Areas of Service

Healthcare

our INDUSTRY expertise

The healthcare industry is one of the largest sectors contributing to the Indian economy. Growing at a rate of CAGR of 22% it is expected to reach USD 372 billion in 2022[1]. The hospital industry accounts for nearly 80% of the market and is estimated to be valued at USD 132 billion by 2023.[2] Additionally, the market also comprises of the medical tourism market valued at approximately USD 6 million and the diagnostics industry valued at approximately USD 4 billion.[3]

In the recent past, the increased push of the Indian Government to create an interoperable healthcare system has also led to the emergence of an ancillary services segment consisting of EHR/EMR service providers and healthcare administrative services.

The Indian healthcare industry has witnessed tremendous opportunities and growth in the last decade due to increased Governmental focus. The Ayushman Bharath Digital Health Mission and the Ayushman Bharath Scheme have incentivized the growth of this industry. Additionally, the COVID-19 pandemic has created new segments within the industry including telemedicine and health e-service aggregators.

• Electronic health records have become a major focus of all healthcare establishments and the insurance sector due to the shift in the Government policy encouraging digitization and interoperable health data records. There is increased integration of blockchain, AI and cloud computing into healthcare management systems.
• As a step-up from the present-day telemedicine, remote diagnostics is being explored as cross section between the healthcare and medical device industry to enable healthcare practitioners to conduct complete accurate diagnostics remotely.
• There is increased focus on marketing practices and digital outreach of hospitals and healthcare professionals.
• Innovative collaborations with pharmaceutical industry for product promotions, clinical trials and data analytics.

The Healthcare industry is an area of practice in which Nishith Desai Associates (“NDA” or the “Firm”) has built a significant expertise.  At NDA we endeavor to combine our rich international experience and expertise in domestic laws/regulations with our research capabilities to devise innovative structures and provide strategic advice on undertaking business activities to healthcare companies in India.

SCOPE OF SERVICES

• Strategic advice on Industry Law issues: The Firm advises on legal, strategic and compliance issues related to the laws governing the healthcare industry. The Firm provides practical solutions, on the basis of the extensive domain knowledge of the industry marketing practices targeting healthcare practitioners, limitations on services of AYUSH practitioners and allied healthcare practitioners etc.
• Documentation: The Firm undertakes drafting and review of service agreements, clinical trial agreements, consent forms etc.
• Regulatory advice: The Firm provides advice with respect to regulatory issues which may arise due to business models and transactions in the healthcare industry which may have implications under the applicable laws. These include advice on marketing practices of pharmaceutical companies in engagement with healthcare professionals.
• Litigation: The Firm has a robust Dispute Resolution Practice with members having skill and expertise to represent clients in different forums ranging from the NCLAT, CCI, High Courts to the Supreme Court of India.

regulatory and legal framework applicable to the industry

National Medical Commission Act, 2019

• Regulates medical education and profession in India
• Only persons eligible as per the Act are permitted to practice modern medicine in India
• Provides for penalties for medical practitioners in contravention of the provisions of the Act

Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (MCI Code)

• Regulates professional conduct of registered medical practitioners in India
• Violation of MCI Code may amount to professional misconduct resulting in penal action to the extent of permanent disqualification to practice, over and above any other civil or criminal action which may lie under relevant law

Clinical Establishments Act (Registration and Regulation) Act, 2010

• The clinical establishments act is operational and applicable across a few states such as Rajasthan, Uttar Pradesh, Uttarakhand, Jharkhand, Assam, Haryana and all Union Territories (except NCT Delhi). The remaining states have their own state clinical establishment legislations.
• The Act mandates registration of all clinical establishments, including diagnostic centres and single-doctor clinics across all recognized systems of medicine both in the public and private sector (except for defence sector establishments)
• The National Council for Clinical Establishment overlooks the administration of the Act
• Lays down the minimum standards for facilities and services, personnel, reporting and record keeping.

Telemedicine Practice Guidelines, 2020

• Appended to the MCI Code to enable registered medical practitioners to practice telemedicine in India
• Regulates the practice of telemedicine and provide guidance on the nature of care that may be given through telemedicine and the manner of providing such care
• Prohibits the prescription of certain categories of medicines

The National Commission for Allied and Healthcare Professions Act, 2021

• Provides standards for education and services performed by allied and healthcare professions such as ophthalmic science professionals, cardiovascular technology professionals and behavioral health sciences professional
• National Commission for Allied and Healthcare Professions will be the regulatory body under the Act. It is responsible for determining the scope of practice of each profession, basic standards of education, recognizing qualifications and arranging for exit licensing exams.

National Commission for Indian System of Medicines Act, 2020

• It regulates the education and practice of Indian System of Medicine (Ayurveda, Unani, Siddha & Homeopathy)
• The National Commission for Indian System of Medicine regulates the medical institutions and medical professionals of Indian System of Medicine and provides for registration of medical professionals
• Provides for penalties for practitioners in contravention of the provisions of the Act

National Commission for Homoeopathy Act, 2020

• Regulates Medical institutions and Homeopathic medical professionals
• National Commission for Homeopathy is responsible for the administration of the Act

The Dentists Act, 1948

• Dentistry is regulated independently from modern medicine
• The Act regulates the education and practice of dentistry in India
• The Dentists Council is responsible for the administration of the Act

Pharmacy Act, 1948

• Regulates pharmacy education, profession and practice of pharmacy in India
• Provides that an offense in a professional capacity by a registered pharmacist may lead to penal action under the Act to the extent of permanent deregistration
• Impersonation as a registered pharmacist is also punishable under the Act

Consumer Protection Act, 2019

• Healthcare is a service under the Act and may therefore be applicable against all healthcare establishments and individual healthcare professionals
• Provides all-round protection of consumers and safeguards against commercial exploitation

Drugs and Cosmetics Act, 1945 and Rules

• Regulates manufacturing, import, distribution and sale of drugs (includes certain medical devices) and cosmetics
• Lays down the manner of prescription of drugs

CONCLUSION

The Indian healthcare industry is widespread and encompasses several fields of medicine in addition to multiple segments such as primary healthcare institutions, diagnostic centres, telemedicine platforms and ancillary services. However, the laws governing this industry is dispersed and therefore causes uncertainty in its applicability and impact. Nevertheless, it is important to note that this is a heavily regulated industry and requires methodical compliance at every stage. Given the enormous growth in the past decades and the market forecasts, we envision India to lead the healthcare market and increased regulatory focus on emerging trends and innovations.

REPRESENTATIVE CLIENTS

• Healthcare providers: Apollo Hospitals, Fortis Healthcare, Narayana Health, Aster DM Healthcare, Shalby Hospitals, Thyrocare
• Healthcare Management Systems: IBM, Philips, Cognizant, MocDoc