Himachal Pradesh High Court
M/S Kings Surgicals Memoodpur Mafi And ... vs State Of Himachal Pradesh on 19 September, 2019
Author: Sandeep Sharma
Bench: Sandeep Sharma
IN THE HIGH COURT OF HIMACHAL PRADESH AT SHIMLA
CrMMO No. 509 of 2018
Decided on: September 19, 2019
.
_____________________________________________________________
M/s Kings Surgicals Memoodpur Mafi and others
.........Petitioner
Versus
State of Himachal Pradesh ...Respondent
_____________________________________________________________
Coram
Hon'ble Mr. Justice Sandeep Sharma, Judge.
Whether approved for reporting?1 Yes.
_____________________________________________________________
For the petitioners: Mr. Maan Singh, Advocate.
For the respondent: M/s Sudhir Bhatnagar, Sanjeev Sood
r and Sumesh Raj, Additional
Advocates General with Mr. Kunal
Thakur, Deputy Advocate General.
_____________________________________________________________
Sandeep Sharma, J. (Oral)
Instant petition filed under S.482 CrPC, lays challenge to summoning orders dated 30.5.2018 and 8.10.2018 issued by learned Chief Judicial Magistrate, Chamba, Himachal Pradesh in Case No. 03/2018 titled State of Himachal Pradesh vs. Parmesh Puri and others under S.18(a)(i) of Drugs and Cosmetics Act, 1940 (hereinafter, 'Act'), whereby notices came to be issued to the petitioners, who have been arrayed as accused Nos. 3 to 5 in the aforesaid case.
Whether reporters of the Local papers are allowed to see the judgment? .
::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -2-2. Precisely the facts of the case, as emerge from the record, are that on 24.5.2018, Drug Inspector, Chamba, filed a .
complaint under S.18(a)(i) of the Act in the court of learned Chief Judicial Magistrate, Chamba, against the petitioners as well as other persons namely Shri Parmesh Puri and Shri Suresh Kumar, alleging therein that on 15.10.2016, he (Drug Inspector) inspected premises of M/s Puri Medical Store, Chaugan Bazaar, Chamba, Tehsil and District Chamba, and took sample of rolled bandages un-sterilized 5cm x 2.5m, Batch No. 161, Manufacturing Date 06/2016 and manufactured by M/s Kings Surgicals, Memoodpur Mafi, Dhampur Road, Kant Dhampur, UP, under the provisions of the Act. Samples drawn by the Drug Inspector were sent to the Government Analyst, Kandaghat, vide letter No. CBA/DI/2016-109 dated 17.10.2016, who vide report No. CTL-Drugs/2016-372, dated 21.1.2017, declared the samples of rolled bandages un-sterilized to be not of standard quality in respect of; (a) expiry date of the samples has not been mentioned in the sample, (b), average number of warps and wefts per dm is less than the prescribed limit; (c) average weight per metre square of the bandage is less than the prescribed limit and (d) width of the bandage was found less ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -3- than the prescribed limit. Proprietor of M/s Puri Medical Store, in response to communication No. CBA/DI/2017-193- .
194 dated 7.2.2017 disclosed that he had purchased bandages in question from M/s S.K. Scientific Enterprises Pharmaceuticals Distributors, Jassur, Tehsil Nurpur, District Kangra, Himachal Pradesh. Vide communication dated 27.2.2017, M/s S.K. Scientific Enterprises Pharmaceuticals Distributors, Jassur claimed that the manufacturer of the rolled bandages is M/s Kings Surgicals Memoodpur Mafi, Dhampur Road, Kant, Dhampur, UP. Since petitioner No.1 i.e. M/s Kings Surgicals failed to produce any evidence to contradict the report submitted by Government Analyst, Drug Inspector, took up the matter with the State Government for launching prosecution. Permission to launch prosecution against all the accused came to be granted vide communication dated 14.6.2017 by State Drug Controller, Himachal Pradesh. In nutshell, complainant claimed before the trial court that after thorough investigation of the present case, it is evident that accused Nos. 1 and 2 had sold/distributed and accused Nos. 3 to 5 (petitioners herein) had manufactured /sold/distributed the drug, which is not of standard quality, to the public and acted against the interests ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -4- of the public, as such, they are liable to be punished under S.27(d) of the Act and the provisions of Drugs and Cosmetics .
Rules, 1945 (hereinafter, 'Rules'), framed thereunder.
3. Taking cognizance of aforesaid complaint, learned Court below i.e. Chief Judicial Magistrate, Chamba, District Chamba, Himachal Pradesh, after having recorded its satisfaction to the effect that there exist sufficient grounds to proceed against the accused for the commission of offences punishable under S. 27(d) of the Act, issued notices to all the accused including present petitioners, as is evident from Annexure P-11. In the aforesaid background, petitioners, who are accused Nos. 3 to 5 before learned Court below, have approached this Court in the instant proceedings, praying therein to set aside the summoning orders dated 30.5.2018 and 7.7.2018 (Annexure P-11) and to quash the complaint (Annexure P-3).
