Checking The Pulse – Recent Legal Developments In The Indian Healthcare And Pharma Sector

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INDUSLAW is a multi-speciality Indian law firm, advising a wide range of international and domestic clients from Fortune 500 companies to start-ups, and government and regulatory bodies.
Over the past couple of months, the National Health Authority has taken active steps to successfully implement the Ayushman Bharat Digital Mission and drive the cause of digital health in India forward.
India Food, Drugs, Healthcare, Life Sciences

INTRODUCTION

Over the past couple of months, the National Health Authority has taken active steps to successfully implement the Ayushman Bharat Digital Mission and drive the cause of digital health in India forward. In addition, significant amendments to the New Drugs and Clinical Trials Rules, 2019, blanket ban on the manufacture and sale of pain relief drug S(+) Etodolac + Paracetamol, and formulation of draft guidelines on good manufacturing practices for pharmaceutical products dominated the headlines in this space.

In this edition of 'Checking the Pulse', we delve into key updates from August 2024 to September 2024 in the healthcare and pharmaceutical sectors, while also tapping on notable deals that have gained interest from the industry.

LEGAL & REGULATORY DEVELOPMENTS

National Pharmaceutical Pricing Authority revises ceiling prices of 4 (four) drugs and fixes retail price of 70 (seventy) new formulations

In exercise of its powers conferred by the Drugs (Prices Control) Order, 2013, the National Pharmaceutical Pricing Authority ("NPPA") issued an order dated August 6, 2024, fixing the retail prices of 70 (seventy) new medicines.1 These prices were determined based on a comprehensive evaluation of data submitted by pharmaceutical companies with the aim of ensuring fair pricing for both consumers and pharmaceutical companies.

Further, pursuant to the directive issued by the Department of Pharmaceuticals, the NPPA on August 8, 2024, took significant steps to regulate drug pricing in India by revising the ceiling prices of 4 (four) essential drugs – valganciclovir, metoprolol, lamivudine and montelukast.2 The decision to revise the ceiling prices has been met with criticism from industry stakeholders due to the high cost of producing these drugs. However, the NPPA has reiterated its commitment of ensuring the availability of drugs at affordable prices to the public.

Central Government notifies new rule for rapid launch of breakthrough drugs in India

On August 7, 2024, the Central Government issued a notification under Rule 101 of the New Drugs and Clinical Trials Rules, 2019 ("NDCT Rules"), enabling the faster launch of breakthrough drugs in India ("Notification").3 The Notification specifies that certain categories of drugs which have already been approved in select developed countries such as United States of America, United Kingdom, Japan, Canada etc. can now be introduced in India without the requirement of undergoing mandatory local clinical trials.

The Notification outlines specific categories of drugs eligible for the waiver from requirement of undergoing trials, including orphan drugs for rare diseases, gene and cellular therapy products, drugs for pandemics and defence purposes, and those demonstrating significant therapeutic advancements over current standard care.

While the move is expected to benefit patients by providing quicker access to life-saving therapies for critical conditions such as cancer and rare diseases, applications for such breakthrough drugs will be subject to stringent evaluation by the Drugs Controller General of India ("DCGI") or subjected to expert committees under the Central Drugs Standard Control Organisation ("CDSCO"). Additionally, the CDSCO officials anticipate that this decision will also foster research collaborations between Indian and global pharmaceutical companies, potentially resulting in increased drug manufacturing and affordability within the country.4

CDSCO releases draft guidelines on good distribution practices for pharmaceutical products

CDSCO released the draft guidelines on good distribution practices for pharmaceutical products on August 9, 2024 ("Draft GDP Guidelines") with the aim of ensuring the quality and integrity of drugs throughout the supply chain, from manufacturing to the end consumer.5 The move comes in response to the growing concern over counterfeit and sub-standard medicines in India. The Draft GDP Guidelines, prepared in line with the report on 'good storage and distribution practices for pharmaceutical products' issued by the World Health Organisation ("WHO"), propose to lay down steps to facilitate regulation of the different stages within the supply chain to avoid the introduction of spurious, adulterated, misbranded and not of standard quality products into the market. These stages include, but are not limited to procurement, purchasing, storage, distribution, transportation, documentation, and record-keeping.

