Q: We are involved in wholesaling the drugs under the conditions of an appropriate license. A drug sample was collected by area Drug Inspector from our premises during the inspection. Further, the sample was declared as substandard and a complaint was filed in this regard. Kindly advice, can we also be held liable for this substandard drug? – Subhash Kumar

A: A trader/wholesaler can be held liable for the substandard, spurious and misbranded drugs, if he is found to have proper knowledge and information about such law breaking activities. In such cases, the prosecution is required to prove if the trader or wholesaler has really any involvement and has information which caused law breaking activities and those activities led to any substandard/ spurious/ misbranded drugs. Although, for the accused there are few available defenses, which he can avail to get rid of charges of substandard/ spurious/ misbranded drugs. On the other hand, to avoid such circumstances, he should have the proper

knowledge and information as how to deal appropriately with the drugs, since the drugs should be stored properly, the temperature under which the drugs are kept/stored should be as per the statutory requirements, the drugs manufacturer should be genuine at the best of his knowledge from whom he purchases the drugs, the drugs which he is acquiring/purchasing should not contravene the relevant provisions of the Act/D&C Act. Therefore, depending on the situations, the trader/wholesaler can be held liable for such offences jointly with other parties or alone.

In case of Glaxo Smithkline Pharmaceuticals limited et al Vs The State of Bihar and Rakesh Nandan Singh (2011-PATHC), it was held that it was evident that the protection could only be granted, if the proposed accused was in a position to satisfy the court that he had acquired the Drug from the Licensed Manufacturer, Distributor or Dealer and he did not know that the Drug in question was contrary to any of the provisions and the same was in his possession and kept properly. In the present case, fact remained that Drugs in question were misbranded and contrary to the provisions of loan license i.e. without obtaining loan license, M/s Glaxo Smith Kline Pharmaceuticals Ltd. was marketing the Drugs manufactured by M/s Emecure Pharmaceuticals Ltd. The plea that he was protected under the relevant provision of the Drugs Act could not be examined or entertained by this Court, while hearing a petition under Section 482 of the Code of Criminal Procedure filed against an order of cognizance. Accordingly, on the basis of plea of application of said relevant provision of the Drugs Act, the order of cognizance in the present case could not be interfered with.

Consequently, it is opined that if the sample was declared as substandard and a complaint was filed against trader/wholesaler then he can be held liable solely or jointly for the substandard drug if he was found contravening the relevant provisions of the Act.

Dr. Javed Hasan, Advocate
(High Court, Delhi)
For, Drugs & IPR Laws
Email :


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