U.S. FDA to Conduct Quality Awareness Workshops for Indian Pharma Companies

Published By : 17 Feb 2014 | Published By : QYRESEARCH

In the wake of the recent discussions pertaining to the Toansa unit of Ranbaxy, the U.S. Food and Drug Administration has been prompted to conduct awareness workshops across various locations in India. These workshops are being conducted with the aim of spreading awareness pertaining to the quality benchmarks required in the U.S. market, among various pharma companies in India. According to sources close to the matter, these awareness workshops at Indian pharma companies by the US FDA will be conducted in 2015. The details of the program or the individual workshops have not been finalized yet.

The sources were quoted as saying, in some media, that the workshops will likely be conducted across three or four key locations in India. During these comprehensive workshops, those at the helm of affairs will be familiarized with the exact nature of requirements and expectations that the FDA has from drugs that are manufactured by Indian pharma companies.

Sources further added that this issue came up for discussion between the US FDA commissioner Dr Margaret Hamburg and stalwarts of Indian pharma companies. This meeting saw participation from leaders of the Indian pharma companies such as Ranbaxy MD and CEO Arun Sawhney, founder of Sun Pharma Dilip Shanghvi, and Habil Khorakiwala, the chairman of Wockhardt.

Following qualities issues in several products originating from Indian pharma companies, the FDA had been forced to restrict the shipment of these drugs from India into the U.S. Considering that the U.S. is the primary export market for Indian pharmaceutical giants, these restricts would deal a strong blow to the industry. It is being hoped that the series of workshops would better orient members of the Indian pharmaceutical sector into delivering better products.
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