4. I have heard learned counsel for the parties and perused the material available on record.
5. Before adverting to the factual matrix of the case, this Court deems it necessary to elaborate upon the scope and competence of this Court to quash the criminal proceedings while exercising power under Section 482 of Cr.PC. Hon'ble ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -5- Apex Court in judgment titled State of Haryana and others vs. Bhajan Lal and others, 1992 Supp (1) SCC 335 has laid .
down several principles, which govern the exercise of jurisdiction of High Court under Section 482 Cr.P.C. Before pronouncement of aforesaid judgment rendered by the Hon'ble Apex Court, a three-Judge Bench of Hon'ble Court in State of Karnataka vs. L. Muniswamy and others, 1977 (2) SCC 699, held that the High Court is entitled to quash a proceeding, if it comes to the conclusion that allowing the proceeding to continue would be an abuse of the process of the Court or that the ends of justice require that the proceeding ought to be quashed. Relevant para is being reproduced herein below:-
"7....In the exercise of this wholesome power, the High Court is entitled to quash a proceeding if it comes to the conclusion that allowing the proceeding to continue would be an abuse of the process of the Court or that the ends of justice require that the proceeding ought to be quashed. The saving of the High Court's inherent powers, both in civil and criminal matters, is designed to achieve a salutary public purpose which is that a court proceeding ought not to be permitted to degenerate into a weapon of harassment or persecution. In a criminal case, the veiled object behind a lame prosecution, the very nature of the material on which the structure of the prosecution rests and the like would justify the High Court in quashing the proceeding in the interest of justice. The ends of justice ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -6- are higher than the ends of mere law though justice has got to be administered according to laws made by the legislature. The compelling necessity for making .
these observations is that without a proper realisation of the object and purpose of the provision which seeks to save the inherent powers of the High Court to do justice, between the State and its subjects, it would be impossible to appreciate the width and contours of that salient jurisdiction."
6. Subsequently, Hon'ble Apex Court in Bhajan Lal (supra), has elaborately considered the scope and ambit of Section 482 Cr.P.C. Subsequently, Hon'ble Apex Court in Vineet Kumar and Ors. v. State of U.P. and Anr., while considering the scope of interference under Sections 397 Cr.PC and 482 Cr.PC, by the High Courts, has held that High Court is entitled to quash a proceeding, if it comes to the conclusion that allowing the proceeding to continue would be an abuse of the process of the Court or that the ends of justice require that the proceedings ought to quashed. The Hon'ble Apex Court has further held that the saving of the High Court's inherent powers, both in civil and criminal matters, is designed to achieve a salutary public purpose i.e. a court proceeding ought not to be permitted to degenerate into a weapon of harassment or persecution. In the aforesaid case, the Hon'ble Apex Court taking note of seven categories, where ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -7- power can be exercised under Section 482 Cr.PC, as enumerated in Bhajan Lal (supra), i.e. where a criminal .
proceeding is manifestly attended with malafides and/or where the proceeding is maliciously instituted with an ulterior motive for wreaking vengeance on the accused and with a view to spite him due to private and personal grudge, quashed the proceedings
7. Hon'ble Apex Court in Prashant Bharti v. State (NCT of Delhi), (2013) 9 SCC 293, while drawing strength from its earlier judgment titled as Rajiv Thapar and Ors v.
Madan Lal Kapoor, (2013) 3 SCC 330, has reiterated that High Court has inherent power under Section 482 Cr.PC., to quash the initiation of the prosecution against an accused, at the stage of issuing process, or at the stage of committal, or even at the stage of framing of charge, but such power must always be used with caution, care and circumspection. While invoking its inherent jurisdiction under Section 482 of the Cr.P.C., the High Court has to be fully satisfied that the material produced by the accused is such, that would lead to the conclusion, that his/their defence is based on sound, reasonable, and indubitable facts and the material adduced on record itself overrules the veracity of the allegations contained in the accusations levelled by the prosecution/complainant.
::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -8-The material relied upon by the accused should be such, as would persuade a reasonable person to dismiss and condemn .
the actual basis of the accusations as false. In such a situation, the judicial conscience of the High Court would persuade it to exercise its power under Section 482 Cr.P.C. to quash such criminal proceedings, for that would prevent abuse of process of the court, and secure the ends of justice.
In the aforesaid judgment titled Prashant Bharti v. State (NCT of Delhi), (2013) 9 SCC 293, the Hon'ble Apex Court has held as under:-
"22. The proposition of law, pertaining to quashing of criminal proceedings, initiated against an accused by a High Court under Section 482 of the Code of Criminal Procedure (hereinafter referred to as "the Cr.P.C.") has been dealt with by this Court in Rajiv Thapar & Ors. vs. Madan Lal Kapoor wherein this Court inter alia held as under: (2013) 3 SCC 330, paras 29-30)
29. The issue being examined in the instant case is the jurisdiction of the High Court under Section 482 of the Cr.P.C., if it chooses to quash the initiation of the prosecution against an accused, at the stage of issuing process, or at the stage of committal, or even at the stage of framing of charges. These are all stages before the commencement of the actual trial. The same parameters would naturally be available for later stages as well. The power vested in the High Court under Section 482 of the Cr.P.C., at the stages referred to hereinabove, would have far reaching consequences, inasmuch as, it would negate the prosecution's/complainant's case without allowing the prosecution/complainant to ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP -9- lead evidence. Such a determination must always be rendered with caution, care and circumspection. To invoke its inherent jurisdiction under Section 482 of the Cr.P.C. the .
