cffeda63f239a121.pdf
2. The Circular can be accessed here: https://cdsco.gov.in/opencms/opencms/ system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_ id=MTI1NDA=
3. The Order can be accessed here: https://www.fssai.gov.in/upload/advisories/2025/02/67bdc964e9432Order%20dated%2025.02.2025.pdf
4. The Public Notice can be accessed here: https://cdsco.gov.in/opencms/ resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/CRO%20 registration.pdf
5. The Judgment can be accessed here: https://www.livelaw.in/pdf_upload/324-siddharth-dalmia-v-union-of-india-4-mar-2025-592579.pdf
6. The Public notice can be accessed here: https://cdsco.gov.in/opencms/ opencms/system/modules/CDSCO.WEB/elements/download_file_division. jsp?num_id=MTI1Nzg=
7. The Press release can be accessed here: https://pib.gov.in/PressReleaseIframePage.aspx?PRID=2108570#:~:text=The%20addendum%20introduces%20key%20measures,well%2Drounded%20and%20informed%20deliberations
8. The Addendum can be accessed here: https://www.icmr.gov.in/icmrobject/ uploads/Guidelines/1740984016_icmraddendumethicalrequirementsforresearchinintegrativemedicine.pdf
9. The Judgment can be accessed here: https://dhccaseinfo.nic.in/jsearch/ judgement.php?path=dhc/592/judgement/24-03-2025/&name=59224032 025SC5672024_191049.pdf
10. The Notice can be accessed here: https://cdsco.gov.in/opencms/opencms/ system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_ id=MTI2MjM=
11. To the extent any transactions involve clients of INDUSLAW, the information herein is based on statements in the media and not our professional knowledge of the relevant transaction.
12. INDUSLAW advised Tirupati Medicare Limited and its promoters.
16. https://www.fiercepharma.com/pharma/heels-fda-approval-cancer-drugsun-pharma-buys-checkpoint-416m
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