Welcome to the latest edition of our monthly Lifesciences and Healthcare Newsletter for the month of October 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

Regulation of Class C and D Medical Devices under the Licensing Regime

The Central Drugs Standard Control Organisation (CDSCO) has published a notification on October 12, 2023, which states that, if an existing manufacturer/ importer who is already importing or manufacturing Class C and D Medical Devices and has already submitted an application to the Central Licensing Authority for the grant of an import/manufacturing license, as per the provisions of the Medical Devices Rules, 2017, such application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) for up to six months from the date of issue of this order or till the time the Central Licensing Authority takes their decision, whichever is earlier. Read More

Podcast

Healthcare Huddle: Episode 1: The Licensing Regime for Medical Devices – Registration of Class C and D Medical Devices

Catch the first episode of Healthcare Huddle: The Licensing Regime for Medical Devices – Registration of Class C and D Medical Devices. Click Here

Events & 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 Pharmaceutical Pricing Authority revises price ceiling of 438 scheduled formulations

On October 25, 2023, the National Pharmaceutical Pricing Authority (NPPA) notified the revised ceiling price of 438 scheduled formulations in order to rectify an anomaly that took place while calculating the revised prices based on the Wholesale Price Index (WPI) increase of 12.1218 per cent. It has also notified the revised price for Bare Metal Stents, with a price increase of 0.01 paise.

Link Here

The Central Drugs Standard Control Organisation issued a notice for the classification of In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017

On October 25, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued a notice classifying In-Vitro Diagnostic Medical Devices, under Medical Device Rules, 2017 (MDR 2017), based on general intended use (device may have specified or intended use as specified by its manufacturers/ importers) against each of the device for guidance to the applicants who intend to furnish applications to import/ manufacture under MDR 2017, risk associated with the device and other parameters as specified in the First Schedule. Further, the updated list of In-vitro Diagnostics placed from Annexure A to E is subject to revision from time to time.

Link Here

The CDSCO has introduced a new protocol for the submissions for online applications of Post Approval Changes (PAC) w.r.t Clinical Trial Permission and Post Marketing Surveillance (PMS) for Human Vaccines and Anti-Sera 

On October 26, the CDSCO, issued a circular to streamline the regulatory submission procedure the submissions on PAC w.r.t Clinical Trial Permission in Form CT-06 and Approval for Protocol/ Report of PMS for Human Vaccines and Anti-Sera. The online system is now functional through the SUGAM portal, under ‘Post Approval Changes.’ All applicants seeking PAC must apply through the online portal.

The facility of offline submission through hard copy will not be available for processing from November 1, 2023.

Link Here

General Updates

1. The Pharmacopoeial Discussion Group (PDG) announced the Indian Pharmacopoeia Commission (IPC) as a PDG member on October 5, 2023 during PDG Stakeholder’s meeting in Hyderabad. IPC officially joined as a member in the PDG at the PDG’s Annual Meeting which was held on October 3 and 4, 2023 in Hyderabad. After a year of the pilot phase, based on IPC’s involvement, contribution and potential the decision to include IPC as a permanent member was taken.

The PDG aims to bring together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP), the United States Pharmacopeia (USP) and Indian Pharmacopoeia (IP) to harmonize global pharmacopoeial standards. Read More

2. On October 25, 2023, the Pharmacy Council of India directed all State Governments and State Pharmacy Councils to implement the Jan Vishwas (Amendment of Provisions) Act, 2023 issued by the Ministry of Law and Justice. Read More

3. The Ministry of Health and Family Welfare, on October 25, 2023, introduced the ‘The Indian Red Cross Society Bill, 2023’ with the aim of providing comprehensive oversight to the Indian Red Cross Society (IRCS). Read More

Contributors to the newsletter:

• Nusrat Hassan, Managing Partner
• Pradnesh Warke, Partner
• Tanay Jha, Associate
• Khushi Shah, Trainee Associate