The right to re-analysis of drug samples and the legal responsibility of individuals in the conduct of business under the Drugs and Cosmetics Act, 1940.

JUDGMENT

(Prayer:petition under Section 482 of the Criminal Procedure Code seeking to call for the records and quash the complaint and proceedings in S.T.C.No.255 of 2023 pending on the file of learned Judicial Magistrate IV, Vellore.)

1. This criminal original petition has been filed seeking to quash the proceedings pending in S.T.C.No.255 of 2023 before learned Judicial Magistrate-IV, Vellore (hereinafter called the Court below).

2. The petitioners herein have been arrayed as accused Nos.1 to 3 in the complaint filed by the respondent for contravention of Sections 18(a)(i) and 18(c) of the Drugs and Cosmetics Act, 1940 (for brevity, the Act) read with Rule 74 of the Drugs Rules, 1945 (for short, the Rules) read with Condition No.3 of the Conditions of Licence stated in Form 25, punishable under Section 27(d) of the Act.

3. The brief facts leading to filing of this petition are stated as hereunder :

(i) The Drugs Inspector collected a sample of Glycerin Oral Solution U.S.P. 50% manufactured by the Christian Medical College (for short, the CMC), Vellore for analysis on 25.6.2021. The samples drawn were sent for analysis to the Drugs Testing Laboratory, Chennai on the same day. A report dated 30.7.2021 was received from the State Laboratory wherein it was found that the sample did not conform to the U.S.P. specification with respect to pH. In other words, the Glycerin Oral Solution was supposed to have U.S.P. between 5.5 and 7.5 whereas the U.S.P. found in the sample was 8.643.

(ii) A show cause notice dated 03.8.2021 was issued to the CMC, Vellore calling for an explanation. On receipt of the same, the explanation was given by the CMC, Vellore on the same day. Thereafter, yet another show cause notice dated 10.8.2021 was issued. In the second show cause notice, apart from the contravention of Section 18(a)(i) of the Act, the contravention under Section 18(c) of the Act was also pointed out on the ground that the drug was manufactured without a valid product permission and the explanation was called for from the CMC, Vellore, which gave a reply dated 12.8.2021. Even thereafter, two more replies were given on 13.8.2021 and 16.8.2021.

(iii) The third show cause notice dated 22.11.2021 came to be issued by the respondent to the CMC, Vellore calling for explanation within 15 days. Again, a reply was sent on 02.12.2021. A personal hearing was also conducted by the Director of Drugs Control and the explanation was given.

(iv) Ultimately, the last show cause memo, which can be taken to be the composite show cause notice, dated 20.12.2021 was issued calling for explanation from the CMC, Vellore. A reply dated 28.12.2021 was sent by the Director of the CMC, Vellore wherein the In-House Quality Control Analysis report was pointed out, which showed that the pH level was well within the parameter at 7.36. In view of the same, a request was made for re-testing the sample in the Central Drugs Laboratory.

(v) Ultimately, the complaint came to be filed before the Court below 04.1.2023 for the contravention of the provisions of the Act, the Rules and the Conditions of Licence. The said complaint was taken cognizance by the Court below and summons were issued to the petitioners. Aggrieved by the same, the above criminal original petition has been filed before this Court.

4. Heard the learned Senior Counsel appearing on behalf of the petitioners and the learned Government Advocate (Criminal Side) appearing for the respondent.

5. The first ground raised by the learned Senior Counsel appearing on behalf of the petitioners is that the petitioners have been deprived of their valuable right conferred under Section 25(4) of the Act to have the second sample re-analysed from the Central Drugs Laboratory. According to him, the samples were drawn on 25.6.2021 and the expiry date of the drug was 19.1.2023. It was further submitted that the petitioners had conducted their in-h