Centurion Laboratories (Div. of Centurion Remedies Private Limited) and Ambalal V. Patel v. Drugs Inspector, Office of the Assistant Drugs Controller, Kakkanad, Ernakulam and State of Kerala

## **IN THE HIGH COURT OF KERALA AT ERNAKULAM** **PRESENT:** ## **THE HONOURABLE MR. JUSTICE A.HARIPRASAD** **WEDNESDAY, THE 9TH DAY OF JULY 2014/18TH ASHADHA, 1936** ## **Crl.MC.No. 739 of 2012 () --------------------------** ## **AGAINST THE ORDER/JUDGMENT IN CC 1160/2007 of ADDL.C.J.M., ERNAKULAM .** ## **PETITIONERS:ACCUSED 1 & 2 :** **-----------------------------------------------** **1. CENTURION LABORATORIES,** - **DIV. OF CENTURION REMEDIES PRIVATE LIMITED, G/5 INDUSTRIAL ESTATE, GORWA, BARODA-390 026, INDIA.** **2. AMBALAL V. PATEL,** - **MANAGING DIRECTOR OF M/S. CENTURION LABORATORIES, DIV. OF CENTURION REMEDIES PRIVATE LIMITED, AT G/5, INDUSTRIAL ESTATE GORWA, BARODA-390 026, INDIA.** **BY ADV. SRI.M.SREEKUMAR.** ## **RESPONDENTS: COMPLAINANT & STATE :** **------------------------------------------------------------** **1. DRUGS INSPECTOR, OFFICE OF THE ASSISTANT DRUGS CONTROLLER, KAKKANAD, ERNAKULAM.** **2. STATE OF KERALA, REPRESENTED BY THE PUBLIC PROSECUTOR, HIGH COURT OF KERALA, ERNAKULAM.** **BY PUBLIC PROSECUTOR SRI.JUSTIN JACOB.** **THIS CRIMINAL MISC. CASE HAVING BEEN FINALLY HEARD ON 09-07-2014, ALONG WITH CRMC. 4195/2013, THE COURT ON THE SAME DAY PASSED THE FOLLOWING:** ## **Crl.MC.No. 739 of 2012 ()** ## **APPENDIX** ## **PETITIONER(S) EXHIBITS :** |**ANNEXURE A:**|**A TRUE COPY OF THE COMPLAINT IN CC NO. 1160/07 ON THE**| |---|---| ||**FILE OF THE ADDITIONAL CHIEF JUDICIAL MAGISTRATE**| ||**COURT, ERNAKULAM DATED 29.5.2007.**| |**ANNEXURE B:**|**TRUE COPY OF THE LETTER NO. A6.5789/2006/ADC/EKM.**| ||**DATED 17.1.07.**| |**ANNEXURE C:**|**TRUE COPY OF THE REPORT OF THE GOVERNMENT ANALYST**| ||**DATED 6.11.2006.**| |**ANNEXURE D:**|**TRUE COPYOF THE REGISTERED LETTER DFROM THE**| ||**PETITIONERS TO THE 1ST RESPONDENT DATED 10.2.2007.**| |**ANNEXURE E:**|**TRUE COPYOF THE REGISTERED LETTER DFROM THE**| ||**PETITIONERS TO THE 1ST RESPONDENT DATED 22.3.2007.**| |**ANNEXURE F:**|**TRUE COPY OF THE RELEVANT PAGES OF REGISTRATION**| ||**BOOK ISSUED BY THE POST MASTER, GORWA INDUSTRIAL**| ||**ESTATE POST OFFICE.**| |**ANNEXURE G:**|**TRUE COPY OF THE CERTIFICATE ISSUED BY THE MASTER**| ||**GORWA INDUSTRIAL ESTATE POST OFFICE DATED 24.2.2012.**| |**ANNEXURE H:**|**TRUE COPY OF SUMMONS DATED 26.5.2010 ISSUED FROM**| ||**THE ADDITIONAL CHIEF JUDICIAL MAGISTRATE COURT,**| ||**ERNAKULAM.**| ## **RESPONDENTS' EXHIBITS : NIL.** **//TRUE COPY//** **P.A TO JUDGE** **amk** ## **A.HARIPRASAD, J.** **-----------------------------------------------Crl.M.C Nos.739 of 2012 & 4195 of 2013 -----------------------------------------------Dated this the 9[th] day of July, 2014.** **Crl.M.C Nos.739 of 2012 & 4195 of 2013** ## **C O M M O N O R D E R** Petition filed under Section 482 Cr.P.C. Crl.M.C Nos.739 of 2012 is filed by the first and second accused in C.C No.1160/2007 on the file of the Additional Chief Judicial Magistrate Court, Ernakulam. The offences alleged against them are under Sections 18(a)(i) and 27(d) of the Drugs and Cosmetics Act, 1940 (in short 'the Act'). First petitioner is licensed to manufacture of drugs for sale under the provisions of the Act. Second petitioner is the Managing Director of the first accused The first accused is the company. company manufacturer of “Aluminium Hydroxide Tablets IP 500 Mg”. On 26-09-2006, the first respondent/drugs inspector conducted an inspection at Taluk Head Quarters Hospital, Thrippunithura, Ernakulam. During the course of investigation, he took samples from Aluminium Hydroxide Tablets IP 500 Mg, manufactured by the first petitioner with expiry date 7/07. One portion of the **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 2-** sample was sent to the Government Analyst, Drugs Testing Laboratory, Thiruvananthapuram. Test report dated 06-11-2006 was received from the Government Analyst and it disclosed that the sample was not of standard quality. Hence, the prosecution was launched alleging the said offences. 