Welcome to the latest edition of our monthly Lifesciences and Healthcare Newsletter for the month of August 2023. We are excited to share a few key sector updates and our recent activities/ achievements as Dentons Link Legal with you.

This Newsletter will also provide you with personalized interviews of industry KOLs (Key Opinion Leaders) along with podcasts on interesting topics. Do check our brain teaser and send us your answers..

News Updates

National Medical Commission Registered Medical Practitioners (Professional Conduct) Regulations, 2023 was notified under the National Medical Commission Act, 2019, which has thereafter been held in abeyance with immediate effect.

The National Medical Commission (“NMC”) had issued the National Medical Commission Registered Practitioner (Professional Conduct) Regulations, 2023 (“RMP Regulations”) on August 3, 2023, and which came into effect on August 9, 2023. Thereafter, on August 23, 2023, the National Medical Commission Registered Medical Practitioners (Professional Conduct) (Amendment) Regulations, 2023 (“Amendment”), was issued which put the RMP Regulations in abeyance with immediate effect. The NMC has further clarified that the RMP Regulations shall not be operative and effective till further notification in the official gazette.

Further, it is imperative to note that the erstwhile Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, which had been overridden by the RMP Regulations have been re-adopted and made effective under the Amendment. It is speculated that the changes brought about by the RMP Regulations were not industry friendly and therefore a revision of the same is on the cards.

[Link to RMP Regulations here] [Link to Amendment here]

Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution, has released ‘Endorsement Know-hows! - For Celebrities, Influencers and Virtual Influencers on Social Media Platforms’

The Department of Consumer Affairs, under the Ministry of Consumer Affairs, Food and Public Distribution, has released additional guidelines for celebrities, influencers and virtual influencers in the field of health and wellness (“Additional Influencer Guidelines”). These guidelines are an important extension to the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022 released on June 9, 2022, and in lieu of the ‘Endorsement Know-hows!’ guide booklet released on January 20, 2023.

The Additional Influencer Guidelines have been developed after detailed discussions with all stakeholders including (a) Ministry of Health, (b) Ministry of Ayush, (c) Food Safety and Standards Authority of India (FSSAI), and (d) Advertising Standards Council of India (ASCI).

[Link to Additional Influencer Guidelines here]

Various private member bills introduced in the Indian Parliament for protection of healthcare personnels and institutions against violence and harassment.

The following private member bills concerning protection of healthcare personnels and institutions against violence and harassment, were introduced in the Indian Parliament on August 4, 2023:

1. The Prevention of Violence Against Healthcare Professional and Clinical Establishments Bill, 2022 [Bill No. 280 of 2022], by Dr. DNV Senthilkumar S., M.P.; [Link to Bill here]
2. The Healthcare Service Providers and Facilities (Prevention of Violence and Damage to Property) Bill, 2023 [Bill No. 98 of 2023], by Dr. Jawed Mohammed, M.P.; [Link to Bill here]
3. The Healthcare Personnel and Healthcare Institutions (Prohibitions of Violence and Damage to Property) Bill, 2023 [Bill No. 99 of 2023], by Dr. Shashi Tharoor, M.P.; and [Link to Bill here]
4. The Healthcare Professional (Protection from Violence and Harassment) Bill, 2023 [Bill No. 105 of 2023], by Shri Hibi Eden, M.P. [Link to Bill here]

The aforesaid bills broadly propose to provide for protection of healthcare professionals from violence and acts of aggression, and damage/ loss to property of healthcare institutions.

The National Dental Commission Act, 2023 and the National Nursing and Midwifery Commission Act, 2023 have been notified.

The National Dental Commission Bill, 2023, was introduced to elevate dental education and healthcare standards, and it also proposed to replace the the Dentists Act, 1948. The said bill is now passed in the Indian Parliament, received the assent of the President, and notified in the gazette on August 11, 2023, as the National Dental Commission Act, 2023.

Similarly, the National Nursing and Midwifery Commission Bill, 2023, was introduced in the Indian Parliament for comprehensive reforms in nursing sector, and it also proposed to replace the Indian Nursing Council Act, 1947. The said bill has now been passed in the Indian Parliament, received the assent of the President, and notified in the gazette on August 12, 2023, as the National Nursing and Midwifery Commission Act, 2023.

