Major Indian drug makers, who have scored on compliance with the US Food and Drug Administration (USFDA) in recent years, are now facing the heat of regulatory action.
Of 174 USFDA inspections in India in 2018, only seven were classified as official action indicated (OAI), according to a study by the Indian Pharmaceutical Alliance (IPA) and consultancy firm McKinsey. This was a significant improvement over the previous year when 22 inspection outcomes were classified as OAI.
This year, however, started on a tense note for drug makers with at least eight OAI inspections in the past six months. The list of these companies
includes Alkem (St Louis), Aurobindo, Lupin, Emcure, Strides Pharma Science, and Jubilant Life Sciences.
Some of the inspections have not yet received a final classification, which raises the potential for OAIs. They are Aurobindo (unit III in May), Alkem (Baddi in May), Cadila Healthcare (Moraiya in May), and Torrent Pharma (Dahej in May and Indrad in April).
Analysts at Spark Capital noted that the nature of the observations in some of the recent form FDA 483s is a cause of concern. “Observations on failure to thoroughly review discrepancies in tests, inadequate procedures/processes to ensure drug specifications, and data integrity violations appear to be repetitive with progress being gradual over the years,” Spark Capital noted, adding these might take longer for resolution.
On top of it, product recalls by Indian companies
increased 87 per cent in 2018 following the detection of nitrosamine impurities in ‘sartan’ drugs (hypertension).