Summary
A Chennai chemicals trader bought 75 kg of pyridoxal-5-phosphate. He was prosecuted under Section 18(c) of the Drugs and Cosmetics Act for allegedly breaking up the bulk material and selling it in smaller packs, which was said to amount to manufacture. The Madras High Court refused to quash the complaint. The Supreme Court quashed it. The substance is listed as a food ingredient under the Food Safety law and is not in the Indian Pharmacopoeia. Dual-use substances are exempt under Schedule K, and the traders held wholesale drug licences in any case. No packs were recovered and no evidence of repacking was produced. There was an unexplained four-year delay between inspection and complaint.
Issues
- Whether a complaint under Section 18(c) of the Drugs and Cosmetics Act, 1940, alleging that a trader broke up and repacked pyridoxal-5-phosphate, disclosed an offence warranting continuation, or should be quashed under Section 482 CrPC.
- Whether an unexplained delay of over four years between inspection and complaint is a relevant ground for quashing.
Provisions considered
- Section 482, Code of Criminal Procedure, 1973Applying Bhajan Lal, Golconda Linga Swamy and R.P. Kapur, the Court may quash where the allegations taken in full disclose no offence or the evidence is clearly inconsistent with the accusation; the High Court erred in treating the issues as merely triable. (¶¶ 8, 9, 10, 11, 15, 28)
- Sections 3(f) and 18(c), Drugs and Cosmetics Act, 1940The charge rested on treating the alleged breaking up and repacking of a bulk substance as manufacture without licence, but there was no evidence that the substance was solely a drug or that the original packing had been broken. (¶¶ 14, 19, 21, 22)
- Section 3(1)(j), Food Safety and Standards Act, 2006Pyridoxal-5-phosphate is a bulk food substance listed as a food ingredient in Schedule I of the Food Safety and Standards Regulations, 2016, and needs no specific licence under the Drugs and Cosmetics Act. (¶¶ 16, 17)
Held
- The substance falls within the definition of food, is not a drug in the Indian Pharmacopoeia, and as a dual-use substance is exempt from Chapter IV under Schedule K and Rule 123; the Drug Inspector produced no scientific or other evidence that it was used solely to manufacture drugs. (¶¶ 16, 17, 18, 19)
- Even assuming the substance to be solely a drug, the appellants held wholesale drug licences in Forms 20B and 21B, so the allegations taken in toto disclose no offence; no recovery was made and no evidence showed that the original packing was broken or that sold packets were tampered with. (¶¶ 20, 21, 22)
- Following Bijoy Singh, unexplained delay must be explained by the prosecution; although delay alone may not justify quashing, an unexplained delay of over four years between inspection, show-cause memo and complaint is a crucial factor, and after such delay the court may expect at least bare-minimum evidence; criminal law must be a shield for the innocent, not a sword to harass. (¶¶ 23, 24, 25, 26, 27)
Result
Criminal Appeal No. 2310 of 2022 allowed; the Madras High Court order dated 23.08.2021 in Crl. O.P. No. 6445 of 2018 set aside and C.C. No. 6351 of 2017 before the Metropolitan Magistrate-IV, Saidapet, Chennai quashed.