Ministry of Health and Family Welfare bans pain relief combination S(+) Etodolac + Paracetamol

On August 12, 2024, the Ministry of Health and Family Welfare ("MoHFW") issued a blanket ban on the manufacture, sale, and distribution of the pain relief drug combination S(+) Etodolac + Paracetamol.6 The decision comes in view of the recommendation from the Drugs Technical Advisory Board ("DTAB"), which concluded that the drug combination lacks therapeutic justification and poses potential risks to human health. Despite arguments from the drug's manufacturer Emcure Pharmaceuticals highlighting the purported benefits of S(+) Etodolac compared to the racemic etodolac, the MoHFW has opted for a complete ban, based on the DTAB's findings.

The ban imposed on the pain relief drug is the latest development in relation to the manufacture, sale, and distribution of the drug. In 2018, the Central government had issued a notification ("D&C Notification") to prohibit the manufacture, sale and distribution of the aforementioned drug for human use in exercise of its power under Section 26A of the Drugs and Cosmetics Act, 1940. The D&C Notification was set aside by the High Court of Delhi following a challenge by Emcure Pharmaceuticals which claimed that the drug was not covered under the D&C Notification. The matter was remanded back to DTAB for examination in accordance with the directions issued by the Supreme Court of India in Union of India and Anr. v. Pfizer Limited and Ors. (Limited).7

Accordingly, the DTAB constituted a sub-committee in 2022 for evaluation of the drug in line with the directions of the High Court of Delhi. Upon further examination, the subcommittee deemed the fixed dose combination irrational and recommended for its prohibition in public interest.

NITI Aayog recommends new legislation to tackle future public health crises in newly issued report

On September 11, 2024, NITI Aayog released a report titled 'Future Pandemic Preparedness and Emergency Response - A Framework for Action' ("PPER Report") to provide a blueprint for responding to public health emergencies or pandemics in future and having a rapid response system in the country.8

The PPER Report has been prepared in view of the warning received from WHO concerning the inevitability of public health threats and large-scale infectious threats to humans in the future. NITI Aayog constituted an expert group to prepare the PPER Report, with over 60 (sixty) experts and stakeholders analysing national and global success stories, along with their experiences to identify critical gaps that needed attention.

The recommendations in the PPER Report emphasize on 4 (four) pillars: (a) governance, legislation, finance and management; (b) data management, surveillance and early predictive warning, forecasting and modelling; (c) research and innovation, manufacturing, infrastructure, capacity building/ skilling; and (d) partnership, community engagement including risk communication, private sector partnerships, and international collaborations.

Most significantly, the PPER Report has recommended a new Public Health Emergency Management Act to address various aspects beyond epidemic, including noncommunicable diseases, disasters, and bio-terrorism, and allow for a holistic approach towards health management, covering prevention, control and disaster response.

National Health Authority signs multiple MoUs to drive Ayushman Bharat Digital Mission forward

On September 12, 2024, the National Health Authority ("NHA") and Indian Institute of Technology, Kanpur ("IIT Kanpur") signed a memorandum of understanding ("IITK MoU") to develop an innovative data platform under the Ayushman Bharat Digital Mission ("ABD Mission") for development of digital public goods for AI in healthcare.

Under the IITK MoU, IIT Kanpur has undertaken to develop: (a) a federated learning platform across a variety of machine learning model pipelines; (b) a quality-preserving database; (c) an open benchmarking platform for comparing and validating AI models; and (d) a consent management system for research under the ABD Mission. The platform will subsequently be operated and governed by NHA, thereby unlocking the immense potential of AI for improving health outcomes.9

NHA had earlier added impetus on the effective implementation of the ABD Mission by signing a memorandum of understanding with Maharashtra University of Health Sciences on August 14, 2024 ("MUHS"), to drive digital health education across India ("MUHS MoU").10 Under the MUHS MoU, MUHS undertook to: (a) offer its digital health foundation course to NHA; and (b) develop further digital health programmes in collaboration with NHA. The health foundation course is curated by leading doctors and industry experts and intends to provide a comprehensive understanding of digital health fundamentals to medical students, doctors and healthcare providers across the country.

