Operon Strategist

An Overview: In a significant regulatory update, the Indian government has amended the Medical Devices Rules (MDR), officially classifying surgical and medical examination gloves as medical devices. The Ministry of Health and Family Welfare (MoHFW) has also designated 27 Medical Device Testing Officers (MDTOs) across six laboratories for enhanced regulatory oversight. Key Amendments in the […]

India’s Growth in MedTech: 19 Projects Commissioned Under PLI Scheme for Medical Devices The Government of India has introduced several Production Linked Incentive (PLI) Schemes to strengthen domestic manufacturing in the pharmaceutical and medical device sectors. These initiatives aim to reduce import dependence, encourage investment, and boost local production. PLI Scheme for Bulk Drugs: This

An Overview: Prolonged delays in clearing imports of essential components are causing significant disruptions in the manufacturing of critical medical devices in India. Industry leaders warn that these delays could hinder the progress of the government’s Make in India initiative for the medical device sector, jeopardizing the timely availability of life-saving diagnostic tools. Industry Challenges

India’s MedTech Industry Emerges as a Global Powerhouse with $3.8 Billion Exports and Rapid Growth India’s medical device sector is rapidly evolving from being import-dependent to a global MedTech powerhouse. With a surge in exports, valued at $3.8 billion in 2023-24, and a projected market size of $50 billion by 2030, the Indian MedTech industry

Overview of the Illegal Pathology Laboratories in Gujarat In Gujarat, approximately 10,000 pathology laboratories are allegedly operating illegally. As per regulations, an MD in Pathology is a mandatory qualification for running a laboratory. However, reports indicate that individuals with only 10th or 12th-grade qualifications, currently enrolled in Medical Lab Technology courses, are operating these labs.