IN THE HIGH COURT OF KARNATAKA AT BENGALURU DATED THIS THE 18TH DAY OF JULY 2019 BEFORE THE HON’BLE MR. JUSTICE JOHN MICHAEL CUNHA CRIMINAL PETITION NO.4900 OF 2011 BETWEEN:
M/S. PILCO PHARMA PVT LTD 123/37, SARESH BAGH, KANPUR-08012 REPRESENTED BY ITS DIRECTOR S.K.RAIZADA ... PETITIONER (BY SRI: D PRABHAKAR, ADVOCATE) AND STATE AT THE INSTANCE OF DRUGS CONTROLLER CHITRADURGA CIRCLE, CHITRADURGA. ... RESPONDENT (BY SRI: VIJAYAKUMAR MAJAGE, ADDL. SPP) THIS CRL.P IS FILED U/S.482 CR.P.C PRAYING THAT THIS HON'BLE COURT MAY BE PLEASED TO QUASH THE PROCEEDINGS AGAINST THE PETRS. IN C.C.NO.1694/07 ON THE FILE OF THE PRL. C.J., (JR.DN.) AND JMFC, CHITRADURGA.
THIS CRL.P COMING ON FOR ORDERS THIS DAY, THE COURT MADE THE FOLLOWING:-
O R D E R Heard learned counsel for petitioner and the learned Additional SPP on I.A.1/2019 for recalling the order dated 7.6.2019 wherein the petition had been dismissed for non- prosecution.
For the reasons sated in the memorandum of facts, I.A.1/2019 is allowed. The order dated 7.6.2019 is recalled. Petition is restored to file.
2. Petitioner has called in question the legality of the prosecution instituted against him in C.C.No.1694/2007.
3. Heard learned counsel for the petitioner and learned Additional SPP for the respondent. Perused the records.
4. The main contention urged by the learned counsel for the petitioner is that the petitioner herein though sought to be prosecuted as the manufacturer of the offending drug, yet no portion of the sample as drawn from the Government Hospital has been sent to the petitioner herein in terms of Section 23(4) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as ‘the Act’ for brevity) and hence, prosecution of the petitioner is illegal. In support of his submission learned counsel has placed reliance on the following decisions :
i. State of Karnataka v. V.C. laboratories, 1975 Cri.
L.J. 332 (Karnataka);
ii. State of Maharashtra v. Shantilal Saremal, LAWS (BOM) 1999 22;
iii. Laborate Pharmaceuticals India Pvt. Ltd. And Ors. V. State of Tamil Nadu, Laws 2018 (15) SCC 93;
iv. State of Gujarat v. M/s Alpin Industries New Delhi and Ors., 2003 Cri.L.J. 329 v. Drugs Inspector, Central Drugs Standard Control Organisation (South) Zone, Madras-6 v. M/s. Modern Drugs and Anr. 1982 Cri.L.J. 2285 (para 23) vi. M/s Medicamen Biotech Ltd. And Anr. v. High Court of Delhi, AIR 2008 SC 1939.
5. Learned Additional SPP while defending the impugned action submitted that all the requisite formalities are duly complied with. The petitioner has not availed the opportunity by challenging the test report and hence, the petitioner is estopped from disputing the validity of the procedure followed by the Drug Inspector and thus sought to dismiss the petition.
6. I have considered the submissions and have perused the records.
7. There is no averment in the entire complaint that Section 23(4)(iii) of the Act has been complied. The averments in the complaint go to show that on 2.12.2003, the Assistant Drug Controller took sample of Ciprofloxacin eye/ear drops manufactured by the petitioner for test and analysis from the premises of District Hosptial, Chitradurga as per intimation in Form 17-A dated 2.12.2003. The test report in Form No.13 was received on 26.4.2004. CW2 issued one copy of the test report in Form-13 along with the letter dated 5.5.2014 to the District Surgeon, District Hospital, Chitradurga, as required under Section 25(2) and 25(4)(iii) of the Act and sent one copy of the test report in Form No.13 and sealed portion of the said drug to the Joint Director, Government Medical Store, Magadi road, Bengaluru. Further, it is averred that vide letter dated 7.5.2004 bearing No.DCD/ADC-CTG/HOSP/54/Test/03-04/46 under acknowledgment sent a Photostat copy of Form-13 to M/s.Pilco Pharma Pvt. Ltd. Kanpur and asked them to submit the following documents :-
1) Batch Manufacturing records of the said drug.
2) Test analysis reports of the finished product for the testing done in your labs.
3) Names and address of the manufacturing and analytical chemist responsible for manufacturing and testing of the said drug.
4) Certified copies of the licenses to manufacturer the said drug along with the renewal certificate.
5) Certified copy of the lift of drugs permitted to manufacturer;
6) Documents regarding certification of the manufacturing firm with the certificate of registrations as Pvt. Ltd. Company.
8. These averments make it evident that no sample of the drug drawn from the District Hospital Chitradurga was sent to the petitioner as required under Section 23(4) (iii) of the Act. In this context, it may be apposite to refer to the decision of the Hon’ble Supreme Court in Laborate Pharmaceuticals India Ltd. and Ors. vs. State of Tamil Nadu reported in (2018) 15 SCC 93 wherein the Hon’ble Supreme court considering the scope and amplitude of the aforesaid provisions in paragraph 7 has held as follows :-
“A reading of the provisions of Section 23(4) and 25 of the Act would indicate that in the present case the sample having been taken from the premises of the retailer had to be divided into four portions; one portion is required to be given to the retailer; one portion is required to be sent to the Government Analyst and one to the Court and the last one to the manufacturer whose name, particulars, etc. is disclosed under Section 18A of the Act. In the present case, admittedly, one part of the sample that was required to be sent to the appellant (manufacturer) under Section 23(4)(iii) of the Act was not sent. Instead, what was sent on 22nd March, 2012 was only the report of the Government Analyst. When the part of the sample was not seen to the manufacturer, the manufacturer could not have got the same analysed even if he wanted to do so and, therefore, it was not in a position to contest the findings of the Government Analyst. In the present case, the sample was sent to the appellant- manufacturer on 10th August, 2012 and on 13th September, 2012 the appellant had indicated its desire to have another part of the sample sent to the Central Laboratory for re-analysis. This was refused on the ground that the aforesaid request was made much after the stipulated period of 28 days provided for in Section 25(3) of the Act.”
9. In the light of the above factual and legal position and in view of the failure of the respondent to comply with the mandatory requirements of Section 23(4)(iii) of the Act, the impugned proceedings are vitiated and are liable to be quashed on that ground.
Accordingly, petition is allowed. The impugned proceedings are quashed insofar as the petitioner is concerned.
Sd/- JUDGE rs