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2016 DIGILAW 433 (HP)

Caplin Point Laboratories Limited v. Union of India

2016-04-07

TARLOK SINGH CHAUHAN

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JUDGMENT : Tarlok Singh Chauhan, J. 1. This petition under Section 482 of the Code of Criminal Procedure seeks quashing of complaint instituted against the petitioners under the Drugs and Cosmetics Act, 1940 (for short the ‘Act’) and further seeks quashing of the orders passed by the learned trial Magistrate on 23.07.2015 and 04.09.2015. 2. The case of the petitioners is that it is a public limited company manufacturing wide range of products which are entirely meant for export. The petitioners came to know that respondent No. 1 had instituted a complaint against it under Section 18(a)(i) read-with Section 27(d) of the Act before the learned Judicial Magistrate at Nalagarh and after obtaining the certified copies of the proceedings, they put in appearance before the learned Court below. It was then that the petitioners learnt that the Court had already issued process against them and have, therefore, prayed for quashing of these proceedings on the ground that they are sought to be prosecuted on the basis of the report regarding Diclofenac Sodium Gel 1% (for short ‘Gel’) which was declared as “not of standard quality” by the Government Analyst, RDTL, Chandigarh, ignoring the fact that the said Gel was only for export purpose and not for domestic sale. It is further contended that the laboratories of the countries to which the aforesaid Gel is exported had found the Gel to be conforming to the standards as laid down by such countries and, therefore, in such circumstances, the proceedings cannot be permitted to continue as the same would only amount to abuse of process of law. 3. Shri Chandranarayana Singh, learned counsel for the petitioners has vehemently argued that the Gel in question is a proprietary medicine and not a Pharmacopoeia specification to which the provisions of the Act could be held to be applicable. The petitioners were only required to comply with the standards laid down by the countries to which the product was to be exported and, therefore, the standards as laid down in the Indian Pharmacopoeia would not be applicable to the Gel since it had been manufactured under the standards laid down in the British Pharmacopoeia. 4. The petitioners were only required to comply with the standards laid down by the countries to which the product was to be exported and, therefore, the standards as laid down in the Indian Pharmacopoeia would not be applicable to the Gel since it had been manufactured under the standards laid down in the British Pharmacopoeia. 4. Shri Ashok Sharma, learned Assistant Solicitor General of India, on the other hand, has argued that once the Gel in question is manufactured by the petitioners in India, then they are required to comply with the standards as laid down by the Indian Pharmacopoeia unless so exempted by any order to this effect. Therefore, even if, it is assumed that the Gel in question complies with the standards laid down in the British Pharmacopoeia, the same is of no avail. 5. It is well settled that the inherent power of the High Court under Section 482 Cr. P.C. should be sparingly exercised in rare cases only when the Court comes to the conclusion that there would be manifest injustice or there would be abuse of the process of Court, if such power is not exercised and the Court would then quash the proceedings. The legal position is well settled that when the prosecution at the initial stage is asked to be quashed, the test to be applied by the Court is, as to whether the uncontroverted allegations as made in the complaint establish the offence. The High Court being superior Court of the State should refrain from analyzing the materials which are yet to be adduced and seen in their true perspective. However, quashing of complaint and criminal proceedings would still depend upon the facts and circumstances of each case. 6. The principles to be considered for proper exercise of jurisdiction, particularly, with regard to quashing of charge either in exercise of jurisdiction under Section 397 or Section 482 Cr. P.C. or together, as the case may be, have been summarized by the Hon’ble Supreme Court in Amit Kapoor vs. Ramesh Chander and Another, (2012) 9 SCC 460 , as follows:- “1. Though there are no limits of the powers of the Court under Section 482 of the Code but the more the power, the more due care and caution is to be exercised in invoking these powers. Though there are no limits of the powers of the Court under Section 482 of the Code but the more the power, the more due care and caution is to be exercised in invoking these powers. The power of quashing criminal proceedings, particularly, the charge framed in terms of Section 228 of the Code should be exercised very sparingly and with circumspection and that too in the rarest of rare cases. 