The court upheld the classification of the trial as a summons case, emphasizing that procedural rights were adequately observed throughout, rejecting claims of improper procedure due to earlier assumptions by the petitioners.

ORDER :

M. NIRMAL KUMAR, J.

The petitioners/A1, A3, A5, A7, A8 & A9 have filed a petition under Section 36 (A) of The Drugs and Cosmetics Act, 1940 (In short 'The Act') r/w 260(2) and 259 of Cr.P.C in Crl.M.P.No.11949 of 2023 in C.C.No.6686 of 2013 before the learned IV Metropolitan Magistrate, Saidapet, Chennai and the same was dismissed vide impugned order, dated 22.12.2023.Against which, the present criminal revision case is filed.

2.The learned Senior Counsel appearing for the petitioner submitted that the 1^st petitioner is the manufacturer of the Easyfive TT vaccine with self life of two years from Okhla Facility and got another manufacturing facility for the same product in Baddi, Himachal Pradesh. In the year 2004, manufactured drug 'Easyfive' which is a pentavalent vaccine given to infants. This vaccine provides active immunization against five severe diseases namely Diphtheria, Tetanus, Pertussis, Heptitis-B and infections caused by Haemophilus Influenzae type b (Hib). In the year 2007, since PanEra Biotec Private Limited, a sister concern of the 1^st petitioner started supplying one of the antigenic components of the product indigenously sourced by the 1^st petitioner for manufacturing Easyfive vaccine. In this regard, the manufacturing permission in Form 46 of the Drugs Rules was granted by the Drugs Controller General of India for manufacturing the vaccine. Subsequenlty, the license to manufacture Easyfive Second Formulation at Okhla Facility as an additional item was granted by the Government of National Capital Territory of Delhi, Drugs Control Department. The NCT Delhi, Drugs Control Department approved the expiry date of Easyfive Second Formulation for two years from the date of manufacturing. The compositions of Easyfive (for export only) and Easyfive TT are the same and this amendment to the Form 28-D was only brought about for the brand name. Hence, by permission, dated 10.09.2010, the Central Drugs Standard Control Organization approved the extension of shelf life of Easyfive Second Formulation from two years to three years with brand name Easyfive. Since the 1^st petitioner had already manufactured Easyfive Second Formulation vaccine batches with shelf life of 24 months only and the amendment with different brand names of the Easyfive Second Formulation approved, there was necessity for the 1^st petitioner to relabel the existing vials with an extended shelf life period of three years with brand name Easyfive-TT for domestic supply. The relabeling which was permitted could not be done immediately due to some disturbance in the export and market condition. Further there was no specification how the relabelling to be done and some medicine was found in the 1^st petitioner's godown in Chennai by the respondent herein who alleged it had violated the Drugs Act and thereafter a case has been launched for the above said offence punishable under Section 27 (d) of the Act.

3.He further submitted that the petitioners presumed that the case against them is being tried as warrant case under the Code of Criminal Procedure since the cognizance order, dated 26.12.2013 misinformed the accused as if the present case is taken on file for an offence punishable under Section 27 (a) of the Act and later only it was verified and found that it was under Section 27 (d) of the Act. He further submitted that initial questioning under Section 251 of Cr.P.C does not specifically call upon the accused plea of guilty or if he has any defence to make. The previous Presiding Officer recorded the chief examination and cros