Andhra Pradesh High Court - Amravati
Parenteral Surgicals Limited And 4 ... vs The State Of A.P.,Rep.,Pp on 4 June, 2019
Author: T. Rajani
Bench: T. Rajani
HIGH COURT OF ANDHRA PRADESH TUESDAY, THE FOURTH DAY OF JUNE TWO THOUSAND AND NINETEEN PRESENT THE HON'BLE SMT JUSTICE T. RAJANI CRIMINAL PETITION NO: 8871 OF 2018 KL Between: 1. Parenteral Suryicals Limited, Shri Ganesh Chambers, A.B.Road, Naviakha Crossing, Indore Dist. M.F. &. Nitin Gujrat, Director, M/s Parenteral surgicals Limited Shri Ganesh Chambers, A.B Road, Naviakha Crossing, Incore Dist., M. P. a. Mano Khandelwal, Director, M/s Parenteral Surgicals Limited Shri Ganesh Chambers, A.B.Road, Naviakha Crossing, indore Dist., M. P. 4 Pradeep Verma, Director, M/s Parenteral Surgicals Limited, Shri Ganesh Chambers, A.B. Road, Navlakha Crossing, Indore Dist, M. FP. 2. Sanjay Shah, Director, M/s Parenteral Surgicals Limited, Shri Ganesh Charnbers, A.B Road, Navlakha Crossing, Indore Dist., M. P .fetitioner/Accused Nos. 1 ta5 ANDB The State of Andhra Pradesh, Rep by its Public Prosecutor, High Court Building, Hyderabad. The Drug inspector Zone-1 Viayawada, Krishna District. . _Respondent/Complainant Petition under Section 482 of Cr.P.C praying that in the circumstances stated in the Memorandum of Grounds filed in support of the Criminal Petition, the High Court may be pleased to Quash the camplaint in SC Spl. No. 32 of 2018 on the file af the iff Additional Oisirict and Sessions Judqe, Viiayawada, Krishna District in exercise of inherent power of u/sec. 482 Cr.P.C and pass. CRLPMP. NO: 8917 OF 2015 Petition under Section 462 of Cr.P.O praying that in the circumstances stated inthe atidavit filed in Support of the petition, the High Court may be pleased to stay all further SC Spt. Noa, 32 of 2018 on the file of the il Additional District and Sessions Judge, Viayawada, Krishna District pending this Cri.P. pending disposal of CRLP Seay of 2015, an the file af the High Court. {case number and Court name is amended as per Gourt Order dt: 01/04/2019 in 1A. No, 2/2079 in CrLP. No. 8871/2018} The Fetition coming on for hearing, upon perusing the Petition and Memorandum of Grounds and upon hearing the arguments of Sri R. Raghunandan, Serdor Counsel for Sri S. Ganesh, Advocate for the Petitioners and of the Public Froasecutor on behall of the Respondent. The Court made the following: ORDER Lenenrnre ton SMT PUSTICE T.RATANI CRIMINAL PETTION No.8871 of 2015 IUDGMENT: This petition is filed seeking for quash of the proceedings against the petitioners, who are Al to AS, in SC SPL. No.32 af 2018 on the fle of the court of TT Additional District & Sessions Judge, Vuayawada, Krishna District. 2. Heard 5n R.Raghunandan, learned senior counsel appearing for the petitioners and the Public Prosecutor appearing for the respondent. Law The complaint fled against the petitioners under Section 32 ofthe Drugs and Cosmetics Act, 1940 and the Rules, 1945 (for short. "the Act" and "the Rules" respectively), is with the following facts, in brief The complainant, who was appointed as Drugs Inspector, mspected Al Company-M/s.Parenteral Surgicals Limited, which had loan heence in Form 20A, valid upto 13.05.2014. A2 to AS are the Board of Directors for manufacture of subjected drug along with other drugs manufactured by Al Company. All of them are responsible for the day to day activities of Al Company. During inspection, the complainant picked up seven types of drugs for testing/analysis by complying with the prescribed procedure. He sent the seized samples to the Government Analyst Drugs Control Laboratory, Hyderabad and the report of the analysts, declaring the said drug as not of standard quality, stating that the sample does not meet 1.P. requirements in respect of description of the sample under parental preparation, was received on 31.05.2011. On 01.06.2011, the complamant addressed a letter to LW3, enclosing a copy of the analytical report. LW3 gave a reply on 04.06.2011 to LWI1 submitting two stock transfer notes of the subject drug. The complainant addressed a letter dated 06.06.2011 under Sections ISA and 18B, along with a copy of analytical report in Form-{3 dated 26.05.2011, enclosing one of the sealed sarmmple portion of the subject drug and sent the same by registered post to Al company. On 12.07.2011, investigation was taken up by LWe. On 25.07.2011, LW2 addressed a letter to the superintendent of head post office, Vijayawada, for non-receipt of acknowledgment card. The receipt of the said notice copy, Form 13 and sample portion by Al Company was confirmed by the reply of the superintendent of pastal department. On 14.09.2011, LW2 inspected Al Company and collected the required self attested docurnents and relevant information for the subject drug. On £8.06.2012, the complainant addressed a letter to AL Company requesting about any change in the constitution of Directors asking