1. By way of instant criminal revision petition filed under Section 397/401 of Cr.PC, challenge has been laid to order dated 16.12.2021, passed by the learned Sessions Judge, Sirmour District at Nahan, H.P., in Criminal Complaint No. 43/3 of 2015 (registered as ST No. 3-ST/7 of 2017), whereby court below after being satisfied that prima-facie case under Section18(a) (i) read with Section 17-B (d) punishable under Sections 27 (d) and 27 (c) of the Drugs & Cosmetics Act, 1940 (in short the “Act”) exists against the petitioners, proceeded to frame charges against them.

2. For having bird’s eye view, facts necessary for adjudication of the case are that petitioners No. 2 and 3 are the sole partners in M/s Elnova Pharma i.e. petitioner No.1, whereas petitioner No.3 is the General Manager/Production In-charge of petitioner No.1- M/s Elnova Pharma. On 16.4.2008, Drug Controller-cum-Licensing Authority, Shimla, H.P. granted licence bearing No. MB/08/692 to the petitioner-firm for manufacturing for sale/distribution of the drugs specified in Schedule C & C(i) of Form 28. On the same day, authority detailed herein above also granted license bearing No. MNB/08/691 to petitioner No.1 for manufacturing for sale and distribution of drugs other than specified in Schedule C & C(i). On 30.1.2012, the Drug Inspector visited the premises of petitioner No.1-M/s Elnova Pharma and during the course of the inspection drew samples of 11 drugs including EP-KOFF capsules, which were in the form of Soft Gelatin Capsules in batch No. EPKSG1102 and sent the same to CTL Kandaghat for chemical analysis on 7.1.2012. Government Analyst CTL Kandaghat vide report bearing No. CTL-Drugs/2010-4702 dated 29.6.2012 declared the sample of drug in question as “not of standard quality” (Annexure P-1). As per essay test, out of combination of the three drugs, one drug i.e. Dextromethorphan HBR was found as claimed, whereas remaining two drugs were not found as per claimed quantities.

3. Aforesaid report of Government Analyst CTL Kandaghat, came to be conveyed to the petitioners through registered post vide letter dated 9.7.2012. In response to the aforesaid communication, M/s Elnova Pharma-petitioner No.1 vide letter dated 13.8.2012, expressed its intention of adducing evidence in contravention of the adverse report of CTL Kandaghat as per rules framed under the Act. Alongwith aforesaid communication, petitioner-firm also supplied manufacturing & sales record of the batch in question to the Drug Inspector (Annexure P-2). Besides above, petitioner-firm withdrew the entire batch of drug from the market. Pursuant to aforesaid request/intention to lead the evidence in contravention of the adverse report issued by the CTL Kandaghat, second sample drawn by the Drug Inspector was sent to Central Drug Laboratory, Kolkata for analysis/testing under Section 25 of the Act. Pending result from Central Drug Laboratory, Kolkata, petitioner-firm also got sample tested from the govt. approved laboraratory namely Devansh Testing & Research Laboratory Pvt. Ltd., who vide report dated 3.11.2011 found samples of batch of EP-KOFF capsules to be of “standard quality” (Annexure P-5).

4. On 1.2.2013, petitioner-firm made a request to learned Chief Judicial Magistrate Nahan, District Sirmour for sending the Working Standards & Method of Analysis for the drug EP-KOFF capsules to the Central Drug Laboratory, Kolkata, which fact is evident from application dated 1.2.2013 (Annexure P-5), however, aforesaid prayer made by the petitioners was not acceded to. Director, In-charge of Central Drug Laboratory, Kolkata submitted the report of test and analysis of the drug in question on Form-2 vide No. 2-1/2012-SS/CC-232/699 dated 21.3.2013, reporting therein drug in question to be “not of standard quality” Annexure P-6). The assay test of the drug in question as contained in Central Drug Laboratory, Kolkata report, reveals that out of combination of three drugs, assay test was found to be performed on two drugs. The same is as under:

5. After having received the aforesaid report from the Central Drug Laboratory, Kolkata, the State Drug Inspector Himachal Pradesh granted sanction for launching prosecution against the petitioner-firm under Section18(a) (i) read with Section 17-B (d) of the Act vide letter dated 24.5.2013, which was subsequently amended vide letter dated 1.6.2013. Accordingly, criminal complaint dated 31.12.2014, bearing registration No. 43/3 of 2015 came to be filed against the petitioners (Annexure P-7).

6. Though complaint was preferred in the year, 2014, but it took seven years to the court below to frame charges. On 17.11.2021, arguments were heard on the point of charge and thereafter, court below vide order dated 16.12.2021, held that prima-facie case under Section18(a)

(i) read with Section 17-B (d) of the Act punishable under Sections 27 (d) and 27 (c) of the Drugs & Cosmetics Act is made out the against the petitioners and accordingly, charges under the aforesaid provisions of law came to be framed against them. In the aforesaid background, petitioners have approached this Court in the instant proceedings, praying therein to set-aside the aforesaid order dated 16.12.2021, whereby charges under Section18(a) (i) read with Section 17-B (d) of the Act came to be framed by the court below as well as consequent proceedings i.e. charge sheet dated 6.1.2022.