High Court has to be fully satisfied, that the material produced by the accused is such, that would lead to the conclusion, that his/their defence is based on sound, reasonable, and indubitable facts; the material produced is such, as would rule out and displace the assertions contained in the charges levelled against the accused; and the material produced is such, as would clearly reject and overrule the veracity of the allegations contained in the accusations levelled by the prosecution/complainant. It should be sufficient to rule out, reject and discard the accusations levelled by the prosecution/complainant, without the necessity of recording any evidence. For this the material relied upon by the defence should not have been refuted, or alternatively, cannot be justifiably refuted, being material of sterling and impeccable quality. The material relied upon by the accused should be such, as would persuade a reasonable person to dismiss and condemn the actual basis of the accusations as false. In such a situation, the judicial conscience of the High Court would persuade it to exercise its power under Section 482 of the Cr.P.C. to quash such criminal proceedings, for that would prevent abuse of process of the court, and secure the ends of justice.
30. Based on the factors canvassed in the foregoing paragraphs, we would delineate the following steps to determine the veracity of a prayer for quashing, raised by an accused by invoking the power vested in the High Court under Section 482 of the Cr.P.C.:-
30.1 Step one, whether the material relied upon by the accused is sound, reasonable, and indubitable, i.e., the material is of sterling and impeccable quality?
30.2 Step two, whether the material relied upon by the accused, would rule out the assertions contained in the charges levelled ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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against the accused, i.e., the material is sufficient to reject and overrule the factual assertions contained in the complaint, i.e., the material is such, as would persuade a .
reasonable person to dismiss and condemn the factual basis of the accusations as false.
30.3 Step three, whether the material relied upon by the accused, has not been refuted by the prosecution/complainant; and/or the material is such, that it cannot be justifiably refuted by the prosecution/complainant?
30.4 Step four, whether proceeding with the trial would result in an abuse of process of the court, and would not serve the ends of justice?
30.5 If the answer to all the steps is in the affirmative, judicial conscience of the High Court should persuade it to quash such criminal - proceedings, in exercise of power r vested in it under Section 482 of the Cr.P.C.
Such exercise of power, besides doing justice to the accused, would save precious court time, which would otherwise be wasted in holding such a trial (as well as, proceedings arising therefrom) specially when, it is clear that the same would not conclude in the conviction of the accused."
8. Hon'ble Apex Court in Asmathunnisa v. State of A.P. (2011) 11 SCC 259, has held as under:
"12. This Court, in a number of cases, has laid down the scope and ambit of the High Court's power under section 482 of the Code of Criminal Procedure.
Inherent power under section 482 Cr.P.C. though wide have to be exercised sparingly, carefully and with great caution and only when such exercise is justified by the tests specifically laid down in this section itself. Authority of the court exists for the advancement of justice. If any abuse of the process leading to injustice ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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is brought to the notice of the court, then the Court would be justified in preventing injustice by invoking inherent powers in absence of specific provisions in the .
Statute.
13. The law has been crystallized more than half a century ago in the case of R.P. Kapur v. State of Punjab AIR 1960 SC 866 wherein this Court has summarized some categories of cases where inherent power can and should be exercised to quash the proceedings. This Court summarized the following three broad categories where the High Court would be justified in exercise of its powers under section 482:
r (i) where it manifestly appears that there is a legal bar against the institution or continuance of the proceedings;
(ii) where the allegations in the first information report or complaint taken at their face value and accepted in their entirety do not constitute the offence alleged;
(iii) where the allegations constitute an offence but there is no legal evidence adduced or the evidence adduced clearly or manifestly fails to prove the charge."
14. In Smt. Nagawwa v. Veeranna Shivalingappa Konjalgi and Others (1976) 3 SCC 736, according to the court, the process against the accused can be quashed or set aside :
"(1) where the allegations made in the complaint or the statements of the witnesses recorded in support of the same taken at their face value make out absolutely no case against the accused or the complaint does not disclose the essential ingredients of an offence which is alleged against the accused;
(2) where the allegations made in the complaint are patently absurd and inherently improbable so that no prudent person can ever reach a conclusion ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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that there is sufficient ground for proceeding against the accused;
(3) where the discretion exercised by the Magistrate in issuing process is capricious and arbitrary .
having been based either on no evidence or on materials which are wholly irrelevant or inadmissible; and (4) where the complaint suffers from fundamental legal defects, such as, want of sanction, or absence of a complaint by legally competent authority and the like".
