16 drugs manufactured by 13 Himachal firms found substandard

Ambika Sharma

Solan, October 19

As many as 16 drug samples of 13 pharmaceutical companies housed in various industrial clusters of the state were declared substandard by the national drugs regulator in the monthly drugs alert issued today.

Treated hypertension, asthma ailments

An eye drop for bacterial eye infection, hypertension drug and others used to treat common ailments like pain, mental health conditions, cough associated with bronchial asthma, kidney disease, indigestion, allergy, common cold, vitamin tablets, acid reflux, pain, fever and skin infection figure in the list.

They figure among the 1,188 drug samples which were tested nationally in September. As many as 1,126 samples were declared of standard quality while 62 were declared not of standard quality by the Central Drugs Standard Control Organisation (CDSCO).

An eye drop for bacterial eye infection, hypertension drug and others used to treat common ailments like pain, mental health conditions, cough associated with bronchial asthma, kidney disease, indigestion, allergy, common cold, vitamin tablets, acid reflux, pain, fever and skin infection figure in the list.

They are among the most commonly used drugs by the patients. Issues like dissolution, disintegration, lack of assay content, which effect the efficacy of a drug, have been cited as the reasons for their being declared substandard. Presence of particulate matter in a Levocarnitine Injection used to prevent and treat patients with kidney disease on dialysis has also been cited as another reason which was a serious lapse. The said injection is manufactured by a Solan-based unit.

The drug samples, which failed quality parameters, are Diclofenac Sodium, multivitamin with ascorbic acid syrup, paroxetine controlled release tablets, Ambroxol HCl, Guaiphenesin, Terbutaline Sulphate & Menthol Syrup, Levocarnitine Injection, Calcium Carbonate tablets, Paracetamol, Phenylephrine Hydrochloride & Cetirizine Hydrochloride Tablets, Ascorbic acid tablets,pantaprazole tablets, paracetamol tablets, Rabeprazole sodium gastro resistant , Telmisartan and Amlodipine tablet, Tobramycin, ophthalmic solution and Povidone-Iodine ointment.

Navneet Marwaha, State Drugs Controller, said, “Several companies whose samples have been declared substandard today have been covered under the risk-based inspection where the state and Central authorities have jointly inspected the units. At least three of them face partial stop manufacturing. Their manufacturing would be restored after they show total compliance to the conditions of license. Units which figure for the first time in this list will be investigated in-depth for laxities and due action depending on the gravity of the findings would be taken against them.”