Karnataka High Court
M/S Asa Biotech vs The State At The Instance Of on 7 July, 2022
Author: Hemant Chandangoudar
Bench: Hemant Chandangoudar
1
IN THE HIGH COURT OF KARNATAKA AT BENGALURU
DATED THIS THE 7TH DAY OF JULY, 2022
BEFORE
THE HON'BLE Mr. JUSTICE HEMANT CHANDANGOUDAR
CRIMINAL PETITION No. 2062 OF 2018
BETWEEN:
1. M/S. ASA BIOTECH
REP. BY ITS PARTNERS,
PLOT NO.124, HPSIDC,
INDUSTRIAL AREA, BADDI,
SOLAN,
HIMACHALA PRADESH-173205
2. MR. JEETINDER DUA,
S/O R.S.DUA,
AGED ABOUT 45 YEARS,
PARTNER OF M/S ASA BIOTECH,
PLOT NO.124, HPSIDC,
INDUSTRIAL AREA, BADDI,
SOLAN (HIMACHAL PRADESH)-173205
R/O JAINA BLOCK-8, H.NO.101,
AMRAVATI APARTMENTS,
BADDI DISTRICT, SOLAN,
HIMACHALA PRADESH-173205
3. SMT. SEEMA DUA,
W/O JEETINDER DUA,
AGED ABOUT 42 YEARS,
PARTNER OF M/S ASA BIOTECH,
PLOT NO.124, HPSIDC,
INDUSTRIAL AREA, BADDI,
SOLAN (HIMACHAL PRADESH)-173205
R/O JAINA BLOCK-8, H.NO.101,
AMRAVATI APARTMENTS,
BADDI DISTRICT, SOLAN,
HIMACHALA PRADESH-173205
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4. SRI. ANIL KUMAR
S/O LATE SRI MULA SINGH,
AGE: 51 YEARS, NO.904, 9TH FLOOR,
AUTHORIZED SIGNATORY OF
M/S ASA BIOTECH,
PLAT NO.124, HPSIDC,
INDUSTRIAL AREA, BADDI,
SOLAN (HIMACHAL PRADESH)-173205
RESIDING AT#265, HOUSING
BOARD, BADDI, SOLAN,
HIMACHALA PRADESH-173205
...PETITIONERS
(BY SRI SUNIL RAO, ADVOCATE FOR
SRI JAGADISHA.S.G, ADVOCAE)(PH)
AND:
THE STATE AT THE INSTANCE
OF ASSISTANT DRUGS CONTROLLER-1,
DAVANAGERE CIRCLE,
DAVANAGERE,
OFFICE OF THE DEPUTY DRUGS
CONTROLLER, NO.376/2,
2ND FLOOR, 4TH MAIN, 8TH CROSS,
P.J.EXTENSION,
DAVANAGERE-577002
REPRESENTED BY THE STATE OF KARNATAKA
BY SPECIAL PUBLIC PROSECUTOR,
HIGH COURT OF KARNATAKA
BANGALORE-560001
...RESPONDENT
(BY SRI ROHITH B.J, HCGP)
THIS CRL.P FILED U/S. 482 CR.P.C BY THE
ADVOCATE FOR THE PETITIONER PRAYING THAT THIS
HON'BLE COURT MAY BE PLEASED TO QUASH THE
ENTIRE PROCEEDINGS IN SPECIAL CASE NO.48/2017,
PENDING AND SESSIONS JUDGE, DAVANAGERE AND
ORDER TAKING COGNIZANCE DATED 27.03.2017 WHICH
IS MARKED AS ANNEXURE-A AND B BY HOLDING THAT,
THE SAME AS ILLEGAL AND UNSUTAINABLE IN THE EYE
OF LAW.
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THIS CRIMINAL PETITION COMING ON FOR
ADMISSION, THIS DAY, THE COURT MADE THE
FOLLOWING:
ORDER
A private complaint under Section 200 of Cr.P.C was filed for the offences punishable under Sections 18(a)(i) read with Section 17-B(d) and under Sections 27(d) and 27(c) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Act" for short) alleging that the legal sample of "Cefiliv-CV" manufactured by accused No.1 - firm was drawn by the Drugs Inspector concerned and the said drug sample was sent to the Government Analyst on 10.12.2013 as specified under Sections 23 and 24 of the Act.
2. It is further alleged that on 07.05.2014, CW- 2 received the certificate of test of the sample drug that was manufactured by accused No.1 from the Government Analyst, wherein the subject drug was declared as "Not of Standard Quality".
3. It is also further alleged that on 07.05.2014, CW-2 served a notice on CW-3 along with the certificate of test. CW-2 received a reply from CW-3 stating that she 4 purchased the subject drug from the petitioner. In turn, M/s. Mission Health Care had replied stating that the subject drug was purchased from accused No.1. CW-2, thereafter, sent a report to the Drugs Controller requesting to visit accused No.1 - firm for further investigation.