[Link to the National Dental Commission Act, 2023 here] [Link to the National Nursing and Midwifery Commission Act, 2023]

General Information

• Ministry of Home Affairs, Government of India has notified the creation of a new category of Ayush (AY) visa for foreign nationals for treatment under Ayush systems/Indian systems of medicine. [Link here]
• Government of India has launched Ayushman Bharat Digital Mission (ABDM) which aims to develop the backbone necessary to support the integrated digital health infrastructure of the country and create longitudinal Electronic Health Record (EHR) for the citizen. [Link here]
• The National Medical Commission (NMC) is in the process of launching an integrated web portal that will serve as a comprehensive platform for all key stakeholders within the medical community, including State Medical Councils (SMC), medical colleges, registered medical practitioners (RMPs), etc., to facilitate the registration process for medical practitioners. [Link here]

Events and Seminars

Upcoming Webinar

• Dentons Link Legal, in collaboration with Knowledge Partner HSBC is organizing the fourth webinar in the Galloping MedTech Industry & its Evolution 1.0 series on the topic ‘Ethics and Compliance: Cornerstones of Success for MedTech Companies’ on September 26, 2023.

Past Webinars

Dentons Link Legal, in collaboration with Knowledge Partner HSBC organized webinars in the ‘Galloping MedTech Industry & its Evolution 1.0’ series on the following topics:

1. 3rd Webinar on August 22, 2023: MedTech Evolution with Start-Ups and Current Investment Environment [Link to webinar recording].
2. 2nd Webinar on April 4, 2023: Laws relating to interaction with HCPs [Link to webinar recording].
3. 1st Webinar on March 14, 2023: MedTech Impact on Healthcare Industry [Link to webinar recording].

Interview

Kuldeep Mirani, an MBA, and a Chartered Accountant, resides in Singapore and is the co-founder & CEO of Beyond Seed, a pioneering venture builder platform situated in Singapore. Beyond Seed is a Seed platform dedicated to furnishing both financial and intellectual support to early-stage startups in India, facilitating their global expansion endeavors. Passionate about assisting startup founders in constructing prosperous ventures, Kuldeep's diverse experiences have equipped him with a profound understanding of entrepreneurial success.

DLL: Do you think India is an appealing destination for investors because of the rapidly expanding fast increasing MedTech market?

KM: The healthcare sector in India is witnessing remarkable growth, driven by factors such as a burgeoning population (local demand), rising healthcare awareness, increasing lifestyle diseases, and need for cost-effective solutions. The MedTech industry plays a pivotal role in addressing these challenges and hence the Indian MedTech Market is undeniably an appealing destination for the investors.

DLL: Do you believe there is currently a funding winter, or are investors becoming more cautious? How should entrepreneurs navigate through this difficulty?
KM: While there is a phase of consolidation in the startup funding landscape, it's important to note that funding opportunities have not entirely vanished. Investors still have available capital, albeit with a heightened sense of caution in recent months. Entrepreneurs can navigate through these challenges by bootstrapping and focusing on traction, whether in terms of user acquisition, revenue growth, or product development milestones. And entrepreneurs should use this phase in building and nurturing relationships with potential investors & attend networking events and seek mentorship from experienced individuals in their industry.

DLL: Where do you think it is easier to raise funds for start-ups – India or abroad? Please share your thoughts on the present investment climate in relation to Indian start-ups.

KM: The ease of raising funds for startups can vary depending on several factors, including the nature of the business, the stage of development, business model and growth strategy. Both India and foreign markets have their advantages and challenges. In India, the startup ecosystem has grown significantly in recent years. The government has introduced initiatives like "Startup India" to promote entrepreneurship, and there is a growing number of venture capital firms, angel investors, and crowdfunding platforms. This has made it relatively easier for Indian startups, especially in technology and innovation-driven sectors, to access early-stage funding. However, raising funds in foreign markets can also be attractive for certain startups, particularly those with global ambitions or those operating in specialized niches. Foreign investors may be more willing to invest in startups that offer innovative solutions or have a strong market presence. Regardless of the choice, a strong pitch, a well-defined business plan, and a focus on execution are critical to attracting investors in any location.

For more insights, please click here to see the recording of our webinar on the subject matter: 

Articles

A look in the future: Impact and adoption of MedTech in the healthcare industry

Interaction with HCPs: Is it awareness or advertisement activity?

Salient Features of the National Nursing and Midwifery Commission Act 2023

Healing the future: Indian startups paving the way through technology and innovation

Contributors to the newsletter:

Nusrat Hassan, Managing Partner

Pradnesh Warke, Partner & Practice Head - Lifesciences & Healthcare

Tanay Jha, Associate

Subham Biswal, Associate

Khushi Shah, Trainee Associate