Indian Council of Medical Research signs memorandum of agreements with industry and academic partners to advance first-inhuman phase 1 clinical trials

In a bid to attain self-sufficiency in clinical development and advance indigenous pharmaceutical agents, the Indian Council of Medical Research ("ICMR"), on September 14, 2024, announced formalisation of memorandum of agreements ("MoAs") with multiple prominent industry and academic partners to advance first-in-human phase 1 clinical trials for 4 (four) promising molecules.11

The clinical trials include: (a) collaborative research over a small molecule for multiple myeloma in collaboration with Aurigene Oncology Limited; (b) development of Zika vaccine in collaboration with Indian Immunologicals Limited; (c) coordinating seasonal influenza virus vaccine trial with Mynvax Private Limited; and (d) CAR-T cell therapy advancement study for a new indication of chronic lymphocytic leukaemia with ImmunoACT. The initiative is a crucial step towards establishing India as a leader in the clinical development of pharmaceutical agents.

The move comes soon after ICMR selected 4 (four) strategically located institutions across India to build a network of phase 1 clinical trial units to enhance India's capacity to conduct early-phase clinical trials, backed by infrastructure and manpower at each site. These institutions are: (a) Post Graduate Institute of Medical Education and Research, Chandigarh; (b) King Edward Memorial, Mumbai; (c) Advance Centre for Treatment, Research and Education in Cancer, Mumbai; and (d) SRM Institute of Science and Technology, Chennai.

CDSCO streamlines process for grant of permission to manufacture and import veterinary drugs and cosmetics

In recent months, CDSCO has taken pro-active steps to streamline the procedure for grant of permission through its System for Unmanned Gateways Approval of Manufacturers ("SUGAM") online portal, with the aim of bringing about digitization and efficiency in the regulatory procedure.

On September 12, 2024, the veterinary division of CDSCO issued a circular announcing its decision to switch the submission of Form 44 for grant of permission to import or manufacture a new drug under the Drugs and Cosmetics Rules, 1945 from offline to online mode. Furthermore, applicants seeking permission or approval for: (a) importing finished formulation of new drug in Form 45; (b) manufacturing new drug formulation in Form 46; (c) importing raw material (new bulk drug substance) in Form 45A; and (d) manufacturing raw material (new bulk drug substance) in Form 46A are also required to apply through the SUGAM online portal.12

Earlier, the cosmetics division of CDSCO had announced its decision to streamline the process of making applications for registration and import of cosmetic products, including post-approval changes, through a circular dated August 9, 2024. Pursuant to this, CDSCO restricted the number of products in a single online application to a maximum of 50 (fifty) while permitting multiple applications to be made. The change became effective from August 16, 2024, and is expected to ensure the timely processing and disposal of applications as per the Cosmetics Rules, 2020.13

CDSCO releases draft guidelines on good clinical practices for generating clinical drug data

On September 12, 2024, CDSCO released the draft guidelines on Good Clinical Practices for generating clinical drug data ("Draft GCP Guidelines") with the aim of ensuring that clinical trials are conducted ethically and scientifically and the pharmaceutical substances used for the investigation get properly documented along with their clinical properties.14

The fundamental tenet of the Draft GCP Guidelines is that in research involving human participants, the interest of science and society should never take precedence over considerations related to the well-being of the study participant. Accordingly, the guidelines seek to establish two cardinal principles: (a) protection of the rights, safety and well-being of human participants; and (b) authenticity of bio-medical/ clinical data generated from research.

Prepared in line with the NDCT Rules as well as guidelines issued by notable international organisations such as WHO, the Draft GCP Guidelines place major emphasis on: (a) inclusion of innovative digital health technologies such as wearables and sensors in clinical trials; (b) compensation for research-related harms suffered by human participants; (c) guidelines for studies involving stem cells and nano-particles; and (d) privacy and confidentiality protections, and thus, mark an essential step forward in regulating clinical trials in India.

MoHFW mandates registration of clinical research organisations under NDCT Rules

On September 19, 2024, MoHFW notified amendments to the NDCT Rules ("Amendment Rules 2024") to the effect of defining clinical research organisations ("CROs") and mandating their registration with the central licensing authority ("CLA") under the NDCT Rules as a pre-requisite to undertaking clinical trials, and bio-availability and bioequivalence studies of new drugs, or investigational new drugs in humans.15 The Amendment Rules 2024 shall come into effect from April 1, 2025 onwards.

