Himachal's pharmaceutical firms under lens as 47 drug samples fail quality test

With 47 drug samples manufactured by pharmaceutical firms in Himachal Pradesh declared substandard, the state’s quality control mechanism has come under scrutiny.

These samples were part of 141 drugs across the country that failed to meet quality parameters in the monthly drug alert issued by the Central Drugs Standard Control Organisation on Tuesday.

The list includes commonly used medicines such as amoxicillin and potassium clavulanate tablets, diclofenac potassium, paracetamol and chlorzoxazone tablets, Clavocil-375, telmisartan, prochlorperazine maleate mouth-dissolving tablets, allopurinol, cefixime, metronidazole tablets, rabeprazole sodium, pregabalin and methylcobalamin tablets, levocetirizine dihydrochloride tablets and pre- and probiotic capsules.

A Nalagarh-based unit manufacturing sterile water for injection was found lacking in sterility, raising serious concerns about its manufacturing protocols.

Several injectable drugs also failed to meet quality standards. A diclofenac sodium injection did not conform to identification tests and was found deficient in assay, affecting its potency.

Povidone-iodine solution, widely used to treat and prevent infections in minor wounds, cuts, abrasions and burns, and as a pre-operative skin disinfectant, was also found deficient in assay content.

These medicines are commonly used to treat ailments such as bacterial infections, inflammation, hypertension, nausea, high uric acid, parasitic infections, gastric ulcers, chronic pain and allergies. The list also includes certain life-saving injections and cough syrups.

The drugs were manufactured by firms based in Una, Baddi-Barotiwala-Nalagarh, Parwanoo, Kala Amb, Kangra and Paonta Sahib.

Laboratory tests revealed serious deficiencies, including failure in dissolution (solubility), assay (active ingredient content), content uniformity, pH levels, sterility, microbial contamination, disintegration and labelling. Some drugs were found to be misbranded, while in others the active ingredient did not meet prescribed standards. Experts warn that such flaws can reduce drug efficacy or pose risks to patients.

State Drug Controller Manish Kapoor said notices would be issued to manufacturers whose samples failed quality tests, directing them to immediately recall the affected batches from the market. He added that strict action would be taken against firms with repeated failures. Assistant Drug Controllers have been directed to conduct joint inspections of such units and submit detailed reports. “No compromise on quality in pharmaceutical manufacturing will be tolerated,” he said.