Point of Law: Criminal prosecution, right to defend oneself is an absolute and unbridled right.

ORDER :

By way of instant petition, petitioner has prayed for setting aside the order dated 15.6.2022, passed by learned Additional Chief Judicial Magistrate, Nalagarh, District Solan, H.P. in Complaint No. 239/4 of 2022, whereby the prayer of the petitioner to send the seized second sample, lying in the custody of the Court, for its analysis to Central Drugs Laboratory, Kolkata has been rejected.

2. Brief facts necessary for adjudication of petition are as under: -

2.1 Petitioner is one of the accused in complaint case No. 239/4 of 2022, pending adjudication before learned Additional Chief Judicial Magistrate, Nalagarh, District Solan, H.P.

2.2 The complaint has been filed by Union of India through Drug Inspector under Section 18 (a)(i) and (vi) read with Section 16 (i)(a), punishable under Section 27 (d) of The Drugs and Cosmetics Act, 1940 (for short, ‘the Act’).

2.3 It is alleged in the complaint as under :

(i) That on 15.3.2021, the Drug Inspector had drawn the drug samples of Azilsartan Medoxomil tables 80mg (Abel-80), manufactured by petitioner at its manufacturing Unit at Baddi, District Solan, H.P. under Section 23 of the Act from the premises of M/s Lupin Limited, Zirakpur, Punjab. The spot reports were prepared at the time of sampling.

(ii) The sample was sent to Government Analyst, Regional Drugs Testing Laboratory, Chandigarh for its test and analysis on 15.3.2021.

(iii) The Government Analyst vide report dated 3.6.2021 declared the sample as not of standard quality.

(iv) One copy of Test Report dated 3.6.2021 was made available to the petitioner along with notice under Section 18 (b), 22(1)(cca) and 25 (3) of the Act on 17.6.2021. In addition, one sealed portion of sample was also handed over to the petitioner on the same day i.e. 17.6.2021.

(v) The petitioner got the controlled sample tested and found the same as per prescribed standard.

(vi) Petitioner communicated with Drug Inspector vide its letter dated 13.7.2021 and disclosed the result of test got conducted by it on controlled sample. Petitioner, however, opted not to challenge the FDA results.

2.4 During the pendency of the complaint, petitioner filed an application before learned Additional Chief Judicial Magistrate, Nalagarh under Section 25 (4) of the Act, making a prayer to send the second sample, lying in the custody of the Court for analysis to Central Drugs Laboratory, Kolkata.

2.5 The prayer for sending the second sample was made on following grounds:

(i) That a bare perusal of complaint did not disclose even a prima-facie case against the petitioner, therefore, framing of charge against the petitioner and consequent trial would be an exercise in futility and as such, petitioner was entitled for sending the seized sample by the Drugs Inspector for analysis by Central Drugs Laboratory, Kolkata.

(ii) Petitioner further had placed reliance on the analysis of the Control Sample, CDSCO (Portion of Withdrawn Sample) and Hub Sample (received from Lupin Hub) and as per analytical research all the samples were found complying with the specifications.

(iii) It was further submitted that in view of satisfactory product development report, R&D stability data along with stability data of marked batch, coupled with analytical results of above noted samples, the dissolution result report in Form-13 by Government Analyst might be due to moisture absorption/improper integration of peak or analytical error/calculation error/instrumental error etc.

2.6 Learned Additional Chief Judicial Magistrate, Nalagarh rejected the prayer of the petitioner on the ground that the petitioner vide its letter dated 13.7.2021, addressed to Drugs Inspector had clearly mentioned that the petitioner did not intend to challenge the FDA results and had initiated the batch recall as per FDA instructions.

2.7 Thus, the learned trial Court inferred that the petitioner had forfeited the claim to chal