India (Sort-of) Optimistic About FDA Assistance

India media sources called assistance from the FDA a "welcome change" but the Drug Controller General of India might have a slightly less optimistic view.

By Karen Langhauser, Digital Content Manager

India's called assistance from the FDA a "welcome change" but the Drug Controller General of India might have a slightly less optimistic view.

The article was positive regarding the news that US-based online compliance and regulatory learning solutions company, Underwriters Laboratories (UL) EduNeering, which trains drug regulators to ensure safety of FDA related pharma products, is planning to assist leading Indian pharma companies with compliance training. 

UL EduNeering and the FDA announced in early February that they extended their Cooperative Research and Development Agreement (CRADA) for five additional years, extending the agreement to 2019. A CRADA is a written agreement between a private company and a government agency to work together on a project; FDA’s CRADA with UL is the only learning technology agreement of its kind between FDA and a private-sector company.

This new agreement will expand the learning resources and provide quality educational opportunities to investigators, scientists, analysts and state and local regulatory officials in the U.S. and  in other countries, such as India.

Additionally, UL is hosting a compliance summit in India on Feb 20 to focus on the latest pharmaceutical regulations and compliances from both Indian and global perspectives.

Despite the postive outlook of the media, the Drug Controller General of India reportedy told Reuters that while he sees scope for India's Central Drugs Standard Control Organization working with the FDA and improving regulatory practice, the Indian regulator will continue to follow its own quality standards.

"We don't recognize and are not bound by what the U.S. is doing and is inspecting," G.N. Singh said. "The FDA may regulate its country, but it can't regulate India on how India has to behave or how to deliver."

This statement followed the FDA Commissioner Margaret Hamburg's visit to India, where she and ministry officials signed a statement of intent to achieve, among other things, "convergence in regulations in keeping with international standards."


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