12 drugs used for treating asthma, BP substandard

Ambika Sharma

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Solan, July 20

As many as 12 of the 48 samples declared not of standard quality nationally by the national drugs regulator in the monthly alert list issued today pertain to pharmaceutical units of Himachal.

As many as 1,273 drug samples were tested from various states by the various drug authorities. Out of this 1,225 were declared of standard quality while 48 failed to adhere to the quality and were declared not of standard quality while one was declared spurious.

Clorin capsules used to clean water tanks also figure in this list which also includes Nicoumalone tablets, Erythromycin Stearate tablets, tablets of D-Biotin, NAcetyl L-Cysteine, Nuhenz capsule, Montelukast tablet, Mupirocin ointment, Telmisartan, Acetazolamide, Chlorpheniramine Maleate and Codeine Phosphate Syrup, Pantoprazole Sodium and Domperidone capsules.

Flutrol 250 inhalation, used by asthma patients, was also found lacking the requisite assay content.

Drugs which were declared substandard are used to prevent and treat harmful blood clots, bacterial infection of the respiratory tract, asthma, blood pressure, swelling caused by heart disease, cough and peptic ulcers. Two nutritional supplement used to prevent hair loss and another which helps in the formation of red blood cells have also been included in this list.

A majority of them lacked the requisite assay content or failed the dissolution test. Both the factors impact the efficacy of a drug and reflects shortcomings in the manufacturing process.

Navneet Marwaha, State Drugs Controller, when contacted, said strict action was being taken against pharmaceutical units which repeatedly figure in this list. Partial stop manufacturing has already been ordered in the case of Zee Laboratories while Wings Pharma has also been directed stop manufacturing. Field officials will inquire into all such cases after issuance of a show cause notice while all such batches which figure in the list will be immediately withdrawn.1