Prosecution quashed for delay in sample testing beyond 60 days without extension under Rule 45 and failure to send sample to manufacturer under Section 23(4)(iii), depriving re-analysis right post shelf-life expiry.

JUDGMENT :

N.J.J AMADAR, J.

1. Rule. Rule made returnable forthwith, and, with the consent of the learned Counsel for the parties, heard finally.

2. By this Petition under Article 227 of the Constitution of India, the Digitally signed by Petitioners seek to quash and set aside criminal prosecution initiated against Date: 2026.03.24 21:29:55 +0530 the Petitioners in Special Case No.32 of 2021 before the Special Judge, Dadra and Nagar Haveli, Silvasa, for an offence punishable under Section 27 (d) of the Drugs & Cosmetics Act, 1940 (the Drugs Act, 1940).

3. The background facts necessary for the determination of this Petition can be summerized as under :

3.1 The Petitioner No.1 is a Partnership firm. It is engaged in pharmaceutical manufacturing business. Petitioner Nos.2 to 5 are the partners of Petitioner No.1. The Petitioner No.1 manufactures drugs at Baddi, District Solan, Himachal Pradesh. The Petitioner No.1 was holding a valid licence to manufacture FEXINOL-12 – Fexofenadine Hydrochloride Tablets IP. 3.2 Respondent-complainant is a Drugs Inspector appointed under the Drugs Act, 1940. Respondent claimed that, on 29 November 2016, he had visited and inspected the premises of Vinoba Bhave Civil Hospital’s Central Medical Store at Silvasa, and, drawn a sample of FEXINOL-12, Batch No.CBT-400/16, manufactured by the Petitioner No.1. The said sample was purportedly drawn for the purpose of test and analysis by issuing Form No.17. On 30 November 2016, one portion of the sealed sample was allegedly sent by the Respondent to Government Analyst, Central Drugs Testing Laboratory, Mumbai, in Form No.18. The Respondent allegedly received a report in Form No.13 dated 6 July 2017 from the Government Analyst, opining that the sample was ‘not of standard quality’.

3.3 Thereupon, Respondent issued a show cause notice along with one sealed portion of the sample, to the Central Medical Store, Civil Hospital, Silvasa, directing the store to stop usage / distribution and to disclose the name / address of the firm/ person from whom the said drug was obtained.

3.4 Eventually, the distribution chain of the subject drug was traced back to Petitioner No.1. A joint investigation was carried out by the Deputy Drugs Controller (I), CDSCO, Baddi Zone, alongwith State FDI Officials. A joint investigation report dated 4 September 2017 was prepared. Thereafter, on 6 November 2019 sanction to initiate prosecution against the Petitioners was obtained from the Drugs Controller General of India.

3.5 Armed with the said sanction, the Respondent filed a complaint before the Special Judge at Silvasa on 28 September 2021. By an order dated 28 September 2021, the learned Special Judge, Dadra and Nagar Haveli, Silvasa, was persuaded to issue process against the Petitioners for an offence punishable under Section 27 (d) of the Drugs Act, 1940.

4. The Petitioners have assailed the prosecution by raising a slew of exceptions. Firstly, in clear violation of Rule 45 of the Drugs Rules, 1945, there was an inordinate and unexplained delay in testing the samples. Secondly, there was non-compliance of the mandate contained in Section 23 (4)(ii) of the Drugs Act, 194