2022 (12) TMI 1104 - SC - Indian Laws

Pyridoxal 5 Phosphate: Food, Not Drug, Court Quashes Proceedings

The court held that the impugned substance, Pyridoxal 5 Phosphate, was classified as a food substance under the Food Safety and Standards Act, 2006, not ... Appreciation of evidence - failure to give any evidence indicating that the substance “Pyridoxal 5 Phosphate” - extraordinary delay of more than four years between the initial site inspection, the show cause notice, and the complaint - powers of Respondent/ Drugs Inspector under Section 22 of the Drugs and Cosmetics Act, 1940 - HELD THAT:- Upon perusal of the legal nature of the impugned substance, it can be seen that the impugned substance has been categorized as a bulk food substance falling under the definition of food as per Section 3(1)(j) of the Food Safety and Standards Act, 2006. The impugned substance has specifically been mentioned as a food ingredient in Serial No.4(ii) of the Schedule-I of the Food Safety and Standards Regulations, 2016 - It is also worth mentioning that the Respondent has made no effort to prove that the alleged substance is only a drug and not a food- manufacturing substance. No scientific evidence or otherwise has been furnished to prove that the alleged substance is solely used for manufacturing drug and not food items. Prima Facie, due to the lack of evidence adduced by the Respondent in the four-year period between the initial enquiry and the complaint, this court cannot presume that the alleged substance can only be classified as a “drug”. There has been a gap of more than four years between the initial investigation and the filing of the complaint, and even after lapse of substantial amount of time, no evidence has been provided to sustain the claims in the complaint. In the present case, the Respondent has provided no explanation for the extraordinary delay of more than four years between the initial site inspection, the show cause notice, and the complaint. In fact, the absence of such an explanation only prompts the Court to infer some sinister motive behind initiating the criminal proceedings - While inordinate delay in itself may not be ground for quashing of a criminal complaint, in such cases, unexplained inordinate delay of such length must be taken into consideration as a very crucial factor as grounds for quashing a criminal complaint. It must be noted that the High Court while passing the impugned judgment, has failed to take into consideration to the facts and circumstances of the case. While it is true that the quashing of a criminal complaint must be done only in the rarest of rare cases, it is still the duty of the High Court to look into each and every case with great detail to prevent miscarriage of justice. The law is a sacrosanct entity that exists to serve the ends of justice, and the courts, as protectors of the law and servants of the law, must always ensure that frivolous cases do not pervert the sacrosanct nature of the law. The impugned order dated 23.08.2021 passed by the High Court is not liable to be sustained and is hereby set aside - Appeal allowed. 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.