Analysis On The Issues Raised By The Regulatory Authorities On Indian Pharma Companies And Inputs Provided By Them

Pharmaceutical industry across the globe bench marks the standard of regulatory processes carried out by Food and Drug Administration of USA (USFDA). India which has th e highest number of USFDA approved plants outside of USA itself, has been confronted with slew of warning letters and import alerts from the said regulatory authority, which especially were accentuated during last six years i.e. from FY13-FY18. The current article delineates upon analysis on classification of violations cited by FDA for Indian Pharma cos, inputs provided by them while concluding with solutions to overcome majority of the regulatory observations.

- D Naveen Kumar & Vidhyasagar L

With market size of around $ 35 bn in FY2018, Indian pharmaceutical industry is ranked third globally in terms of volume and thirteenth in terms of value. Indian pharmaceutical companies, over decades of arduous efforts, have gradually developed the necessary technology, capacities and capabilities to meet the demand and to explore the opportunities provided by global regulated markets; and currently, United States of America (USA) contributes about one third of the total Indian pharmaceutical exports. Furthermore, Indian pharmaceutical manufacturing companies accounted for 36% of the total Abbreviated New Drug Application (ANDA) approvals by USA in 2017 as compared with 34% in 2016; the total number of ANDA approvals has increased from 201 to 304 during the same period. India has second highest number of USFDA (United States Food and Drug Administration) approved manufacturing plants, ie, about 700 units with over 5000 ANDA approved drug products during last decade i.e. 2008-2017.

With all the aforesaid accolades, however, lately, it has been noted that there has been a spurt in the issuance of the import alerts and warning letters for domestic manufacturing facilities significantly over the past years following USFDA’s increasing focus on compliance of guidelines of cGMP. This restricts the manufacturing units to supply drugs to the US market from that facility resulting in the decline of revenue for the companies particularly to US market and also from other markets subsequently if the issues are not closed out to the earliest.

Sequence observed by USFDA in regulatory enforcement: