Telangana High Court
M/S Theon Pharmaceuticals ... vs P.P., Hyd on 21 January, 2022
Author: G. Radha Rani
Bench: G. Radha Rani
THE HON'BLE Dr. JUSTICE G. RADHA RANI
CRIMINAL PETITION No.12312 of 2015
ORDER:
This petition is filed by the petitioners - A1 and A2 under Section 482 Cr.P.C. to quash the proceedings in CC No.1549 of 2013 on the file of Additional Judicial Magistrate of First Class, Karimnagar taken on file against them.
2. The facts of the case as per the complaint filed by the Drugs Inspector, Karimnagar was that on 27-2-2009, the Drugs Inspector Karimnagar inspected M/s.Sai Ganesh Medical Agencies, Sastri Road, Karimnagar and picked 4x5x6 Cavmox-625, Amoxycillin and Potassium Clavulanate tablets USP, Batch No. 23 AT 804, Mfg. date July 2008, Expiry date December 2009, manufactured by Theon Pharmaceuticals Limited, Village Saini Majra, Tehsil Nalagarh, District Solan: 174101 Himachal Pradesh and paid cost of the drug and obtained acknowledgement. He also obtained acknowledgment for receipt of one sealed sample of drug portion. He sent one of the sealed sample portions to Government Analyst, DCL Hyderabad for analysis on 27-2-2009 itself. On 29-9-2009 he received Form-13 dated 18-9-2009 in triplicate from the Government Analyst declaring that the drug was "not of standard quality" as the sample did not meet the USP requirement in respect of clavulanic acid.
3. On 29-9-2009 itself he addressed a letter to the partner of M/s Sai Ganesh Medical Agencies by serving Form-13, to disclose the name, address and particulars of the persons from whom he obtained Dr.GRR,J 2 CrlP.No.12312 of 2015 the drug, as required under Section 18A of Drugs and Cosmetics Act 1940 (for short 'D&C Act').
4. On the same day i.e. on 29-9-2009, based on the address on the label of the sample drug, Lw1 addressed a letter to A1 under Section 18A, 18B and 22(1)(cca) to submit the information regarding whether they had manufactured the subject product and to furnish the self attested copies of the drug licenses held by them and the constitution particulars of the firm along with the distribution statement and the efforts made by the company to recall the product. He also served a copy of Form-13 dated 18-9-2009 and one sealed portion of the sample of the subject drug to A1 as required under Section 23(4)(iii) of D&C Act 1940 and informed them that if they wished to challenge the said report, they could do so within the statutory period of 28 days from the date of receipt of the report.
5. LW1 issued reminder notices to A1 on 3-8-2010, 15-10-2010 and 20-12-2012.
6. On 1-2-2013, the Drugs Inspector received a reply letter dated 17-1-2013 from A1 stating that they had analyzed the control sample and requested to submit the sample to CDL for re-testing.
7. On 15-4-2013, the Drugs Inspector, Karimnagar proceeded to Solan District, HP and collected the attested copies of the memorandum and articles of association and Drug Licenses, authorization letter of the responsible person and list of approved products of the firm and filed the complaint launching prosecution against A1 and A2 for violation of Section 18(a)(i) of D& C Act 1940.