Once the Amendment Rules 2024 come into effect, CROs will be required to make an application in Form CT-07B to the CLA for the purpose of obtaining registration. Upon receiving such application, the CLA will scrutinize the information provided by the CRO in order to: (a) grant registration or reject the application for reasons to be recorded in writing within a period of 45 (forty-five) working days; or (b) inform the applicant of any deficiency to be rectified in the application not later than 45 (fortyfive) working days, from the date of receipt of application.

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 the CLA. However, in the event the application is rejected, the applicant may request the 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 (fortyfive) days from the date of the decision made by the CLA.

Pertinently, registered CROs will be required to allow any officer authorized by the CLA to enter its premises with or without prior consent, to inspect, search or seize any record, document, investigational product and other related material and is obligated to reply to queries raised by the inspecting authority in relation to functioning of the organisation.

MAJOR DEALS IN INDIA IN THE PHARMA AND HEALTHCARE INDUSTRY.

The following are the key deals announced during the months of August 2024 and September 2024, in the pharma and healthcare industry:16

Fischer Medical Ventures partners with Bio Angle Vacs Sdn Bhd

Fischer Medical Ventures ("Fischer") has confirmed its investment and collaboration with Bio Angle Vacs Sdn Bhd, a biotechnology company based in Malaysia. This partnership aims to establish a production facility in India to serve the local and Middle Eastern markets, which have the highest livestock populations. Through this collaboration, Fischer is advancing its commitment to strengthening global food security and health, thereby contributing to improved healthcare and healthier lives.17

Sun Pharmaceutical Industries invests in biopharmaceutical company Pharmazz

Sun Pharmaceutical Industries ("Sun Pharma") has announced a strategic investment of up to USD 15 million (fifteen million dollars) in Pharmazz Inc. ("Pharmazz"), a US-based biopharmaceutical company.18 Following the investment, Sun Pharma will acquire more than a 5% (five per cent) stake in Pharmazz.

Pharmazz is developing two key drug candidates: (a) Sovateltide for stroke treatment; and (b) Centhaquine for hypovolemic shock. Both drugs have already been approved in India and are currently being developed for sale in the US and other global markets. Pharmazz is gearing up for Phase III clinical trials for both drug candidates in the US, with the aim of securing market approval. As part of the deal between Sun Pharma and Pharmazz, Sun Pharma will secure exclusive rights to market and distribute Sovateltide in certain emerging markets.

The investment is structured in two tranches, with USD 7.5 million (seven million five hundred thousand dollars) to be invested by August 2024 and the remaining amount by February 2025. This strategic partnership between Sun Pharma and Pharmazz is expected to strengthen their respective positions in the pharmaceutical industry.

Vishnu Chemicals Limited acquires Jayansree Pharma Private Limited to strengthen speciality chemicals manufacturing capabilities

On August 19, 2024, Vishnu Chemicals Limited ("VCL"), a manufacturer of high-performance speciality chemicals, announced the 100% (one hundred percent) equity acquisition of Jayansree Pharma Private Limited ("JPPL") for a total consideration of INR 51.99 crore (fifty-one crore ninety-nine lakh rupees). The acquisition is aimed at enhancing VCL's speciality chemicals manufacturing capabilities, with JPPL aligning its operations to fit the strategic goals of its new parent company.19

The JPPL plant is based at Visakhapatnam, Andra Pradesh, where VCL has a strong foothold. Importantly, VCL plans to commission the production of the inorganic chemical 'strontium carbonate' at the JPPL plant to accelerate growth and market expansion at the earliest.

SeQuent Scientific Limited and Viyash Lifesciences Private Limited merge to create leading animal health venture

On September 27, 2024, SeQuent Scientific Limited ("SSL") and Viyash Lifesciences Private Limited ("VLPL") announced a merger to create a platform with leadership in animal pharmaceuticals and expanded capabilities across the larger global pharmaceutical market.20 Upon the scheme of merger becoming effective, all shareholders of VLPL will be issued shares of SSL at the ratio of 56 (fifty-six) equity shares of SSL for every 100 (one hundred) equity shares of VLPL, based on the swap ratio.

The merger is expected to enhance the combined entity's scale, deepen its research and development capabilities, and strengthen its supply chain.

Zydus Lifesciences Limited acquires 50% (fifty percent) stake in Sterling Biotech Limited

Zydus Lifesciences Limited ("ZLF") and Perfect Day Inc. ("PDI"), a Temasek portfolio company have entered into an agreement wherein ZLF, through its wholly owned subsidiary, has acquired 50% (fifty percent) equity stake held by PDI in Sterling Biotech Limited ("SBL").21 SBL, a major pharmaceutical company with two manufacturing facilities in Gujarat, specialises in gelatine, di-calcium phosphate and select active pharmaceutical ingredients. Following the transaction, SBL has become a 50:50 joint venture with equal representation on the board of directors from ZLF and PDI. The acquisition marks ZLF's foray into specialised biotech products for health and nutrition, specifically catering to consumers who prefer animal-free protein or suffer from lactose intolerance.

Footnotes

1. The order can be accessed here: https://www.nppaindia.nic.in/uploads/ tender/58eddec8232e4ada093b846e5b5ccb7f.pdf

2. The order can be accessed here: https://www.nppaindia.nic.in/uploads/ tender/e01968b448a02439c97bfbe66589d99d.pdf

3. The order can be accessed here: https://cdsco.gov.in/opencms/resources/ UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Orde101%20NDCT. pdf

4. https://theprint.in/health/govt-notifies-rule-for-rapid-launch-ofbreakthrough-drugs-in-india-bypassing-local-clinical-trials/2214197/

5. The draft guidelines can be accessed here: https://cdsco.gov.in/opencms/ opencms/system/modules/CDSCO.WEB/elements/download_file_division. jsp?num_id=MTE1OTA=

6. The notification can be accessed here: https://cdsco.gov.in/ opencms/resources/UploadCDSCOWeb/2018/UploadGazette_ NotificationsFiles/2024.08.12_%20S.O.%203284(eEtodolac.pdf

7. 2018 (2) SCC 39.

8. The report can be accessed here: https://www.niti.gov.in/sites/default/ files/2024-09/Report-of-the-Exper-Group--Future-Pandemic-preparednessand-emergency-response_0.pdf

9. https://www.pharmabiz.com/NewsDetails.aspx?aid=172402&sid=2

10. https://www.biospectrumindia.com/news/22/25028/national-healthauthority-and-maharashtra-university-of-health-sciences-sign-mou-to-drivedigital-health-education.htm

11. The press release can be accessed here: https://pib.gov.in/PressReleasePage. aspx?PRID=2054864

12. The circular can be accessed here: https://thehealthmaster.com/wp-content/ uploads/2024/09/DCGI-circular-dt-12-09-2024-Online-application-in-Form44-for-issuance-of-New-Drug-permission-of-Bulk-API-drugs-vaccinesin-Form-45A-46A-and-finished-formulation-in-Form-45-46-Field-TrialPermission-for-Veterinary-purpose-only.pdf

13. The circular can be accessed here: https://cdsco.gov.in/opencms/opencms/ system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_ id=MTE1ODg=

14. The draft guidelines can be accessed here: https://cdsco.gov.in/opencms/ opencms/system/modules/CDSCO.WEB/elements/download_file_division. jsp?num_id=MTE4OTU=

15. The notification can be accessed here: https://cdsco.gov.in/opencms/ opencms/system/modules/CDSCO.WEB/elements/download_file_division. jsp?num_id=MTIwMTM=

16. 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.

17. https://www.expresspharma.in/fischer-medical-ventures-partners-with-bioangle-vacs-sdn-bhds-in-science-technology-and-marketing/

18. https://www.cnbctv18.com/market/sun-pharma-share-price-pharmazzinvestment-15-million-5-percent-stake-tranches-drugs-exclusivity-19459840. htm

19. https://www.thehindubusinessline.com/markets/vishnu-chemicals-acquiresjayansree-pharma-in-52-crore-deal/article68542253.ece

20. https://www.moneycontrol.com/news/business/markets/sequent-scientificshares-rise-12-over-mega-merger-with-viyash-life-sciences-12830708.htm

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