Cr.M.C No. 6455 of 2016 - M/S Agron Remedies Pvt. Ltd. v. State of Kerala and Drugs Inspector, Thiruvananthapuram

## **IN THE HIGH COURT OF KERALA AT ERNAKULAM** ## **PRESENT** ## **THE HONOURABLE MRS. JUSTICE SOPHY THOMAS WEDNESDAY, THE 23[RD] DAY OF MARCH 2022 / 2ND CHAITHRA, 1944 CRL.MC NO. 6455 OF 2016** **AGAINST THE ORDER/JUDGMENT IN CC 1941/2014 OF ADDITIONAL CHIEF JUDICIAL MAGISTRATE, THIRUVANANTHAPURAM PETITIONER/ACCUSED:** 1 M/S. AGRON REMEDIES PVT. LTD. SURRENKHERA, MORADABAD ROAD, KASHIPUR, UDHAMSINGNAGAR, UTTARKHAND-244 713. 2 GOPALAKRISHNAN AGARWAL AGED ABOUT 54 YEARS, S/O. LATE SRI. JAGADISH PRASAD AGARWAL, SINGHAN STREET, KASHIPUR (DIST. U.S.NAGAR) UTTARKHAND. 3 ATUL KUMAR PATHAK S/O. NARESH CHAND PATHAK, H.NO. 25, GANDHI NAGAR, BHARATHANA DISTRICT, ETAWAH U.P. 4 MANOJKUMAR SHARMA S/O. JAYANTHI PRASAD, R/O. 126/A, GALI NO. 14, BHAGWATI GARDEN EXTN. UTTAM NAGAR, NEW DELHI. 5 VISHAL SING S/O. SAMAR SINGH, VILLAGE JAGATPURPATHI, JASPUR, KISHIPUR, UTTARKHAND. BY ADV. SRI.P.V.ANOOP ## **RESPONDENTS/COMPLAINANT & STATE:** - 1 DRGU INSPECTOR OFFICE OF THE DRUG CONTROLLER, VANCHIYOOR, THIRUVANANTHAPURAM, PIN- 695 035. Crl.M.C No.6455 of 2016 2 2 STATE OF KERALA REPRESENTED BY THE PUBLIC PROSECUTOR, HIGH COURT OF KERALA, ERNAKULAM, KOCHI-682 031 ## **OTHER PRESENT:** SRI.SANAL P RAJ, GOVT. PLEADER. THIS CRIMINAL MISC. CASE HAVING BEEN FINALLY HEARD ON 16.03.2022, THE COURT ON 23.03.2022 PASSED THE FOLLOWING: Crl.M.C No.6455 of 2016 3 ## **SOPHY THOMAS, J. C.R** ------------------------------------ Crl.M.C No.6455 of 2016 ----------------------------------- Dated this the 23[rd] day of March, 2022 ## **O R D E R** This Crl.M.C has been filed by the accused in C.C No.1941 of 2014 on the file of Additional Chief Judicial Magistrate Court, Thiruvananthapuram to quash the proceedings in that case, invoking the inherent powers of this Court under Section 482 of Cr.P.C. 2. The State of Kerala represented by Drugs Inspector, Thiruvananthapuram filed Annexure-A complaint against the petitioners herein under Section 32 of the Drugs and Cosmetics Act, 1940, alleging offences punishable under Section 18(a)(i) read with Section 27(d) of the said Act. 3. The allegation in the complaint was that, on 31.01.2011, the Drugs Inspector inspected District Drug Warehouse, Kerala Medical Services Corporation Ltd and drew sample of the drug Crl.M.C No.6455 of 2016 4 Enalapril Maleate Tablets IP 2.5mg, Batch No.EEK 04, manufactured and sold by the petitioners. On analysis, the sample was declared 'not of standard quality' as it failed to comply with the test for assay, in violation of Section 18(a)(i) read with Section 27(d) of the Act. 4. Learned Additional Chief Judicial Magistrate Court, Thiruvananthrapuram took cognizance of the offence and complaint was taken on file as C.C No.1941 of 2014. The petitioners are contending that cognizance would not have been taken by the Magistrate on the basis of Annexure A complaint, and so the complaint and the proceedings pursuant thereto are liable to be quashed. 