Bottle Of Lies proves A bitter medicine 4 DCGI #In_IndiaJanuary 15, 2020
Eban, following an investigation spanning several years, has recounted incidents of how products from Indian generic drug companies failed quality tests or had not been effective.
After the book’s release in India, the Health Ministry wrote to the DCGI, demanding to know how much truth the book carried, and what the drug quality watchdog was doing to make sure that consumers were supplied safe drugs that worked.
BusinessLine had access to a copy of the DCGI’s reply, in which the regulator said Eban’s book contained ‘fiction-filled stories of the Indian pharma industry’.
DCGI officials rubbished the Ranbaxy scandal as a one-off case.
But there is little doubt as to the widespread incidence of fraud within Indian generic companies.
“We analysed USFDA findings from inspections over the last five years.
For example, between 2015 and 2019, there were 8,966 inspections and 1,723 instances of non-compliance in Jharkhand, but only seven cases were prosecuted.
On how companies can comply better with standards, Eban said: “Drug companies act more responsibly when they fear regulators.
The problem comes when they don’t fear regulators.
My sense, from reporting in India, is that the Indian plants don’t fear being shut down by regulators due to negative findings.”
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