CDSCO Flags 51 Drugs In July Alert From Cipla, Sun Pharma, Alkem Health Science & Others
In the latest drug alert for the month of July, the Central Drug Standard Control Organisation (CDSCO) has flagged as many as 51 drug formulations from top pharma giants such as Cipla, Sun Pharma and Alkem Health Science among others.
The CDSCO tested 1,306 drug samples in the month of July and out of those 1,252 were declared of 'Standard Quality' while 51 drug samples were declared 'Not of Standard Quality' or substandard and 3 drug samples in total were regarded as 'Spurious'.
According to the drug alert list, some of the not of standard quality drugs included Rosuvastatin Tablets IP (Rosuvas 10 Tablets), batch number SID3056A from Sun Pharma indicated for lowering bad cholesterol, Tamsulosin Hydrochloride & Dutasteride Tablets batch number GH20067 from Cipla indicated for benign prostatic hyperplasia (BPH).
Other drugs such as Folic Acid Tablets IP, Paracin Plus Suspension, Ornidazole & Ofloxacin Tablets IP, MONZET (Montelukast Sodium and Levocetrizine Hydrochloride Tablets IP) and Lonapam MD 0.5 were also flagged as substandard seen by BW Healthcare World.
CDSCO found three spurious drugs in the month of July from Alkem Health Science which subsumed Pantoprazole Gastro-resistant and Domperidone Prolonged Release Capsules IP, Amoxycillin and Potassium Clavulanate Tablets IP and Pantoprazole Gastro-resistant Tablets IP.
Alkem Health Science informed the CDSCO that the impugned batch of the product had not been manufactured by them and that it was a spurious drug.
Meanwhile, 15 drugs out of the 51 drugs were linked to the pharmaceutical manufacturing units in Himachal Pradesh. Common drugs like Olmesartan indicated for high blood pressure, Albendazole indicated for parasitic infections and Ondansetron used for nausea and vomiting were also labelled as substandard by the top Indian regulator.
Some of the other highlighted drugs included supplement drugs, antibiotics, painkillers and eye drops. As many as 22 drugs failed the Assay test which determines the potency of the drug. 12 drugs failed the dissolution test that measures the extent and rate of solution formation from a dosage form and is helpful in ascertaining the therapeutic effectiveness of the medicine. Other reasons for drug failures were disintegration tests, particulate contamination and description and identification tests.
Solan-based pharma firm Cypher Pharma accounted for five substandard drugs, while Zee Laboratories, Deep Pharma, and Shine Pharmaceuticals accounted for three drugs each that were termed as 'Not of Standard Quality' by the CDSCO. Drug companies like ANG Lifesciences, Stadmed, Maxheal Pharmaceuticals and DM Pharma were responsible for supplying two substandard drugs each as detected in the month of July by the drug regulator.
Another spurious drug from Alkem Health Science a unit of Alkem Laboratories, Pantoprazole Gastro-Resistant Tablets IP (PAN40) carrying the batch numbers: 22440483 and 22441073 was flagged by the CDSCO in its revised drug alert for the month of June.
