Gujarat drug authority apprised of 2 firms supplying spurious APIs

The State Drugs Controller (SDC) recently apprised the Gujarat state drugs authority about two firms that were indulging in the illicit trade of spurious raw material for drugs manufacturing and demanded appropriate action against them.

The Baddi-based Drugs Control Administration (DCA) had seized 950 kg of Active Pharmaceutical Ingredient (API) Sucralfate, a critical drug used in the treatment and prevention of duodenal ulcers, from M/s Adinath Healthcare, Baddi, recently.

The authorities had found 30 drums of API labelled as Sucralfate, claimed to be manufactured by M/s Legend Industries, Gujarat, and eight drums of Sucralfate, labelled as manufactured by M/s Par Drugs and Chemicals Ltd, Gujarat. The lab analysis of the samples revealed zero content of Sucralfate, indicating that the API consignments were grossly spurious.

“We are also tracing the backward linkages of the drugs manufactured by firms, which had bought this spurious raw material, including the recall of specific batches from the market. Since a drug has a three-year expiry period, it is feared that some drugs manufactured using spurious material will still be available in the market,” said Manish Kapoor, SDC.

The case, however, has brought into focus the malpractices of the drug firms and the defiance of the manufacturing norms. All raw material to be used for manufacturing a drug have to be tested in-house in the quality control lab of a drug firm prior to undertaking any manufacturing. Once a drug is manufactured, each batch is once again tested on various quality parameters before it is released in the market. Firms that used spurious material for manufacturing drugs appear to have defied all norms, thus putting a question mark on their manufacturing operations. The record of all tests is also to be maintained, as per the norms, to ensure a drug recall in case an issue pertaining to its quality is flagged. The case reflects short-cuts being adopted by firms while conveniently compromising with quality.

Himachal Tribune