7. Mr. Abhishek Sethi, learned counsel appearing for the petitioners vehemently argued that as far as drugs manufactured, sold & distributed in India are concerned, Section 16 (1) (a) provides that if such a drug complies with the standards set out in the Second Schedule, it is deemed to be “of standard quality”. While inviting attention of this court to the Second Schedule, Mr. Sethi submitted that Second Schedule reveals that the standards to be complied with as far as Proprietary Drugs are concerned i.e. “the formula of list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed.” Mr. Sethi further submitted that drug in question EP-KOFF is a “Proprietary Drug” within the meaning of Section 3 (h) (ii), which is a combination of three drugs mixed in specific quantities in an emulsion base, which are contained in soft gelatin capsules. He argued that all the three drugs contained in EP-KOFF Capsules are mentioned in the Indian Pharmacopoeia, but the combination of these three drugs is not mentioned in the Indian Pharmacopoeia or any other Pharmacopoeia authorized in this behalf by the Central Government and as such, same could not be tested with the protocols used by both the laboratories i.e. CTL Kandaghat and Central Drug Laboratory, Kolkata. While referring to the Rules 6 and 46 of the Act, learned counsel submitted that a test or analysis report of a drug must contain full protocols of the tests applied by the laboratory. Rule 46 provides for Procedure on Receipt of a Sample by the Government Analyst. He submitted that it was incumbent upon the Central Drug Laboratory, Kolkata to have tested the drug as per the Indian Pharmacopoeia after separating the contents thereof according to the method of separation/analysis supplied by the manufacturer i.e. petitioner- firm vide its letter Annexure P-5A. While referring to the report of Central Drug Laboratory, Kolkata (Annexure P-6), learned counsel for the petitioners argued that method of separation and analysis conducted by the said laboratory was taken from page 439 of the book HPLC Quantitative Analysis of Pharmaceutical Formulations (Vol-2 page 439) authored by P.D. Sethi & Rajat Sethi (1st Edition) (Annexure P-8), perusal whereof reveals that method of separation of analysis of combination of Guaiphenesin, Terbutaline Sulphate and Bromhexine Hydrochloride has been provided as opposed to a combination of Guaiphenesin, Dextromethorphan HBR and Bromhexine Hydrochloride in the drug in question. He submitted that since book authored by P.D. Sethi & Rajat Sethi prescribes the method of separation & analysis of altogether different combination of drugs as compared to the combination of drugs in question, report submitted by both the laboratories cannot be said to be valid as same does not comply with Rules 6 and 46 of the Drug Rules, 1946. While making this Court peruse Section 25(4) of the Act, learned counsel for the petitioners argued that report of Central Drug Laboratory, Kolkata, is conclusive proof of the contents thereof, meaning thereby, author is not required to be examined as witness during the trial, for the report to be read as in evidence against the petitioners. He submitted that since petitioners had raised specific question with regard to standards and protocol adopted/used by the Central Drug Laboratory, Kolkata, while rendering its report on second sample of the drug in question, court below ought to have examined whether Central Drug Laboratory, Kolkata complied with Rules 6 and 46 of the Drug Rules, 1946. Lastly, learned counsel for the petitioners invited attention of this Court to report submitted by the CTL, Uttarakhand qua the same drug and of the same batch, whereby drug in question was found to be of standard quality (Annexure P-9). He submitted that report of CTL, Uttarakhand clearly states that constituents of the combination of drug in question were separated by using In-house Specifications (I.H.S.) and thereafter, the separated constituents were tested as per Indian Pharmacopoeia, 2010. The assay test of the drug was found to be of standard quality. He submitted that since one laboratory at Uttarakhand had declared the drug in question of the same batch of the standard quality, it was bounden duty of the learned trial court to sift through the aforesaid valuable piece of evidence. In support of aforesaid submissions, learned counsel for the petitioners placed heavy reliance upon judgment passed by the Hon’ble Apex Court in Krishnan and Anr. v. Krishnaveni and Anr. (1997) 4 SCC 241, [LQ/SC/1997/112] Vishal Pharmaceuticals and Anr. v. State of MP, 1999(2) MPLJ 378, M/s Caplet India (P) Ltd and Anr v. The State of Wes Bengal and Ors, 1999 (1) Cal. H.C.N. 323 and judgment passed by this Court in Varun Bhardwaj v. State of HP (Cr.R. No. 268 of 2016 decided on 25.4.2017, wherein it is held that while framing charges, court is required to evaluate the material and documents available on record with a view to find out that if the facts emerging therefrom, taken on their face value, disclose the existence of all the ingredients, constituting the alleged offence or not and for the limited purpose, court may sift the evidence. While making this court to read the judgment rendered by this Court in Varun Bhardwaj’s case supra, learned counsel for the petitioner- firm argued that true it is that at the stage of framing of charge, court is required make formal opinion that accused is guilty of having committed offence, but with a view to infer prima-facie case, court is required to sift the evidence and see the evidentiary value of the same, to arrive at a conclusion whether same would be sufficient to connect the accused with the offence alleged to have been committed by him/her or not.

8. Mr. Narender Guleria, learned Additional Advocate General, appearing on behalf of the respondent-State while supporting the impugned order framing charge and refuting the aforesaid submissions made by the learned counsel for the petitioners, strenuously argued that though there is ample material available on record suggestive of the fact that drug in question manufactured by the petitioners was not found to be of standard quality and as such, petitioners rightly came to be booked under the aforesaid provisions of law, but even otherwise, questions/issues as have been raised and highlighted by the petitioners in the petition and further argued by his counsel, could not have been gone into details by the court while framing charge, rather at the time of framing of the charge, court is/was required to see whether prima-facie case under the aforesaid provisions of law exists or not. He submitted that since bare reading of reports submitted by both the laboratories i.e. CTL Kandaghat and Central Drug Laboratory, Kolkata establish prima facie case of contravention of provisions as contained in the Act, no illegality can be said to have been committed by the court while framing charge. Mr. Guleria, while making this Court to peruse the provisions contained in Section 397 of Cr.PC as well as judgment passed by the Hon’ble Apex Court in State of Kerala Vs. Puttumana Illath Jathavedan Namboodiri” (1999) 2 Supreme Court Cases 452, [LQ/SC/1999/159] submitted that this Court has very limited jurisdiction to re- appreciate the evidence while exercising revisionary jurisdiction under Section 397 Cr.PC. Mr. Guleria, further submitted that prior to filing of petition at hand, petitioners had approached this Court by way of petition under Section 482 Cr.PC for quashing of proceedings i.e. Cr.MMO No. 241/15, which was decided vide judgment dated 22.7.2016 and as such, present petition is otherwise not maintainable.

9. I have heard the learned counsel for the parties and gone through the records.

10. Before considering the rival submissions having been made by learned counsel representing the parties vis-à-vis correctness of the impugned order sought to be quashed, this Court at the first instance deems it necessary to discuss/elaborate scope and competence of this Court to quash the order framing charge as well as consequent proceedings, if any, pending in the competent court of law while exercising power under Sections 397 & 482 Cr.P.C.

