Paracetemol, some antibiotics do not meet regulator’s quality norms

Next time you buy a pill or an over-the-counter antibiotic from a drugstore be sure to look at the quality code.

The country’s drug-quality regulator, Central Drugs Standard Control Organisation (CDSO), has found a range of basic medicines, such as ranitidine (used to treat ulcers and acidity), levocetirizine (used to treat cold), paracetemol and amoxicillin (an antibiotic), to be sub-standard.

The regulator’s zonal offices across the country sampled and tested a range of medicines, such as aspirins, pain killers, antibiotics, and other drugs. According to CDSO sources, the sub-standard samples include those made by Rallis Heathcare, Elder Pharmaceuticals, Hecatomb Laboratory, Scott-Edil Pharmacia Ltd, and Laborate Pharmaceuticals.

Poor quality

The CDSO study found at least 66 substandard drug samples between January and March 2014. While some of the medicines failed tests for dissolution and disintegration, others were found to be misbranded or carrying labels with incorrect information, the sources said.

According to official data, last year, 706 drug samples were taken from nine States. Of these, 306 were tested and 35 declared as samples of sub-standard quality.

Senior CDSO officials said action could be taken against the manufacturers under the Drugs and Cosmetics (Amendment) Act, 2008.

As there is no restriction on who can produce these generic medicines, many companies have gotten into the business, and quality standards have been hit, said the CDSO sources.

According to official guidelines, manufacture of spurious or adulterated drugs face imprisonment of more than 10 years and a fine of ₹10 lakh or three times the value of the drug confiscated, whichever is more.

(This article was published on April 15, 2014)
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