In the last fiscal year, the Food and Drug Administration (FDA) tested over 6,500 drugs sold in the market across the state and found that 392 of them, including vitamin tablets, syrups, steroids and injections were “substandard”. The FDA said that around “five per cent” of the tested drugs in the market are “not of standard.”
Officials from FDA said that majority of the substandard drugs were manufactured outside Maharashtra. The average percentage of spurious drugs in the state stood between 6.87 and 7.21 per cent, while drugs from outside the state stood at 7.22 to 11.8 per cent. And, only 2.8 per cent of drugs manufactured in Maharashtra were found “not of standard.”
To monitor the quality of drugs being sold, FDA drug inspectors collect samples from medical stores, which are sent for laboratory investigations.
“If the drug composition is not as specified, it will have little or no effect on the patient. Also, drug tablets if found powdered or if the pH levels of liquid drugs are not maintained, we label them as substandard,” said Kamlesh B. Shende, joint commissioner, FDA. “Immediately the batch is recalled and action is initiated against the manufacturer.”
Under the Drugs and Cosmetic Act, FDA officials can prosecute, suspend, and even cancel the licences of manufacturers who are found guilty of producing substandard drugs.