15. This court in State of Karnataka v. L. Muniswamy & Others (1977) 2 SCC 699, observed that the wholesome power under section 482 Cr.P.C.
entitles the High Court to quash a proceeding when it comes to the conclusion that allowing the proceedings to continue would be an abuse of the process of the rcourt or that the ends of justice requires that the proceedings ought to be quashed. The High Courts have been invested with inherent powers, both in civil and criminal matters, to achieve a salutary public purpose. A Court proceeding ought not to be permitted to degenerate into a weapon of harassment or persecution. In this case, the court observed that ends of justice are higher than the ends of mere law though justice must be administered according to laws made by the Legislature. This case has been followed in a large number of subsequent cases of this court and other courts."
9. Hon'ble Apex Court in Asmathunnisa (supra) has categorically held that where discretion exercised by the Magistrate in issuing process is capricious and arbitrary having been based either on no evidence or on materials which ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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are wholly irrelevant or inadmissible; and where the complaint suffers from fundamental legal defects, such as, want of .
sanction, or absence of a complaint by legally competent authority and the like, High Court would be justified in exercise of its powers under S. 482 CrPC.
10. From the bare perusal of aforesaid exposition of law, it is quite apparent that exercising its inherent power under Section 482 Cr.PC., High Court can proceed to quash the proceedings, if it comes to the conclusion that allowing the proceedings to continue would be an abuse of process of the law.
11. Now in the light of the aforesaid exposition of law, this Court shall make an endeavor to examine the material available on record vis-à-vis impugned orders with a view to arrive at a conclusion that whether facts of the case warrant exercise of power by this court under Section 482 Cr.PC for quashing of summoning process or not?
12. In the case at hand, admittedly, the complaint has been filed under S.18(a)(i) of the Act with a prayer to punish the accused under S.27(d) of the Act and Rules framed thereunder. At this stage, it would be apt to take note of Ss. 18 and 27(d) of the Act as under:
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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 or spurious;] [(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof [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 r means, purports or claims 4 [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 [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 [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:::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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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.
[18A. Disclosure of the name of the manufacturer, etc.-- Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.] [18B. Maintenance of records and furnishing of information.--Every person holding a licence under clause
(c) of section 18 shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.]"
......
......
27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter:
(a)..
(b)...
(c)...
(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 ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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be less than one year but which may extend to two years 8 [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."
13. Careful perusal of aforesaid provisions of law clearly suggests that no person can manufacture, for sale or for distribution or sell or stock or exhibit, any drug which is not of standard quality or is mis-branded, adulterated or spurious.
14. Ss.12 and 33 of Chapter IV of the Act empower Central Government to make Rules for the purpose of giving effect to the provisions contained in Chapter IV of the Act.
Rule 124(c) specifies the standards for "surgical dressings", which otherwise stand laid down in Schedule F(II), which is reproduced herein below:
"PART IV GENERAL
1. For the purpose of this Schedule any test or method of testing described in the British Veterinary Codex shall be deemed to be a method approved by the Licensing Authority.
2. The Licensing Authority shall publish in the official Gazette from time to time particulars of any test or method of testing approved by him.] 353 Drugs and Cosmetics Rules, 1945 1 [SCHEDULE F (II) ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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(See Rule 124-C) STANDARDS FOR SURGICAL DRESSINGS Synonyms: Bandage Cloth, Bleached Bandage Cloth, .
Rolled Bandage, Open Wove Bandage, Cotton Bandage Cloth.
Bandage Cloth consists of cotton cloth of plain weave made from machine spun yarn of suitable count to comply with a bleached count between 20 tex and 25 tex for warp and between 25 tex and 30 tex for weft. The fabric contains no filling, sizing or dressing material. It may be supplied uncut and folded or cut to suitable size and rolled.
Description for uncut bandages:
Uncut bandages are cotton cloth of plain weave, in one continuous length showing no joints or seams, with well-formed selvedges. The cloth is bleached to a good white, is clean and odourless and reasonably free from weaving defects and from seed and leaf debris. Description for cut bandage:
Same as for uncut bandages, except for selvedges which shall not be included in cut bandages. In addition, both the extremes and edges of cut bandages shall be straight and evenly cut, with reasonable freedom and loose threads.
Threads per dm: - Warp not less than 150 and weft not less than 85.
Weight in g/m2 : - 57 ± 5.
Length and Width: - The length and width shall not be less than 99 per cent each of the length and width stated on the label. For cut bandages, each of the bandages in a packing complies with this requirement.
Foreign matter: - Not more than 2 per cent. Fluorescence:
When viewed under screened ultra-violet light, not more than occasional points of fluorescence are observed.::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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Packing, Labelling and Storage:
Bandage Cloth shall be packed securely so as to allow normal handling and transport without tearing and exposing .
the contents. In packages of cut and rolled bandages, each bandage shall also individually be wrapped in a suitable paper. The net content is stated on the label in terms of length and width. Bandage Cloth must be stored in packed condition protected from dust. The packings of Bandage Cloth shall be labelled prominently with the words "Non- Sterile".
15. Having carefully perused Schedule F(II) in Part IV of the Rules (Annexure P-3 of the reply filed by the respondent), there cannot be any dispute with regard to the fact that at the time of drawing samples of "rolled bandages"
from M/s Puri Medical Store, same were not found conforming to the standards prescribed for "surgical dressings", which fact otherwise has not been disputed by the petitioners, who are manufacturers of such rolled bandages. Petitioner No.1, in reference to communication sent by Drug Inspector, Chamba, vide communication dated 20.3.2017 (Annexure P-9), agreed with the report of the Government Analyst, Kandaghat and assured that the offence committed by them would not be repeated in future. However, the fact remains that the aforesaid request made by the petitioners herein was not acceded to by the Drug Inspector, Chamba and complaint in ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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question ultimately came to be filed before competent Court of law, which, after having taken note of the material placed .
before it, proceeded to issue summons to all the accused.
16. However, on 31.1.2018, Ministry of Health and Family Welfare, notified the Medical Devices Rules, 2017 (Annexure P-1 of reply filed by the respondents). Rule 90 of Chapter XII of the Medical Devices Rules, 2017 provides that the medical devices specified in the Eighth Schedule shall be exempted from the provisions of these Rules to the extent and conditions specified in the Schedule. Medicated dressings and bandages for first aid, which were otherwise prescribed at Sr. No. 2 of the Eighth Schedule also came to be exempted from the provisions of Medical Devices Rules, 2017 and in this background, petitioners have approached this Court in the instant proceedings for quashing of complaint as well as summoning orders.
17. Ministry of Health and Family Welfare, Government of India, vide communication dated 29.8.2018, further clarified that, "the bandages which do not come in contact with wound, injured skin or tissue, but are used for providing support/compression are not covered under the category of "Surgical Dressing."", and as such, no ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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manufacturing licence for the manufacture of such products is required from the State Government or Central Government.
.
18. In the aforesaid background, case of the petitioners is that since the Medical Devices Rules, 2017, came into force with effect from 1.1.2018, whereby rolled bandages came to be exempted from the provisions of the Medical Devices Rules, 2017 before filing of the complaint in question, learned Court below ought not have issued summons against the accused.
19. Mr. Maan Singh, learned counsel for the petitioners, while inviting attention of this Court to the Medical Devices Rules, 2017, vehemently argued that under the provisions of Rule 90 of the aforesaid Rules, medical devices specified in the Eighth Schedule have been exempted from the provisions of Medical Devices Rules, 2017 as such, discrepancies pointed out by the Drug Inspector in the complaint are of no consequence. Learned counsel for the petitioners further contended that in the case at hand, petitioners were duly licensed to manufacture rolled bandages and gauze but now in view of the Medical Devices Rules, 2017 and clarification issued by the Government of India, no manufacturing licence is required to be obtained for ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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manufacture of rolled bandages, which do not come in contact with the wound, injured skin or tissue.
.
20. Mr. Sudhir Bhatnagar, learned Additional Advocate General, while fairly admitting the factum with regard to promulgation of Medical Devices Rules, 2017, strenuously argued that since samples were drawn much prior to promulgation of the aforesaid Rules, complaint filed by Drug Inspector, which admittedly pertains to the period prior to promulgation of Medical Devices Rules, 2017, deserves to be adjudicated by learned Court below, on its own merits.
21. Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, by way of Notification dated 31.1.2017, promulgated the Medical Devices Rules, 2017, relevant portion of which is reproduced herewith alongwith Rule 90 thereof:
"MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 31st January, 2017 G.S.R. 78(E).--
WHEREAS the draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and Sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government, after ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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consultation with the Drugs Technical Advisory Board, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of .
thirty days from the date on which copies of the said Gazette containing the said notification were made available to the public; AND WHEREAS, copies of the Gazette containing the said notification were made available to the public on the 17th October, 2016; AND WHEREAS, all objections and suggestions received in response to the said draft notification have been duly considered by the Central Government; NOW, THEREFORE, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules, namely,- CHAPTER I PRELIMINARY 1. Short title and commencement.--(1) These rules may be called the Medical Devices Rules, 2017. (2) These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018.
CHAPTER XII MISCELLANEOUS
90. Exemption from provisions related to medical devices.--(1) The medical devices specified in the Eighth Schedule shall be exempt from the provisions of these rules to the extent and subject to the conditions specified in that Schedule. (2) The Central Government may, by notification, from time to time, amend or modify the entries in the Eighth Schedule.::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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22. No doubt, in the case at hand, rolled bandages manufactured by the petitioners were not found conforming to .
the standards prescribed under the Rules, when samples were drawn, as such, Drug Inspector was well within his right to launch prosecution, but this Court cannot lose sight of the fact that before such complaint could be filed in the competent Court of law, Medical Devices Rules, 2017 came into force.
Chapter XII, Rule 90 clearly lays down that the medical devices specified in the Eighth Schedule would be exempted from the provisions of these Rules. It is not in dispute that the rolled bandages were specified in the Eight Schedule, as such, they are exempted from the provisions of the Medical Devices Rules, 2017.