5. The grounds alleged are as follows: The complaint is barred by limitation. The Government Analyst report was dated 01.06.2011, and so the complaint ought to have been filed on or before 01.06.2014. But, it was filed only on 23.06.2014 and therefore, it is barred by limitation. The code of the sample in Form No.17 is not tallying with the code of the sample in Form No.18. So it has to be inferred that the analyst Crl.M.C No.6455 of 2016 5 report is not pertaining to the sample seized. No offence was made out against the petitioners under Section 18(a)(i) of the Act. The Drug Inspector had no jurisdiction to take the sample, as he failed to produce his appointment order as Drug Inspector for the local area. Moreover, the Drug Inspector had no right to represent the State of Kerala in the complaint filed. When the manufacturer and manufacturing activities were not within the jurisdiction of the Drug Inspector, an enquiry under Section 202 Cr.P.C was mandatory, before issuing summons to the accused. According to them, for these reasons, the complaint as well as the proceedings in C.C No.1941 of 2014 are liable to be quashed. 6. The main ground of attack is that, the complaint is barred by limitation. The sample was taken on 31.01.2011 and the Analyst Report was dated 01.06.2011. The complaint was filed only on 23.06.2014. 7. An offence punishable under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'the Act') is punishable with imprisonment for a term which shall not be less than one year but which may extend to two Crl.M.C No.6455 of 2016 6 years and with fine which shall not be less than Rs.20,000/-. 8. Section 468 (2)(c) of Cr.P.C reads thus: ## “ **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) xxx - (b) xxx - (c) three years, if the offence is punishable with imprisonment for a term exceeding one year but not exceeding three years”. When a special enactment does not stipulate any specific period of limitation to initiate prosecution or to take cognizance, the provisions in Cr.P.C will govern the period of limitation. Relying on Section 468(2)(c) of Cr.P.C, the petitioners would say that, the complaint ought to have been filed on or before 01.06.2014, but it was filed only on 23.06.2014. Cognizance of the offence was taken on the complaint even on a later date. 9. Now let us see what shall be the crucial date on which the Crl.M.C No.6455 of 2016 7 period of limitation commences, whether it is the date of offence, date of knowledge or date of identification of the accused? ## 10. Section 469 of Cr.P.C reads thus: ## “ **Commencement of the period of limitation** .- (1) The period of limitation, in relation to an offence, shall commence,- (a) on the date of the offence; or (b) where the commission of the offence was not known to the person aggrieved by the offence or to any police officer, the first day on which such offence comes to the knowledge of such person or to any police officer, whichever is earlier; or (c) where it is not known by whom the offence was committed, the first day on which the identity of the offender is known to the person aggrieved by the offence or to the police officer making investigation into the offence, whichever is earlier. (2) In computing the said period, the day from which such period is to be computed shall be excluded”. ## 11. It is true that only when the sample seized was analysed in chemical lab, it could be found out whether it is of standard quality or not, and before analysis no offence is said to have been committed. Crl.M.C No.6455 of 2016 8 12. Learned counsel for the petitioners relied on the decision **State of Rajasthan** _vs._ **Sanjay Kumar and others** (1998 KHC 968) to say that, when the essence of the offences charged is manufacture of adulterated, substandard misbranded, spurious drugs within the meaning of the relevant provisions of the Act and/or storage, distribution and sale of such drugs in contravention of the provisions of the Act, it could not have been said