Indian Drug Makers Wary as US FDA Sharpens Focus on Quality Control


The US is Indian pharma’s biggest market

Indian drug makers wary as US FDA Sharpens

US FDAcut prior intimation time for plant inspections to as little as 24 hours from 25-30 days

Inspection frequency has increased to once or even twice a year, compared with once in two-three years earlier

55% of the warning letters issued by FDA were to facilities in India and China have not been resolved yet

Indian drug makers are finding that it’s not enough to just tick the boxes on the quality control front but be fanatic about every tiny aspect to meet the US drug regulator’s elevated expectations.

The US Food and Drug Administration (FDA) has not only increased the frequency of its inspections but also intensified scrutiny on drug manufacturing facilities in India.

Apart from issues relating to data integrity, improper quality control systems or batch failure investigations companies are now being pulled up for lapses such as inappropriate clothing of employees, improper washing conditions and inadequate lighting.


Nirmal Bang Securities analyst Vishal Manchanda said, “The issues raised point that FDA is getting into tremendous level of details and, more importantly, looking to inculcate a much more proactive approach in firms towards ensuring product quality.”

In the past six months, plants of drug makers including Sun Pharmaceutical Industries Ltd, Cadila Healthcare Ltd, Dr. Reddy’s Laboratories Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Glenmark Pharmaceuticals Ltd and  Biocon Ltd underwent an audit by US FDA and were issued Form 483, listing observations related to good manufacturing practices (GMP) violation.

According to the FDA database, inspections of Indian manufacturing facilities rose to 290 in 2015 from 108 in 2009. India has a total of 572 USFDA-approved plants currently, compared with 433 in 2013.

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