Samples of 11 drugs made in Himachal declared substandard

Ambika Sharma

Solan, July 19

Eleven drug samples manufactured in nine pharmaceutical units of Himachal were among 31 declared substandard nationally by the national drugs regulator, Central Drugs Standard Control Organisation (CDSCO), in its monthly alert issued this evening.

Batches to be withdrawn

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• State Drugs Controller Manish Kapoor said the drug batches figuring in the list will be withdrawn from the market
• A field investigation will be initiated to find the cause of drugs being declared substandard.

Paonta Sahib-based firm, which has a record of figuring in this list every month, topped the list once again as its Gentamicin Sulphate injection was found substandard for serious flaws like presence of particulate matter as well as description-related issues.

Besides this, Ceftriaxone Injection manufactured by a Baddi-based firm was declared substandard due to the presence of particulate matter. Both injections are used to treat bacterial infection.

Presence of particulate matter in the injection hits the safety of a patient while affecting its potential quality, according to pharma experts.

Three batches of alovera glycerin and vitamin E soap manufactured by a Baddi based skin care products manufacturing company were also declared substandard as the matter was found to be insoluble in alcohol as per quality parameters.

Other drugs like Cefixime and Ofloxacin tablets, Fexofenadine Hydrochloride tablets, Albendazole table, Hydrochloride tablet and Iron and Folic acid syrup were also declared substandard. These drugs are used for common ailments like allergy, blood disorder, parasitic infection, asthma, bacterial infections besides providing energy and vitality.

Various reasons were attributed for their failure to meet quality parameters which include failing in dissolution test and lacking assay content which are considered serious flaws. They affect the efficacy of the drugs.

Tablets and capsules failing in disintegration tests comprise grossly substandard drugs as per the guidelines of the Central Drugs Standard Control Organisation.

State Drugs Controller Manish Kapoor said the drug batches figuring in the list will be withdrawn from the market and a field investigation will be initiated to find the cause of drugs being declared substandard.