1 APHC010486602008 IN THE HIGH COURT OF ANDHRA PRADESH AT AMARAVATI (Special Original Jurisdiction) [3560] TUESDAY,THE THIRTY FIRST DAY OF MARCH TWO THOUSAND AND TWENTY SIX PRESENT THE HONOURABLE SRI JUSTICE SUBHENDU SAMANTA CRIMINAL REVISION CASE NO: 1680/2008 Between: 1. M/S. VAPI CARE PHARMA PVT.LTD., & 2 OTHERS, PLOT NO.225/3, GIDC, NEAR MORARJI CIRCLE, VAPI - 396 195. 2. KAMAL J.SHAH,, DIRECTOR M/S. VAPI CARE PHARMA PVT. LTD., PLOT NO.225/3, GIDC, NEAR MORARJI CIRCLE, VAPI - 396 195. 3. DR.AJAY ACHARYA,, DIRECTOR M/S. VAPI CARE PHARMA PVT. LTD., PLOT NO.225/3, GIDC, NEAR MORARJI CIRCLE, VAPI - 396 195. ...PETITIONER(S) AND 1. THE STATE OF A P, Through the Drugs Inspector, Tenali, Guntur Dist., Rep. by the Public Prosecutor, High Court of A.P., Hyderabad. ...RESPONDENT Revision filed under Section 397/401 of CrPC praying that in the circumstances stated in the affidavit filed in support of the CriminalRevisionCase, the High Court may be pleased topresent this memorandum of grounds of Crl.R.C., before this Hon'ble Court against the Judgment dated 17.11.08 passed in Crl.A.No.216 of 2007 on the file of the Court of the I Addl. Dist. & Sessions Judge, Guntur, confirming the Judgment dated 28.06.07 passed in C.C.No.226 of 2007 on the file of the Court of the I Addl. Judl. First Class Magistrate, Tenali. 2 IA NO: 1 OF 2008(CRLRCMP 2309 OF 2008 Petition under Section 151 CPC praying that in the circumstances stated in the affidavit filed in support of the petition, the High Court may be pleased to release the petitioners on bail by suspending the operation of the Judgment dated 17.11.08 passed in Crl.A.No.216 of 2007 on the file of the Court of the I Addl. Dist. & Sessions Judge, Guntur, pending disposal of the Crl.R.C. IA NO: 2 OF 2008(CRLRCMP 2346 OF 2008 Petition under Section 151 CPC praying that in the circumstances stated in the affidavit filed in support of the petition, the High Court may be pleased to release the petitioner herein on bail by suspending the operation of the Judgment dated 17.11.2008 passed in Crl.A.No. 216 of 2007 on the file of the Court of I Addl. District and Sessions Judge, Guntur, Guntur Distirct, pending disposal of the above Criminal Revision Case IA NO: 1 OF 2009(CRLRCMP 1398 OF 2009 Petition under Section 151 CPC praying that in the circumstances stated in the affidavit filed in support of the petition, the High Court may be pleased IA NO: 1 OF 2025 Petition under Section 151 CPC praying that in the circumstances stated in the affidavit filed in support of the petition, the High Court may be pleased to recall NBW dated 18.02.2025 issued by this Hon’ble Court in CRLRC. No. 1680/2008 pending before this Hon’ble Court IA NO: 2 OF 2025 Petition under Section 151 CPC praying that in the circumstances stated in the affidavit filed in support of the petition, the High Court may be pleased to recall NBW dated 18.02.2025 issued by this Hon’ble Court in CRLRC. No. 1680/2008 pending before this Hon’ble Court Counsel for the Petitioner(S): 1. AISHWARYA NAGULA 2. M JAGADISH KUMAR Counsel for the Respondent: 1. PUBLIC PROSECUTOR 3 THE HONOURABLE SRI JUSTICE SUBHENDU SAMANTA CRIMINAL REVISION CASE NO: 1680/2008 The Court made the following: The instant Criminal Revision Case has been preferred against the Judgment dated 17.11.2008 passed by the learned I Additional District & Sessions Judge, Guntur confirming the Judgment dated 28.06.2007 passed in C.C.No.226 of 2004 by the learned I Additional Judicial Magistrate of I Class, Tenali wherein and where under present petitioners were found guilty for the offence punishable under section 27(d) of the Drugs & Cosmetics Act, 1940 (‘said Act’ in short) for contravening section 18(a) (1) r/w Section 16 punishable under Section 27(d) of the Drugs & Cosmetics Act, 1940. 2. Learned counsel for the petitioner at the outset submits that the impugned order of conviction and sentence is illegal as PW.1 is not a Gazetted inspector or authorized person to make a seizure in respect of the alleged offence under said Act. He further submits that the mandatory provisions under section 20, 21, 22, 23(4) (iii), 23(6), 25(3) (4) (5) Rule 45, 76 of Drugs & Cosmetics Rules, 1945 are not properly followed by prosecution. It is further argued that the offence punishable under the Drugs & Cosmetics Act, 1940 required very technical proof of the matter. In this case, the technicalities envisaged under the provisions of law has not been properly complied with by the prosecution and thereby conviction against the present petitioner is liable to be set aside. 4 3. It is further argued that the petitioner No.1 is a company, petitioner Nos.2 and 3 are the directors, they are not directly involved regarding day to day business of the company, even if, any offences were committed, the present petitioners cannot be liable for the said offences, unless it has been specifically proved regarding their involvement in commission of the said offences. 