Quality Systems in India
Quality Systems for Medical Devices in India
Quality Systems for Pharmaceuticals/Drugs in India
India is growing rapidly as a destination for medical device and pharmaceutical manufacturing. Costs to manufacture in India can sometimes be significantly less than the manufacturing costs in China. PBM has recently helped a number of international medical companies set up their quality systems in India.
India's Good Manufacturing Practice (GMP) standards for medical devices and pharmaceuticals are listed in Schedule M and Schedule M III of the Drugs and Cosmetics Act. These requirements are based on World Health Organization guidelines.
PBM's India quality experts can advise you on ensuring that your Indian operations or partners comply with U.S. FDA quality requirements, international quality requirements, and/or your company's internal regulatory standards.
For more information on Indian quality standards, please see the following PBM publications and/or contact us to discuss your specific needs.
- 2011 India Medical Device Updates (webcast June 15, 2011)
- India Medical Devices Manufacturers, Distributors, Exporters Directory 2011 (First of its kind!)
- India Pharmaceutical Regulatory Report 2011 (publication for sale)
- New Updates on India's Expanding Medical Device Market (webcast for sale)
- Looking East for R&D and Clinical Trials
- Sourcing Medical Devices in Asia 2010 (publication for sale)
- India's Pharmaceutical Markets (webcast for sale)
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