11. Hon'ble Apex Court in case titled Amit Kapoor v. Ramesh Chander and Anr, (2012) 9 SCC 460 [LQ/SC/2012/789] held that framing of a charge is an exercise of jurisdiction by the trial Court in terms of Section 228 of the Cr.PC unless the accused is discharged under Section 227 Cr.PC. The Hon'ble Apex Court has further held that under the Section 227and 228 Cr.PC, the Court is required to consider the 'record of the case' and the documents submitted therewith and, after hearing the parties, may either discharge the accused or where it appears to the Court and in its opinion there is ground for presuming that the accused has committed an offence, it shall proceed to frame the charge. The Hon'ble Apex Court has further held that once the facts and ingredients of the Section concerned exists, then the Court would be right in presuming that there is ground to proceed against the accused and frame the charge accordingly. Most importantly, the Hon'ble Apex Court in the aforesaid judgment has concluded that the satisfaction of the Court in relation to the existence of constituents of an offence and the facts leading to that offence is a sine qua non for exercise of such jurisdiction. At this stage, this court deems it fit to reproduce the following paras of aforesaid judgment having been passed by the Hon'ble Apex Court as follows:-

"27. Having discussed the scope of jurisdiction under these two provisions, i.e., Section 397 and Section 482 of the Code and the fine line of jurisdictional distinction, now it will be appropriate for us to enlist the principles with reference to which the courts should exercise such jurisdiction. However, it is not only difficult but is inherently impossible to state with precision such principles. At best and upon objective analysis of various judgments of this Court, we are able to cull out some of 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 of the Code or together, as the case may be :

27.1. 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. 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.

27.2. 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.

27.3. 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.

27.4. 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 loathe to interfere, at the threshold, to throttle the prosecution in exercise of its inherent powers.

27.5. 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.

27.6. 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.

27.7. The process of the Court cannot be permitted to be used for an oblique or ultimate/ulterior purpose.

27.8. 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.

27.9. Another very significant caution that the courts have to observe is that it cannot examine the facts, evidence and materials on record to determine 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.

27.10. It is neither necessary nor is the court called upon to hold a full- fledged enquiry or to appreciate evidence collected by the investigating agencies to find out whether it is a case of acquittal or conviction.

27.11. 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.

27.12. 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 with by the prosecution.

27.13. 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.

27.14. 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.

27.15. 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.”

12. The Hon'ble Apex Court in judgment titledL. Krishna Reddy v. Stateby Station House Officer and Ors, (2014) 14 SCC 401, [LQ/SC/2013/1194] has held that Court is neither substitute nor an adjunct of the prosecution, rather once a case is presented to it by the prosecution, its bounden duty is to sift through the material to ascertain whether prima-facie case has been established, which would justify and merit the prosecution of a person. The relevant paras are as follows:-

"10. Our attention has been drawn to Stree Atyachar Virodhi Parishad v. Dilip Nathumal Chordia as well as K. Narayana Rao but we are unable to appreciate any manner in which they would persuade a court to continue the prosecution of the parents of the deceased. After considering Union of India v. Prafulla Kumar Samal, this Court has expounded the law in these words: (Stree Atyachar Virodhi Parishad case, SCC p. 721, para 14) "14. ... In fact, Section 227 itself contains enough guidelines as to the scope of enquiry for the purpose of discharging an accused. It provides that "the Judge shall discharge when he considers that r there is no sufficient ground for proceeding against the accused". The 'ground' in the context is not a ground for conviction, but a ground for putting the accused on trial. It is in the trial, the guilt or the innocence of the accused will be determined and not at the time of framing of charge. The Court, therefore, need not undertake an elaborate enquiry in sifting and weighing the material. Nor it is necessary to delve deep into various aspects. All that the Court has to consider is whether the evidenciary material on record if generally accepted, would reasonably connect the accused with the crime. No more need be enquired into.”

11. The court is neither a substitute nor an adjunct of the prosecution. On the contrary, once a case is presented to it by the prosecution, its bounden duty is to sift through the material to ascertain whether a prima facie case has been established which would justify and merit the prosecution of a person. The interest of a person arraigned as an accused must also be kept in perspective lest, on the basis of flippant or vague or vindictive accusations, bereft of probative evidence, the ordeals of a trial have to be needlessly suffered and endured. We hasten to clarify that we think the statements of the complainant are those of an anguished father who has lost his daughter due to the greed and cruelty of his son-in-law. As we have already noted, the husband has taken his own life possibly in remorse and repentance. The death of a child even to avaricious parents is the worst conceivable punishment."

13. Aforesaid exposition of law laid down by Hon’ble Apex Court from time to time, clearly reveal that High Court while exercising power under Sections 397 & 482 Cr.P.C can proceed to quash and set-aside the complaint, summoning order as well as order framing charge, if it is satisfied that evidentiary material adduced on record would not reasonably connect the accused with the crime and if trial in such situation is allowed to continue, person arrayed as an accused would be unnecessarily put to arduous of the protracted trial on the basis of flippant and vague evidence.

14. Now being guided by the aforesaid law laid down by the Hon’ble Apex Court, this Court would make an endevaour to ascertain the correctness and legality of the order impugned in the instant proceedings, but before that it would be apt to take note of Sections 17 and 18 of the Act, which reads as under:-

“Section 17 Misbranded drugs: For the purposes of this Chapter, a drug shall be deemed to be misbranded,-

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or

(b) if it is not labelled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

17A. Adulterated drugs.—For the purposes of this Chapter, a drug shall be deemed to be adulterated,—

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

17B Spurious drugs:-For the purposes of this Chapter, a drug shall be deemed to be spurious,-

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

17C. Misbranded cosmetics: For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded,-

(a) if it contains a colour which is not prescribed; or

(b) if it is not labelled in the prescribed manner; or

(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

17D. Spurious cosmetics: For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-

(a) if it is manufactured under a name which belongs to another cosmetic; or

(b) if it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic unless it is plainly and conspicuously marked so as to re veal its true character and its lack of identity with such other cosmetic; or

(c) if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.]

17E. Adulterated cosmetics: For the purposes of this Chapter, a cosmetic shall be deemed to be adulterated,-

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.]