4. It is further argued that the drug which was seized as date of expiry on June, 2003 but the complaint has been lodged on June, 2004 after expiry period of the said drug. It is further argued that in terms of section 25 of the Drugs & Cosmetics Act, 1940. Reports of the Government Analyst was sought to be distinguished by the company within 28 days from the date of receipt of the report. But the said challenge by the company was not adopted and the company has no option to contradict the report of Government Analyst. It is further submitted prosecution does not follow mandatory provisions of Section 25 of the said Act, 1940, thus the conviction and sentence passed by the learned Trial Court, confirmed by the learned Appellate Court required to be set aside. 5. Sri K.Sandeep, learned Assistant Public Prosecutor submits that though in this type case there are some technicalities which required to be complied with by the prosecution but the prosecution has successfully proved against the present petitioner beyond all reasonable doubt. He further submits, learned Trial Court has carefully gone through the evidence on record and is of view that the present petitioners are guilty for the offence punishable under 5 Section 27(d) of the Drugs & Cosmetics Act, 1940. He further submits that during the Appeal, some points are raised the learned Appellate Court has gone through each and every point and is of opinion that conviction is maintainable. Hence, there are no merits to entertain the Revision. 6. Heard the learned counsel for the petitioner. Perused the case record. It appears that on 08.10.2002, PW.1, who appears to be Drugs Inspector, Tenali took a sample of the drug ‘Versazyme Digestive Engimes Liquid” Pineapple flavour with batch No.9701084 with manufacturing date as July, 2002 and expiry date as June, 2003, manufactured by M/s Vapi Care Pharma Private Limited, marketed by M/s Ranboxy Laboratories Limited, New Delhi for the purpose of analysis vide Form No.17 dated 08.07.2002 from M/s Sri Siva Sai Medical Agencies, Tenali in the presence of its proprietor by following due procedure. It appears that one of the samples of the drug was sent to the Government Analyst, who declared that the drug was not of standard qualities vide report in Form-13 (Ex.P6) as it does not comply for the assay of pepsin as per IP96. 7. It has been alleged before this Court that PW.1 was not the Gazetted Drug Inspector, Tenali at the material point of time. The seizure was effected on 08.10.2002. One Gazette Notification of Andhra Pradesh Government dated 27.02.1992 was placed on record by the learned Trial Court as Ex.P39, which discloses the name of the Gazetted Inspector wherein and where under EX.P39 of Drugs and Cosmetics Act, 1940 the State appointed as many as 6 eight (08) persons as Drug Inspector in the State of Andhra Pradesh as follows: 1. Anjum Abida 2. B.Venkateswarlu. 3. M.Pandu Ranga Prasad, 4. M.Venkata Ramana Reddy. 5. P.Venkateswarlu. 6. P.Veer Raju. 7. S.Vijaya Kumar 8. A.Visala. 1 The name of PW.1 is not appearing as Drug Inspector under the said Gazette Notification. 8. Section 21 of the Drugs and Cosmetics Act, 1940 provided wherein and where under Central Government or State Government shall issue notification to appoint a person having prescribed qualifications to be the inspector for specific areas as may be assigned by the State Government for the purpose of this Act. Section 21 of the Drugs and Cosmetics Act, 1940 read as [21. Inspectors.--(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be. 7 (2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or 2[classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed. (3) No person who has any financial interest 3[in the import, manufacture or sale of drugs or cosmetics] shall be appointed to be an Inspector under this section. (4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such authority 4[having the prescribed qualifications, as the Government appointing him may specify in this behalf.] 9. It is argued that PW1, who seized drugs in this case is not a Gezetted Inspector, in terms of Section 21 of Drugs and Cosmetics Act, 1940.This issue has time and again decided by Hon’ble Supreme Court and different High Courts amongst which the learned counsel for the petitioner has cited some decisions namely (i) Gaba Pharmacuticals Vs State of Andhra Pradesh1, (ii) Jhonson & Jhonson Ltd, Himachal Pradesh and another Vs. State of Andhra Pradesh 2 and also before the Hon’ble Supreme Court in Chennakesava Bandage Vs State of Andhra Pradesh3. 10. On thorough perusal of the above said authorities, it appears that this Court as well as the Hon’ble Supreme Court is in consonance of the directives of Section 21 of the Drugs and Cosmetics Act, 1940 is of view that it is a mandatory, the Drug Inspector, who lift the Drug for analysis must be a person under Gazette Notification. Before, the Hon’ble Supreme Court in Chennakesava’s case, the prosecution has not placed any notification. But in 1 2006 Law suit (Hyd)2 2 2015 (2) ALD (Crl.) 457 3 2010 1 ALD(Crl) 24. 