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Thursday, September 30, 1999

FDCA shuts down 15 units

Rajesh Moudgil  
VADODARA, Sept 29: Cracking the whip against pharmaceutical companies producing sub-standard drugs in Gujarat, the State Food and Drugs Control Administration has ordered at least 15 units to close down in the past month. More than 2,000 licensed drug-making units have been told to follow laws or face the music.

According to FDCA Commissioner S P Adeshara's letter to the Gujarat board of the Indian Drugs Manufacturers' Association (a copy of which is in the possession of Express Newsline), the units were guilty of ``manufacturing drugs in the total absence of technical persons and not carrying out any kind of testing on the main acting ingredients... yet using the same to manufacture formulations and releasing it for open market, government hospitals and institutions''.

Talking to Express Newsline on Wednesday, FDCA commissioner S P Adeshara said that henceforth, licences would be granted only after ensuring the manufacturer had complete knowledge of the current good manufacturing practice and supporting documentary evidence. His letter to the IDMA also noted that the ``defaulting units ran in total absence of basic hygiene, safety of workers and public and any kind of sale/purchase records''.

Laboratory tests on samples, Adeshara said, revealed that the drugs often contained no active ingredients at all, while some had only 50 per cent of what their label claimed. Most samples were found to be grossly sub-standard, he said, adding, ``All this goes on with the connivance of the manufacturers''.

Though FDCA sources said the action was taken ``in the larger interest of public health'', the IDMA, however, was afraid that the closure of so many units in quick succession would tarnish the industry's image outside the State.

IDMA chairman Dushyant Patel and secretary Ketan Naik, who have been apprised of the impending ``strict action'' (read revocation of licenses), while endorsing the action against the erring units, said it could also lead to harassment of genuine drugs manufacturers.

Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.


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