23. Extent and conditions of exemption as mentioned in the Eight Schedule though suggest that medical dressing and bandages for first aid would be exempted from the provisions of Chapter II of these Rules, which require them to be covered by Sale Licence, subject to the condition that such products have been manufactured by a licensed manufacturer but, as has been taken note herein above, Central Government vide subsequent communication dated 29.8.2018, has clarified that the bandages, which do not come in contact with the wound, inured skin or tissue but are simply used for providing ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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support and compression, are not covered under the category of "surgical dressings". Standards prescribed in Schedule F(II) .
strictly deal with surgical dressings and not with rolled bandages.
24. No doubt, samples of rolled bandages were found not conforming to the prescribed standards hence, complaint made by the Drug Inspector cannot be said to be without any justification but, offence, if any, committed by the accused amounts to technical violation of standards prescribed under Schedule F(II), "Standards for Surgical Dressings:, wherein length and width etc. of the rolled bandages stand prescribed.
25. The next question raised before this Court is whether the Medical Devices Rules, 2017 will have retrospective effect or prospective effect. Mr. Sudhir Bhatnagar, learned Additional Advocate General vehemently argued that at the time when offence was committed, Medical Devices Rules, 2017 had not come into force, as such, case of the petitioners deserves to be considered and decided under the Drugs and Cosmetics Act, 1940/Drugs and Cosmetics Rules, 1945, but having carefully perused Rule 90 of the Medical Devices Rules, 2017 and communication dated 29.8.2018, this Court is in agreement with Ms. Maan Singh, learned counsel for the petitioners that exemption under Rule ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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90 of Medical Devices Rules, 2017 has been purposely provided to correct the position of standards of surgical .
dressings with reference to the latest research on the subject.
26. In the case of the petitioners, length, width and average warps/wefts were admittedly not found conforming to the standards laid down in Schedule F(II) Part IV of the Rules but such omission on the part of the petitioners definitely cannot be said to be injurious to the health of the public, because, in view of promulgation of the Medical Devices Rules, 2017, rolled bandages have been taken out from the definition of "surgical dressings", especially those bandages, which do not come in contact with the wound, injured skin or tissue.
27. In a similar case, Hon'ble Apex Court, in Krishan Gopal Sharma v. Govt. of N.C.T. of Delhi, (1996) 4 SCC 513, has held addition of saccharin in the pan masala to be a technical violation and quashed the criminal proceedings in that case, subject to costs of Rs.7500/-. The Hon'ble Apex Court in the judgment (supra) held as under:
"12. In the back drop of aforesaid exposition of law for offences under the Prevention of Food Adulteration Act it is necessary to consider the facts and circumstances of the case. In these appeals, there is no dispute that saccharin was not added to Pan Masala and Mouth Freshner. It is contended that even if addition of saccharin to the extent as stated to ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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have been found by the Analyst is accepted to have been correctly determined, such addition, as a matter of fact, was neither injurious to health nor it .
degenerated the articles sold so that they could be branded as adulterated fact. The ban on the use of saccharin in Pan Masala and mouth Freshner was imposed on a misconception and erroneous view of its injurious effect on human system. But later on, it has been accepted by the Rule making authority that use of saccharin to the extent of 8000 ppm in pan masala will not be harmful for human consumption and Rule 47 of the Rules has been amended. As use of saccharin to the extent of 2000 and 2450 ppm was not injurious to health at any point of time, it must be held that even before amendment of Rule 47 such r use of saccharin to the above extent did not constitute an offence for adulterating food with substances injurious to health.
13. In our view, at the relevant time, saccharin content in Pan Masala and Mouth Freshner to the extent of 2000 and 2450 ppm as found by the Analyst was not permissible under the Prevention of Food Adulteration Rules. We have indicated that such Rule was valid and operative at the relevant time. Hence, there had been violation of the Food Adulteration Act and the Rules framed thereunder in selling Pan Masala and Mouth Freshner with saccharin content to the extent of 2000 and 2450 ppm. Hence, the complaints made by the Health Department of Delhi Administration and initiation of criminal cases against the accused cannot be held to be without justification. It cannot also be contended that on the face of the complaint, no offence was prima facie committed. Hence, the impugned decision of the High ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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Court in dismissing the applications under section 482 Cr.P.C. can not be held to be unjustified.
14. It, however, appears to us that even if the complaint .
is accepted to be correct, the only offence committed by the appellants amounts to technical violation of the mandate of Rule 47 for adding saccharin to the extent of 2000 and 2450 ppm in the Chutki Pan Masala and Mouth freshner. Such addition of saccharin cannot be held to be injurious to health because, considering later findings on research and analysis on the effect of saccharin on human system, addition of saccharin to the extent 8000 ppm in Pan Masala has been allowed by amending Rule 47. The articles sold are not alleged to be injurious to health and such allegations, even if made, cannot be r accepted. There is no allegation that any other injurious substance was added to the articles sold making them potentially health hazards. It is also not the case that Pan Masala and Mouth Freshner were of inferior quality and sub-standard. In a case like this, the offence committed is on account of technical violation of Rule 47. It should be emphasized that strict adherence to Prevention of food Adulteration Act and Rules framed thereunder should be insisted and enforced for safeguarding the interest of consumers of articles of food. In the Constitution Bench decision in Tejani's case (supra) it has been indicated that in ordered to prevent unmerited leniency in the matter of awarding sentence for an offence under the Prevention of food Adulteration Act, the legislature by amendment has incorporated the provision of minimum sentence. But it was also been indicated that the court, for adequate and special reasons, may bring down the minimum sentence. The ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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Constitution Bench has also observed that all violations of provisions of the Act and Rules need not be treated alike because "there are violations. In the .
