After Ranbaxy saga, USFDA gets cracking on drug facilities in India

The US Food and DrugAdministration (USFDA) is increasing its inspections offacilities of drug makers in India, the second largestprovider of finished dose products to the US, to ensurecompliance of approved manufacturing norms.

The US health regulator, which has been cracking thewhip against many Indian pharmaceutical firms, includingRanbaxy Laboratories and Wockhardt, is also recruiting andtraining additional drugs investigators in India.

In order to meet requirements of the new Food and DrugAdministration Safety and Innovation Act (FDASIA) - GenericDrug User Fee Amendments (GDUFA) , the USFDA said it isstepping up the inspections in India.

“In March 2013, the (US) FDA received approval from theIndian government to add seven additional drugs investigatorsin India. We are currently recruiting and training staff forthese positions…,” a spokesperson for USFDA Christopher CKelly told PTI in an emailed response.

The USFDA’s presence in India is being increased to 19from 12 American staff based in-country, including 10dedicated specifically to medical products. Other staffinclude foods and devices inspectors, and policy analysts.

“Having these additional inspectors in-country willassist the agency in meeting our legislative mandates. So weare increasing our rates of inspection,” Kelly added.Under the FDASIA, the USFDA is required to achieve thesame inspectional schedule for foreign facilities as domesticmanufacturers, and to clear the backlog of applications by theend of the first five-year user fee authorisation period.

Stressing on the importance for good compliance, Kellysaid: “(US)FDA seeks to ensure that Indian manufacturingfacilities importing to the United States understand the risksassociated with their product’s processes and assure theyremain compliant to (US)FDA’s regulations.”

India, as the second largest provider of finished doseproducts to the US with almost 10 per cent of that market,has, for many years, been a consistent provider of low-costand quality medical products for many countries of the world,he added.

“Our presence in India allows us to better collaboratewith our Indian regulatory counterparts and enables us toleverage our combined resources, harmonise science-basedstandards and increase regulatory capacity.

“In doing so, FDA continues to ensure that medicalproducts moving in international commerce are safe, effective,and of high quality, he added.

PTI