Karnataka High Court
M/S Stadmed Private Ltd vs Union Of India on 11 July, 2022
Author: Hemant Chandangoudar
Bench: Hemant Chandangoudar
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IN THE HIGH COURT OF KARNATAKA AT BENGALURU
DATED THIS THE 11TH DAY OF JULY, 2022
BEFORE
THE HON'BLE MR. JUSTICE HEMANT CHANDANGOUDAR
CRIMINAL PETITION NO.891/2017
BETWEEN:
1. M/S STADMED PRIVATE LTD.,
NO.15, JAWPORE ROAD,
KOLKATA-70074,
REPRESENTED BY ITS DIVISIONAL MANAGER,
(INSTITUTIONS AND GENERIC SALES),
SRI PRADIP KUMAR BHATTACHERJEE.
2. SRI AMIT RAY
AGED ABOUT 61 YEARS,
S/O LATE SRI GOUR GOPAL SAHA,
DIRECTOR OF M/S STADMED PRIVATE LTD.,
NO.84, CHORINGHEE ROAD,
KOLKATA-700020.
3. SRI ASHISH PAL
S/O LATE SRI BANSHI BADAN,
TABLET PRODUCTION DEPARTMENT,
M/S STADMED PRIVATE LTD.,
R/AT NO.80/2,
NEOGI PARA ROAD,
KOLKATA-700026.
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4. SRI SUDIPTA GANGOPADHYAY
S/O LATE SRI GANESH CHANDRA GANGOPADHYAY,
DEPUTY MANAGER,
QUALITY CONTROL DEPARTMENT,
M/S STADMED PRIVATE LTD.,
R/AT NO.71, GANGAPURI,
P.O. PURBA PUTIARY,
KOLKATA-700093.
...PETITIONERS
(BY SRI DESU REDDY G., ADVOCATE)
AND:
UNION OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
O/O THE CENTRAL DRUGS STANDARD CONTROL
ORGANIZATION,
DIRECTORATE GENERAL OF HEALTH SERVICES,
2ND FLOOR, O/O DRUGS CONTROLLER FOR THE
STATE OF KARNATAKA,
PLACE ROAD,
BENGALURU-560 001,
REPRESENTED BY DRUGS INSPECTOR,
CDSCO, SUBZONE,
BANGALORE-560 001.
...RESPONDENT
(BY SRI GOWTHAM DEV C. ULLAL, ADVOCATE)
THIS CRIMINAL PETITION IS FILED UNDER SECTION 482
OF THE CODE OF CRIMINAL PROCEDURE, PRAYING TO QUASH
THE ENTIRE PROCEEDINGS PENDING ON THE FILE OF
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PRESIDING OFFICER SPECIAL COURT FOR (ECONOMIC
OFFENCES), BANGALORE IN C.C.NO.121/2016.
THIS CRIMINAL PETITION COMING ON FOR ADMISSION
THIS DAY, THE COURT MADE THE FOLLOWING:
ORDER
Private complaint under Section 200 of Cr.P.C. was filed by the respondent for contravention of Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 (for short "Drugs Act") punishable under Section 27(d) of the said Act, alleging that the subject drug which was manufactured by the petitioner was sent by the drug inspector concerned to the Government analyst for analysis in Form-No.13 as specified under Rule 46 of the Rules. The Government analyst submitted a report dated 22.1.2014, declaring that the subject drug manufactured by the petitioners- accused as not of the standard quality and the said report was received by the drug inspector concerned on 31.1.2014.
2. The learned Magistrate took cognizance of the aforesaid offence and issued summons. Taking exception of the same, this petition is filed.
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3. Learned counsel appearing for the petitioners- accused submits that the subject drug was manufactured by the petitioners-accused in the month of February 2011 and its shelf life was valid till January 2014. He further submits that the drug inspector concerned served notice to the petitioners-accused with a copy of the test report in Form No.13 after the expiry of the shelf life of the subject drug had expired, thus depriving the petitioners-accused of their valuable rights to send the subject drug for re-analysis with the Central Drugs Laboratory as specified under section 25 (4) of the Drugs Act. In support, reliance is placed on the decision of the Apex Court, in the case of Medicamen Biotech Limited and another vs. Rubina Bose, Drug Inspector, reported in (2008) 7 SCC 196.
4. On the other hand, learned counsel appearing for the respondent submits that the subject drug was sent to Central Drug Laboratory and the report submitted by the said laboratory is conclusive and in the absence of any prejudice caused to the petitioners-accused, the petitioners cannot be said to have been deprived of their valuable rights for sending the subject drug for 5 re-analysis as specified under Section 25(4) of the Drugs Act. In support, the learned counsel places reliance on the decision of the Hon'ble High Court of Himachal Pradesh in the case of M/s Marc Laboratories Limited & others -Vs- Union of India in Cr.MMO No.43/2019, disposed of on 30.09.2019.
