As one of the world’s a leading pharma manufacturers, India supplies about 20 percent of the global pharmaceuticals demand in terms of volume, yet the industry remains plagued with quality compliance issues. After Sun Pharma, Aurobindo and Zydus found themselves on the FDA’s radar earlier this year, two more Indian manufacturers have been hit with quality reprimands from the US regulator.


The Indian Pharmaceutical Alliance (IPA), the organization that groups 24 of India’s principal pharma companies, has endeavoured to set benchmarks and address quality assurance issues across the industry through its Quality Forum, created in partnership with McKinsey & Company. “The IPA recognizes that quality issues have the potential to affect patients adversely and is committed to addressing these quality challenges comprehensively and upgrading quality management systems to deliver world-class outcomes,” reads the IPA website. Despite these efforts, India’s pharma manufacturers continue to struggle with quality compliance as two more companies have been served recommendations from the FDA this year.


Form 483s 

Generic and biosimilars producer Biocon, after the inspection of its manufacturing plants in Bengaluru, India, and Johor, Malaysia, received several Form 483s, the forms issued by the FDA when objectionable conditions are observed during inspections, and a total of 17 observations.

In a statement, the company said the problems were related to microbial control, enhancing quality oversight, software and computer tools, facility upgrades and the need for risk assessment tools.

Another Indian manufacturer, Cipla, has also recently landed a Form 483 after an inspection of its site near Indore. According to the FDA, the facility was not cleaned and maintained at correct intervals to prevent contamination and there was no raw data available for surface area calculation on the site’s manufacturing equipment.


Additional Indian drugmakers pinpointed this year

Unfortunately, this is not a first for either company. Biocon was served a Form 483 last year and Cipla has racked up seven since 2016. And, earlier in the year, Sun Pharma, Aurobindo and Zydus also received Form 483s with Aurobindo becoming the target of several FDA recalls as well.

The issues faced by Indian manufacturers are not unique to India and the FDA has not specifically targeted the country for inspections as the former head of the US FDA India Office, Dr Letitia Robinson, stated: “Our risk-based site selection model focuses on drug manufacturing establishments, rather than countries.”