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This is an archive article published on March 29, 2005

HC raps FDA on spurious drug racket mess

The State has cut a sorry figure before Bombay High Court on a reported spurious drugs racket in Maharashtra when the court found that offic...

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The State has cut a sorry figure before Bombay High Court on a reported spurious drugs racket in Maharashtra when the court found that officials of the Food and Drugs Administration (FDA) had filed ‘‘contradictory’’ affidavits on the matter.

Taking a serious cognizance of these affidavits, as well as a World Health Organisation report describing India as ‘‘a major global producer of spurious drugs, accounting for a third of the world’s fake drugs market,’’ a division bench has directed the State chief secretary and the Drugs Controller General of India (DCGI) to file fresh and ‘‘proper’’ affidavits based on proper verification of all documents and literature.

The bench of Chief Justice Dalveer Bhandari and Justice S.A. Bobde asked the respondents to consider the issue a serious problem afflicting the country. The next hearing is on March 30. The DCGI has been asked to clarify the extent of the presence of spurious drugs in the country and steps taking by his office to curb the menace.

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Similarly, the State Chief Secretary has been asked to clarify whether there are any manufacturing units in the state involved in spurious drugs and whether such drugs are being imported from other states or countries. Also, to detail the names of organisations and individuals involved in clandestine distribution of spurious drugs. The court has asked the state to explain what steps have been taken to curb the menace and how many raids have been conducted in the past one year.

This follows a Public Interest Litigation filed by Chinchwad-based businessman Lakhpatraj Mehta alleging presence of a spurious drugs racket in the state. Mehta and his two sons, Aman and Alpesh, were involved in an accident and were admitted to the KEM Hospital. Mehta had purchased an injection prescribed by the hospital authorities, from the KEM Medical Stores, which was administered to his son. However, his son suffered several reactions and later, the injection was found to be fake.

Following a complaint by Mehta, the FDA raided the medical store and cancelled its licence on November 23, 2002. However, the move was stayed by the then Minister of State for Home. Meanwhile, Mehta’s son, Aman, died.

Responding to the show cause notices, FDA assistant commissioner and Licensing Authority M.R. Mahakalkar and Assistant Commissioner (Intelligence Branch) FDA O S Sadhwani had filed separate affidavits. While the former denied any existence of spurious drugs racket, the latter mentioned that 30 cases of spurious drugs were detected and being examined. The court observed that these affidavits were contradictory.

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