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2021 DIGILAW 459 (JK)

Shipra Bansal v. Drug Inspector, Udhampur

2021-09-03

JAVED IQBAL WANI

body2021
ORDER : 1. Inherent jurisdiction of this Court under Section 561-A (Section 482) is being invoked by the petitioner for quashment of complaint titled as “Drug Inspector (HQ) Vs. Rajinder Kumar Sharma and others” pending before the Court of learned Chief Judicial Magistrate, Udhampur (for brevity “trial Court”). 2. The petitioner claims to be the proprietor of M/S Santoshiba Herbs India having its registered office at Sector -27-28, Industrial Area, Hisar, Haryana. The said concern of the petitioner is stated to be possessed of a license under License No. 387-ISM (HR) for manufacturing Ayurvedic Drugs granted under and in terms of the Drugs and Cosmetics Act of 1940 and Drugs and Cosmetics Rules, 1945 (hereinafter for short “the Act and the Rules”). 3. A criminal complaint is stated to have been filed in the Court of learned Chief Judicial Magistrate Udhampur by the respondent No. 1 against the petitioner herein, besides M/S Aee Dee Enterprises and one Rajinder Kumar Sharma, proprietor of M/s Sudesh Pharmaceuticals, Main Bazar, Udhampur for having committed offences under Sections 18 (a) (i) read with Section 27 (b) (i) [for manufacturing sale and distribution of an adulterated drug, Sweet Night Capsules (Batch No. SN-112)] and Section 18(c) read with Section 27(b) (ii) of the Act. 4. The precise allegation levelled in the said compliant against the accused persons (including petitioner herein) is that on 09.07.2010, upon visit to the premises of respondent No. 3, he was found to have stocked and exhibited drugs for sale in his premises including a Drug, namely, “Sweet Night Capsules” (Batch No. SN-112), Mfg. dt. Jan 2010 with Exp. Dt. Dec 2014 manufactured by the concern of the petitioner herein. Upon lifting of sample of drug in question by the complainant-respondent No. 1 herein, in accordance with the provisions of the Act and Rules had send one sealed sample of drug in question to Government analyst (C.F.D.L. Patoli Jammu) which found that the sample in question not of standard quality as defined in the Act and further that the same contained a drug namely “Sidenafil Citrate”. 5. 5. Upon presentation of the complaint in question before the Trial Court, cognizance came to be taken by the trial Court in terms of order dated 03.02.2012 where under the trial Court had been prima facie satisfied that the accused persons appear to have committed the offences punishable under Section 18 (a) (i) read with Section 27 of the Act. 6. The complaint and proceedings undertaken thereof by the trial Court are being challenged in the instant petition, inter alia on the grounds which are in extenso, extracted and reproduced here under:- (I) FOR THAT throughout the length and breadth of the petition of complaint there is no reference to the actual role played by the petitioner in the alleged offence which is the subject matter of the instant case and in the absence of any such specific role being attributed to the petitioner the said petitioner cannot be made an accused person merely on the ground that he is the proprietor. I (A) That sanctioning authority i.e. controller Drugs and Food Control Organisation have not applied his mind before granting sanction for prosecution in the present case, it is submitted that vide report dated 26.02.2011 the Govt. Analyst declared the Drug in question to be of not of Standard Quality further in review opinion dated 06.03.2011 declared the Drug in question to be adult rated. Further the sanctioning authority without perusing the proper record have given the sanction for launching the prosecution for not of standard quality, the investigating authority and the sanctioning authority have confused themselves about the offence committed by the petitioner herein without proper application of mind reports are drawn by analyst and sanction is given without verifying record. Hence complaint is liable to be quashed. (II) FOR THAT continuation of the proceeding against the petitioner is illegal, without jurisdiction and liable to be quashed. (III) FOR THAT the alleged search and seizure conducted in the instant case is contrary to the mandatory requirement of law and has resulted in denial of vital rights enshrined under law in favour of the petitioner. (IV) FOR THAT initiation of the impugned proceedings without resorting to the vital right of the petitioner as enshrined under Section 25(4) of the Drugs & Cosmetics Act, 1940 renders the same without jurisdiction, illegal and the same is liable to be quashed. (IV) FOR THAT initiation of the impugned proceedings without resorting to the vital right of the petitioner as enshrined under Section 25(4) of the Drugs & Cosmetics Act, 1940 renders the same without jurisdiction, illegal and the same is liable to be quashed. (V) FOR THAT the failure of the opposite party to promptly send the sample for test by Central Drugs Laboratory in view of the objection raised by the petitioner with regard to the report of the Government Analyst which is contrary to the report submitted by the approved laboratory as mentioned above and petitioner's company has caused severe prejudice and denial of opportunity to the petitioner to avail of the vital right provided under Section 25(4) of the Drugs & Cosmetics Act, 1940. (VI) FOR THAT Chapter IVA of the said Act is titled "Provisions Relating to Ayurvedic, Siddha and Unani Drugs". Section 33B of the Act which is the first Section in Chapter IVA clearly stipulates that this Chapter shall apply only to Ayurvedic, Siddha and Unani Drugs. Succeeding Sections in Chapter IVA prescribe, stipulate as well as provide for independent mechanism and set up as well as prohibition, penalties etc. with respect to the Ayurvedic Drugs apart from Siddha and Unani