Pantocid DSR found of Substandard Quality- Drug Regulator

Rajasthan: The quality of some of the commonly used medicines in India including antacids and anti-allergics have been found to be substandard after the Rajasthan Drug Controller tested certain samples, last month.

The drugs that went under the state regulator's scrutiny included some of the commonly used brands, including Sun Pharma’s Pantocid DSR, Cipla’s Montair LC, Alkem’s Pan 40 and Aristo’s Pantop DSR

Following the sample testing, the Rajasthan FDA, red-alerted, has asked its drug control officers to make sure that the stocks of these drugs are not consumed anymore and are withdrawn from the market. The companies, on the other hand have clarified that the samples tested by the regulator are counterfeit or spurious.

Indian Express reports that a bulletin containing the name of the total 8 brands of the four companies that were found to be of “not of standard quality” was sent to its officer by the drug controller of Rajasthan on 2nd August 2018. The bulletin also contains the names of nine brands of smaller companies. The bulletin further stated

"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.”

It has been reported that among those tested, Pantocid DSR, the popular brand of Sun Pharma (the batch number EMS 2060) was found to be substandard. Pantocid DSR is used to treat acidity, nausea and heartburn. However, the company clearly stated that these medicines that were tested were spurious.

Replying to the queries sent by The Indian Express, Sun Pharma spokesperson said: “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.”

This is not the first time, Sun Pharma is facing such an issue. A report in Economic times pointed out that  last year in the month of October, 2017, CDSCO, the apex drug regulator in the country had tested and red-flagged Sun Pharma’s popular medicine brands ‘Pantocid’ and ‘Pantocid DSR’ for failing quality tests. The company at that time also had the firm claims the samples of these brands that were tested by the regulator were fake imitations of its products.

Besides Pantocid- DSR, the state drug regulator has also found Montair LC,  the popular brand of Cipla that is used to treat sneezing and runny nose to allergies as substandard. A response, similar to that of Sun Pharma was given by the CIPLA spokesperson, “The suspect product (allegedly bearing the same batch number) is not of Cipla origin. We are committed to providing only the highest quality medication, in keeping with our purpose of Caring for Life. Cipla products assure absolute integrity and robustness in its quality standards”, the spokesperson informed the daily

Besides these, the three brands Clavam 625, Taxim-O 200 and Pan 40 of Alkem Laboratories as well as three brands of Aristo Pharmaceuticals — Pantop DSR, Pantop 40 and Monocef-O 200 were also found substandard and they did not contain their respective ingredient drugs in them.

A senior Alkem official told The Indian Express, “The batches of the three drugs were spurious. We have informed the state drug regulator that these samples were not manufactured by us.”

Meanwhile, Aniruddha Khandewale, senior vice-president, marketing, Aristo Pharmaceuticals, wrote to company’s field staff: “As you may be aware the FDA officials in Rajasthan had unearthed a spurious medicines racket under which they had seized Rs 40 lakh worth products of different leading pharma companies… Spurious copies of our products like Pantop DSR, Pantop 40, Monocef O 200 were illegally manufactured by someone else by counterfeiting Aristo’s popular brands.”