Operon Strategist

Introduction to Proposed Changes The Central Drugs Standard Control Organization (CDSCO) has initiated a 30-day consultation period to review proposed updates to the Good Clinical Practice (GCP) guidelines in India. The revision aims to enhance the current 121-page document by adding 30 new pages, focusing on integrating advanced technology into clinical study and research practices. […]

An Overview: The Indian government has expanded the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) to provide health coverage for all citizens aged 70 and above, with Rs 5 lakh per year in benefits. This move aims to ease medical expenses for seniors, but industry leaders have raised concerns about timely payments and adequate

MPIDC Allocates Land to Medical Device Industries The Madhya Pradesh Industrial Development Corporation (MPIDC) has made significant strides in boosting the medical devices industry by allocating land to 36 medical devices and associated industries at the Medical Devices Park in Ujjain. This park has been strategically established to enhance the production and export of medical

The Indian government has issued the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024, aiming to regulate and curb unethical practices in the medical device industry. Ethics Committees to Oversee Complaint Handling As part of the new code, all medical device associations must establish an Ethics Committee for Marketing Practices in Medical Devices

FDA Draft on PCCPs for Medical Devices The U.S. Food and Drug Administration (FDA) has issued a draft guidance document for its proposed policies for predetermined change control plans (PCCPs) for medical devices. The guidance provides the FDA’s current thinking and recommendations on the information to include in a PCCP in a marketing submission for

20% Capital Subsidy for Domestic MedTech Component Production NEW DELHI: The government plans to launch a new scheme to incentivize the MedTech or medical technology industry to manufacture components for digital X-ray, CT scan, and MRI machines in the country. Currently, most such components are imported leading to the high cost of the devices and,