Welcome to the latest edition of our monthly Lifesciences and Healthcare Newsletter for the month of September 2023.

Articles

NMC - Professional Conduct Review - Lessons from Case Archives

On October 5, 2023, the National Medical Commission (NMC) unveiled its first publication titled, "Professional Conduct Review - Lessons from Case Archives" by the Ethics and Medical Registration Board (EMRB). It is a compilation of case studies related to medical ethics and negligence involving registered medical practitioners (RMPs) and their patients. Read More

India's Healthcare Sector's Ethical and Compliant Journey to Success

The healthcare industry plays a pivotal role in the well-being of a nation's population. In India, a country with a diverse and densely populated demographic, the healthcare sector faces unique challenges. Among these challenges, ensuring ethics and compliance within the industry is of paramount importance. This article delves into the intricacies of ethics and compliance in the Indian and international healthcare sector, exploring key issues, regulatory frameworks, and potential areas for improvement. Read More

Events and Webinars

Ethics and Compliance: Cornerstone of Success for MedTech Companies | September 26, 2023.

Watch the recording here.

MedTech Evolution with Start-Ups and Current Investment Environment | August 22, 2023

Watch the recording here.

Laws relating to interaction with HCPs | April 4, 2023 

Watch the recording here.

Industry Updates

The National Medical Commission notifies the Maintenance of Standards of Medical Education Regulations, 2023.

On, September 19, 2023, the National Medical Commission (“NMC”) notified the Maintenance of Standards of Medical Education Regulations, 2023 (“MSMER-2023”) to ensure smooth compliance with its functions and maintain a high quality and high standards in medical education. The MSMER-2023 specifies various compliance requirements to be satisfied by the medical colleges or institutions, including but not limited to furnishing of annual disclosure reports. The medical education boards viz. post graduate medical education board (PGMEB) and undergraduate medical education board (UGMEB), as applicable, are empowered to undertake evaluation of the said annual disclosure reports for verification of compliance by the medical colleges and institutions. On successful compliance with the prescribed requirements, the relevant medical colleges and institutions are awarded with a renewal certificate for continuation of the course(s) and admission of students thereof for the upcoming academic year. Failure to comply with the requirements under the MSMER-2023 may attract penalties, inter alia, issuance of warning with direction to rectify/ comply, monetary penalties on the medical institution extending up to INR 1 crore per violation, monetary penalties of INR 5 lakhs on the faculty/ head of department/ dean/ director/ doctor submitting false declaration/ documents/ records, withholding the accreditation process, reduction in the number of students intake, stoppage of admission to one or more courses, recommendation to the NMC for withdrawal of permission, and withholding and withdrawal of accreditation for a period of up to five academic years.

Link to MSMER-2023 here.

Union Health Minister Dr. Mansukh Mandaviya launches National Policy on Research and Development and Innovation in Pharma-MedTech Sector in India and Scheme for Promotion of Research and Innovation in Pharma MedTech Sector.

The Union Health Minister Dr. Mansukh Mandaviya launched the National Policy on Research and Development and Innovation in Pharma-MedTech Sector in India (“Policy”) and introduced the Scheme for the promotion of Research and Innovation in Pharma MedTech Sector (“PRIP”) on September 26, 2023. 

National Policy on Research and Development and Innovation in Pharma-MedTech Sector in India

Link to the Policy here. 

Scheme for Promotion of Research and Innovation in Pharma MedTech Sector

Link to the Policy here 

Launch of the 'Ayushman Bhav' campaign, initiated by the Ministry of Health and Family Welfare, Government of India

Launch of the 'Ayushman Bhav' campaign, initiated by the Ministry of Health and Family Welfare, Government of India.

As part of the Seva Pakhwada, Ayushman Bhav Abhiyan for saturation of essential health services is being held across the country from September 17, 2023, to October 2, 2023. The 'Ayushman Bhav' campaign aims to redefine healthcare accessibility and inclusivity across the country and embodies a whole-of-nation and whole-of-society approach. The core objective of the Sewa Pakhwada is to extend comprehensive healthcare coverage to every village and town, transcending geographical barriers and ensuring that no one is left behind. 

Link Here.

General Updates

1. In a bid to strengthen investment and bolster manufacturing, the government is poised to recalibrate the Production-Linked Incentive (PLI) schemes, focusing on pivotal sectors like the pharma industry, drones, and textiles. [Read More]
2. The Drugs Controller General of India (DCGI) has taken proactive measures to elevate Pharmaceutical Manufacturing Standards within the country. In an effort to ensure the production of safe and effective drugs, the DCGI has directed state drug regulators to closely monitor approximately 200 micro, small, and medium enterprises (MSMEs) engaged in drug manufacturing. This initiative underscores the importance of strict adherence to Good Manufacturing Practices (GMP) norms at their production facilities. [Read More ]
3. Honourable President of India, Smt. Droupadi Murmu virtually launches Ayushman Bhava Campaign, and the Ayushman Bhava Portal. This historic launch marks a significant leap towards achieving Universal Health Coverage (“UHC”) and ensuring healthcare for all. It strives to further consolidate the accessibility and affordability of healthcare services particularly for the underserved. [Read More ]

Contributors to the newsletter:

Nusrat Hassan, Managing Partner

Pradnesh Warke, Partner

Tanay Jha, Associate

Subham Biswal, Associate

Khushi Shah, Trainee Associate