Clinical investigator (CI) inspections account for nearly half of the total scrutiny conducted by US FDA in Indian drug manufacturing facilities. This is followed by Bioavailability/Bioequivalence (BA/BE) studies which make up for a little for a quarter.
 
Under its Bioresearch Monitoring (BIMO) Programme in India, the US regulatory authority conducts 7 types if inspections beginning with CI, BA/BE study, Institutional Review Boards (IRB), Post Marketing Adverse Drug Experience (PADE), Sponsors, Good Laboratory Practices (GLP) and Risk Evaluating and Mitigating Strategy (REMS).
 
The purpose is to verify the quality and integrity of data, protect the rights and welfare of human research subjects and ensure that the manufacturing and human studies are conducted in compliance with applicable regulations, according to Jennifer Adams, consumer safety officer, India office, US FDA.
 
The most frequent checks are on the clinical investigators. This is because it is under their direction the drug is administered or dispensed to a human subject. If an investigation is conducted by a team of individuals, the CI is the responsible leader of the team. CI checks is 46%, BA/BE is 26%, IRB is 9%, PADE is 8%, Sponsor is 7%, GLP is 3 percent and REMS is 1%, she added.
 
Adams while addressing the final leg of the DIA multi centre USFDA-EMA-CDSCO GCP workshop in Bengaluru said that proportion of inspections types have been relatively stable between 2014 – 2017.

However of the inspections done in India represent over one-third of the BE inspections done worldwide, she added.
 
During an inspection of a site, if regulatory authority observes a discrepancy, then it is listed in the FDA Form 483. The final compliance depends on the review of observations made at the production plant along with the firm’s response. Then there are three more classifications to assess the company’s compliance. These are No Action Indicated(NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI).
 
NAI indicates that the data is acceptable by the regulatory authority. VAI highlights deviations and enables voluntary correction of data. A serious non-compliance observation is OAI where data is unacceptable requiring regulatory or administrative action by FDA.
 
From an Indian stand point, 64 per cent of the inspections are NAI compared to 77 per cent globally followed by 25 per cent of VAI as against 19 per cent from other countries and 12 per cent of OAI in contrast to 5 per cent from other locations, stated Adams in her presentation titled findings of inspections of global and Indian sites.
 
The most common observations among NAI, VAI and OAI are failure to select and retain test and reference investigational products, no source of documentation, some or all records not available at the site and in the worst case the company or the clinical research organization is unable to verify that the human subjects existed or participated in a study at all, said Adams.