ARTICLE
2 January 2025

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

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IndusLaw

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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 medical devices sector in India has witnessed significant developments, with the Central Drugs Standard Control Organisation successfully obtaining affiliate...
India Food, Drugs, Healthcare, Life Sciences

Introduction

Over the past couple of months, the medical devices sector in India has witnessed significant developments, with the Central Drugs Standard Control Organisation successfully obtaining affiliate membership of the International Medical Device Regulators Forum to Strengthen Medical Device Regulations. In addition, India has further solidified its status as a major player in the global vaccine market, with the National Regulatory Authority of India successfully meeting standards for vaccine regulation prescribed by the World Health Organisation. Other key developments such as recent amendments brought to the Drugs and Cosmetics Rules, 1945 by the Ministry of AYUSH and the continued efforts of the Department of Pharmaceuticals to successfully implement the Uniform Code of Marketing Practices in Medical Devices have dominated headlines in the space.

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

LEGAL & REGULATORY DEVELOPMENTS

The Central Drugs Standard Control Organisation obtains affiliate membership of the International Medical Device Regulators Forum to Strengthen Medical Device Regulations

On October 3, 2024, the Ministry of Health and Family Welfare ("MoH&FW") announced that the Central Drugs Standard Control Organisation ("CDSCO") has obtained affiliate membership of the International Medical Device Regulators Forum ("IMDRF").1

The IMDRF, founded in 2011, is a collaborative group of global medical device regulators dedicated to accelerating the harmonisation and convergence of international medical device regulations. The global forum includes national regulatory authorities from the United States of America ("USA"), Australia, Canada, the European Union and Japan, among others.

In an attempt to achieve global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry, and boost transnational prominence, the CDSCO had applied for affiliate membership of the IMDRF earlier this year. Following constructive discussions at the 26th (twenty sixth) session of the IMDRF held in Seattle, USA, the CDSCO has now been approved as an affiliate member, gaining opportunities for increased collaboration and reliance on international regulatory bodies.

Pursuant to this designation, India will participate in open sessions conducted by the IMDRF, sharing information on technical topics and regulatory strategies. This collaboration will aid India in improving its medical device framework, support innovation, and ensure the safety and efficacy of medical devices. It also facilitates the global acceptance of Indian medical devices, allowing local manufacturers to meet the regulatory standards of the IMDRF member countries and enhancing the country's presence in international markets.

The Department of Pharmaceuticals issues clarifications for effective implementation of the Uniform Code for Marketing Practices in Medical Devices

On October 4, 2024, the Department of Pharmaceuticals ("DoP") issued an order, providing clarity in relation to paragraph 8 of the Uniform Code for Marketing Practices in Medical Devices, 2024 ("Medical Devices Code").2

The Medical Devices Code aims to provide guidelines that would mitigate unethical practices, and ensure transparency, integrity, and accountability in the marketing of medical devices across India. In this regard, the code focuses on: (a) the ethical promotion and sales of medical devices; and (b) facilitating transparent interactions between medical devices companies and healthcare professionals.

Pursuant to the objective set out in point (b) above, paragraph 8.2 of the Medical Devices Code prohibits companies and its representatives from extending travel facilities and benefits to healthcare professionals or their family members for attending conferences, seminars, workshops etc., unless they are a speaker or participant in DoP-approved Continuing Medical Education ("CME")/ Continuing Professional Development ("CPD") programmes or training programmes. In similar vein, paragraph 8.3 of the Medical Devices Code prohibits companies from extending hospitality benefits to the aforesaid class of healthcare professionals. In this regard, the DoP has clarified that these restrictions shall not apply to speakers for CME/ CPD programmes being organised within India i.e., medical devices companies can confer travel and hospitality benefits upon speakers at these programmes, so long as such programmes are conducted in India. However, the restrictions shall continue to apply upon: (a) participants of such programmes; and (b) both speakers and participants of programmes conducted overseas.

The National Regulatory Authority of India successfully meets standards for vaccine regulation established by the World Health Organisation

On October 11, 2024, the MoH&FW announced that the National Regulatory Authority of India ("NRA"), along with the CDSCO and affiliated institutions, successfully met the standards prescribed by the World Health Organisation ("WHO") for assessing the functionality of the vaccine regulatory system.3 The announcement followed a comprehensive and in-depth scientific review of India's vaccine regulatory system conducted by a team of WHO-led international experts from September 16 to September 20, 2024.

The WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, and establishment of pre-qualification programme of vaccines. As per these standards, safety, efficacy, and quality serve as the core parameters for assessment of vaccines.

In relation to the assessment of the vaccine regulatory system prevailing in India, WHO aimed at: (a) assessing and documenting the status of the system; (b) re-benchmarking the status of the system against the WHO Global Benchmarking Tool Version VI ("GBT VI"); and (c) measuring the maturity of the system.

The assessment was undertaken in respect of 9 (nine) different functionalities, including key regulatory activities such as licensing, market authorisation, vigilance, clinical trials oversight, and lot release procedures. Following the assessment, India has been declared 'functional' with a maturity level 4 in respect of 5 (five) functions, and maturity level 3 in respect of 4 (four) functions. As per GBT VI, maturity level 4 indicates good results and sustained improvement trends, while maturity level 3 indicates systematic process-based approach, early stage of systemic improvements, data availability regarding conformance to objectives and existence of improvement trends. The affirmative result underlines India's ability to meet WHO pre-qualification standards, and further solidifies India's status as a major vaccine producer and supplier in the global market.

National Pharmaceutical Pricing Authority fixes retail price of 20 (twenty) drug formulations

In exercise of its powers conferred by the Drugs (Prices Control) Order, 2013 ("DPCO"), the National Pharmaceutical Pricing Authority ("NPPA") has fixed the retail prices of 20 (twenty) drug formulations through an order dated October 14, 2024.4 Drug formulations such as: (a) Bisoprolol and Amlodipine tablets, for managing blood pressure; (b) Gentamicin and Dexamethasone eye drops; (c) Levosalbutamol and Ipratropium Bromide Respules, for easing airway muscles; and (d) Atorvastatin, Aspirin, and Clopidogrel capsules, for preventing blood clots and reducing cholesterol levels, among others, had their prices fixed. Pertinently, the relevant order prescribed that the manufacturer/ marketing company would be required to deposit the overcharged amount along with interest in accordance with the provisions of the DPCO read with the Essential Commodities Act, 1955, in the event the new retail prices are not complied with.

Earlier in the month, the NPPA had invoked its extraordinary powers under paragraph 19 of the DPCO to approve the increase in ceiling prices of 11 (eleven) scheduled formulations of 8 (eight) drugs, including: (a) Benzyl Penicillin 10 lakh IU injection; (b) Atropine injection 06.mg/ml; (c) Streptomycin powder for injection 750 mg and 1,000 mg; and (d) Salbutamol tablet 2 mg and 4 mg and respirator solution 5 mg/ml, among others.5

The High Court of Delhi rejects Abbott GmbH's plea for cancellation of trademark registration for "Mebufen".

On October 22, 2024, the High Court of Delhi ("Delhi HC") upheld the Registrar of Trademarks' decision to reject an objection filed by Abbott GmbH ("Abbott"), which challenged the approval of the trademark 'Mebufen' for a painkiller produced by Meridian Medicare Limited ("Meridian Medicare"), on the grounds of similarity of the mark to its analgesic brand 'Brufen'.6

'Brufen' is a registered trademark that Abbott has been using since 1973 and covers analgesics and antiinflammatory drugs. In 2005, Meridian Medicare applied and successfully obtained registration for the trademark 'Mebufen' under Class 5, covering medicinal and pharmaceutical products. This registration was opposed by Abbott, contending that 'Mebufen' was deceptively similar to 'Brufen', and would confuse consumers with "average intelligence and imperfect recollection" on account of: (a) similar use in pain relief products containing ibuprofen; and (b) phonetic similarity of the marks.

On the other hand, Meridian Medicare argued that the concerned trademarks were structurally, visually and phonetically distinct, and only shared the suffix 'Fen', which is derived from ibuprofen and commonly used in pharmaceutical trademarks. Resultantly, Abbott could not claim exclusivity over the suffix. Further, Meridian Medicare contended that the packaging and branding styles of the trademarks were distinct enough to avoid confusion amongst the customers.

The Delhi HC ruled in favour of Meridian Medicare, in light of the precedent that competing trademarks should not be dissected letter-by-letter but rather should be evaluated in totality for structural and phonetic resemblance, set out in LA Roche & Co. Limited v. Geoffrey Manners & Co. Private Limited.7 The Delhi HC concurred with the submissions made by Meridian Medicare against Abbott's claim of exclusivity over the suffix 'Fen', and held that the concerned trademarks were sufficiently different in both structure and sound, noting that the prefixes 'Bru' and 'Meru' created a clear distinction.

