Indian Medical Device Industry Conferences

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Safety Assessment of Medical Devices and Conduct of GLP Compliant Toxicity Studies

In regulated markets of the world strict controls are enforced for ensuring safety of medical devices to the users. Government of India too has recently taken initiatives to bring medical devices under regulatory controls. The matrices of required safety tests differ with the type of medical devices, the part of body with which it comes in contact, the nature of contact and duration of such contact.

Different types of toxicity studies have been designed to assess hazard potentials of medical devices in terms of their cytotoxicity, allergenicity, local tissue reaction, systemic toxicity by acute and/or repeated exposure, reproductive toxicity, toxicity to genetic material of the cells etc. There exist differences across countries in specifying safety requirements and the testing procedures and serious attempts are on way to bring in a global harmonisation with respect to these. These tests which support the safety of products in regulatory dossiers are required to be conducted in compliance with Good Laboratory Practices (GLPs) to become acceptable to regulatory agencies. Indian medical device industry, which is poised for growth with a focus on National and International markets need to become aware of such safety standards so as to compete with other global players. This industry has to work closely with reputed and GLP certified CROs of India to attain this mission.

Dr. Narendra S. Deshmukh looks over the responsibility of the Technical Director at INTOX and is a founder Director of INTOX PVT. LTD. Dr. Deshmukh earned his Master’s degree (M. V. Sc.) in Veterinary Pathology in 1990 from the Department of Pathology, Bombay Veterinary College, Mumbai, and later completed his curriculum for a Ph.D. (Veterinary Pathology) from the same Department, from where he is in process of thesis submission.

Dr. Narendra S. Deshmukh, Director, INTOX PVT. LTD., India

After working in a toxicological CRO for 4.5 years (1990-1994) he joined Ranbaxy Research Laboratories, New Delhi where, during 1994-1996, he was instrumental in establishment of the pre-clinical toxicology laboratory of Ranbaxy’s New Drug Discovery Research (NDDR).

In December 1995 Dr. Deshmukh co-founded a toxicological CRO, INTOX, with few more colleagues, which became operational since 1996.

Today after 13 years of its foundation, INTOX PVT. LTD. is one of the premier GLP Certified toxicological CROs of India. INTOX has been accredited for compliance with GLP (OECD Principles of Good Laboratory Practice) by Government of The Netherlands and also by Department of Science and Technology, Government of India. Since 1996, and during his previous assignments, Dr. Deshmukh has been involved in planning and executing several types of safety assessment (toxicity) studies on a diverse range of products such as chemical and biological pharmaceuticals and plant protection products including GM plants and also medical devices.