IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT THE HONOURABLE MR.JUSTICE V.G.ARUN THURSDAY, THE 6^TH DAY OF MARCH 2025 / 15TH PHALGUNA, 1946 CRL.MC NO. 10814 OF 2024 AGAINST THE ORDER/JUDGMENT DATED IN CC NO.1235 OF

2022 OF ADDITIONAL CHIEF JUDICIAL MAGISTRATE, THIRUVANANTHAPURAM PETITIONER:

SRI. PRASANTH WILSON, AUTHORISED SIGNATORY OF CADILA HEALTH CARE LTD., VIII NANNDPUR TEHSIL BADDI DIST. SOLAN, HIMACHAL PRADESH, RESIDENT OF PANCHKULA, PIN - 173205 BY ADVS.

V.B.UNNIRAJ M.C.BINDUMOL P.ANITHA ADHIL P.

B.G.HARINDRANATH (SR.)

RESPONDENTS:

1 STATE OF KERALA, REPRESENTED BY PUBLIC PROSECUTOR, HIGH COURT OF KERALA ERNAKULAM, PIN - 682031

2 CHIEF INSPECTOR (DRUG INTELIGENCE SQUAD), OFFICE OF THE DRUGS CONTROLLER, VANCHIYOOR, THIRUVANANTHAPURAM-695035, PIN - 695035 BY ADVS.

PUBLIC PROSECUTOR ADDL.DIRECTOR GENERAL OF PROSECUTION OTHER PRESENT:

SR. ADV. B.G. HARINDRANATH FOR THE PETITIONER.

SRI. GRASHIOUS KURIAKOSE, FOR ADGP.

THIS CRIMINAL MISC. CASE HAVING BEEN FINALLY HEARD ON

03.03.2025, ALONG WITH Crl.MC.10686/2024, THE COURT ON

06.03.2025 PASSED THE FOLLOWING:

IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT THE HONOURABLE MR.JUSTICE V.G.ARUN THURSDAY, THE 6^TH DAY OF MARCH 2025 / 15TH PHALGUNA, 1946 CRL.MC NO. 10686 OF 2024 PETITIONERS:

1 CADILA HEALTHCARE LTD., VIII NANNDPUR TEHSIL BADDI DIST. SOLAN, HIMACHAL PRADESH REPRESENTED BY THE MANAGING DIRECTOR, PIN - 173205

2 SRI.PANKAJ R. PATEL, S/O. RAMANBHAI PATEL MANAGING DIRECTOR OF CADILA HEALTHCARE LTD. (NOW IT IS KNOWN AS ZYDUS LIFESCIENCES LIMITED) RESIDING AT 16, AZAD SOCIETY, AMBAWADI, AHMEDABAD-380015, PIN - 380015 BY ADVS.

V.B.UNNIRAJ M.C.BINDUMOL P.ANITHA ADHIL P.

B.G.HARINDRANATH (SR.)

RESPONDENTS:

1 STATE OF KERALA, REPRESENTED BY PUBLIC PROSECUTOR, HIGH COURT OF KERALA, ERNAKULAM, PIN - 682031

2 CHIEF INSPECTOR (DRUG INTELIGENCE SQUAD), OFFICE OF THE DRUGS CONTROLLER, VANCHIYOOR, THIRUVANANTHAPURAM, PIN - 695035 BY ADVS.

PUBLIC PROSECUTOR ADDL.DIRECTOR GENERAL OF PROSECUTION THIS CRIMINAL MISC. CASE HAVING BEEN FINALLY HEARD ON

03.03.2025, ALONG WITH Crl.MC.10814/2024, THE COURT ON

06.03.2025 PASSED THE FOLLOWING:

V.G.ARUN, J = = = = = = = = = = = = = = = = =

Crl.M.C.Nos.10686 and 10814 of 2024 = = = = = = = = = = = = = = = = = = Dated this the 6th day of March,2025

O R D E R

The petitioners in these Criminal Miscellaneous cases are an Allopathic Drug Manufacturing Company, its Chairman cum Managing Director and authorised representative, challenging Annexure A1 complaint filed by the Drugs Inspector, Thiruvananthapuram and further proceedings thereon. Briefly stated, the allegations in Annexure A1 complaint filed under Section 32 of the Drugs and Cosmetics Act, 1940 ('the Act' for short) are as under;

The 1^st accused, M/s. Cadila Healthcare Limited is engaged in the manufacture and sale of Allopathic Drugs, the 2^nd accused is its Chairman and Managing Director and 3^rd accused is the person responsible for manufacturing the drugs.

On 01.01.2020, the Drugs Inspector drew a statutory sample of the drug METHOTREXATE TABLETS IP 2.5 manufactured by the 1^st accused from the paying counter at the Medical College, Thiruvananthapuram. Verification of the sample revealed that on the primary packing (label on the strip), the name of the drug was written as 'Methotrexate Tablets I.P. 2.5 mg,' whereas in the secondary packing, it was written as LETRAZOLE TABLETS I.P. Thereupon, one portion of the sealed sample and copy of the intimation was handed over to the paying counter- in-charge in the Medical College, as required under Section 23(4) of the Act, and one portion was sent to the Government Analyst with a request to test the sample as per the standards specified in the monograph for 'Methotrexate Tablets I.P. 2.5 mg' and if the sample does not comply with the standards of identification and test for methotrexate, to test the sample as per the standards specified in the monograph for 'Letrazole Tablets I.P.' After testing the sample, the Government Analyst declared the drug was 'not of standard quality',