Dr.GRR,J 3 CrlP.No.12312 of 2015
8. Heard the learned counsel for the petitioners and the learned Additional Public Prosecutor.
9. The learned counsel for the petitioners submitted that the Drugs Inspector inspected the premises of M/s.Sai Ganesh Medical Agencies, Karimnagar on 27-2-2009 and seized the sample of subject drug. He was aware that the drug was going to expire in December 2009. As per the mandate of Section 23(4) of D&C Act, the Drugs Inspector was required to send one portion of the seized sample to the manufacturer immediately after making such seizure, but the Drugs Inspector failed to do so. The Government Analyst gave his report after a lapse of 6 months. The petitioner received the show cause notice dated 16-12-2009 from Assistant Drugs Controller, Licensing Authority cum Controlling Authority Himachal Pradesh and it was brought to the notice of the petitioners that the sample of Cavmox 625 had been declared not of standard quality by the Government Analyst Hyderabad. The petitioners sent a reply dated 31-12-2009 and contended that the control sample had been re-analyzed and found that all qualitative parameters were confirming to the specifications. On 19-1-2013 the petitioner company wrote to the Drug Inspector informing him about the control sample confirming to the specifications and further stated that clavulanic acid was a very fast degrading molecule and the storage conditions at retailer's end need to be investigated and requested for sending the sample to Central Drug Laboratory for re-testing. The Drug Inspector thereafter approached the Drug Controller, HP and collected the constitution particulars of Dr.GRR,J 4 CrlP.No.12312 of 2015 the petitioner company and filed the complaint dated 19-12-2013 after a lapse of 4 years. The complaint was filed in violation of the provisions under Section 468 Cr.P.C. and in clear violation of Section 19(3)(c) of D&C Act as the person from whom the subject drug was recovered had not been arrayed as accused but shown as a witness. In the complaint it was not averred that the subject drug was kept at ideal storage condition at the retailer's end and prayed to quash the proceedings.
10. The learned Additional Public Prosecutor opposed the petition contending that the subject drug was below the standard level and the petitioners were the manufacturers of the said drug, as such the proceedings could not be quashed against the petitioners.
11. Perused the record. The complaint would disclose that the sample of the subject drug 4x5x6 Cavmox-625, Amoxycillin and Potassium Clavulanate tablets USP, Batch no 23 AT 804, was collected by the drug inspector on 27-2-2009 from M/s.Sai Ganesh Medical Agencies, Karimnagar. The manufacturing date of the said drug was July 2008 and its expiry date was by December 2009. Though one of the sealed sampled portions was sent to the Government Analyst, DCL Hyderabad on the same day, the Government Analyst gave his report on 18-9-2009, 6 months later. As per the opinion of the Government Analyst, the sample was not meeting the USP requirement in respect of clavulanic acid. But the complaint was filed by the Drug Inspector on 19-12-2013 after a lapse of 4 years against the petitioners.
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12. The learned counsel for the petitioners relied upon the judgment of the Hon'ble High Court of Bombay in Quixotic Health care and others v. State of Maharastra and Others1 wherein it was held that:
"10. The most important point to be noted is that since beginning, the complainant had the knowledge that the shelf life of the drug, of which the sample has been taken, would expire on 31-08-2010. When he had received the report on 02-02-2010 and got the knowledge that the accused want to get the sample rechecked as expressed in their letter dated 02-03- 2010, so also, the sanction for prosecution was taken on 15-02-2010 itself, then why he was required to wait till 30-08-2010 to lodge the report is a question and the entire contents of the complaint are silent on this point. The learned Magistrate totally erred in passing the order of issuance of process as he did not consider that on the next day of the presentation of complaint, the drug was to expire. Even after the order of issuance of process has been passed on the same day of the presentation of complaint i.e. 30-08-2010, the summons would not have been served immediately. Learned Magistrate failed to consider that testing of the sample was not done with the mandatory period by the Laboratory. There is total non application of mind by the learned Magistrate while passing the impugned order. Therefore, definitely, the observations by this Court in Parenteral Drugs (India) Ltd. (Supra) are applicable here. Further the ratio in M. Sea Pharmaceutical Pvt. Ltd. (Supra) and M.S. Medicamen Biotech Ltd. (Supra) are also applicable. When the vital right of the accused to get the sample rechecked under Section 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940 have been violated because of belated filing of the complaint, then this is a fit case where the constitutional powers of this Court under Article 227 of the Constitution of India should be exercised."1
2020 ALLMR (Crl) 1880 Dr.GRR,J 6 CrlP.No.12312 of 2015
13. The Hon'ble Apex Court in Medicamen Biotech Ltd. v. Rubina Bose, Drug Inspector2 held 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 Section 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them."