Drugs. Section 33H of the said Act lays down that provisions of Sections 22, 23, 24 and 25 of the Act would be applicable to Ayurvedic Drugs as well. A combined reading of the aforesaid provisions therefore clearly reveal that in so far as Ayurvedic Drugs are concerned, neither Section 18 nor Section 27 of the Act have any application. This is more specifically reinforced by the fact that Section 33A of Act which is a part of Chapter IV of the Act clearly lays down that save as aforesaid provided in the Act, nothing contained In Chapter IV shall apply to Ayurvedic drugs. On this count alone the prosecution of the petitioner under the aforesaid Sections of the said Act is not maintainable because admittedly the complaint in question relates to Ayurvedic Drugs only and not to any other types or categories or classes of Drugs. (VII) FOR THAT the search and seizure in the instant case and the purported chemical examination by an unauthorized person is contrary to the mandatory requirements of law. (VII) FOR THAT the search and seizure in the instant case and the purported chemical examination by an unauthorized person is contrary to the mandatory requirements of law. The opposite party who conducted illegal search and seizure in the instant case had no statutory authority to do so under the Act in respect of ayurvedic drugs which are covered under the provisions of Chapter IVA of the Drugs and Cosmetics Act, 1940. That apart, the test report of the Governmental Analyst, Jammu was issued in Form 13 which does not relate to Ayurvedic Drugs. Any report of ayurvedic drugs are statutorily required to be made in Form 13A in terms of Rule 163(5) of the Drugs & Cosmetics Rules, 1945. It is submitted that the search and seizure in the instant case was conducted by an unauthorized person and is wholly illegal and non-est in law. The test report has also been issued contrary to the statutory mandate as required under Section 163(5) of the Drugs & Cosmetics Rules, 1945 and not in the statutory Form 13A as appended to the said Rules. In view of such facts, the very basis of the prosecution which is the product of such illegal search and seizure by an unauthorized person and based on a purported test report which has been issued in violation of mandatory provisions of law, is wholly without jurisdiction, nonest in the eye of law and liable to be quashed. (VIII) FOR THAT the purported test report by the Governmental Analyst, Jammu which is the foundation of the instant prosecution is a non-speaking one without communicating any specific protocol test of the ayurvedic drug to come to the alleged conclusion that the same contains "Sidenefil Citrate" which also does not indicate the extent and quantity of such steroid in its report. It is submitted that the initiation of prosecution on the basis of such a bald and non specific report is contrary to the mandatory provisions of the Act and Rules framed thereunder, is baseless and the same is liable to be quashed. (IX) FOR THAT neither the Drug Inspector nor 'did Government Analyst is notified as per the mandate of section 33 G and 33F of the Drugs and Cosmetics Act, 1940. Further the investigation and prosecution of the case is maintained by the un-notified/incompetent person which is void-abinitio and the same is liable to be quashes. (IX) FOR THAT neither the Drug Inspector nor 'did Government Analyst is notified as per the mandate of section 33 G and 33F of the Drugs and Cosmetics Act, 1940. Further the investigation and prosecution of the case is maintained by the un-notified/incompetent person which is void-abinitio and the same is liable to be quashes. (X) FOR THAT continuation of the impugned proceedings against the petitioner is an abuse of the process of law and the same is liable to be quashed in the interest of justice. 7. Heard learned counsel for the parties and perused the record. 8. The fundamental ground urged by the learned counsel for the petitioner against the prosecution launched in terms of the complaint and proceedings thereof is that the case of the petitioner ought to have been dealt with by the respondents in terms of Chapter IV- A of the Act and that the respondents instead have launched the prosecution against the petitioner under Chapter IV of the Act. Thus, the complaint instituted as also proceedings undertaken thereof are contended to be without competence and jurisdiction. 9. According to the learned counsel for the respondent No. 1, the prosecution launched against the petitioner has been validly and legally launched in terms of Chapter IV A of the Act and the respondent No. 1 is competent thereof to launch such prosecution against the petitioner and that the complaint filed as also proceedings undertaken thereof are legally tenable. 10. Before adverting to the rival contentions of the parties, it would be advantageous and appropriate to refer to the following provisions of the Act, being relevant and germane herein.:- Chapter IV of the Act deals with Manufacture, Sale and Distribution of Drugs and Cosmetics. Section 18 of the Chapter IV provides for prohibition of manufacture and sale of drugs and cosmetics and reads as under:- Section 18:- Prohibition of manufacture and sale of certain drugs and cosmetics. Section 18 of the Chapter IV provides for prohibition of manufacture and sale of drugs and cosmetics and reads as under:- Section 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 means, purports or claims 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; 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. A plain reading of above Section suggests that it prohibits any person from manufacturing for sale or for distribution or sell or stock or exhibit or offer for sale or distribute any drug which is not of a standard quality or is misbranded, adulterated or spurious. It provides that no person shall himself or by