that, any offence was committed before the report of the Government Analyst was received. Only on analysis, it could be proved whether the sample of drug taken was adulterated, substandard or misbranded. So, the date of commission of offence with respect to Section 469 of Cr.P.C to reckon the commencement of the period of limitation is, where the commission of the offence was not known to the person aggrieved by the offence, or to any police officer, the first day on which such offence comes to the knowledge of such person or to any police officer, whichever is earlier. 13. To determine the period of limitation in the case in hand, the relevant provision applicable is Section 469(1)(b) of Crl.M.C No.6455 of 2016 9 Cr.P.C. Though the sample was taken on 31.01.2011, unless and until the Government Analyst Report was received, the complainant Drug Inspector was not aware of the fact that, the sample was not of standard quality. The Analyst Report is dated 01.06.2011. The complaint was admittedly filed on 23.06.2014. Going by Section 468(2)(c) of Cr.P.C, the period of limitation was three years from the date of commission of the offence. So, the complaint filed on 23.06.2014 is clearly barred by limitation. 14. Now let us see whether Section 473 of Cr.P.C could save the period of limitation, in this case. Section 473 reads as follows: “ **Extension of period of limitation in certain cases** . Notwithstanding anything contained in the foregoing provisions of this Chapter, any Court may take cognizance of an offence after the expiry of the period of limitation, if it is satisfied on the facts and in the circumstances of the case that the delay has been properly explained or that it is necessary so to do in the interests of justice”. 15. Here no petition was filed by the complainant at pre- cognizance stage to condone the delay with satisfactory Crl.M.C No.6455 of 2016 10 explanation, if cognizance has to be taken even after expiry of the period of limitation. Moreover no grounds were shown to condone the delay in the interest of justice. The delay has to be explained satisfactorily and it should have been condoned before taking cognizance of the offence, and Section 473 of Cr.P.C cannot have any application, after cognizance was taken on a time barred complaint. The provisions of Section 473 of Cr.P.C has to be invoked at the pre-cognizance stage, and once cognizance is taken, the court cannot go back to condone the delay to save the period of limitation. Before taking cognizance the learned Magistrate should have applied his mind to see that the prosecution is within time. 16. Another ground urged by the petitioners is that, when the manufacturer and the manufacturing activities were outside the local jurisdiction of the Magistrate, before taking cognizance and issuing summons to the manufacturer, an enquiry under Section 202 of Cr.P.C was mandatory. Here, admittedly, the petitioners, who are the manufacturers, are not residing or doing manufacturing activities within the local limits of the Magistrate Crl.M.C No.6455 of 2016 11 and so, cognizance taken against the petitioners without conducting an enquiry under Section 202 Cr.P.C is bad in the eye of law. ## 17. Section 32A of the Act reads thus: ## “ **Power of Court to implead the manufacturer,** **etc** .