After imposing a ban on Ranbaxy Laboratories from shipping drugs and raw ingredients from its Toansa plant in Punjab to the US market, the US Food and Drug Administration (USFDA) commissioner Margaret Hamburg is likely to visit India next week to meet health minister Ghulam Nabi Azad and commerce and industry minister Anand Sharma.
A senior official told The Indian Express that the meeting has been set up for February 10 and India will take up all the issues ranging from the Ranbaxy ban to access of certain fruits to the US market.
“The meeting is very crucial as this is the fourth unit of the Indian drug maker which is facing the US ban. It is imperative that there is better cooperation between the USFDA and Indian regulators. The meeting will be an attempt towards that,” the official said.
On January 23, the USFDA banned the import of products from Ranbaxy’s plant in Punjab due to manufacturing violation, effectively halting shipment of all products of the pharmaceutical company to the US.
Ranbaxy’s Toansa factory is one of the oldest active pharmaceutical ingredient (API) manufacturing facilities in the country and before the ban it was catering to over 70 per cent of Ranbaxy’s captive requirement for API used in medicine formulations.
Several other Indian pharmaceutical companies including Wockhardt, and RPG Life Sciences have also received warning letters from the USFDA on lack of current good manufacturing practices.
In light of the recent events, Hamburg is “likely to take up the issue of developing new tools and standards to assess safety, efficacy, and quality of all FDA-regulated products and discuss new ways of product development,” the official said.
Since 2005, the US body has conducted repeated checks on all Ranbaxy facilities at Paonta Sahib, Dewas and at Batamandi besides Toansa after whistleblower Dinesh Thakur revealed the company had faked test results to get marketing rights in the USA.
Some of these checks have happened even without the knowledge of the Drugs Controller General of India (DCGI).
Further, in the meeting India will also identify areas of collaboration between the drug regulators of the two countries. “It may seek market access for fruits such as mangoes, pomegranates and grapes which face non-tariff barriers in the US,” the official added.
The Indian agricultural products including mangoes, litchi, pomegranate, grapes and certain organic products face non-tariff barriers due to high cost of certification, alternative method for fumigation, in terms of