Ministry of Ayush amends Drugs and Cosmetics Rules, 1945 to introduce perpetual renewal of manufacturing and loan licenses

Through a notification dated October 28, 2024 ("Notification"), the Union Ministry of AYUSH has amended the Drugs and Cosmetics Rules, 1945 ("D&C Rules") to bring about significant changes in the existing paradigm. Pertinently, the erstwhile system of periodic license renewal for manufacturers of ayurveda, siddha, unani and homoeopathy medicines has been replaced by the one-time registration framework, mandating the aforesaid manufacturers to renew their manufacturing and loan licenses to perpetuity by depositing a onetime retention fee within a period of 1 (one) year, regardless of the period of their license renewal.8

In this regard, the newly amended Rule 153 of the D&C Rules now requires existing license holders to deposit: (a) a one-time fee of INR 1,000 (Indian Rupees One Thousand) for existing ayurvedic, siddha, and unani medicines; and (b) INR 100 (Indian Rupees One Hundred) per product for other drugs. Similar changes have been made to Rule 85B, which regulates manufacturing license applications for homoeopathic medicines. The provision setting out stipulations for renewal of license has been removed from the aforesaid rule, and the fee structure has been revised, with applicants being required to deposit: (a) INR 2,000 (Indian Rupees Two Thousand) for any number of single ingredient homoeopathic medicines; and (b) INR 200 (Indian Rupees Two Hundred) per product for combination of ingredients of homoeopathic medicines.

The notification has further introduced rules concerning application for loan license to manufacture homoeopathic medicines, inclusion of sowa-rigpa drugs within the scope of the D&C Rules, and procurement of good manufacturing practices certificate for homoeopathic medicines manufacturing units, among others.

DoP issues operational guidelines for Strengthening of Medical Device Industry Scheme

On November 8, 2024, the DoP issued operational guidelines in relation to the newly launched Strengthening of Medical Device Industry Scheme ("SMDI Scheme"), aimed at bolstering the medical device sector in India.9 The SMDI Scheme unifies two previous schemes: (a) the Assistance to Medical Device Clusters for Common Facilities; and (b) the Human Resource Development in Medical Devices, under a unified framework. Pursuant to the scheme, the DoP plans to provide targeted financial support to the medical device sector across 5 (five) key dimensions with a total outlay of INR 500 crores (Indian Rupees Five Hundred Crores): (i) manufacturing; (ii) skill development; (iii) clinical research; (iv) shared infrastructure; and (v) industry promotion.

In this regard, the SMDI Scheme shall provide substantial capital subsidies for domestic manufacturers, with the goal of reducing import dependence for over 350 (three hundred and fifty) medical devices. The scheme shall also cover project costs incurred in establishment of common facilities and testing labs by both government entities (up to 70% (seventy per cent)) and private institutions (up to 50% (fifty per cent)). Importantly, the focus of the scheme is geared towards enhancement of medical device education, through issuance of grants for post-graduate and skill development courses.

The overall goal of the SMDI Scheme is to foster innovation, reduce import dependency, and build a skilled workforce capable of meeting the rapidly evolving demands of the medical technology sector.

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Footnotes

1. The order can be accessed here: https://pib.gov.in/PressReleasePage.aspx?PRID=2061397

2. The code can be accessed here: https://pharmaceuticals.gov.in/sites/default/files/UCMPMD_0.pdf

3. The press release can be accessed here: https://pib.gov.in/PressReleseDetailm.aspx?PRID=2064070®=3⟨=1

4. The order can be accessed here: https://thehealthmaster.com/wp-content/uploads/2024/10/S.O.-4497-dt-14-10-2024-NPPA-has-fixed-retail-pricesof-20-formulations-under-Drugs-Prices-Control-Order-2013-based-on-thedecision-of-127th-Authority-meeting-dated-08.10.2024.pdf.

5. The press release can be accessed here: https://mohfw.gov.in/?q=pressrelease-110.

6. A. (COMM. IPD-TM) 9/2023.

7. 1970 AIR 2062.

8. The notification can be accessed here: https://thehealthmaster.com/wp-content/uploads/2024/11/GSR-No.-669E-dt-28-10-2024-Drugs-Fifth-Amendment-Rules-2024-regarding-Homoeopathy-Ayurvedic-Siddha-and-Unani-Drugs.pdf.

9. The guidelines can be accessed here: https://pharmaceuticals.gov.in/sites/default/files/Final%20guidelines%20for%20SMDI-8.11.2024.pdf

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