14 drugs manufactured in Himachal declared substandard

Ambika Sharma

Solan, February 21

Fourteen of the 46 drugs declared substandard nationally by the Central Drugs Standard Control Organisation (CDSCO) today were manufactured in 12 pharmaceutical firms of Himachal.

As many as 932 drug samples, medical devices and cosmetics were tested in January out of which 886 were declared to be of standard quality while 46 failed the various quality parameters.

Nearly one-third of the drug samples declared sub-standard nationally pertain to drug firms of Himachal. They were manufactured by 12 pharmaceutical firms located in Baddi, Paonta Sahib, Nalagarh, Solan, Barotiwala and Sansarpur Terrace. They also comprised three injections — Clindamycin, Amikacin Sulphate and Diclofenac.

Other drug samples which figure in the national list were Cyproheptadine HCl & Tricholine Citrate syrup, Moxifloxacin & Prednisolone Acetate eye drops, Tranexamic Acid & Mefenamic Acid tablets, Pantoprazole tablets, Levocetirizine tablets, Glimepiride, Pioglitazone and Metformin tablets, Montelukast Sodium & Levocetirizine Hydrochloride tablets.

Acting State Drugs Controller Manish Kapoor said batches of all drugs which figure in the monthly alert would be immediately withdrawn from the market and the field staff will enquire into the reasons for their having been declared substandard. Further action would be initiated as per the findings of the report.

These drugs are used to treat common ailments like bacterial infections, meningitis, reviving appetite, bacterial infection of the eye, control bleeding during periods, acidity, runny nose, sneezing, restore insulin in the body and allergy.

Reasons like presence of particulate matter, error in the description, lack of assay and dissolution in buffer stage were the commonly cited reason for their failing quality parameters.

Drugs, which have active ingredient contents below 70% and those which fail in dissolution test are termed as grossly substandard drugs by the CDSCO. Drugs like injections also fall under this category. Such defects may arise out of gross negligence or non-conformance to Good Manufacturing Practices during manufacture as per the guidelines issued by the central drugs regulator.