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2022 (12) TMI 1104 - SC - Indian Laws


Issues Involved:
1. Whether the impugned substance "Pyridoxal 5 Phosphate" is classified as a drug under the Drugs and Cosmetics Act, 1940, or as a food substance under the Food Safety and Standards Act, 2006.
2. Whether the Drug Inspector had the authority to initiate proceedings under the Drugs and Cosmetics Act, 1940.
3. Whether the appellants had the necessary licenses to deal with the impugned substance.
4. Whether there was sufficient evidence to support the allegations of manufacturing by breaking bulk quantities into smaller packs.
5. Whether the inordinate delay in filing the complaint affects the validity of the proceedings.

Issue-wise Detailed Analysis:

1. Classification of the Impugned Substance:
The appellants argued that the impugned substance, Pyridoxal 5 Phosphate, falls under the definition of "food" as per Section 3(1)(j) of the Food Safety and Standards Act, 2006, and not as a drug under Section 3(b) of the Drugs and Cosmetics Act, 1940. The court noted that the impugned substance is categorized as a bulk food substance in the Food Safety and Standards Regulations, 2016, and is not included as a drug in the Indian Pharmacopoeia. Therefore, it does not require a specific license under the Drugs and Cosmetics Act, 1940.

2. Authority of the Drug Inspector:
The appellants contended that the Drug Inspector could not exercise powers under Section 22 of the Drugs and Cosmetics Act, 1940, as it is subject to Section 23 of the same Act. The court found that the Drug Inspector had not provided any evidence to prove that the impugned substance is solely a drug and not a food-manufacturing substance.

3. Licenses Held by the Appellants:
The appellants claimed they had a valid Wholesale Drug License in forms 20B and 21B of the Drugs and Cosmetics Rules, 1945. The court observed that even if the impugned substance were considered a drug, the appellants would not be liable under the Drugs and Cosmetics Act, 1940, as they possessed the necessary licenses.

4. Evidence of Manufacturing:
The complaint alleged that the appellants broke up the bulk quantity of Pyridoxal 5 Phosphate into smaller packs and sold them, which was classified as "manufacturing" under Section 18(c) read with Section 3(f) of the Drugs and Cosmetics Act, 1940. However, the court found no evidence to support this claim. No recovery of the sold packets was made to ascertain whether the original packaging was tampered with, and no scientific evidence was provided to prove that the substance was solely used for drug manufacturing.

5. Inordinate Delay in Filing the Complaint:
There was a gap of more than four years between the initial investigation and the filing of the complaint. The court noted that the respondent provided no explanation for this delay, which can be fatal to the prosecution's case. The court referred to the judgment in Bijoy Singh & Anr. Vs State Of Bihar, which states that unexplained inordinate delay can be a crucial factor in quashing a criminal complaint.

Conclusion:
The court concluded that the High Court failed to consider the facts and circumstances of the case properly. The impugned order dated 23.08.2021 passed by the High Court was set aside, and the proceedings of C.C. No. 6351 of 2017 pending in the Court of Metropolitan Magistrate-IV, Saidapet, Chennai, were quashed. The appeal was allowed.

 

 

 

 

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