“18. Prohibition of manufacture and sale of certain drugs and cosmetics.—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;

(ii) any cosmetic which is not of a standard quality or is misbranded, adulterated or spurious;]

(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 3 [the true formula or list of active ingredients contained in it together with the quantities thereof];

(iv) any drug which by means of any statement design or device accompanying it or by any other means, purports or claims 7 [to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;

(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;

(b) [sell or stock or exhibit or offer for sale,] or distribute any drug 9 [or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;

(c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug 9 [or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:

Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis:

Provided further that the [Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the [manufacture for sale or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs not being of standard quality.”

15. Careful perusal of aforesaid provisions of law reveals that no person can manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale or distribute, any drug which is not of standard quality and misbranded and spurious. Section 18(c) specifically talks about the issuance of licence for manufacture of drugs. In exercise of the powers conferred under the Act, Drugs & Cosmetics Rules, 1945 have been framed, wherein Rule 69 provides that an application for grant of a licence to manufacture and sale of drugs other than those specified in Schedule C & C(I) is to be made to the Licensing Authority appointed by the State Government.

16. Precisely, the grouse of the petitioner as is highlighted in grounds of the petition and further canvassed by Mr. Abhishek Sethi, learned counsel representing the petitioner is that since Central Drug Laboratory, Kolkata had not followed the prescribed protocol, while conducting the test and report submitted by it is /was conclusive, court below while framing charge could not have straightaway accepted the allegations contained in the complaint, rather it ought to have made an endevaour to ascertain whether test conducted by the Central Drug Laboratory, Kolkata, is in conformity with the mandate of Rules 6 and 46 of the Drug Rules, which provide for procedure on receipt of a sample by the Government Analyst. Before ascertaining the application of aforesaid Rules 6 and 46, it is pertinent to take note of the fact that Drug and Cosmetics Act recommends or provides for patent or proprietary medicines. At this stage, it would be apt to take note of rules 6 and 64, which read as under:

“6. The Central Drugs Laboratory.—

(1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter: Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs 1[or cosmetic or class of cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs 1[or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.

(2) The Central Government may, after consultation with the Board, make rules prescribing—

(a) the functions of the Central Drugs Laboratory; 31 [***]

(d) the procedure for the submission of the said Laboratory 3[under Chapter IV or Chapter IVA] of samples of drugs 31 [or cosmetics] for analysis or test, the forms of the Laboratory’s reports thereon and the fees payable in respect of such reports;

(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions;

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1).”

“46. Procedure on receipt of sample.

On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet 1[or on portion of sample or container] with the specimen impression received separately and shall note the condition of the seals on the 2[packet or on portion of sample or container]. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied. 3[Explanation.—It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of “protocols of the tests or analysis applied”, if—

(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;

(2) for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;

(3) for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report;

(4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given the report;

(5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report.”

17. Careful perusal of Rule 6 reveals that a test or analysis report on drug must contain full protocols of the test applied by the laboratory. As per report of Government Analyst, Kandaghat (Annexure P-1) as well as that of Central Drug Laboratory, Kolkata (Annexure P-6), drug in question was tested as per book “HPLC Quantitative Analysis of Pharmaceutical Formulations (Vol-2 page 439) authored by P.D. Sethi & Rajat Sethi (1st Edition) (Annexure P-8). Similarly, Rule 46 provides for procedure to be followed by the Government Analyst on receipt of a package from an Inspector containing a sample for test or analysis. The explanation to this Rule is most important and relevant as far as controversy at hand is concerned. Explanation-2 may be relevant as far as present case is concerned as it provides that for the patent or proprietary medicines, for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias should be given in the report. Explanation (3) provides that for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied must be given in the report. Most importantly, Explanation (4) provides that for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, shall be given in the report.

18. Section 3 (h) (ii) of the Act defines the term “patent or proprietary medicines” in relation to the allopathic drug. Even the Second Schedule provides that for patent or proprietary medicines (other than homeopathic medicines), the standards mentioned on the label or container are to be followed, meaning thereby, patent or proprietary medicines are to be tested as per in house specifications. Section 3 (h) (ii) reads as under:

“Section 3 (h) “patent or proprietary medicine” means,—

(ii) in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under Section 5”

19. It is not in dispute that drug in question being EP-KOFF Capsules is a combination of three drugs mixed in specific quantities in an emulsion base, which are contained in soft gelatin capsules. Though all the three drugs contained in EP-KOFF Capsules are mentioned in the Indian Pharmacopoeia, but combination of these three drugs is not mentioned in the Indian Pharmacopoeia or any other Pharmacopoeia authorized in his behalf by the Central Govt., rather it being a patent or proprietary medicines has their own working standards and method of analysis i.e. In house specification for testing the standards of identity, purity & strength of the ingredients thereof. As per Section 33 of the Act, Central Government in consultation or of recommendation of the Drug Technical Advisory Board may frame rules for the purpose of giving effect to the provisions of the act. As per Section 33 (ii) (c) of the Act, such rules may also prescribe the methods of test & analysis to be employed in determining whether a drug is of standard quality. In furtherance thereof, the drug rules 1945 were notified.

20. Mr. Abhishek Sethi, while inviting attention of this court to the formulations authored by authored by P.D. Sethi & Rajat Sethi (Annexure P-8) argued that method of testing & analysis mentioned at page 439 of the book HPLC Quantitative Analysis of Pharmaceutical Formulations, contemplates dissolution of drug sample in water, whereas drug in question is in emulsion form and as such, could not have been dissolved in the water. He argued that method of testing/analysis provided in the Book authored by P.D. Sethi & Rajat Sethi was not meant for test of the drug/medicine in question. Hence, it can be safely concluded that wrong protocol was followed/adopted for testing and analysis of the medicines in question by both the Laboratories i.e. CTL Kandaghat and Central Drug Laboratory, Kolkata and thus, there is violation of Rules 6 and 46 of the Drug Rules, 1946. Mr. Sethi submitted that being a patented & proprietary medicine had the drug in question been examined as per the working Standard & Method of Analysis supplied by the manufacturer, the same would not have failed the assay test. In support of his aforesaid contention, he invited attention of this Court to the sample of the drug in question i.e. EPKSG1102, drawn by the Drug Inspector, District Hardwar, UK, as per in house specifications. Mr. Sethi submitted that working standard method of analysis supplied by the manufacturer was applied while testing the drug in question and drug in question was found to be “of standard quality”. Result of assay test performed by the Government Analyst, Uttarakhand is as follows:

