11 drugs declared substandard

Tribune News Service

Solan, November 13

Eleven drugs, made in pharmaceutical companies in the state, have been declared of substandard quality in the monthly alert issued by the Central Drug Standard Control Organisation (CDSCO) today.

These are among 36 drugs from across the nation. All such drug batches are supposed to be withdrawn from the market as per the CDSCO directions.

Additional Drug Controller Manish Kapoor said in a bid to rein in the companies, a move to suspend manufacturing of brand names had been initiated. Since a manufacturer has several brands of a particular salt, suspending the making of generic drugs would force a firm to check the laxities in future and ensure manufacture of quality drugs.

Drugs like azithromycin oral suspension, ibuprofen tablets, moxiford eye drops, tobotor eye drops, betamethasone cream, two batches of amoxicillin and potassium clavulanate tablets, cefixime dispersible tablet, luliconazole cream, calcium carbonate tablets,amikacin sulphate injection and Ramipril tablets manufactured by pharmaceutical companies of Sansarpur Terrace, Una, Baddi, Nalagarh and Kala Amb had been declared standard.

Key issues like lack of assay content, dissolution, uniformity of volume and presence of particulate matter in the injection, which was a serious flaw, have been listed as the cause of drugs failing to be of standard quality. Dissolution is also a serious flaw in a tablet as it measures the rate of drug release from a dosage form which indicated its efficacy, opine experts. — TNS