8 this case the notification has been marked, the name of PW1 is not appearing. Thus it goes to show that the prosecution failed to comply with the mandatory provisions of Section 21 of Drugs and Cosmetics Act, 1940. It has been rightly pointed out by the learned Counsel for the petitioner that the person, who lift the samples from M/s Sri Siva Sai Medical Agencies, Tenali has no authority to initiate the prosecution or seize the samples from the said area. The directives of under Section 21 of the Drugs and Cosmetics Act, 1940 is very specific, the Drug Inspector must have been notified by the Central or State Governments in dealing with the Drugs and Cosmetics and other powers invited their under as per provisions of Section 22 of the said Act. Unless and until a person was appointed or notified under the Gazette of State or Central Governments under Section 21 of the said Act, such person has no power to act upon as per provisions of the Section 22 of the said Act. The powers of Drug Inspector has been notified under section 22 of the said Act, wherein the Gazetted person has authority to search. In this particular case, PW.1 admittedly not a Gazetted Drugs Inspector, who lift the drugs from the particular medicines and initiated for analysis to Government analyst. 11. In view of the fact mentioned above, in my view, the learned Trail court as well as learned Appellate Court has misread the provisions and directives of Section 21 and 22 of Drugs and Cosmetics Act, 1940. Thereby, lifting of drugs and initiation of procedure of seizure affected by PW1 appears to be faulty one. The learned Appellate Court as well as learned Trail Court should have considered the matter according to the directives of the statuette but 9 they have not followed the directives. Accordingly, the order of conviction and sentence appears to be defective against the present petitioners. 12. Another point was raised by the learned counsel for the petitioner regarding compliance of Section 23 (4) of the Drugs and Cosmetics Act, 1940. It is argued that PW1 has not complied with the mandatory provisions under Section 23(4) of the said Act. Thereby, the initiation of prosecution and order of conviction and sentence is liable to be set aside. Section 23 (4) of the Drugs and Cosmetics Act, 1940. The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows: - (i) one portion or container he shall forthwith send to the Government Analyst for test or analysis; (ії) the second he shall produce to the court before which proceedings, if any, are instituted in respect of the drug or cosmetic; and (ili) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18A. 13. On plain perusal of the provisions of section 23 of the Drugs and Cosmetics Act, 1940, it appears that this provision laid down the procedure of Inspector who lift the sample of the drug or cosmetics and what are the requirement to be carried out by the Inspector. 10 14. According to the section 23(4) Drugs and Cosmetics Act, 1940, the Inspector who takes the sample from the company or the seller shall divide it into three portions. First portion shall be sent to the Government Analyst for test of analysis, second portion shall be produced before the Court before whom the proceedings are instituted in respect of the Drug or cosmetic and third portion shall be forwarded to the persons whose name, address and other particulars have been disclosed in the drug under Section 18A of the said Act. 15. In this particular case, the Inspector-PW.1 has send one portion of container to the Government Analyst for test, the rest two portions were not forwarded as per directives of the Section 23(4)(2)(3) of the said Act. 16. This issue was raised before the Hon’ble Supreme Court in Laborate Pharmaceuticals India Ltd and others Vs. State of Tamilnadu reported in 2017 Supreme (SC) 827. On perusal of the directives of the said authority, it appears that the Hon’ble Apex Court has quashed the Criminal proceedings against the manufacturer, for violation of the provisions of Section 23(4) and 25 of the said Act. Under Section 23(4) of the Drugs and Cosmetics Act,1940, samples has to be forwarded one portion to Government Analyst, one portion to the Court and last one to the manufacturer. In this case, the same was not forwarded. 17. Furthermore, when the report of the Government Analyst was forwarded to the present petitioners by virtue of a specific letter dated 23.05.2003. 11 Petitioner intended to advertence evidence in contravention of the report as provided under Section 25(3) of the Act within the stipulated period of 28 days. But the prosecution has not forwarded the said samples for reverification. 