them to inform the same changes within seven days of the date of receipt of the letter, but no reply was received from Al Company. Considering that Al to AS violated Section 18(a)(i) of the Act, the complaint was laid seeking for punishment under Section 27(d) ofthe said Act. t. The grounds on which the petitioners now come before this caurt seeking for quash are that, the company is manufacturing drugs + 2 strictly as per WHO-GMP & revised schedule 'M' requirements and is one af the established manufactures of the Pharma products in the country. The manutacturing process is strictly in accordance with the provisions of the revised schedule M requirements and with in-process contrat and checks at all the stages of manufacturing. After completion of production, each batch is tested. The petitioner company reviewed the batch manufacturing record of above referred batch and found the sameé to be of standard quality as per the Quality Control Analytical report dated 26.05.2011 of above referred batch and found that it complies with all parameters as per the specifications. The report shows that only four bottles of the subject drug were taken for testmg which were found to be having particles and not of standard quality due to failure in description. The batch is of standard quality and only four bottles developed particles due to mishandling or improper storage conditions and the contention of the petitioner's counsel is substantiated from the said fact that the sample portion supplied to the applicant company was also in leakage condition. The said fact was brought to the notice and accepted by the complainant Drug Inspector and the same was acknowledged. The failure of the sample portion was mainly due to improper storage or mishandling during the transportation, leading to cracks and it cannot be said to be a ground for failure of the whole batch. The petitioners also relied on clauses 3 and 4 of guidelines, which specifies that in case particular drugs manufactured by licenced manufacturer under a valid licence is found to be grossly sub-standard, only administrative measures are to be taken and the weapon of Prosecution is to be used only when administrative measures fail to meet the ends of justice. The report of the Government analyst does not specity as to what foreign matter was detected. The mere presence of particles does not imply that the particles in the medicines were of CXWARCOUS substance and not of the requisite contents thereof. The subject drug was manufactured in the month of January, 2011 with expiry in the month of December, 2013. A copy of the subject analytical report was received by the complainant on 31.05.2011. The complainant vide letter, dated 05.06.2011 informed Al company that the subject drug has been declared to be not of standard q uality and called for certain documents and information. tn response, Al company vide letter, dated 04.07.2011, challenged the test report and once again carried out the hecessary tests on the sample portion available with it, as the sample portion supplied by the complainant was damaged and was in leaking condition. By sending the reply, dated 04.07. 2011, Al company had appropriately challenged the subject rest reported dated 26.05 2011. However, the complainant, for the reasons best Known to him did not send the subject drug for retesting to the Central Drugs Laboratory as mandatorily required under Section 25 3) of the Act. Ss, Though all the above grounds were mentioned in the grounds af the petition, at the time of arguments, the counsel for the petitioners stressed only on the aspect of the failure of the complainant to send the second sample for analysis within the prescribed period, before the expiry date of the drug and hence, the valuable right given to the petitioners under Section 25(3) of the Act stands defeated. In order to appreciate the said argument, we need to have a glance at Section 2503) of the Act, which is extracted hereunder for ready re eTENCE: "Cry Any document purporting to be a repor. signed by 4 Government Analyst under this Chapter shall be ev idence of the facts stated therein, and such evidence shall be conclusive unfess the person fom whom the sample was taken or the persan whose name, address and other particulars have been disclosed under Section ISA has, within twenty cight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence im controversion of the report." sa 6. it is clear from the above provision that within 28 days of the receipt of the copy of the report, the person receiving the copy should intimate that he intends to adduce evidence In contraversion 0 F the report. [t would be beneficial to read through clause (4) also which runs as under: "(4) Uniess the sample has already been tested or analysed im the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion 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 