In addition to the stringent USFDA audits carried out at manufacturing plants to check for compliance and current good manufacturing practices (cGMP), inspectors will now carry out post-marketing adverse drug experience (PADE) inspections at the corporate offices of Indian pharmaceutical companies.
For the safer and more effective use of medicines, the US drug regulator expects companies to monitor the effects of drugs after they have been approved for use. The companies need to have procedures and systems in place to identify and evaluate any previously unreported adverse reactions.
The USFDA will conduct inspections using a risk-based approach based on the firm’s past compliance history, identified deficiencies, recently approved drugs, and specific inputs from USFDA offices.
The USFDA expects companies to have standard operating procedures (SOPs) or to flag any adverse event within 15 days. These should cover all the processes in PADE handling as well as how cases are handled after normal business hours, electronic sources of such as websites emails, social media handles and even their comment boards.
The audit is so extensive, that USFDA inspectors aren't just focused on pharmacovigilance department, but are also poring through company emails and social media accounts of corporate communication, sales, marketing, legal and even the administrative departments to search for potential adverse event information reporting.
For instance, in a recent inspection conducted at an Indian drug company, the USFDA inspectors didn't spare their corporate communications team as well. They inspected the kind of SOPs the communication team has implemented identify, collect and report any adverse events appearing in news reports, social media posts and comment board below mentioning company's products sold in US.
The inspectors who spent days at the headquarters of the company have even checked emails and social media accounts of the team.
A person close to the developments told Moneycontrol that it was their first brush with USFDA inspectors, and they have provided what ever data that was asked from the team.
"They have raised a few queries, and we have answered them. There is much emphasis on written procedures related to capturing and the reporting of adverse events," the person said.
The team was relieved as the inspection was cleared by the USFDA with the receipt of an Establishment Inspection Report (EIR).
But Indian companies will have to brace for more of such USFDA inspections as they launch specialty and complex drugs in US.
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