21. Careful perusal of formulations given at page 439 of the Book authored by P.D. Sethi & Rajat Sethi (Annexure P-8), reveals that same provides for methods and testing for an entirely different combination of drugs as compared to the drug in question. The drug EP-KOFF Capsules is a combination of Guaiphenesin, Dextromethorphan HBR and Bromhexine Hydrochloride, whereas formulations given by P.D. Sethi & Rajat Sethi provides method of testing & analysis for a medicine which has a combination of Bromhexine Hydrochloride, Terbutaline Sulphate and Guaiphenesin. Report further reveals that combination of Bromhexine Hydrochloride Terbutaline Sulphate and Guaiphenesin is contained in hard capsules in powder form, whereas EP-KOFF Capsule is a combination of Guaiphenesin, Dextromethorphan HBR and Bromhexine Hydrochloride, which are dissolved in emulsion and thereafter, filled in gelatin capsules. Method of testing and analysis mentioned at page 439 of the Book “HPLC Quantitative Analysis of Pharmaceutical Formulations” (Vol-2 page 439) authored by P.D. Sethi & Rajat Sethi (1st Edition) (Annexure P-8), contemplates the dissolution of the drug sample in water, whereas as has been noticed herein above, drug in question is in emulsion form and as such, it is not understood that how laboratory concerned conducted the test of the drug in question as per method of testing and analysis mentioned in the book authored by P.D. Sethi & Rajat Sethi.

22. Explanation 4 to Rule 46 which has been reproduced herein above, clearly provides that for patent or proprietary medicines, for which no pharmacopoeial tests or methods of analysis are available or can be applied, but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, shall be given in the report. In the case at hand, though reference has been given while conducting the test on the drug in question, which is a patent or proprietary medicine, but same could not have been applied for testing the drug in question, which contained combination of Dextromethorphan HBR and Guaiphenesin, whereas method of testing and analysis applied by the laboratories is concerned, they applied the formula to test the drug in the combination of Bromhexine Hydrochloride Terbutaline Sulphate and Guaiphenesin contained in hard capsules powder form. Since combination of three drugs contained in EP-KOFF Capsules is not mentioned in Indian Pharmacopoeia or any other Pharmacopoeia, it was incumbent upon the CTL Kandaghat and Central Drug Laboratory, Kolkata to have examined the drug in question as per Working Standard Method of Analysis supplied by the manufacturer as was done by the Government Analyst, Uttarakhand (Annexure P-9), in whose report, all the drugs claimed to be used while manufacturing the drug in question were found to be of sufficient quantity. Being a patent or proprietary medicine EP-KOFF Capsules have its own working standard and method of analysis (in-house specification) for testing the standards of identity, purity & strength of the ingredients thereof. Had the Government Analyst Kandaghat and CDL, Kolkata used the method of separation of the drug in question supplied by the manufacturer vide letter Annexure P-5, both the laboratories would have found the drugs in question of the standard quality as was found by the Government Analyst Uttarakhand. Report of Drug Analyst, Uttarakhand clearly states that constituents of the combination of the drug in question were separated by using In-House Specifications (IHS) and thereafter the separated constituents were tested as per the Indian Pharmacopoeia, 2010.

23. At this juncture, reliance is placed upon judgment dated 6.11.1998, rendered by the High Court Madhya Pradesh in Vishal Pharmaceuticals and Anr v. State of MP (1999) 2 MPLJ 378 (Cr.R. No. 174 of 1998), relevant paras whereof read as under:

“16. In each prosecution under the Act it is obligatory on the prosecution and the complainant to give evidence that he has complied with the provisions. These provisions have been brought in existence for the purpose of avoiding any possibility of tampering with the samples before they reach to the laboratory of government analyst. It ensures safeness in the analysis and report of the government analyst which is taken to be evidence against the accused in such prosecution. Special evidentiary value has been rendered to the report of the government's analyst and, therefore, the compliance of provisions of Rule 4 are mandatory in nature. In the present case there is no evidence adduced by the complainant in the prosecution to show that complainant had sent impression of seal which was used while sealing the samples separately to the Director by registered post. The report of the government's analyst does not show anything about that.

17. Rule 6 provides that -

"After test or analysis the result of the test or analysis together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.

Indian Pharmacopia and Pharmacopia of Britain have indicated different tests for the purpose of analysis of the drugs which are likely to be sent to the Laboratory of Government's Analyst or Director of Central Drugs Laboratory. This is also necessary because it brings the right information about test carried and Court gets sufficient material for the purpose of finding out whether there has been compliance of mandatory provisions of the Act. When the tests have been differently indicated by these two pharmacopias, the Government's analyst is obliged to indicate in his report as to which tests have been followed by him for arriving at a conclusion which gets embodied in the said report. After all, the Act has given special evidentiary value to the report of Government's analyst without he being examined in the Court of law. When that is the value given to that report, it is obligatory on the part of the complainant to adduce evidence to show that provisions of Rule 6 which are mandatory in nature, have been complied with.

18. This rule is mandatory because Rule 46 has also cast a duty on Government's analyst that he shall compare the seals on the packet or (or on portion of sample or container) with the specimen impression received separately and shall note the condition of the seals on the packet or on portion of sample or container. It is also his duty that after the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied. Explanation to this provisions of Rule 46 provides-

"It shall be deemed to be full and sufficient complaince with the requirement of the rule in respect of the supply of "protocols of the tests or analysis applied." if (1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report.

(2) for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;

(3) for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report;

(4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given in the report;

(5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report."

