39 Samples Failed In Quality Tests During June 2021: CDSCO

New Delhi : CDSCO has released an alert Notice for drug samples tested during June, 2021 by its regional laboratories. This list does not include the sample tested by state drug testing laboratories.

During this period samples of Ivermectin were tested manufactured by Psychotropics India Ltd, SIDCUL, Ranipur (Iverpil-12 Dispersible Tabs 12 mg) , which failed in Aerobic Microbial Count and another of Maan Pharmaceuticals Ltd, GIDC Phase-II, Mehsana, Ivermectin Tabs USP 6 mg, this fails in dissolution.

This is only the random sampling. This drug was widely prescribed during Covid Pandemic and gives a clear message that other batches of manufacturers available in the market were also failing in statutory tests.

Several Injectables were also found particulate matter eg Diclofenac Sod Inj IP 75 mg 3ml of Hindustan Antibiotics Ltd, Faridabad; Amikef-500-2ml( Amikacin Sulphate Inj IP) of Lupin Ltd, Vapi; Amikacin Sulphate Inj IP 500 mg/2 ml of Karnataka Antibiotics Ltd, Bengaluru; Sangenta Inj (Gentamicin Inj IP, 30 ml) of Jpee Drugs, SIDCUL, Haridwar; Sandexa Inj 30 ml (Dexamethasone Sod Phosphate Inj IP 2 mg/ml) of Jpee Drugs, SIDCUL, Haridwar; and Maxobal Inj  (Methylcobalamin, Pyridoxine HCl and Nicotinamide Inj ) of Havik Pharma, Sansarpur (HP)

One sample of Remdesivir for Inj 100 mg/vial (Covipri Inj) Purported to be manufacturerd by Pristine life Sciences, Sikkim also failed in Identification of Remdesivir, Particulate matter and Sterlity; which shows the sample to be spurious.

Two Samples  of Coldbest-PC Syrup manufactured by Digital Vision, Kala-Amb were found adulterated with Diethylene Glycol (DEG), which is contaminant in consumer products; this has resulted in numerous epidemics of poisoning since the early 20th century.

Several sample also failed in dissolution tests , assays and descriptions, which is serious concern.

It is also of serious concern that in market all ophthalmic drops are marketed in opaque containers. It is now proved fact that when injectables failed in particulate matter. It cannot be ruled out that an ophthalmic drop does not fail in particulate matter. Their opaque packing does not allow, analyst and public to check their contamination.

SOURCE : DrugsControl Media Services

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