Mumbai: The Ghaziabad-based Indian Pharmacopoeia Commission (IPC) will organise a workshop themed “Promoting Medical Devices Safety and Surveillance in India – Stakeholders Summit” on March 20 in New Delhi.
The objective of the workshop is to sensitise manufacturers, importers, distributors and other stakeholders about the safety of medical devices and in-vitro diagnostics (IVDs) and their post marketing requirements in India.
The workshop will majorly cover topics like safety and vigilance of medical devices, challenges in developing indigenous database for medical device safety, medical devices and IVDs online registration in India- procedures and requirements, reporting tools for medical device vigilance and practices among others.
It will also help in strengthening post-marketing surveillance mechanism and help bridge the gap between stakeholders and regulatory authorities towards ensuring safety of medical devices in India.
IPC is an autonomous institution of the union health ministry.
It sets standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region.
It publishes official documents for improving quality of medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP).
IPC also provides measurement standards in the form of IPRS which act as a finger print for identification of an article under test and its purity as prescribed in IP.
The IP, or any part of it, has got legal status under the Second Schedule of the Drugs & Cosmetics (D&C) Act, 1940 and Rules 1945 there under.
IP standards are authoritative in nature and are enforced by the regulatory authorities for quality control of medicines in India.
During quality assurance and at the time of dispute in the court of law the IP standards are legally acceptable.