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Thursday, July 09, 2020

Rajasthan drug regulator: Brands of 4 firms substandard

Companies say samples tested are ‘counterfeit’ or ‘spurious’

Written by Deepak Patel | New Delhi | Published: August 10, 2018 12:09:06 am
Rajasthan drug regulator: Brands of 4 firms substandard Generic drugs are sold by their salt name, while branded generic drugs are sold by a company under a particular brand label. (Representational photo)

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it asked its drug control officers to ensure that “the stocks of these drugs are not consumed anymore” and are “withdrawn” from the market.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.”

The pharma industry earns the majority of its revenue by selling branded generics. Generic drugs are sold by their salt name, while branded generic drugs are sold by a company under a particular brand label. For example, as Paracetamol is the salt name, the generic drug is sold under the label ‘Paracetamol’. However, the branded generic versions are sold in India under the brand labels such as Calpol, Dolo and Sumo.

Rajasthan drug regulator found three brands of Alkem Laboratories — Clavam 625, Taxim-O 200 and Pan 40 — to be substandard. Just like Pantocid DSR, the regulator found that these three drugs of Alkem do not contain their respective ingredient drugs in them. A senior Alkem official told The Indian Express on the condition of anonymity that the batches of the three drugs were “spurious”. He added: “We have informed the state drug regulator that these samples were not manufactured by us.”

The regulator also found three brands of Aristo Pharmaceuticals — Pantop DSR, Pantop 40 and Monocef-O 200 — to be substandard. In response to the queries sent by The Indian Express, the company shared its communication that it sent to its field staff on August 7. In this communication, 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.”

Cipla’s ‘Montair LC’, used to treat sneezing and runny nose to allergies, was found to be substandard. Cipla spokesperson told The Indian Express: “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”.

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