Policy Watch - Pharmaceuticals
Rajasthan drug regulator: Brands of 4 firms are substandard
Companies says samples tested are "counterfeit'' or "spurious"
Rajasthan’s drug regulator found the drug brands of four major companies — Cipla, Sun Pharmaceutical Industries, Aristo Pharmaceuticals and Alkem Laboratories — substandard last month. Subsequently, it asked its drug control officers to ensure that “the stocks of these drugs are not consumed anymore” and are “withdrawn” from the market. However, the companies told The Indian Express on Thursday that the samples tested by the regulator are “counterfeit” or “spurious”. On August 2, the drug controller of Rajasthan sent a bulletin to all its officers, wherein it named total 8 brands of the four companies that were found to be of “not of standard quality”. Nine other drug brands of smaller companies were also named in the bulletin. The regulator wrote in his bulletin: “Particulars of the samples declared as not of standard quality on test/analysis are given…for ensuring that the stocks of these drugs are not consumed anymore and appropriate safeguard to the consumers is provided by withdrawing the available stock and take action as per the provisions of Drugs and Cosmetics Act, 1940 and Rules thereunder.”

Sun Pharmaceutical’s popular brand Pantocid DSR — the batch number EMS 2060 — was found to be substandard last month as it did not contain its ingredient drug Pantoprazole at all. The regulator also found that Pantocid’s another ingredient drug Domperidone was just 37.07 per cent of the claim made in the label of this brand. Pantocid DSR is used to treat acidity and heartburn. In response to the queries sent by The Indian Express, Sun Pharma spokesperson replied: “Pantocid DSR (Batch – EMS2060) drug sample tested by drug officials was not manufactured by Sun Pharma. Based on the request of Drugs Controller, Rajasthan, we have physically verified the samples and declared them as spurious. We are requesting them to remove this product from their list and inform all the stakeholders accordingly.” Read more
ASPA Make Sure India Campaign - Rajasthan
ASPA also raised this concerns almost one year ago with its campaign "Make Sure India" when it conducted a workshop in Jaipur (Rajasthan) towards cost effective anti-counterfeiting solutions to fight this menace in Rajasthan.