4. On 22.05.2014, CW-2 received a reply letter dated 22.05.2014 from accused No.1 - firm, wherein he has stated that he has taken action to stop the sale and recall of subject drug; on 13.06.2014, CW-6 the then Drugs Controller for the State of Karnataka directed CW- 2 and Assistant Drugs Controller to visit the manufacturer of accused No.1 - firm to carry out investigation of the subject drug; on 24.06.2014, CW-2 received a letter from accused No.1 - firm wherein, he has confirmed the manufacture of the subject drug and sale of the same to M/s. Mission Laboratories; on 28.06.2014, CW-2 received a letter from M/s. Mission Health Care, wherein he has disclosed that the subject drug was purchased from accused No.1 - firm and confirmed the supply to M/s. E.Pharma; on 23.06.2014, 5 the complainant and CW-2 visited the office of the State Drugs Controller and requested for necessary assistance and co-operation with respect to investigation of subject drug. The learned Magistrate took cognizance of the aforesaid offences and issued summons to the petitioners-accused. Hence, this petition.
5. Learned counsel appearing for the petitioners submits that the shelf life of the subject drug had expired by the time it was sent to the Central Drugs Laboratory, Kolkata, for the purpose of re-analysis as prescribed under Section 25 of the Act. Hence, he submits that the petitioners-accused have lost a valuable right which is conferred under Section 25 of the Act. Thus, he places reliance on the decision of the Hon'ble Supreme Court in the case of MEDICAMEN BIOTECH LIMITED AND ANOTHER VS. RUBINA BOSE, DRUG INSPECTOR, reported in (2008) 7 SCC 196.
6. He further submits that the offences alleged in the complaint is for contravening Sections 18(a)(i) of the Act and the complaint filed after expiry of six months 6 from the date of cause of action is hit by Section 468(2) of the Code of Criminal Procedure.
7. On the other hand, learned High Court Government Pleader appearing for the respondent-State, submitted that the allegations made in the complaint clearly disclose that the petitioner has not only manufactured the subject Drug as "not of a standard drug" but also manufactured it as "a spurious drug"
which is punishable up to life imprisonment. Hence, he submits that the complaint filed by the respondent is not barred by limitation as specified under Section 468(2) of Cr.P.C.
8. I have considered the submissions made by the learned counsel for the parties.
9. Section 25 of the Act specifies that the Government Analyst to whom a sample of any drug has been submitted for test or analysis under Sub-Section (4) of Section 23 shall, deliver to the Drug Inspector submitting it a signed report in triplicate in the prescribed form. Sub-section (2) of Section 25 specifies that the inspector, on receipt thereof, shall deliver one copy of the 7 report to the person from whom the sample was taken; Sub-section (3) of Section 25 specifies that any document purporting to be a report signed by a government analyst under this Chapter shall be evidence of the facts stated therein; Sub-section (4) of Section 25 specifies that unless the sample has already been tested and analysed in the Central Drugs Laboratory, where a person has under Sub-section (3) notified his intention of adducing evidence in contravention of a government analyst's report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused: cause the sample of the drug produced before the Magistrate under Sub-Section (4) of Section 23 to be sent for test or analysis to the said laboratory.
10. In the present case, the sample of the subject drug was drawn on 10.12.2013 and the Government Analyst sent a report on 05.05.2014 declaring the subject drug as 'Not of Standard Quality'.
11. The Hon'ble Apex Court in the case of Medicamen Biotech Limited and Another has held that the report of the Government Analyst was not 8 conclusive and the accused had a valuable right conferred under Sub-Section (4) of Section 25 of the Act, to send the subject drug for analysis to the Central Laboratory of Kolkata.
12. In the present case, the shelf life of the subject drug had expired. The valuable right conferred under Sub-Section (4) of Section 25 of the Act, to the petitioners have been deprived. Hence, the cognizance taken by the learned Magistrate is vitiated since the petitioners-accused have been deprived of their valuable right conferred under Sub-Section (4) of Section 25 the Act for sending the subject drug for analysis with the Central Laboratory.
13. A perusal of the report submitted by the Government Analyst indicates that the subject drug was 'Not of Standard Quality' as defined under the Drugs and Cosmetics Act, 1940 and Rules thereunder. The report further indicates that the label on the subject drug as under:-
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Assay For Found/Tablet Label Claim/Tablet Cefixime 181.55 mg 200 mg Clavulanic acid Nil 125 mg
14. A reading of the report indicates that the subject drug has been declared as 'Not of Standard Quality', which is punishable under Section 18 (a)(i) of the Act; and the quantity of the substances found in the drug does not match the Label Claim Tablet, which would utmost amount to a misbranded drug as defined under Section 17 of the Act. The contravention of Section 17 and 18(a)(i) of the Act, is punishable under Section 27
(d) of the Act which prescribes that any contravening of Sections 17 and 18 of the Act shall be punishable with imprisonment for a term shall not be less than one year but which may extend to two years and with fine not less than twenty thousand rupees.
15. In the present case, the CW2 sent the ceased subject drug sample on 10.12.2013 and received the certificate of test or analysis from the government 10 analyst on 07.05.2014. The complainant filed the complaint on 25.03.2017 i.e., after a lapse of more than two years and three months from the date of the cause of action. Hence, the complaint filed is within three years from the date of the cause of action and is not barred by limitation.
16. In view of the above analysis, I am of the considered view that the petitioners have been deprived of their valuable right to send the subject drug for re- analysis as specified under Section 25(4) of the Act. Hence, the cognizance taken by the learned Magistrate stands vitiated. Accordingly, I pass the following:
ORDER i. Criminal petition is allowed.
ii. The impugned proceedings in Spl.C.No.48/2017 pending on the file of Principal District and Session Judge at Davanagere is herby quashed.
Sd/-
JUDGE rv