US FDA to speed up approvals for Indian drug-makers

Mumbai February 13, 2014: US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has said that strengthening relations with India, which provides generic medicines to almost 200 countries and is the second largest exporter of generic medicines to the US, is of “utmost importance.”

This statement comes in the wake of the recent actions taken by the US FDA against Indian companies, including Ranbaxy and Wockhardt, leading to many in the industry feeling that Indian companies are being targeted unfairly.

Safety focus

Hamburg stressed the need to focus on safety, efficacy and quality of products under the regulatory framework. She was addressing a roundtable industry interaction here organised by industry body FICCI.

Hamburg also said the US FDA will speed up its process of approvals in order to clear the backlog of applications received from Indian drug manufacturers who have applied for approvals to export their products to the US.

She added that the FDA is looking forward to enhancing partnership with its Indian counterparts. The US regulator will also work with academia, industry and the Indian Government to train and educate stakeholders on its regulatory framework, she said.

However, while saying that patient safety is of utmost importance, GN Singh, Drug Controller General of India, warned against over-regulation.

He said interactive sessions need to be held regularly to streamline the process of approvals and strengthen the regulatory framework.

Overseas inspection

Singh had earlier said the Indian drug regulator, Central Drugs Standard Control Organisation, will start inspecting overseas drug manufacturing facilities that export medical goods to the Indian market within six months.- Business Line