2. The Court should apply the test as to whether the uncontroverted allegations as made from the record of the case and the documents submitted therewith prima facie establish the offence or not. If the allegations are so patently absurd and inherently improbable that no prudent person can ever reach such a conclusion and where the basic ingredients of a criminal offence are not satisfied then the Court may interfere. 3. The High Court should not unduly interfere. No meticulous examination of the evidence is needed for considering whether the case would end in conviction or not at the stage of framing of charge or quashing of charge. 4. Where the exercise of such power is absolutely essential to prevent patent miscarriage of justice and for correcting some grave error that might be committed by the subordinate courts even in such cases, the High Court should be loath to interfere, at the threshold, to throttle the prosecution in exercise of its inherent powers. 5. Where there is an express legal bar enacted in any of the provisions of the Code or any specific law in force to the very initiation or institution and continuance of such criminal proceedings, such a bar is intended to provide specific protection to an accused. 6. The Court has a duty to balance the freedom of a person and the right of the complainant or prosecution to investigate and prosecute the offender. 7. The process of the Court cannot be permitted to be used for an oblique or ultimate/ulterior purpose. 8. Where the allegations made and as they appeared from the record and documents annexed therewith to predominantly give rise and constitute a ‘civil wrong’ with no ‘element of criminality’ and does not satisfy the basic ingredients of a criminal offence, the Court may be justified in quashing the charge. Even in such cases, the Court would not embark upon the critical analysis of the evidence. 9. Even in such cases, the Court would not embark upon the critical analysis of the evidence. 9. Another very significant caution that the courts have to observe is that it cannot examine the facts, evidence and materials on record to determi ne whether there is sufficient material on the basis of which the case would end in a conviction, the Court is concerned primarily with the allegations taken as a whole whether they will constitute an offence and, if so, is it an abuse of the process of court leading to injustice. 10. It is neither necessary nor is the court called upon to hold a fullfledged enquiry or to appreciate evidence collected by the investigating agencies to find out whether it is a case of acquittal or conviction. 11. Where allegations give rise to a civil claim and also amount to an offence, merely because a civil claim is maintainable, does not mean that a criminal complaint cannot be maintained. 12. In exercise of its jurisdiction under Section 228 and/or under Section 482, the Court cannot take into consideration external materials given by an accused for reaching the conclusion that no offence was disclosed or that there was possibility of his acquittal. The Court has to consider the record and documents annexed therewith by the prosecution. 13. Quashing of a charge is an exception to the rule of continuous prosecution. Where the offence is even broadly satisfied, the Court should be more inclined to permit continuation of prosecution rather than its quashing at that initial stage. The Court is not expected to marshal the records with a view to decide admissibility and reliability of the documents or records but is an opinion formed prima facie. 14. Where the charge-sheet, report under Section 173(2) of the Code, suffers from fundamental legal defects, the Court may be well within its jurisdiction to frame a charge. 15. Coupled with any or all of the above, where the Court finds that it would amount to abuse of process of the Code or that interest of justice favours, otherwise it may quash the charge. The power is to be exercised ex debito justitiae, i.e. to do real and substantial justice for administration of which alone, the courts exist. Ref. Coupled with any or all of the above, where the Court finds that it would amount to abuse of process of the Code or that interest of justice favours, otherwise it may quash the charge. The power is to be exercised ex debito justitiae, i.e. to do real and substantial justice for administration of which alone, the courts exist. Ref. State of West Bengal & Others vs. Swapan Kumar Guha & Others, AIR 1982 SC 949 ; Madhavrao Jiwaji Rao Scindia & Another vs. Sambhajirao Chandrojirao Angre & Others, AIR 1988 SC 709 ; Janata Dal vs. H.S. Chowdhary & Others, AIR 1993 SC 892 ; Mrs. Rupan Deol Bajaj & Another vs. Kanwar Pal Singh Gill & Others, AIR 1996 SC 