—Where, at any time during the trial of any offence under this Chapter alleged to have been committed by any person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent is also concerned in that offence, then, the Court may, notwithstanding anything contained in sub-sections (1), (2) and (3) of section 319 of the Code of Criminal Procedure, 1973 (2 of 1974), proceed against him as though a prosecution had been instituted against him under section 32”. ## 18. In **Birla Corporation Ltd. and another** vs. **Adventz Investments and Holdings Ltd. and others** (2019 KHC 6559), the Apex Court held that, conducting of an enquriy under Section 202(1) Cr.P.C is mandatory, when the accused is residing at a place beyond the area of jurisdiction of the Magistrate. 19. Since the complaint is clearly barred by limitation, and Crl.M.C No.6455 of 2016 12 cognizance against the petitioners, who are residing and doing manufacturing activities outside the local jurisdiction of the Magistrate, was taken without conducting an enquiry under Section 202(1) of Cr.P.C, this is a fit case to exercise the inherent powers of this Court to prevent abuse of process of court, and to secure the ends of justice. In the result, the Crl.M.C is allowed. The proceedings in C.C. No.1941 of 2014 on the file of Additional Chief Judicial Magistrate Court, Thiruvananthapuram is hereby quashed. The petitioners are discharged and they are set at liberty forthwith. The bail bonds if any executed by them shall stand cancelled. Sd/- **SOPHY THOMAS JUDGE** smp Crl.M.C No.6455 of 2016 13 ## **APPENDIX OF CRL.MC 6455/2016** PETITIONER ANNEXURES ANNEXURE A TRUE COPY OF THE COMPLAINT FILED BY THE 1ST RESPONDENT DATED 23.06.2014 WHICH IS NOW PENDING AS C.C. NO. 1941/2014 ON THE FILE OF THE COURT OF ADDITIONAL CHIEF JUDICIAL MAGISTRATE THIRUVANANTHAPURAM. - ANNEXURE A(1) TRUE COPY OF THE ORDER SHEET IN C.C.NO. 1941/2014 ON THE FILE OF COURT OF ADDITIONAL CHIEF JUDICIAL MAGISTRATE THIRUVANANTHAPURAM. - ANNEXURE B TRUE COPY OF THE CERTIFICATE OF ANALYSIS BY GOVERNMENT ANALYST IN FORM NO. 13 DATED 01.06.2011 ALONG WITH THE LABORATORY PROTOCOL. - ANNEXURE B1 TRUE COPY OF THE PROTOCOL OF ANALYSIS OF ENALAPRIL MALEATE FINISHED PRODUCT. - ANNEXURE C A COPY OF THE FORM NO. 17 DATED 31.01.2011 ISSUED TO THE KMSCL AUTHORITIES BY THE DRUG INSPECTOR. - ANNEXURE D TRUE COPY OF THE FORM NO.18 DATED 01.02.2011 ISSUED BY THE DRUG INSPECTOR TO THE GOVERNMENT ANALYST. - ANNEXURE E A COPY OF THE RELEVANT PAGES OF THE TENDER FOR THE SUPPLY OF DRUGS AND SUPPLIES TO THE KMSCL FOR THE PERIOD FROM 01.04.2010 TO 31.03.2011. ANNEXURE F TRUE COPY OF THE IN-HOUSE LABORATORY REPORT DATED 17.01.2011 OF BATCH NO. EEK 04 ENALAPRIL MALEATE TABLET IP 2.5 MG. Crl.M.C No.6455 of 2016 14 ANNEXURE G TRUE COPY OF THE ENVELOPE OF ENALAPRIL MALEATE TABLETS IP 2.5 MG. - ANNEXURE H TRUE COPY OF THE RELEVANT PAGES OF THE INDIAN PHARMACOPOEDIA DEALING WITH ENALAPRIL MELEATE TABLETS. - ANNEXURE I TRUE COPY OF THE RELEVANT PAGES (FOUR PAGES) OF THE MEDICINE AND HEALTH CARE PRODUCTS REGULATORY AGENCY (MHRA) WHICH DEALS ABOUT THE FINISHED PRODUCTS STABILITY STUDY UNDER THE HEADING PHARMACEUTICAL ASSESSMENT INENALAP[RIL MALEATE TABLETS IP 2.5 M.G. - ANNEXURE J TRUE COPY OF THE PAGES (TWO PAGES) OF THE PRODUTS MONOGRAPH OF MERCK CANADA INCVASERETIC. - ANNEXURE K TRUE OF CERTIFIED COPY OF THE REPLY DATED 17.03.2012.PRODUCED ALONG WITH THE COMPLAINT. - ANNEXURE L TRUE COPY OF THE REPLY DATED 17.03.2012 SENT BY PETITIONERS BY REGISTERED POST ALONG WITH THE POSTAL RECEIPT. - ANNEXURE M TRUE COPY OF THE DEVANSH TESTING & REASEARCH LABORATORY PRIVATE LIMITED DATED 22.01.2012. - ANNEXURE N TRUE COPY OF THE LETTER DATED 06.3.2014 ISSUED BY THE 1ST PETITIONER. True Copy P.S to Judge smp