19. The provisions of Rule 6 assume mandatory nature because there can be a case in which the public analyst may apply the tests which have been evolved by him. If no protocols are given in the report, it would not be possible for the Court to judge as to whether final opinion of the Government analyst is consistent with the provisions of the Act and soundly based on scientific knowledge and tests. If protocols have not been given, it will not be possible for the Court to note whether the Government analyst has applied the tests indicated by Pharmacopoeia of India or British Pharmacopoeia. The legislature also is of view of mandatoriness of this rule, and, therefore, in addition to Rule 4, Rule 46 has been provided which ensures a safe course during the analysis and submission of the report which acquire special evidentiary value. Needless to point out that when the law confers special evidentiary value to a particular report, law insists its safeness and acceptability beyond doubt.

20. Report of Government analyst in this case is suffering from these infirmities also.

21. When the petitioner No. 2 the accused was examined in view of provisions of Section 313 of Criminal Procedure Code, 1973, the report of Government analyst was not brought to his notice in detail so as to enable the accused to offer his explanation in that context. It is necessary for the Court to bring the circumstances which are against the accused to his notice to give him the opportunity to offer his explanation in that context. When no such opportunity is given, the document or such circumstance cannot be used against him. In the present case the report of Government analyst in its detail has not been brought to the notice of the accused and he was not given opportunity to offer his explanation in that context. That has also caused prejudice to his defence and that has also snatched out the evidentiary value of report of the Government analyst.

22. Shri Bagdia further submitted that the sanction in this case is not a valid one because it is in printed form and it shows no application of mind. Shri Verma, Dy. G. A. submitted that after examination of provisions of the Act, the defect in sanction to the prosecution is not to be viewed so seriously and it does not make a trial invalid. I uphold the submission of Shri Verma and hold that no sanction to the prosecution is necessary in the cases which are the offences under provisions of the Act. But if given, it should not be in cyclostyled form and without mentioning of reasonable facts of the case.”

24. There is another aspect of the matter, Central Drug Laboratory, Kolkata, had performed assay test for two drugs only i.e. Guaiphenesin and Bromhexine Hydrochloride and found them to be absent from the sample., but there is no report, if any, with regard to third drug i.e. Dextromethorphan HBR. To sustain a charge of substitution, wholly or in part, of a drug by another drug or substance, it is required for the Government Analyst or the Central Drug Laboratory to state as to what has the drug been substituted, wholly or in part, with. Though report of the Central Drug Laboratory, Kolkata states that Guaiphenesin and Bromhexine Hydrochloride were found absent from the EP-KOFF Capsules, but there is nothing to suggest that as to what was present in place thereof. In the absence of such report, charge under Section 17–B(d) of the Act is not sustainable in the eye of law. In this regard reliance is placed on judgment dated 24.12.1998 passed by the Calcutta High Court in M/s. Caplet India (P) Ltd and Anr. v. The State of West Bengal and Ors, 1999 (1) Cal. H.C.N. 323 ( WP No. 2107 of 1996), relevant paragraphs whereof read as under:

24. Accordingly, it cannot be said that the sample of the drug alleged to have been manufactured by the writ petitioner No.1 Company as taken by the Drugs Inspector, contained either ‘mis-branded drug; or ‘ adulterated drug’ or ‘spurious drug’, inasmuch as, the test report merely shows that the analyst was of the view that the sample did not contain any paracetamol, but the test report is absolutely silent about the actual ingredients of the said sample.

"25. Because such irregularities and/or illegalities as referred to above and also because of the admitted non-compliance of the provisions of clause (iii) of sub-section (4) of section 23 of eth Drugs and Cosmetics Act, 1940, which are mandatory in nature, in my view, the impugned proceeding is wholly vitiated and as such, cannot be sustained in law and therefore, stands quashed and so also all consequential orders passed in the said enquiry proceedings including the final order passed therein, if there be any, as well as the decision dated 12th of December, 1996 declared by the Director of the Drugs Control, State of West Bengal and Secretary, Licensing Authority, State of West Bengal, in respect of the impugned enquiry proceeding, which also stands set-aside."

25. In the aforesaid judgment, High Court of Calcutta, held that paracetamol was found absent from a drug and the manufacturer was, inter-alia, charged under Section 17-B (d). It was further held that since the Government Analyst report failed to mention as to what was present in the place of paracetamol, the proceedings are not sustainable. High Court of Calcutta held that since charge under Section 17B-(d) of the Act is not sustainable against the petitioners in the eyes of law, the petitioners by any stretch of imagination, could not have been charged under Section 27 (c). Section 27 (C) reads as under:

“Section 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,-

(a) any drug deemed to be adulterated under section 17A or spurious under section [17B and which] when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grevious hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860) solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be [punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more]:

[Provided that the fine imposed on and released from, the person convicted under this clause shall be paid, by way of compensation, to the person who had used the adulterated or spurious drugs referred to in this clause:

Provided further that where the use of the adulterated or, spurious drugs referred to in this clause has caused the death of a person who used such drugs, the fine imposed on and realised from, the person convicted under this clause, shall be paid to the relative of the person who had died due to the use of the adulterated or spurious drugs referred to in this clause.

Explanation.-For the purposes of the second proviso, the expression "relative" means-

(i) spouse of the deceased person; or

(ii) a minor legitimate son, and unmarried legitimate daughter and a widowed mother; or

(iii) parent of the minor victim; or

(iv) if wholly dependent on the earnings of the deceased person at the time of his death, a son or a daughter who has attained the age of eighteen years; or

(v) any person, if wholly or in part, dependent on the earnings of the deceased person at the time of his death,-

(a) the parent; or

(b) a minor brother or an unmarried sister; or

(c) a widowed daughter-in-law; or

(d) a widowed sister; or

(e) a minor child of a pre-deceased son; or

(f) a minor child of a pre-deceased daughter where no parent of the child is alive; or

(g) the paternal grandparent if no parent of the member is alive;]

(b) any drug-

(i) deemed to be adulterated under section 17A but not being a drug referred to in clause (a), or

(ii) without a valid licence as required under clause (c) of section 18, shall be punishable with imprisonment for a term which shall 1 [not be less than three years but which may extend to five years and with fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more]:

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of [less than three years and of fine of less than one lakh rupees];

(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall [not less than seven years but which may extend to imprisonment for life and with fine which shall not be three lakh rupees or three times the value of the drugs confiscated, whichever is more]:

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of [less than seven years but not less than three years and of fine of less than one lakh rupees];

(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]:

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than one year.”

