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Measures to tighten noose against erring drug units

Friday, October 12, 2018
By Raju Vernekar

In view of the large scale violation of provisions of the Drugs and Cosmetics Act, 1940, the state cabinet decided to give powers to Food and Drug Administration (FDA) officers to impose heavy fine upon offenders  including drug manufacturers, distributors, blood and drug testing laboratories on Tuesday

According to the decision, Sections 33-1 (B) and 33 (N2) of the Drugs and Cosmetics Act, 1940, would be amended to empower drug licensing officers to collect heavy fine from the violators. At present, as per Sections 66 (1), 67 (H-1), 82 (2), 159 (1), 22 (O) (1), 142 (1), the officers can cancel or suspend the drug licenses but they cannot collect fine from the offenders.

 As of today, nearly 6000 appeals against the decisions of the FDA are pending in various courts in the state. Besides, over 2200 cases challenging the decisions of the FDA are pending.

The offences include non-compliance of rules including not adhering to quality control measures while manufacturing drugs, non-display of ingredients of products by manufacturers on outside wrappers, illegal storage of drugs, non-destruction of expired medicines, running chemist shops without license, violation of regulations by blood testing laboratories etc.

There are over 4400 drug manufacturers and nearly 76,800 drug sellers in Maharashtra. The  Drugs and Cosmetics Act, 1940, and the  Drugs and Cosmetics Rules, 1945, regulate the import, manufacture, distribution and sale of drugs and cosmetics. However FDA cannot take action except suspension of license and seizure of material and the cases have to be filed in magisterial courts. This takes very long time and hardly serves as a deterrent against the violators. As such the proposed amendment is expected to create fear among offenders and  also enable government to generate more revenue.

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