Sresan Pharma’s facility at Kancheepuram in Tamil Nadu was found to be in a “shoddy and neglected state” during a recent inspection by a central team. It has probably not been audited by the Tamil Nadu state Food and Drug Administration for a long time, they said.
Officials directly involved in investigating the case said state-level authorities should have immediately cancelled the manufacturing licence of Sresan given the scale of the violations. Instead, the site inspectors issued only a stop-production order and a show cause notice, an action that is considered to be mild, they said.
“If the facility had as many as 38 critical and 328 major observations, as reported, it shows there was nothing right,” a senior government official said, adding: “Why then was there no immediate cancellation of licence?”
Among the most critical violations, the inspectors found Sresan Pharma had not tested the raw materials before using them to make the medicines. It also did not conduct any tests before releasing the batches in the market.
“The state FDA had not investigated the operational processes of the company,” the senior official said.
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