Stringent USFDA
Inspections

How was the Pharma sector impacted?

The regulators have become increasingly more active

• The USFDA set up a local office in India in 2008¹
• Between 2010 and 2015, the number of USFDA inspections of Indian companies more than doubled to 270 from 108²
• Several surprise inspections are conducted at Indian drug units
• In 2018, India had 174 inspections by USFDA or 14% of the total inspection conducted by the US drug regulator around the globe³

Pharma players faced significant performance issues due to lapses surfacing during inspections

• Over the past few years, almost all leading Indian pharma players have faced USFDA issues
• Seven of the top ten Indian pharma companies have been issued import alerts or warning letters by the USFDA³.
• Even the leading and well-established players have been grappling with concerns including those related to data integrity lapses. 17% of the 483 observations in 2018 were due to critical data integrity issues¹.

Notes:

1. USFDA data
2. Economic Times
3. Various media sources

How did PEL perform?

PEL’s strategic choices and consistent execution enabled it to emerge stronger despite challenging circumstances

• The Company focussed on building a quality-driven culture
• It maintained a strong focus on robust regulatory compliance, stringent quality control, and providing reliable services to its clientele
• Put in place a strong quality governance model, with the quality function reporting to a Board Member
• The Company embraced world class practices and stayed away from cutting corners

Hence, PEL maintained an exceptional track record despite increasingly stringent regulatory regime

• PEL has successfully maintained a strong track record of inspections
• Cleared 33 US FDA inspections, 143 other regulatory inspection and 989 customer audits in last 8 years

Strong track record of successful inspections