16 drugs manufactured in Himachal declared substandard

Ambika Sharma

Solan, April 16

Sixteen drugs, including multiple batches of the same drug, manufactured in 19 drug firms of Himachal Pradesh, were among 66 drug samples declared not of standard quality by the national drugs regulator, Central Drugs Standard Control Organisation (CDSCO) in its monthly alert issued today.

Used for treating blood clot, BP, arthritis

• These drugs pertain to ailments like bacterial infection of gut, blood clot, pain and inflammation, allergy, acidity, blood pressure, arthritis, headache, chronic bronchitis, heart failure, indigestion, nausea, vomiting, stomach ulcer, cough, antifungal disease.
• Manish Kapoor, officiating State Drugs Controller, said all drug batches which figure in the list would be immediately withdrawn and the field staff would probe the cause behind various flaws listed in the alert.

Alerno tablet, manufactured by a Kala Amb based firm Digital Vision, whose cough syrup had claimed the lives of several infants in Udhampur in Jammu and Kashmir in 2020, also figures in the list. The tablet has been labelled as substandard. It is used to treat allergies.

Out of the 931 drug samples tested from across various states, 864 were found adhering to quality norms while 66 failed to comply with the quality parameters while one was found misbranded.

Dissolution, average weight, description, assay and disintegration of the tablet were pointed as the reasons for declaring these drugs substandard. Tablets failing in disintegration tests are considered grossly substandard as per the CDSCO guidelines while those lacking the requisite assay and weight compromise its efficacy.

Drugs like two separate batches of Rifaximin tablets (200 mg), Diclofenac, Paracetamol and Serratiopeptidase tablets, Montor – LC, Aceclofenac, Telverge H, Opi Soproate tablet, Axiflo-oz tablet, Saluzinc- 20 tablet, Enalapril Maelate tablet, Domipen tablet, Rabeprazole Sodium Gastro-Resistant, Troypod 200 tablets, Alerno tablets and Flutol tablet have been listed in the alert today.

Apart from this, two batches of calcium carbonate tablets were found misbranded and suffered from disintegration. They were manufactured by the same firm based at Barotiwala.

Astriparin injection also figures in the list. It is used to cure blood clot in vein and arteries. Particulate matter, which is considered a serious flaw, was found in the sample tested by the authorities. It is manufactured by a Baddi-based firm.

The CDSCO was specially monitoring the quality of cough syrups. Two cough syrups-Abrodoll-S and L Melt – manufactured by a Taksal firm near Parwanoo have been found substandard. Both lacked the requisite assay content which determines the efficacy of the syrup.