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HindustanTimes Fri,18 Apr 2014

FDA found 392 drugs to be of poor quality last yr

Priyanka Vora, Hindustan Times  Mumbai, May 27, 2013
First Published: 02:53 IST(27/5/2013) | Last Updated: 02:53 IST(27/5/2013)

One out of a sample of 20 everyday drugs tested by the Food and Drug Administration (FDA) were found to be substandard and unfit for consumption. Although some of these substandard drugs may not aggravate the patient’s health condition, others could prove to be fatal, said doctors.

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Between April 2012 and March 2013, the FDA tested 6,716 samples of drugs sold at various chemists stores across the state and found 392 drugs including vitamin tablets, cough syrups and steroid injections, were not up to the requisite standard.

The testing, which is done to monitor the quality of drugs being sold by chemists shops, is done on samples collected by FDA drug inspectors from medical stores.

“If the drug composition is not perfect, it will have little or no effect on the patient’s health. We also label tablets as substandard if they are found to be powdered or if the pH level (acidity) of liquid drugs is not maintained,” said Kamlesh B Shende, joint commissioner, FDA. “In such situations, the batch of medicines is immediately recalled and action is taken against the manufacturer.” 

Under the ambit of The Drugs and Cosmetic Act, FDA officials can prosecute, as well as suspend or cancel the licences of manufacturers found to be manufacturing substandard drugs.

Substandard drugs often delay recovery as the patient keeps popping pills that do not help cure them, said doctors. This could aggravate their illness and worsen their condition.

Although the FDA is sent samples of each batch of drug by the manufacturers themselves even before it reaches the market, inspectors are authorised to collect samples once they are floated in the market as well. In fact, FDA conducts random checks to maintain the quality of drugs.

Officials from FDA said that a majority of substandard drugs were manufactured outside Maharashtra. While 6.45% of drug manufactured outside the state were found to be substandard, around 3.7% of drugs manufactured in the state were substandard.

Common examples are vitamin and digestive tablets. Sensitive to heat, their efficacy might deteriorate if not stored properly. “If we find that a medical store has not stored the drugs properly, they can also face action,” said Shende. “If a pharmaceutical manufacturer is found to be regularly producing substandard drugs, strict action is taken. At times we also find counterfeit drugs which can pose a danger to the patient’s life, as well as violate their rights as consumers.”

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