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THE PHARMA REVIEW (MARCH - APRIL 2011)

Evaluation of Withdrawal of Drugs Sample as per Drugs and Cosmetics
Act, 1940 in light of Criminal Law Jurisprudence

B.L.Das1, Dr.R.N.Gupta2, Dr.A.K. Dorle3

Abstract: The evaluation of withdrawal of Drugs Sample as per Drugs and Cosmetics Act, has been done. The Drugs and Cosmetics Act, 1940 (India) does not have provision to send the copy of Government Analyst Test Report to the manufacturer of the drug. The manufacturer is not given chance to adduce evidence in contra version of the Report while such opportunity is provided to the Retailers and wholesalers. It is inconsistent with the provision of the Constitution of India. This results in the failure of Drugs Control Authorities in the legal battle against the manufacturers of Sub-Standard drugs. Drugs Regulatory Act of United Kingdom and United States of America has such provisions. A provision may be made in the Drugs and Cosmetics Act, 1940 that one copy of the Test Report may be sent to the manufacturer, whose address is stated on the label of the sample, by the sampling officer. The manufacturer should be given chance to adduce evidence in contra version of the Government Analyst Report.
Introduction
Drawing sample either randomly or of suspected drug from market or from manufacturing premises, for test and analysis is a very important tool to evaluate the presence of spurious/ adulterated/ Counterfeit / sub - standard drugs in the market. Drawing samples for test and analysis is meant to detect intrusion of sub-standard drugs into distribution channel. Everywhere in the world it is a practice that Drugs Regulatory Agency draws samples from market or manufacturing houses by for test and analysis.
Procedure of Sampling
The process and method used for collection of samples and its dispatch to laboratory for its analysis differs from country to country. The procedures for further action, if the drug is found not of standard quality after test, are also different. Many tools are also provided in the Act to the manufacturer or traders as a defense against misuse of this provision. These procedures always affect the later course of action to be taken against offenders. .

 

 

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