The Food and Drug Administration (FDA) in the month of May, has, so far, in its inspection of drugs, declared seven products covered under drugs as ‘not of standard’.
The seven products range from ‘Absorbent Cotton Wool I.P’ to ‘Wexol’, a steroid injection. These products were labelled after drug inspectors from across the state collected samples from chemist stores, and sent them for test to the FDA labs in Aurangabad and Mumbai.
Joint commissioner of FDA for greater Mumbai Kamlesh B. Shende said, “Drug inspectors collect samples from the stores routinely and send it to our labs. Though it is a routine activity, the purpose is to tighten the net around manufacturers, so that they avoid making mistakes owing to carelessness and adhere to the directives.”
The FDA is sent samples of every batch of drugs by the manufacturers themselves, even before they reach the market, but the FDA inspectors are also authorised to collect samples once they are floated in the market. The volume of samples collected depends on the capacity of the FDA lab to carry out quality tests on the drugs.
“Our aim is to make the people aware about these sub-standard drugs. Manufacturers are always under pressure that their name would be made public in case the poor quality of their drugs is discovered, which makes them maintain utmost precaution.” said Mr Shende.
The manufacturers of these drugs have been sent notices by the FDA depending on the extent of failure on their side to
maintain the standards in processing the products. In case the FDA lab reports suggest that the non-adherence to directives is more than ‘minor,’ the manufacturer can be prosecuted as well, said Mr Shende.