special facts of these cases, it appears to us that a defferent punishment of imprisonment is not called for and imposition of fine of will meet the ends of justice. The criminal cases were initiated on the basis of samples taken in 1967. The accused appellants have already faced the ordeal of criminal trials for a number of years. In the aforesaid circumstances, further agony of criminal trial need not be prolonged.
Conclusion of the criminal cases will also save time and expenditure of the respondent.
15. In that view of the matter, we direct for quashing the criminal cases in question on payment of costs at r Rs.7500/- in each of these appeals as in our view, on conviction of the appellants in the criminal cases initiated against them, such fine would have met the ends of justice. The appeals are accordingly disposed of."
28. Regarding issue of retrospective effect of the Notification promulgating the Medical Devices Rules, 2017, this Court deems it fit to make a reference to the judgment rendered by Bombay High Court (Aurangabad Bench) in Ahmednagar Municipal Council, Ahmednagar v.
Dullabhadas Haridas Patel, 2010 Cri.L.J. 2155 (Bom), wherein it has been held as under:
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13. It is argued before this Court by learned advocate Shri Bedre that such amendment will not have retrospective effect.
When the offence has taken place, saccharin was totally .
prohibited. Under the circumstances, it cannot be said that no offence is committed. Penal provision, which creates of offence has to be interpreted as prospective and not as retrospective. The learned advocate Shri Vijay Sharma ( 10 ) cited case of Krishan Gopal Sharma and Another V/s. Govt. of N.C.T. Of Delhi (1996) 4 S.C.C.513. In that case as observed in para 8 therein similar situation has arisen as in the present case. At the relevant time when samples of pan masala and the mouth freshner were taken, the saccharin content as found by the public analyst in the said articles of good was in violation of Rule 47 of the Prevention of Food Adulteration Rules. The pan masala and the mouth freshner are undoubtedly within the meaning of 'food' under Section 2 (v) of the Prevention of Food Adulteration Act. In that case the validity of Rule 47 prior to amendment in 1993 restricting use of saccharin in pan masala was challenged on the ground that it was arbitrary, unjust and capricious by the rule making authority. The Supreme Court has held that rule as stood prior to the amendment was valid and it cannot be struck out as being arbitrary and capricious. It is observed in para 8 as follows:-
"8. .......... It has not been demonstrated that despite widely accepted view by the experts about the effect on saccharin on human system on the basis of information flowing from research and analysis, the restriction of user of saccharin in pan masala or mouth freshner as imposed in Rule 47 of the Rules at the relevant ( 11 ) time was wholly arbitrary, unjust and capricious. Human knowledge is not static. The conception about the harmful effect of saccharin on human system has undergone changes because of information derived from further research and analysis. The knowledge about the effect of saccharin on human system as accepted today may undergo a change in future on the basis of further knowledge ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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flowing from subsequent research and analysis and it may not be unlikely that previous view about saccharin may be found to be correct later on. If the rule- making authority on the basis of human knowledge widely accepted by the expert framed rule .
by imposing restriction of user of saccharin in pan masala or mouth freshner at a particular point of time, such exercise of power must be held to have been validly made, founded on good reasons; and challenge of the Rule on the score of arbitrary and capricious exercise of power must fail. ..........."
In that case in para 12 facts of particular case were considered, which were similar to the case in hand and it is observed that there was no dispute that saccharin was not added to pan masala and mouth freshner. It is contended that even if addition of saccharin to the extent as stated to have been found by the analyst is accepted to have been correctly determined, such addition as a matter of fact, was r neither injurious to health or it degenerated the articles sold, so that they could be branded as adulterated food. The ban on the use of saccharin in pan masala and mouth freshner was imposed on a misconception and erroneous view of its ( 12 ) injurious effect on human system. But, later on, it has been accepted by the rule-making authority that use of saccharin to the extent of 8000 p.p.m. in pan masala will not be harmful for human consumption and Rule 47 of the Rules has been amended. So, in para 14 and 15 of the said case it is further observed that in the special facts of those cases, a deterrent punishment of imprisonment is not called for and imposition of fine would meet the ends of justice. These criminal cases were initiated on the basis of samples taken in 1987. The accused-appellants had already faced the ordeal of criminal trials for a number of years. In the facts of the case, the accused were released on fine.