14. In the present case the complaint was filed on 19-12-2013 after a lapse of 4 years, after the shelf life of the drug expired in December 2009. The magistrate failed to consider the said aspect and issued summons to the accused to appear. The petitioners were also deprived of their valuable right under Section 25(3) & 25 (4) of the Act.
15. As per the contention of the petitioners they had not received the copy of Form 13 dated 18-9-2009 and sealed portion of the sample drug sent by the Drug Inspector Karimnagar on 29-9-2009. They were stating that they only received a show cause notice on 16- 12-2009 from Asst. Drug Controller HP whereby it was brought to their notice that the sample of Cavmox- 625 had been declared as not of standard quality by Government Analyst Hyderabad.
16. The Hon'ble Apex Court in Laborate Pharmaceuticals India Ltd v. State of Tamil Nadu3 held that:
2
2008(7) SCC 196 Dr.GRR,J 7 CrlP.No.12312 of 2015 "7. The cognizance of the offence(s) alleged in the present case was taken on 4th March, 2015 though it appears that the complaint itself was filed on 28th November, 2012. According to the Appellant the cough syrup had lost shelf life in the month of November, 2012 itself. Even otherwise, it is reasonably certain that on the date when cognizance was taken, the shelf life of the drug in question had expired. The Magistrate, therefore, could not have sent the sample for reanalysis by the Central Laboratory.
8. All the aforesaid facts would go to show that the valuable right of the Appellant to have the sample analyzed in the Central Laboratory has been denied by a series of defaults committed by the prosecution; firstly, in not sending to the Appellant-
manufacturer part of the sample as required Under Section 23(4)(iii) of the Act; and secondly, on the part of the Court in taking cognizance of the complaint on 4th March, 2015 though the same was filed on 28th November, 2012. The delay on both counts is not attributable to the Appellants and, therefore, the consequences thereof cannot work adversely to the interest of the Appellants. As the valuable right of the accused for re- analysis vested under the Act appears to have been violated and having regard to the possible shelf life of the drug we are of the view that as on date the prosecution, if allowed to continue, would be a lame prosecution."
17. In the present case also the delay in not sending the sample for re-analysis is not attributable to the petitioners-accused.
18. The learned counsel for the petitioners also raised the contention that the complaint was filed in violation of provision of Section 468 Cr.P.C. after the expiry of period of limitation and relied upon the judgment of Hon'ble Apex Court in Johnson Alexander v. State4. The said case was pertaining to the offences under Section 13(1)(d) read with 13(2) of Prevention of Corruption Act and Section 120-B IPC. The Hon'ble Apex Court held that:
"10. The case is registered against the appellant under Section 120-B IPC read with Section 13(1)(d) of the P.C. Act. The learned Magistrate has registered the FIR to continue the proceedings under Section 120-B against the appellant. In view of the clear bar under clause (b) of sub-section (2) of Section 468 CrPC, the complaint is barred by limitation, more so there 3 2018 (265) SCC 93 4 III (2015) CCR 237(SC) Dr.GRR,J 8 CrlP.No.12312 of 2015 is no application filed by the prosecution explaining the delay caused from the date of the alleged occurrence till the date of filing the complaint and registering the FIR against the appellant herein under Section 120-B read with Section 13(1)(d) of the P.C. Act, on this ground alone, the proceedings initiated against the appellant are vitiated in law as there is an express bar under Section 468(2)(b) Cr.P.C.
The aforesaid legal contentions are not examined either by the learned Special Judge or by the High Court while examining the correctness of taking cognizance against the appellant and other accused. Though there is a statutory bar under clause (b) of sub- section (2) of Section 468 CrPC to take cognizance after lapse of the period of limitation, the alleged occurrence is of the year 1995, FIR was lodged and the proceedings are initiated in the year 1999 and taken cognizance on 21.06.2001, therefore, the entire proceedings are vitiated in law. Hence, taking cognizance against the appellant by the learned Special Judge, CBI in C.C. No. 115/2001 is bad in law and liable to be quashed. Accordingly, we set aside the impugned order of the High Court insofar as this appellant is concerned. For the reason that the complaint and FIR is registered beyond one year, therefore, the proceedings are not maintainable in law. On this ground alone, these proceedings are liable to be quashed and we hereby quash the same."