18. Instead of forwarding the samples, the Drug Inspector, Tenali has issued a Phonogram dated 07.06.2003 contending interalia that petitioner may ask for the sample from the Magistrate Court. It appears that the date of expiry of the drug was June, 2003.But the complaint was lodged before the court only on 29.06.2004. On analyzing the entire fact, it appears that the present petitioner had no scope to reverify the drug, which was seized by PW.1 in terms of Section 25(3) of the Drugs and Cosmetics Act, 1940. Accordingly, as per the view of the Hon’ble Apex Court (supra), the valuable right of the petitioner was violated for want of supply of the report of the Government Analyst, which is contrary to law. 19. On perusal of the impugned order of the learned Appellate Court, it appears that the learned Appellate Court is of view that phonogram was issued in June, 2003, the appellant should have taken proper steps to verify the sample. Thus, the learned Appellate Court is of opinion that there was no violation under Section 25(3) of the Drugs and Cosmetics Act, 1940. Appellate Court further opined that the present petitioners deliberately allowed the expiry of the sample. 20. In the entire facts and circumstances, it appears that it is the directives of the provisions under Section 23 (4) of the Drugs and Cosmetics Act, 1940 12 that the drugs, so collected has to be separated in three portions, in this particular case, one portion was sent to Government Analyst and rest two portions was not forwarded through the present petitioners instead they have forwarded to PW.2 and PW.4, who admittedly at the seller of drugs but not manufacturers. 21. In terms of Section 25 (3) it is the directives of the said Act that the person under accusation of this Act has to be given proper opportunity to contrary the report of the Government. In view of such, section 25(3) of the said Act has provided a time bound procedure how the report of Government Analyst can be contradicted. In this particular case, in terms of Ex.P23,(Reply dated 23.05.2003), it appears that the petitioners being manufacturers has received the report on 06.05.2003. They forwarded letter challenging the report to reverify the sample on 23.05.2003 within stipulated period of 28 days. The Drug Inspector has received letter dated 06.06.2003, on the next day ie., 17.06.2003 instead of forwarding the sample, they issued a phonogram to the petitioners contending interalia that they have submitted the portion to the Court and instructed him to approach the court for the sample for analysis. It is the specific direction of the code under Section 25(3) of the Said Act, that after receiving such communication for challenging the said report of Government Analyst, the Drug Inspector shall forward the same to the manufacturer. But in this particular case the Drug Inspector instructed the petitioner to approach the Court. Admittedly, the prosecution has stated by virtue of written complaint dated 29.06.2004 by PW.7. Consequent thereto, 13 there are no scope for the present petitioners to collect or reanalyze the report from the court earlier than 29.06.2004. 22. Thus in this particular case, the reply through phonogram by the Drug Inspector appears to be not following the directives and procedure as laid down under Section 25(3) of the Drugs and Cosmetics Act, 1940. 23. In my view, the compliance of directive under section 25(3) of Drugs and Cosmetics Act, 1940 has specifically mentioned regarding the opportunity to the manufacturer to challenge contradict report of the Government Analyst. The Drug Inspector cannot bypass the said proceedings by simply forwarding a phonogram. Moreover, the petitioners, if at all follow the instructions of phonogram, they had no scope to have the sample of the drug earlier that 29.04.2004 (after date of the drugs expiry). 24. It further appears from Ex.P25 that the Drug Inspector (PW.1) submitted the petition under Section 25(3) of Drugs and Cosmetics Act, 1940 before the Court only on 17.06.2003. The said petition contained the sample along with Form-17 and 18 etc in original. The said report was send by PW.1 on 17.06.2003, but the Court received on 25.07.2003 when the drug has already crossed the period of expiry. Therefore, after analyzing entire evidence on record as well as provisions of Section 25(3) of Drugs and Cosmetics Act, 1940, in my view the observations of the learned Appellate Court is not at all proper legal prospective. Thus, in my view, as present petitioners manufacturer had no scope to reanalyze the report of Government Analyst in 14 provisions of 25(3) of Drugs and Cosmetics Act, 1940, thus they were deprived to their valuable right. Learned Appellate Court as well as learned Trial Court misread, thereby entire prosecution case as well as order of conviction and sentence passed by the learned Trial Court, confirmed by the learned Appellate Court appears to be illegal and the same is hereby set aside. 25. In the above facts, order of conviction is hereby set aside. The present petitioners are acquitted from the case and they are set at liberty. 26. Accordingly, the instant Criminal Revision Case is allowed and disposed of. As a sequel, miscellaneous applications pending, if any, shall stand closed. ___________________________ JUSTICE SUBHENDU SAMANTA Dated:31.03.2026 SSA