14. The point that was not raised in the case of Krishan Gopal Sharma (Supra) but which is raised before this Court is that whether such amendment will have retrospective effect. The learned advocate for the respondents relied upon certain ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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observations in Zile Singh V/s. State of Haryana and Ors., (2004) 8 SCC, 1. The Supreme Court was considering whether disqualification for membership of municipality of a .
person having more than two children on and [upto] the expiry of one year of commencement of Haryana Municipal Act, 1973, ( 13 ) has retrospective or prospective effect. It is held that it is a cardinal principle of construction that every statute is prima facie prospective unless it is expressly or by necessary implication made to have a retrospective operation. However, it is further held that, the rule in general is applicable where the object of the statute is to affect vested rights or to impose new burdens or to impair existing obligations. The presumption against retrospective operation is not applicable to curative or declaratory statutes. In this case amendment to Rule 47 is not declaratory, but it can be said to be curative statute, as it wants to correct the position of standard of saccharine with reference to the latest research on the effect of saccharine on human health and it wanted to permit saccharin to a particular extent.
15. Another case cited by Adv. Shri Vijay Sharma is Vijay V/s.
State of Maharashtra and Others, (2006) 6 S.C.C. 289. In that case also it is laid down that general rule of construing statute is to have prospective effect. It does not apply to disqualifying, curative or clarificatory statutes. If on a plain or literal reading legislative intendment is clear that it is to have retrospective effect ( 14 ) and it does not produce any absurdity or ambiguity thereby, court will give effect thereto. Statute which takes away a right under the existing law is retrospective in nature. Statute enacted for the benefit of the community as a whole may be construed to have retrospective operation.
16. In the present case the saccharin was totally prohibited when the alleged offence took place, but pending the trial, ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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the rule making authority under Section 23 of the Prevention of Food Adulteration Act, in its wisdom thought it right to allow saccharin to the extent of permissible limit. It .
is not disputed that when the rule was amended, trial of respondent Nos. 1 to 5 was pending. The amendment is for the benefit of community as a whole and it was not taking away any vested interest or creating any new obligation or creating new offence. It, in-fact, declared addition of saccharine to Supari within certain limits, as no more offence under the Prevention of Food Adulteration Act. So, relying on law laid down in paras 10, 11 and 12 of the case of Vijay (Supra), in my opinion, in the present case, Rule 47 can be considered as retrospective in as much as it wanted to declare saccharine contents in Supari to certain limits r i.e. ( 15 ) 4000 p.p.m. as permissible in law and no more offence. I quote certain portion from paras 10 and 12 of Vijay (Supra) for ready reference :-
"10. ......... The inhibition against retrospective construction is not a rigid rule. It does not apply to a curative or a clarificatory statute. If from a perusal of the statute, intendment of the legislature is clear, the court will give effect thereto. For the said purpose, the general scope of the statute is relevant. Every law that takes away a right vested under the existing law is retrospective in nature.
..............
12. ........ It is not well settled that when a literal reading of the provision giving retrospective effect does not produce absurdity or anomaly, the same would not be construed to be only prospective. The negation is not a rigid rule and varies with the intention and purport of the legislature, but to apply it in such a case is a doctrine of fairness. When a law is enacted for the benefit of the community as a whole, even in the absence of a provision, the statute may be held to be retrospective in nature. ................"
17. Since the rule was amended pending the Trial and since evidence of Public Analyst Mrs. Aparna Pinge showed that the saccharine contents were within permissible limit as per ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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the amended Rule 47, in my opinion, it is not case where any interference with the order of acquittal is called for."
.
29. Bombay High Court in the aforesaid case, has held that the presumption against retrospective operation is not applicable to curative or declaratory statutes. In the case at hand also, statute in question is a curative statute hence, in view of aforesaid judgment, in the case at hand also, same principles would apply and Rules in question would apply retrospectively.
30. In the case at hand also, in view of promulgation of the Medical Devices Rules, 2017, there is only a technical violation on the part of the petitioners, which is not injurious to the heath of the patients using them, as such, no fruitful purpose would be served by continuing with criminal prosecution of the petitioners, rather same would be only an abuse of process of law.
31. In the peculiar facts and circumstances, it appears to this Court that no fruitful purpose would be served in case proceedings initiated against the petitioners at the behest of Drug Inspector are allowed to continue rather, petitioners would be unnecessarily put to ordeal of protracted trial.
32. Consequently, in view of above, present petition is allowed. Summoning orders dated 30.5.2018 and 8.10.2018 ::: Downloaded on - 26/09/2019 20:24:47 :::HCHP
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(Annexure P-11) issued by learned Chief Judicial Magistrate, Chamba, Himachal Pradesh against the petitioners herein .
(accused Nos. 3 to 5) in Case No. 03 of 2018 titled State of Himachal Pradesh vs. Parmesh Puri and others are set aside and quashed alongwith complaint (Annexure P-3), subject to payment of costs of Rs.20,000/-, to be deposited with the Drug Inspector, Chamba.
Pending applications, if any, stand disposed of.
Interim directions, if any, stand vacated.
r (Sandeep Sharma)
Judge
September 19, 2019
(Vikrant)
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