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India Trade Group Working with Western regulators to Improve Drug QA

India Trade Group Working with Western regulators to Improve Drug QA

India exports $15 billion worth of pharmaceuticals, and is considered the largest generic producer to the world, so improving its quality control has huge ramifications for the country’s revenues.

Gerald Heddell, director of the U.K.’s Inspection, Enforcement and Standards, Medicines & Healthcare products Regulatory Agency, said in a recent Business Standard report that Britain was working “closely” with the Indian government to help improve drug safety.

Gerald Heddell
Gerald Heddell

Heddell added, “India is a very important supplier  of medicines to Britain” and said that a memorandum of understanding signed last year allows Britain and India to work together on sharing of information and collaborating to “ensure that medicines are safe.”

Some drugmakers are turning to automation to improve quality-control issues while others are focusing on training for employees. Others still are encouraging employees to speak up if they see quality control issues reports FiercePharmaAsia.

The secretary general of the Indian Pharmaceutical Alliance, D.G. Shah told Business Standard, “We have been in touch with the US-FDA for the past year and are discussing how the industry and regulators can work together to ensure supply of quality products.”  The alliance has also called on the global consulting firm McKinsey to “prepare data integrity guidelines and suggest measures to improve quality across the sector.”

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