CDSCO Alarms On 62 Drugs From Bharat Biotech, Mankind, Zee Laboratories, More In Sept Alert

On Thursday Central Drugs Standard Control Organisation (CDSCO), the country's top regulator flagged 62 substandard medicines in its latest drug alert for the month of September.

The regulator tested a total of 1,188 drugs out of which 1,126 were of standard quality whereas 62 drugs from pharma companies were termed not of standard quality. 

Bharat Biotech's Typhoid Polysaccharide Vaccine indicated for typhoid, Mankind Pharma's Rabeprazole Gastro-resistant tablets used to treat duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome and Zee Laboratories Tobramycin Ophthalmic Solution USP used for bacterial infections of the eye were among the drugs flagged by the regulator. 

The most common drugs found as substandard by the CDSCO included painkillers like Paracetamol, Mefenamic Acid and Dicyclomine, and Diclofenac; supplement drugs such as Calcium Carbonate tablets, Iron and Folic Acid tablets, Vitamin C and D tablets, Zinc Sulphate tablets and antibiotics that subsumed Doxycycline Hydrochloride, Ciprofloxacin, Metronidazole and Norfloxacin among others.

The list also included common gastric drugs such as Pantoprazole, Rabeprazole and Omeprazole Capsules and antiallergics such as Levocetirizine and Montelukast. Pyrazinamide, a first-line medicine used to treat tuberculosis manufactured by Jackson Laboratories was also part of the September drug alert list. 

The pharma companies that were flagged for the most number of drugs that were found not of standard quality included Jackson Laboratories with five drugs, Ridley Lifesciences, Bonn Schtering Biosciences, with three drugs each and Adwin Pharma, Quest Laboratories, Vivek Pharmachem, SB Lifesciences and ANG Lifesciences with two drugs each among other pharmaceutical firms. 

The most common reason for drug failure was the assay test which is an investigative procedure to assess the purity of the chemical drug, followed by dissolution testing that measures the amount and rate of solution formation from a dosage form. 

The dissolution test is imperative to check a drug’s bioavailability and therapeutic effectiveness. Certain medicines also failed the disintegration, description and water tests. The CDSCO had warned against 48 substandard drugs in August list.