Gujrat drug inspectors to help USFDA officials

Move comes in the wake of several pharma companies coming under the USFDA scanner

In the backdrop of several pharmaceutical manufacturing facilities that export drugs to the US have coming under the drug regulator's scanner recently, the US Food and Drug Administration (USFDA) has now decided to take help from local drug inspectors when visiting pharma facilities.

According to H G Koshia, commissioner of the Food and Drug Control Administration (FDCA) of Gujarat, the government of India has recently initiated a process together with the US drug regulator, whereby local drug inspectors would accompany USFDA officials during their plant visits. "As such at the FDCA we do conduct regular checks on pharma manufacturing facilities whenever there is any compliance issue. However, when one has to export drugs to the US, the manufacturer has to comply with USFDA norms."

He added that only recently, the FDCA officials visited the facility of Marck Parenterals near Ahmedabad as a part of the collaboration. There are around 32 USFDA approved manufacturing sites in Gujarat.

In the recent months, facilities of drug makers like Ranbaxy, Wockhardt, RPG Life Sciences and Strides Arcolab have come under the USFDA's scanner.

This year, around 19-20 Indian drug manufacturing facilities have come under FDA scanner, as against around seven in China, two each in Australia, Canada and Japan, and one in South Africa and Germany.

There are around 200 FDA approved manufacturing facilities in India. During 2012-13, India's pharma exports to the US grew by 32 per cent to $4.23 billion as against its overall pharma exports which grew 10.5 per cent to $14.6 billion. According to estimates, India accounts for nearly 40 per cent of generic drugs and over the counter products in the US, and around 10 per cent of the finished dosages used in the US.

Koshia also added that interactions are on with regulatory authorities to discuss issues related to concerns of Indian manufacturers.

A delegation of  UK Medicines and Healthcare Products Regulatory Agency led by Gerald Heddell, director of inspection, enforcement & standards, UK MHRA visited the Gujarat FDCA this week to discuss regulatory issues, responsibilities of the MHRA as well as the local drug regulator etc.