Stringent USFDA

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.


  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

Financial Year USFDA Inspections Total regulatory
inspections (including
Customer audits
2012 5 13 60
2013 2 10 71
2014 4 14 116
2015 7 17 115
2016 5 26 140
2017 5 25 157
2018 3 27 167
2019 2 44 163
Total 33 176 989