19. Section 468 Cr.P.C. is pertaining to bar to taking cognizance after lapse of the period of limitation. It reads as follows:-
"468. Bar to taking cognizance after lapse of the period of limitation.--
(1) Except as otherwise provided elsewhere in this Code, no Court shall take cognizance of an offence of the category specified in sub-section (2), after the expiry of the period of limitation.
(2) The period of limitation shall be--
(a) six months, if the offence is punishable with fine only;
(b) one year, if the offence is punishable with imprisonment for a term not exceeding one year;
(c) three years, if the offence is punishable with imprisonment for a term exceeding one year but not exceeding three years.
(3) For the purposes of this section, the period of limitation, in relation to offences which may be tried together, shall be determined with reference to the offence which is punishable with the more severe punishment or, as the case may be, the most severe punishment."
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20. The period of limitation is also applicable to the offences under Special Acts where it was not provided therein. The case was taken on file against the petitioners for violation of Section 18(a)(i) punishable under Section 27(d) of D&C Act 1940.
21. Section 18 of D&C Act is pertaining to Prohibition of manufacture and sale of certain drugs and cosmetics. Section 18(a)(i) reads as follows:-
"18. From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf--
(a) manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute
(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious."
22. The punishment section under section 27(d) reads as follows:-
"27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.--
Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,--
(d) any drug, other than a drug referred to in clause (a) or clause
(b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine which shall not be less than twenty thousand rupees."
23. As the punishment for the violation of Section 18(a)(i) as per Section 27(d) is for a maximum term of 2 years, the limitation for taking cognizance of the above offence is 3 years as per section 468(2)(c) Cr.P.C.
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24. But the facts of the case would disclose that the complaint was filed before the court on 19-12-2013 after more than 3 years from the date of detection of the offence on 18-9-2009. As such the complaint is barred by limitation and the court is prohibited from taking cognizance of the offence. The said bar is absolute. Hence the complaint is liable to be quashed on this ground alone.
25. Though the petitioners contended in their reply letter dated 17-1-2013 that Clavulanic acid was a very fast degrading molecule and its storage conditions and handling play an important role in its stability, the complainant had not specified as to how it was stored. Particularly in a place like Karimnagar, which was very hot and if the drug was not stored in a refrigerator, there is every likely hood of the drug being not complied with the specific parameters. The complaint would also disclose that the drug was purchased by M/s.Sai Ganesh Medical Agencies from M/s.Sri Hymavathi Medical Agencies Karimnagar and they purchased it from M/s Devayani Pharmaceuticals Narsaraopet, Guntur and they in turn purchased it from M/s Leeford Healthcare Ltd, Ludhiana and they did not disclose the source of supply. As such, the drug changed several hands from one place to another. The storage conditions at each and every place also play a role in maintaining its standards.
26. Without specifying the storage conditions of the drug at the time of drawing the sample and the manner of sending the sample to the Government Analyst, DCL, Hyderabad and the analyst giving the report with a delay of 6 months could be the reason for the drug to be Dr.GRR,J 11 CrlP.No.12312 of 2015 found of not of standard quality. Hence the entire blame could not be thrown on the manufacturer alone.
27. Hence, considering all these lacunae in conducting the investigation and the complaint filed with a delay of more than 4 years and the same was barred by limitation and the petitioners were deprived of their valuable right under Section 25(3) and 25(4) of D&C Act, it is considered fit to quash the proceedings against the petitioners in CC 1549 of 2013 on the file of Addl. JFCM, Karimnagar.
28. In the result, the Criminal Petition is allowed quashing the proceedings in CC No.1549 of 2013 on the file of Additional Judicial Magistrate of First Class, Karimnagar, against the petitioners-A1 and A2.
Miscellaneous petitions pending, if any, shall stand closed.
_____________________ Dr. G. RADHA RANI, J January 21, 2022 KTL