26. At this stage, Mr. Narender Guleria, learned Additional Advocate General, vehemently argued that report submitted by the CTL Kandaghat as well as Central Drug Laboratory, Kolkata, clearly reveal that they not only followed the protocols specified for testing, but also mentioned the same in their report and as such, court below rightly accepted the same while framing the charge, however this Court is not impressed with the aforesaid submission of learned Additional Advocate General for the reason that drug in question is a patented or proprietary medicine. EP-KOFF Capsules are combination of three drugs mixed in specific quantities in an emulsion base. Since combination of these three drugs is not mentioned in the Indian Pharmacopoeia authorized in this behalf by the central government, drug in question was required to be tested with the method of separation/analysis supplied by the manufacturer as was done by the Government Analyst, Uttarakhand. Leaving everything aside, this Court is of the view that when the sample of the drug in question of the same batch was tested by the Government Analyst Uttarakhand, while applying the method of separation and analysis supplied by the manufacturer and the same was found to be of standard quality, method of testing and analysis adopted by the CTL Kandaghat and Central Drug Laboratory, Kolkata, cannot be said to be correct. Since both the laboratories i.e Kandaghat and Kolkata wrongly tested the drug in question by adopting wrong methods, report to the detriment of the petitioners came to the fore. Otherwise also, as per description given herein above, method of separation of analysis adopted by the CTL Kandaghat and Central Drug Laboratory, Kolkata, taken from page 439 of the book HPLC Quantitative Analysis of Pharmaceutical Formulations (Vol- 2 page 439) authored by P.D. Sethi & Rajat Sethi (1st Edition) (Annexure P- 8), was not to be applied, rather constituents of combination (drug in question ) was required to be tested by way of in house specification and thereafter separated constituents were to be tested as per the Indian Pharmacopoeia, 2010. At this stage, learned Additional Advocate General vehemently argued that at the time of framing of charge, defence of the accused could not be put forth because acceptance of contentions as have been raised by the learned counsel for the petitioners would mean permitting the accused to disclose his defence at the stage of framing of charge. He submitted that since drug in question was not only declared “not of standard quality” by one laboratory at Kandaghat, but also by the Central Drug Laboratory, Kolkata, court below after having found prima facie case under Section Section18(a) (i) read with Section 17-B (d) of the Act, rightly proceeded to frame charge against the petitioners.

27. True it is that at the stage of framing of charge, court is required to sift material and documents available on record to find out whether prima-facie case exists against the accused or not, but by now it is well settled that though at the time of framing of charge, though Court is not required to make formal opinion that the accused is certainly guilty of having committed offence, but it is certainly required to see whether prima- facie case exists against the accused or not. Whether prima-facie case exists or not can only be inferred by sifting the material placed on record by the prosecution. Reliance in this regard is placed upon the judgment Varun Bhardwaj v. State of HP (Cr. Revision No. 268 of 2016 decided on 25.4.2017), which reads as under:

“20.This Court after carefully examining the document made available on record by the Investigating Agency sees substantial force in the argument having been made by the learned counsel for the petitioner that there is/was no material much less substantial available on record to frame charge under Section 307 of the IPC. Similarly, perusal of impugned order passed by the Court below reproduced herein above, nowhere suggests that court below before proceeding to frame charge under Section 228 of the Cr.PC against the accused carefully sifted/perused the material made available on record to ensure/ascertain whether prima-facie case exists against the accused or not The Hon’ble Apex Court in L. Krishna Reddy’s case supra, has specifically held that while framing charge under Section 228 Cr.PC, court must keep in mind the interest of the person arraigned as an accused, who may be put to the ordeals of trial on the basis of flippant and vague evidence. In the instant case, perusal of impugned order nowhere suggests that learned trial Court while proceeding to frame charge made an endeavor to sift/peruse the material adduced on record by the Investigating Agency. There appears to be no application of mind by the learned court below while charging under Section 307 Cr.PC. The Hon’ble Apex Court further held that once a case is presented to it by the prosecution, it is bounden duty of Court to sift through the material to ascertain whether a prima-facie case has been established or not. But even if otherwise, ratio as laid down by the Hon’ble Apex Court in other cases cited above are also taken into consideration, it clearly emerge from the same that in all probabilities, learned court below while framing charge is required to ascertain whether prima-facie case exists or not. Needles to say exercise, if any, carried out by the Court while ascertaining whether prima-facie case, if any, exists against the accused or not, must reflect in order, whereby charge is proposed to be framed. But in the instant case, as has been discussed in detail, there appears to be no attempt, if any, made by the learned trial Court to ascertain whether prima-facie case exists against the accused at the time of framing of charge or not and as such, impugned order is not sustainable being totally contrary to the law laid down by the Hon’ble Apex Court in the judgment referred herein above.

21.True, it is jurisdiction of this Court under Section 397 of the Cr.PC is very limited but same can be exercised so as to examine the correctness, illegality or proprietary of order passed by the trial Court or inferior court as the case may be. The legality, proprietary or correctness of an order passed by an inferior court is the very foundation of exercise of jurisdiction under Section 397 but ultimately it also requires justice to be done. In the judgments referred herein above, the Hon’ble Apex Court has held that jurisdiction vested in this Court in terms of Section 397 Cr.PC can be exercised to the fact that there is a palpable error, non-compliance with the provision of law or where decision is completely erroneous or where the judicial discretion is exercised arbitrarily."

28. It may be noticed that as per Section 25 (4) of the Act, report of Central Drug Laboratory, Kolkata is conclusive proof of the content thereof, meaning thereby, that prosecution with a view to prove such report otherwise not required to examine the author of the report and if the same is accepted, prosecution is either bound to fail or succeed. In case report is negative, prosecution would fail and if the report is positive, prosecution would succeed and person, against whom, report is positive, is liable to be dealt with in accordance with law for his having contravened the provisions as referred herein above. Section 25 (4) reads as under:

“Section 25 (4). Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (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 116 [or cosmetic] produced before the Magistrate under sub-section (4) of section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.”