or cosmetic produced before the Magistrate uicder sub-Section (4) of Section 23 ta be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by or under the authority of, the Director of the Central Drugs LaboOratory the result thereof, and such report shall be conclusive 7. By reading clause (4) of Section 25. what this court can understand is that the pre-condition for sending the sample for second analysis is what is said under clause (3) of Seetion 25, which is that the Person receiving the copy of the report has to notify in writing to the inspector or the court, that he intends to adduce evidence jin contraversion of the report. Tn this case, after receiving the report copy, the petitioners have sent an intimation to the complainant, which is dated 09.07.2011. A reading of the copy of the said fetter Rled. before this court shows that the petitioners have only explained the reason for the contamination, which resulted in the report coming out with the finding that the sample is contaminated, stating that it might be only due to invisible damage to bottles in transit or storage. It does not anywhere question the analyst report, either with regard to the genuineness or with regard to the correctness. When there is no attack made on the report on the said aspects, the report stands to be conclusive. As specitied in Section 25(3) of the Act, no intention to adduce evidence in contraversion of the report can be gathered from a letter, which explains only the reason for the report coming out in the negative. The letter, unless it specifies, either impliedly or expressly, mo that the petitioners intend to adduce evidence in contraversion of the report, cannot be construed as a notification made in comphance of Section 25(3), that he intends to adduce evidence in contraversion of the report. When oo such intention can be gathered by the court, the obligation laid on the court to send the sample on its own or at the request of the complainant or the accused, for second sampling, does not come into operation. 8. The ruling relied upon by the petitioners' counsel reported in ANOTHER ' at paragraph 20 held as under: "20, In the face of the language ernployed in Section 24f4) of the Act, the act of the accused notifying in writing its intention to adduce evidence in controversion of the report in our opinion shall give right to the accused and would be sufficient to clothe the Magistrate with the Jurisdiction to send the sample to the Central Insecticides Laboratory for analysis and it is not required to state that it tends to get the sample analysed from the Central Insecticides Laboratory. True it is that report of the Insecticide Analyst can be challenged on various grounds but the accused cannot be compelled to disclose those grounds and expose his defence and he is required only to natify in writing hus intention to adduce evidence in controversion. The moment it is done, the conclusive evidentiary value of the report gets denuded and the statutory right to get the sample tested and analysed by the Central Insecticides Laboratory gets fructified." 9. There is no quarrel with the said finding. The petitioners cannot be compelled to disclose the grounds on which they seek to contravert the report, but in the considered opinion of this court the letter should be as explicit as to give an understanding to the court that he intends to adduce evidence in contraversion of the said report. In this case no such intention can be gathered from the letter addressed by the petitioners to the Director General, Dru es Control Adm inistration, Hyderabad, for the reasons already mentioned in the afore-ciscussed paragraphs. a0 1 FSCO 734 wor GEE whiny, cen Hence, in view of the above, this court is of the considered opmion that on the ground that the second sampling was not done, the proceedings against the petitioners cannot be quashed. id, With the above observations, the Criminal Petition js dismissed. Interim Slay granted by this court, dated 08.03.2019 shall stand vacated, As a sequel, the miscellaneous applications pending, if any, shall stand closed. vo csusesssessuunsannnevnneten SD/- K. JAGAN MOHAN ASSISTANT REGISTRAR TRUE COPYI/ jue SECTION OFFICER [One Fair Copy to the Hon'ble Smt Justice T, Ralani, For her Lordships Kind Perusal] To, 4. The til Additional District and Sessions Judge, Vijayawada, Krishna District. 2. The Drug Inspector £one-1 Vijayawada, Krishna District. 3. BLR. Copies. 4. The Under Secretary, Union of India, Ministry of Law, Justice and Company Attairs, New Delhi}. oS. The Secretary, AP. Advocates Association Library, High Court Buildings, A.P. 6. One CC to SRLS. GANESH Advocate [OPUC] ID wf . Two CCs to the PUBLIC PROSECUTOR, High Court of ALP. [OUT] 8. Two CD Copies Chp HIGH COURT DATED:04/06/2019 ORDER
CRLP.NG.BSTt of 2015 DISMISSING THE CRIMINAL PETITION Ritigapgit santas ceive ben eine te