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CDSCO says samples labelled as Cipla's and Sun Pharma's drugs failed in July could be spurious

Gireesh Babu, New Delhi
Monday, September 25, 2023, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organisation (CDSCO) has declared the samples of Cipla's benign prostatic hyperplasia drug Urimax D it tested in July as spurious drug, and is investigating on Sun Pharma Laboratories' tip off that its bad cholesterol lowering drug Rosuvas 10 tablets failed during the test is spurious.

During the month of August, the drug regulator reported almost 4.12 per cent of the total number of drug samples tested as Not of Standard Quality (NSQ). This includes drug samples labelled as manufactured by companies including Mankind Pharma Ltd, Intas Pharmaceuticals and public sector manufacturer Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), among others.

According to a revised drug alert from the CDSCO for the month of July, Cipla declared a batch of tamsulosin hydrochloride & dutasteride tablets branded as Urimax D from Cipla, picked up by CDSCO East Zone and tested in Central Drugs Laboratory (CDL), Kolkata and failed, to be not manufactured by them and that it is a spurious drug.

"After enquiry, Joint Investigation Team of CDSCO (East Zone), CDSCO (Goa Sub Zone) and SLA (Goa) have declared the said drug as spurious under section 17B(e) of Drugs and Cosmetics Act, 1940, however, the same is subject to outcome of further investigation," said the drug regulator.

Sun Pharma Laboratories informed CDSCO that a batch of rosuvastatin tablets picked up by the drug control department, Delhi and tested in Regional Drug Testing Laboratory, Chandigarh, and failed the test, has not been manufactured by the company and that it is a spurious drug.

"Thus, the product is purported to be spurious, however, the same is subject to the outcome of investigation," said the drug alert.

In its drug alert for the month of August, 2023, the CDSCO has declared 48 out of the total 1,166 drug samples tested during the month as NSQs, while the rest of 1,118 samples were declared as of standard quality.

The drug samples failed include a batch of antidiabetic combination metformin hydrochloride prolonged release and glimepiride tablets under the brand Glimestar M2 Forte labelled as manufactured by Mankind Pharma in Sikkim.

Another drug sample that failed the test carried the label of Amtas PRP (amlodipine and perindopril tablets) from Intas Pharmaceuticals and refined glycerin CP Grade with the label of Adani Wilmar, New Delhi.

Two drug samples labelled as from KAPL - ciprofloxacin hydrochloride 500 mg tablets and calcium and vitamin D3 tablets - were also declared as NSQ during the month of August. Aspirin gastro-resistant and atorvastatin capsules (75mg/10mg) combination labelled as manufactured by Swiss Garnier Life Sciences was also declared as NSQ.

It may be noted that the drug regulator in the month of August, declared three drug samples it tested in the month of July as spurious and another 51 samples as Not of Standard Quality. It added that two drug samples tested as not of standard quality during June were also alerted by the manufacturer as spurious.

The results declared in August, said that a batch of Pan-D (pantoprazole gastro resistant and domperidone prolonged release capsules IP), Pan 40 (pantoprazole gastro resistant tablets IP), and Clavam 625 (amoxycillin and potassium clavulanate tablets IP), labelled as manufactured by Alkem Health Sciences, a unit of Alkem Laboratories Ltd, were declared as "purported to be spurious" and further investigations were initiated.

In another drug alert, the CDSCO said that two drug samples tested in June, this year, of Pan-40 labelled as manufactured by Alkem Health Science are also purported to be spurious and the same is subject to outcome of investigation.

According to the ministry of health and family welfare, the drug regulators tested a total of 88,844 drug samples during the year 2021-22, out of which 2,545 samples (almost 2.86 per cent) was declared as NSQ and 379 samples (0.42 per cent) as spurious or adulterated.

The Ministry during the Parliament session in August said that the regulator has launched 592 prosecutions for manufacturing, sale and distribution of spurious or adulterated drugs.

In the year 2020-21, the regulator tested 84,874 samples out of which 2652 (3.12 per cent) were declared as NSQ, and 263 (0.30 per cent) samples as spurious/adulterated. A total of 236 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs during the year.

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