2. Crl.M.C No.4195 of 2013 is by the second and third accused challenging the order of committal of the case by learned Magistrate in C.P No.2/2013 to the Court of Sessions, Ernakulam. 3. Heard the learned counsel for the petitioners and the learned Public Prosecutor. 4. Understanding the sequence of events is essential for disposal of the case. The first respondent/drugs inspector conducted inspection in Taluk Head Quarters Hospital, Thripunithura, Ernakulam on 26-09-2006. The drugs allegedly not conforming to the standards were seized on the same date. The drugs were having expiry date by the end of July 2007. It **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 3-** was sent for Government Analyst, Drugs Testing Laboratory, Thiruvananthapuram and a report was obtained on 06-11-2006. Notice required under Section 25(3) of the Act was sent to accused persons on 17-01-2007. It is also submitted that the summons in the case was sent on 26-05-2010 and the accused persons were directed to appear before the court on 31-07-2010. 5. Learned counsel for the accused 1 and 2 drew my attention to Section 23 of the Act which deals with the 'Procedure of Inspectors'. As per Section 23(3) of the Act where an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked. 6. Section 25 deals with the 'Reports of Government **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 4-** Analysists'. It reads as follows : ## _“ .-_ _**25. Reports of Government Analysts**_ _(1) The Government Analyst to whom a sample of any drug or cosmetic has been submitted for test or analysis under subsection (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form._ _(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A and shall retain the third copy for use in any prosecution in respect of the sample._ _(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken or the person whose_ **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 5-** _name, address and other particulars have been disclosed under section 18A has, within twenty-eight 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 in controversion of the report._ _(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under subsection (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 under subsection (4) of section 23 to be sent for test or analysis t the said Laboratory, which shall make the test or analysis and report in writing signed by or under the authority of,_ **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 6-** _the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein._ _(5) The cost of a test or analysis made by the Central Drugs Laboratory under subsection (4) shall be paid by the complainant or accused as the Court shall direct.”_ Sub-section (4) of Section 25 of the Act is relevant for our ## purpose . 7. Learned counsel for the petitioners submitted that the accused 1 and 2 have expressed their intention of adducing evidence of controversion of a Government Analyst's report and sent a letter to the first respondent as early as on 11[th] February, 2007. To prove this fact, a document from the custody of Department of Posts, India, Registration Branch of Gorwa Baroda is produced. It shows that a letter as item No.2206 was sent by registered post in the official address of the first **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 7-** respondent/drugs inspector on 11-02-2007. Learned Public Prosecutor submitted that the first respondent did not get such a communication from the accused persons. I find no reason to discard the genuineness of the certificate issued by the Department of Posts, India to show that the accused 1 and 2 had sent a letter to the first respondent by registered post on 11-02-2007. Section 27 of the General Clauses Act, 1897 has been complied with in this case by sending a letter by registered post in the correct address of the first respondent. Therefore, it is evident that the petitioners in Crl.M.C No.739/2012 have taken steps to adduce evidence in controversion of the Government Analyst's report as provided in Section 25(3) of the Act. 8. Annexure G produced in Crl.M.C No.739/2012 also fortifies this stand of the petitioners. 