309 ; G. Sagar Suri & Another vs. State of U.P. & Others, AIR 2000 SC 754 ; Ajay Mitra vs. State of M.P. AIR 2003 SC 1069 ; M/s. Pepsi Foods Ltd. & Another vs. Special Judicial Magistrate & Others, AIR 1988 SC 128; State of U.P. vs. O.P. Sharma, (1996) 7 SCC 705 ; Ganesh Narayan Hegde vs. S. Bangarappa & Others, (1995) 4 SCC 41 ; Zundu Pharmaceutical Works Ltd. vs. Mohd. Sharaful Haque & Others, AIR 2005 SC 9 ; M/s. Medchl Chemicals & Pharma Pvt. Ltd. vs. M/s. Biological E. Ltd. & Others, AIR 2000 SC 1869 ; Shakson Belthissor vs. State of Kerala & Another, (2009) 14 SCC 466 ; V.V.S. Rama Sharma & Others vs. State of U.P. & Others, (2009) 7 SCC 234 ; Chunduru Siva Ram Krishna & Another vs. Peddi Ravindra Babu & Another, (2009) 11 SCC 203 ; Sheo Nandan Paswan vs. State of Bihar & Others, AIR 1987 SC 877 ; State of Bihar & Another vs. P.P. Sharma & Another, AIR 1991 SC 1260 ; Lalmuni Devi vs. State of Bihar & Others, (2001) 2 SCC 17 ; M. Krishnan vs. Vijay Singh & Another, (2001) 8 SCC 645 ; Savita vs. State of Rajasthan, (2005) 12 SCC 338 and S.M. Datta vs. State of Gujarat & Another, (2001) 7 SCC 659 . 16. These are the principles which individually and preferably cumulatively (one or more) be taken into consideration as precepts to exercise of extraordinary and wide plenitude and jurisdiction under Section 482 of the Code by the High Court. 16. These are the principles which individually and preferably cumulatively (one or more) be taken into consideration as precepts to exercise of extraordinary and wide plenitude and jurisdiction under Section 482 of the Code by the High Court. Where the factual foundation for an offence has been laid down, the courts should be reluctant and should not hasten to quash the proceedings even on the premise that one or two ingredients have not been stated or do not appear to be satisfied if there is substantial compliance to the requirements of the offence.” I have heard the learned counsel for the parties and have gone through the records of the case. 7. At the outset, it may be observed that the petitioners have failed to place on record any material which may even remotely suggest that they are exempted from manufacturing the Gel as per the standards laid down in the Indian Pharmacopoeia. Therefore, even if, it is momentarily conceded that the Gel conforms to the standards of the British Pharmacopoeia, even then the same would be of no consequence as the petitioners were required to specifically not only indicate but produce on record tangible material which could suggest that in matters of export, the petitioners need not comply with the standards laid down by the Indian Pharmacopoeia, so long as they comply with the standards laid down in the British Pharmacopoeia. 8. At this stage, it would be relevant to refer to the certificate of the analysis, the relevant portion whereof reads as under:- “ASSAY : Each gram on an average contains: Content of Obtainedmg Claimmg Obtained Limits Protocol Diclofenac : Diethylamine calculated as Diclofenac Sodium 6.63 mg 10.00 mg 66.30% 95% to 105% RDTL/MS/220 In the opinion of the undersigned the sample referred to above is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 and Rules there under for the reasons given below:- The sample does not conforms to claim as per Patent & Proprietary in respect to the Assay of Diclofenac Diethylamine calculated as Diclofenac Sodium performed.” 9. Evidently, as against the limits of 95% to 105% prescribed for the Diclofenac Diethylamine calculated as Diclofenac Sodium, the Gel in question was only found to be containing 66.30% of Diclofenac Diethylamine calculated as Diclofenac Sodium. Evidently, as against the limits of 95% to 105% prescribed for the Diclofenac Diethylamine calculated as Diclofenac Sodium, the Gel in question was only found to be containing 66.30% of Diclofenac Diethylamine calculated as Diclofenac Sodium. Shri Chandranarayana Singh has though drawn my attention to certificate reports annexed with the petition as Annexure I and II to contend that the laboratories situate in the countries importing the Gel from the petitioners have after analysis found to be complying with all the parameters as per the specification. But, in absence of any material to even remotely suggest that the petitioners are exempted from standards as laid down under the Indian Pharmacopoeia and are only required to comply with the standards as laid down in the Pharmacopoeia applicable to the countries importing Gel from the petitioners, these reports are of no avail. 10. In view of the aforesaid discussion, the petitioners can take no exception to the summoning orders issued against them. Consequently, there is no merit in this petition and the same is accordingly dismissed. Pending application, if any, also stands disposed of. Interim order dated 16.10.2015 is ordered to be vacated.