Section 25 (4) of the Act, clearly provides that party not satisfied with the report of analysis or test, can make request to the Central Laboratory and report submitted by the said Laboratry shall be conclusive.

29. In the aforesaid scenario, it was all the more important for the court below while framing charges against the accused to ascertain that whether report of CTL Kandaghat or Central Drug Laboratory, Kolkata which shall be read against the accused, is as per working standards and method of analysis as provided under Rules 6 and 46. Since in the case at hand, drug in question is /was patent or proprietary medicine, containing combination of three drugs and combination of these drugs is not mentioned in the Indian Pharmacopoeia or in any other Pharmacopoeia authorized in this behalf by the central government, court before proceedings to frame charge was required to ascertain the veracity of method and analysis applied by the laboratories concerned while testing the drug in question. Though in the instant case, method of analysis given in the standard book or journals followed by the laboratories concerned has been given in the report, but as has been discussed in detail herein above, since method of analysis given in the standard book authored by P.D. Sethi & Rajat Sethi was not applicable in the present case, petitioner is right in contending that reports submitted by both the laboratories are not valid and could not be taken into consideration while framing the charge. If it is so, no case, much less under Section Section18(a) (i) read with Section 17- B (d) of the Act is made out against the petitioners. Even if it is presumed that both the laboratories rightly tested the drug/medicine as per the formulations given in the book authored by P.D. Sethi & Rajat Sethi, even then, report submitted by both the laboratories cannot be read against the petitioners for the reason that drug/medicine EP-KOFF is combination of Guaiphenesin and Bromhexine Hydrochloride, whereas method applied by both the laboratories for testing and analysis is/was for medicine having combination of Dextromethorphan HBR, Bromhexine Hydrochloride and Guaiphenesin.

30. Apart from above, Central Drug Laboratory, Kolkata in its report reported that Guaiphenesin and Bromhexine Hydrochloride was found absent from the capsule, but it nowhere stated that what was found in the drug and in the absence of such report, charge under Section 17 B (d) is not otherwise sustainable in the eye of law as has been held by the High Court of Calcutta in M/s Caplet India’s case. Since petitioners may suffer serious consequences of there being held guilty for their having allegedly contravened the provisions, as proved by the report of CTL Kandaghat and Central Drug Laboratory, Kolkata, which otherwise is not required to be proved by examining the author and is conclusive as held in Section 25 (4), court below could not have straightaway accepted the same while framing the charge, rather it should have ascertained whether CTL Kandaghat and Central Drug Laboratory, Kolkata have tested the drugs as per the methods and procedure prescribed in rules or the report is strictly in conformity with the protocols supposed to be followed at the time of testing of drug in question. Since in the case at hand, court below merely on the basis of report submitted by the Central Drug Laboratory, Kolkata proceeded to form a prima-facie opinion that petitioners have contravened the provisions contained in the Act coupled with the fact that report given by the laboratory is conclusive, great prejudice and irreparable loss would be caused to the petitioners in case order framing charge is allowed to sustain. Though Mr. Guleria, vehemently argued that question with regard to correctness of report relied upon by the prosecution cannot be gone into at the stage of framing of charge, rather veracity of the same can be laid challenge during the trial by leading cogent and convincing evidence, but having carefully perused provisions contained under Section 25 (4), this Court finds that report submitted by the Central Drug Laboratory, Kolkata is conclusive, meaning thereby, prosecution is not required to prove the same by examining the author of the report, rather same in any event shall be read against the petitioners.

31. Having taken note of the grievous consequences of report being accepted, special provision has been made in the Section 25 (4) giving therein chances to the party to get the second sample tested from the Central Drug Laboratory, after drug being declared of not of standard quality by the State Laboratory. In this regard reliance is placed upon judgment passed by Hon’ble Apex Court in Medicamen Biotech Limited and another vs. Rubina Bose, Drug Inspector; (2008)7 Supreme Court Cases 196 [LQ/SC/2008/694] , wherein it has been held as under:-

“19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9th May 2005. This is begging the question. We find 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.”

32. Hon’ble Apex Court in Krishnan and Anr. v. Krishnaveni and Anr. (1997) 4 SCC 241, [LQ/SC/1997/112] has held that in case Court notices that there is a failure of justice or misuse of judicial mechanism or procedure, sentence or order is not correct, it is salutary duty of the High Court to prevent the abuse of the process or miscarriage of justice or to correct irregularities/incorrectness committed by the inferior court. Relevant para of the aforesaid judgment reads as under:

“8. The object of Section 483 and the purpose behind conferring the revisional power under Section 397 read with Section 401, upon the High Court is to invest continuous supervisory jurisdiction so as to prevent miscarriage of justice or to correct irregularity of the procedure or to mete out justice. In addition, the inherent power of the High Court is preserved by Section 482. The power of the High Court, therefore, is very wide. However, the High Court must exercise such power sparingly and cautiously when the Sessions Judge has simultaneously exercised revisional power under Section 397(1). However, when the High Court notices that there has been failure of justice or misuse of judicial mechanism or procedure, sentence or order is not correct, it is but the salutary duty of the High Court to prevent the abuse of the process or miscarriage of justice or to correct irregularities/ incorrectness committed by inferior criminal court in its judicial process or illegality of sentence or order.”

33. In view of the detailed discussion made herein above and law taken into consideration, there is sufficient ground for this Court to intervene and quash order framing charge as well as consequent proceedings against the petitioners, to prevent abuse of process of law and to prevent unnecessary harassment to the petitioners. This Court is of the view that continuance of the criminal proceedings against the petitioners in the present case would be a sheer wastage of time of the learned trial Court and the same would amount to subjecting the petitioners to unnecessary and protracted ordeal of trial, which if allowed to continue would amount to sheer abuse of process of law.

34. Consequently, in view of the above, present petition is allowed and order dated 16.12.2021, passed by the learned Sessions Judge, Sirmour, District at Nahan, H.P., whereby it proceeded to frame the charges, is quashed and set-aside, as a consequence of which, consequent proceedings arising therefrom are also set-aside. Accordingly, present petition is disposed of, alongwith pending applications, if any.