9. It is seen from Annexure A complaint that the complainant has taken a stand that the first accused company had not adduced evidence in controversion of the report of the **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 8-** Government Analyst as per Section 25(3) of the Act. This contention of the complainant is not sustainable in view of the above mentioned documents. Learned counsel for the petitioners placing reliance on _**Medicamen Biotech Limited and Another v. Rubina Bose, Drug Inspector ((2008)7 SCC 196)**_ contended that in this case there was complete inaction on the part of the first respondent in forwarding the sample for analysis by Central Drugs Laboratory and that caused great prejudice to the accused. An identical situation was considered in the above case. The ratio therein is as follows : _“ The observations in Amery Pharmaceuticals case are also to the same effect. We find that the aforesaid interpretation supports the case of the appellants inasmuch they had been deprived of the right to have the fourth sample tested from the Central Drugs Laboratory. It is also short clear that the complaint had been filed on 2-7-2002_ **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 9-** _which is about a month short of the expiry date of the drug and as such had the appellant-accused appeared before the Magistrate even on 2-7-2002 it would have been well-nigh impossible to get the sample tested before its expiry.”_ 10. It is evident that the summons was received by the accused to appear before the court only on 31-07-2010. Therefore, it is clear that they could not have availed the opportunity of sending one portion to the Central Drugs Laboratory after appearing before the court because the time of 28 days prescribed in the statute had expired long before. There is no satisfactory explanation on the side of the prosecution for not forwarding the sample to the Central Drugs Laboratory as required under the provisions of the Act. Therefore, I find that the prosecution is an abuse of the process of the court. 11. Crl.M.C No.4195/2013 is filed challenging the committal order passed by the learned Additional Chief Judicial **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 10-** Magistrate, Ernakulam in C.P No.2/2013. Learned counsel for the petitioners invited my attention to Section 36AB of the Act which deals with the constitution of Special Court. This provision has been interpreted by a learned Single Judge of this Court in _**Zest Pharma v. Drug Inspector (2013(4) K.L.T 462).**_ The provision was added by an amendment to the Act by Act 26 of 2008 with effect from 10-08-2009. Admittedly, the alleged offence was detected on 26-09-2006 in this case. Therefore, an accused cannot be tried and convicted on the basis of an ex post facto law. The dictum in _**Zest Pharma**_ (supra) is to the effect that even after the amendment the offence alleged under Section 18(a)(i) r/w Section 27(d) of the Act does not require a committal. Viewing from this angle also, the order impugned in Crl.M.C No.4195/2013 is unsustainable. In the result, both the petitions ( Crl.M.C Nos.739 of 2012 & 4195 of 2013 ) are allowed. Annexure A complaint in C.C No.1160/2007 on the file of the Additional Chief Judicial **Crl.M.C Nos.739 of 2012 & 4195 of 2013 - 11-** Magistrate Court, Ernakulam is hereby quashed. Consequently, the committal order challenged in C.P No.2/2013 on the file of the same court is also found to be bad in law and hence the order is set aside. All proceedings in S.C No.224/2013 pending before the Sessions Court, Ernakulam are hereby quashed. All pending interlocutory applications will stand dismissed. Sd/- **A.HARIPRASAD, JUDGE.** amk //True Copy// P.A to Judge