ACCOUNTABILITY OF RETAILER/CHEMIST IN THE MATTER OF SALES OF SUBSTANDARD DRUGS

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Q: One of my friends runs a retail/chemist shop for selling the drugs/medicines under the valid drug license. Months back, the samples were collected by the Drug Inspector from his premises and declared of Substandard Quality. Will he be prosecuted if the action is initiated in this regard, please clarify? – Ashu Bisht

A: The retailer or chemist is given the license, based on the prescribed qualification he has and the purpose of such qualification gives the indications that a retailer or chemist should follow the proper norms and deal with the drugs/medicines as per the guidelines and standards. A retailer/chemist is believed to 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/dealer/distributer 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 as to best of his knowledge, and the drugs should not be tempered with after he acquired the same.

If the drug samples are collected by the drug Inspector and found to be substandard/spurious/adulterated by the government analyst, the manufacture will be prosecuted and if the retailer /chemist did not take the precautionary measures as given above he alone or jointly with the manufacturer can be prosecuted. If the retailer /chemist proves that drugs after acquiring was stored properly, he acquired the drugs from duly licensed manufacturer/dealer/distributer, and as per his knowledge the acquired drugs were not in the contravention of the relevant provisions of the act, then the chances of being prosecuted against him will be weaker. If the retailer /chemist prove above points, in that case he is discharged by the court. Then the prosecution is carried out by the court against the manufacturer or any other associated entity/person. In some cases, only retailer /chemist can be prosecuted if the wrong has been committed only at his part. For example, if after acquiring the drug, retailer /chemist did not store the drug under proper condition and/or it got tempered and the material contained therein reacted with air or any other compound available in climate or atmosphere which may lead to change the physical & chemical properties of the drug, in that case the drug can be analyzed to be substandard leaving the retailer /chemist only liable for such substandard.

As in the case of Anil Medical Store V State of Rajasthan, it was the question before the high court, whether the cognizance against petitioners (chemist and others) for offence under Section 17-A read with Section 27-B of the D&C Act was valid or not. In this case, the Sessions Judge dismissed the revision petition of the petitioners and

Q: One of my friends runs a retail/chemist shop for selling the drugs/medicines under the valid drug license. Months back, the samples were collected by the Drug Inspector from his premises and declared of Substandard Quality. Will he be prosecuted if the action is initiated in this regard, please clarify? – Ashu Bisht

A: The retailer or chemist is given the license, based on the prescribed qualification he has and the purpose of such qualification gives the indications that a retailer or chemist should follow the proper norms and deal with the drugs/medicines as per the guidelines and standards. A retailer/chemist is believed to 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/dealer/distributer 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 as to best of his knowledge, and the drugs should not be tempered with after he acquired the same.

If the drug samples are collected by the drug Inspector and found to be substandard/spurious/adulterated by the government analyst, the manufacture will be prosecuted and if the retailer /chemist did not take the precautionary measures as given above he alone or jointly with the manufacturer can be prosecuted. If the retailer /chemist proves that drugs after acquiring was stored properly, he acquired the drugs from duly licensed manufacturer/dealer/distributer, and as per his knowledge the acquired drugs were not in the contravention of the relevant provisions of the act, then the chances of being prosecuted against him will be weaker. If the retailer /chemist prove above points, in that case he is discharged by the court. Then the prosecution is carried out by the court against the manufacturer or any other associated entity/person. In some cases, only retailer /chemist can be prosecuted if the wrong has been committed only at his part. For example, if after acquiring the drug, retailer /chemist did not store the drug under proper condition and/or it got tempered and the material contained therein reacted with air or any other compound available in climate or atmosphere which may lead to change the physical & chemical properties of the drug, in that case the drug can be analyzed to be substandard leaving the retailer /chemist only liable for such substandard.

As in the case of Anil Medical Store V State of Rajasthan, it was the question before the high court, whether the cognizance against petitioners (chemist and others) for offence under Section 17-A read with Section 27-B of the D&C Act was valid or not. In this case, the Sessions Judge dismissed the revision petition of the petitioners and upheld the order passed by Chief Judicial Magistrate, taking cognizance against the petitioners for offence under Sec. 17-A read with Section 27-B of the D&C Act. Further, it was held by the high court, that Petitioner has exercised due diligence while acquiring drug and has properly stored the same. Therefore, Petitioner is entitled to protection granted to him under the Act.

Consequently, it is opined that the chemist / retailer should not be prosecuted by the court if he has exercised his rights and took the precautionary measures to deal with the drugs during the course of trading. On the other hand, if he has not performed the precautionary measures including proper due diligence, the prosecution by the court may be carried out against him. To avoid the prosecution by the court, he is expected to perform the due diligence so that the adulterated and spurious drugs should not find any place in the market.

Dr. Javed Hasan, Advocate
(from New Delhi)
For, Drugs & IPR Laws
+91-9818522970
Email : info@alfauniversallaw.com

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