5. I have examined the submissions made by the learned counsel appearing for the parties.
6. The subject drug was manufactured in the month of February 2011 and the shelf life was valid for a period of three years. The sample of the subject drug was drawn from the manufacturing unit of the petitioners-accused on 22.6.2012 and it was sent for analysis to the Government analyst in Form No.13. The Government analyst by report dated 22.01.2014 declared the subject drug as not of standard quality. The report was received by the Drug inspector on 31.1.2014 and by notice dated 23.06.2014, the report of the Government analyst was furnished to the petitioners-accused. The complaint was filed on 4.5.2016 by which time the shelf life of the subject drug had expired.
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7. Section 25 (4) of the Drugs Act specifies that unless the sample has already been tested or analyzed in the Central Drugs Laboratory, the learned Magistrate suo-moto or at the request of the accused, cause the sample of the drug produced before him to be sent for test or analysis to the said Laboratory which shall make the test or analysis and report in writing. The Hon'ble Apex Court in the case of Medicamen Biotech Limited and another (supra) at para 19 has held as follows:
" 18. In Unique Farmaid case [(1999) 8 SCC 190 :
1999 SCC (Cri) 1404] which was a case under the Insecticides Act which has provisions analogous to Section 25(4) of the Act, the Court found that the accused had indeed made a request to the Inspector for sending the sample for retesting within the prescribed time-limit and as this request had not been accepted an important right given to an accused had been rendered ineffective on which the proceedings could be quashed. This is what the Court had to say: (SCC p. 197, paras 12-
13) "12. It cannot be gainsaid, therefore, that the respondents in these appeals have been deprived of their valuable right to have the sample tested from the Central Insecticides Laboratory under sub-section (4) of Section 24 of the Act.
Under sub-section (3) of Section 24 report signed by the Insecticide Analyst shall be evidence of the facts stated therein and shall be conclusive evidence against the accused only if the accused do not, within 28 days of the receipt of the report, notify in writing to the Insecticides Inspector or the court before which proceedings are pending that 7 they intend to adduce evidence to controvert the report. In the present cases the Insecticides Inspector was notified that the accused intended to adduce evidence to controvert the report. By the time the matter reached the court, the shelf life of the sample had already expired and no purpose would have been served informing the court of such an intention. The report of the Insecticide Analyst was, therefore, not conclusive. A valuable right had been conferred on the accused to have the sample tested from the Central Insecticides Laboratory and in the circumstances of the case the accused have been deprived of that right, thus, prejudicing them in their defence.
13. In these circumstances, the High Court was right in concluding that it will be an abuse of process of court if the prosecution is continued against the respondents, the accused persons. The High Court rightly quashed the criminal complaint. We uphold the order of the High Court and would dismiss the appeals."
We find that this judgment helps the case of the appellant rather than that of the respondent because in spite of two communications from the appellant that it intended to adduce evidence to controvert the facts given in the report of the Government Analyst, the fourth sample with the Magistrate had not been sent for reanalysis. The observations in Amery Pharmaceuticals case [(2001) 4 SCC 382 : 2001 SCC (Cri) 724] are also to the same effect. We find that the aforesaid interpretation supports the case of the appellants inasmuch they had been deprived of the right to have the fourth sample tested from the Central Drugs Laboratory. It is also clear that the complaint had been filed on 2-7-2002 which is about a month short of the expiry date of the drug and as such had the appellant-accused appeared before the Magistrate even on 2-7-2002 it would have been well- nigh impossible to get the sample tested before its expiry.
19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before 8 us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9-5-2005. This is begging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for retesting of the drug had been made by the appellant in August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the complaint could not have been filed earlier and the fourth sample sent for retesting well within time. We are, therefore, of the opinion that the facts of the case suggest that the appellants have been deprived of a valuable right under Sections 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them."
8. In the present case, the report of the Government analyst was served on the petitioners-accused or produced before the learned Magistrate, after the shelf life of the subject drug had expired, thus depriving the valuable rights of the petitioners-accused to send the subject drug for re-analysis since the report submitted by the Government analyst is not conclusive as specified under Section 25 (3) of the Drugs Act.
9. Reliance placed by the learned counsel appearing for the respondent on the decision of the Hon'ble High Court of 9 Himachal Pradesh, in the case of M/s Marc Laboratories supra is not applicable to the fact of the case, since, the subject drug was sent to the Government analyst for analysis and not to the Central Government Drugs Laboratory which was the case on hand before the Hon'ble High Court of Himachal Pradesh.
10. Accordingly, I pass the following:
ORDER
i) Criminal petition is allowed.
ii) Impugned proceedings in C.C.No.121/2016, pending on the file of the Special Court for Economic Offences, Bangalore City, is hereby quashed.
Sd/-
JUDGE HR