Regulator Drugs Controller General of India finds 49 drug samples not of standard quality

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India’s drugs regulator on Friday (October 25, 2024) directed manufacturers of 49 medicines to recall their products after samples were found to be “not of standard quality”. Also, action has been initiated to book the makers of four spurious drugs. 

Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi said, “The four samples of drugs lifted from the market that were found to be spurious were those that were manufactured by unauthorised companies.”

Some of the samples that were “not of standard quality” were painkillers, antifungals and diabetes drugs.

Not of Standard Quality (NSQ) drugs refer to drugs that fail to meet quality standards or specifications. The term ‘standards of quality’ is defined in the Drugs & Cosmetics Act, 1940.

“Out of the nearly 3,000 samples tested, 49 drugs were asked to be recalled as they were found less efficacious. Only about 1.5% of the total drugs sampled were found to be less efficacious. This doesn’t mean that the drugs were fake or could cause a threat to life,’’ said Dr. Raghuvanshi.

Every month, the drugs controller tests 2,000 to 3,000 samples from the market and drugs that fail in any minor parameters are put on the list published in the official website.

Dr. Raghuvanshi said that as soon as reports of medicines not being up to the mark come in, the process of recall is initiated. “This doesn’t mean that all the drugs of the brand need to be recalled. It only means that a particular batch of the drug has failed the quality test and needs to be taken off the market. As for the spurious drugs, the government action starts with the seller, goes to the source and then we do the mapping of the whole supply chain,” he added.

Recommendations for prosecution or administrative action depend on the seriousness of non-compliance.

Some of the samples that were found not to be of standard quality were those of metronidazole tablets I.P. 400 mg manufactured by Hindustan Antibiotics Ltd and used for treating infections; oxytocin injection I.P. 5 IU/1 ml manufactured by Pushkar Pharma, a synthetic hormone that helps speed up delivery or controls bleeding after childbirth; metformin hydrochloride 500 mg, manufactured by Swiss Biotech Parenterals that helps to control the amount of glucose (sugar) in blood; diclofenac sodium tablets manufactured by Hindustan Antibiotics Ltd and used as a painkiller; nimesulide and paracetamol tablets by Innova Captab Limited, pantoprazole gastro-resistant tablets by Alkem Health, cefpodoxime tablets by Aristo Pharmaceuticals Pvt. Ltd., amoxicillin and potassium clavulanate tablets by Alkem Health and ciprofloxacin tablets by Cadila Pharmaceuticals Limited.