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Drug Alert : 60 drugs found substandard


Combiflam and D-Cold Total are medicines that are commonly used by many people in times of minor aches and pains and cold and flu respectively.

However, the Central Drugs Standard Control Organization (CDSCO) that regulates the sales and distribution for drugs in India has declared these two popular medicines as substandard.

Combiflam is manufactured by Sanofi India while D-Cold Total is made by Reckitt Benckiser Healthcare India.

Government drug regulators have detected quality-related problems in specific batches of a popular painkiller, several antibiotics and an anti-allergy medication among 60 drugs that failed quality tests in the latest cycle of sample-based screening.

The latest monthly safety bulletin from the Central Drugs Standard Control Organisation (CDSCO), the national drug regulatory agency, lists 60 drugs declared as “not of standard quality, spurious, adulterated, or misbranded” based on tests on specific production batches.

The problem drugs include Combiflam, which combines paracetamol and ibuprofen and is prescribed for relief of pain and fever; D-Cold, a remedy for relief from colds; the anti-allergy medication cetirizine, and specific batches of the antibiotics ciprofloxacin, ofloxacin and capsules combining amoxicillin and clavulanic acid.

The quality issues differ from drug to drug. An injection of gentamycin was found to contain particulate matter. Both the batches of Combiflam and D-Cold tablets failed because of “disintegration” while the ofloxacin samples, among other antibiotics, failed in “assay” or quantitative tests for their ingredients.

The 60 failed drug samples in the CDSCO’s March 2017 safety bulletin is the highest number of drugs declared substandard in a single month’s tests over the past year. The number of drugs labelled substandard ranged from 13 in July 2016 to 29 in November 2016.

The CDSCO has been releasing monthly safety bulletins based on screening tests of batches of drugs since November 2012. Nationwide screening of drugs has in the past indicated that six to seven per cent of drugs from various batches fail quality tests.

Pharmacologists say the quality failure could have any one or more of multiple sources, including poor manufacturing processes, poor transportation or storage and handling along the distribution chain.

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