any other person on his behalf 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. Sections 21, 22 & 23 as contained in the Chapter IV provides for appointment of inspectors, their powers and procedure required to be followed under the Chapter by the said inspectors. Sections 21, 22 & 23 as contained in the Chapter IV provides for appointment of inspectors, their powers and procedure required to be followed under the Chapter by the said inspectors. Section 27 of the Act as contained in Chapter IV provides for Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter and reads as under:- 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 6 [17B and which] when used by any person for or in the diagnosis, treatment, mitigation, or pre - vention 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 7 [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. (b) any drug— (i) deemed to be adulterated under section 17-A 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 2 [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 3 [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 4 [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 5 [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 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. As is evident from above Section 27 postulates three separate categories of cases:- (i) Manufacturing for sale (ii) Actual sale and (iii) Stocking or exhibiting for sale or distribution of any drugs. As is evident from above Section 27 postulates three separate categories of cases:- (i) Manufacturing for sale (ii) Actual sale and (iii) Stocking or exhibiting for sale or distribution of any drugs. Section 32-A of the chapter IV deals with cognizance of offences and provides that no prosecution under this Chapter shall be instituted except by- (a) an inspector, or (b) (xxxx) (c) (xxxx) (d) (xxxx) Section 33-A of the Chapter IV provides that nothing in Chapter IV shall apply to Ayurveda, Siddha or Unani drugs. Chapter IV-A of the Act provides for provisions relating to Ayurveda, Siddha and Unani Drugs. Section 33-B of the Chapter IV-A provides that Chapter IV-A shall apply only to Ayurvda, Siddha and Unani drugs. Section 33-G of the Chapter IV-A provides for appointment of Inspectors. Section 33-M of the Chapter IV-A deals with cognizance of offences and provides that no prosecution under the Chapter shall be instituted except by an inspector. 11. The provisions in Chapter IV and Chapter IV-A are almost identical. 12. The allegation against the petitioner as levelled in the complaint is about use of “Sidenafil Citrate” drug in the preparation and manufacturing of Ayurvedic drug for which the petitioner is stated to be holding a licence thereof and the petitioner thus, being holding the said licence for manufacture of Ayurvedic drug claims that he ought to have been proceeded against under Chapter IV-A instead of Chapter IV of the Act even though the allegation of use of “Sidenafil Citrate” drug therein the Ayurvedic Drug is alleged. 13. The controversy so raised by the petitioner however, stands settled by the Apex Court in case titled as “Drugs Inspector and another Vs. Fizikem Laboratories Pvt. Ltd. and another” reported in 2008 4 SCC 784 and the said controversy is no more res integra. Following has been observed and noticed in paras 16, 17, 18, 19 & 20 by the Apex Court in the judgment (supra). “16. The provisions in Chapter IV and Chapter IVA are almost identical. Chapter IVA deals with special branch of medicines like, Ayurvedic, Siddha and Unani drugs whereas Chapter IV deals with branches other than Chapter IVA. Learned Single Judge has taken the view that since Ozomen capsules had a component like sildenafil citrate, therefore, they may be misbranded, spurious or adulterated for which the prosecution could only be launched by the Inspector authoricsed under Chapter IVA. Learned Single Judge has taken the view that since Ozomen capsules had a component like sildenafil citrate, therefore, they may be misbranded, spurious or adulterated for which the prosecution could only be launched by the Inspector authoricsed under Chapter IVA. But the prosecution in this case was launched under Chapter IV. Therefore, learned Single Judge came to the conclusion that the Inspector under Chapter IV had no jurisdiction to launch the prosecution and it is only the Inspector who has been appointed under Chapter IVA could have launched the prosecution against the accused for breach of the provisions of the Act for adulteration, misbranding in the Ayurvedic drugs. 17. Learned counsel for the appellants submitted that it is not the case that only Chapter IVA is involved but the offence has also been committed under Chapter IV also. Learned counsel for the appellants submitted that Ozomen capsules and Ozomen forte had a component of sildenafil citrate and this medicine does not fall under Chapter IVA. Therefore, learned counsel for the appellants submitted that use of this medicine in the Ayurvedic medicines is also punishable under Chapter IV as accused has no licence to deal with this drug. The accused had to mix this drug with other Ayurvedic drugs, therefore, the accused can also be prosecuted for selling Allopathic drug like sildanefil citrate when licence is required under Section 18. Learned counsel for the appellants submitted that sildenafil citrate is a new drug and it is an Allopathic drug. This cannot be used for the Ayurvedic medicines without displaying in the prescribed manner on the label or container thereof or list of active ingredients contained in it together with the quantities thereof. It is also punishable under Section 18 (a)(iii) read with Section 27(d) of the Act. Learned counsel for the appellants also pointed out that the respondents also manufactured and sold this spurious Ozomen capsules containing sildenafil citrate violating section 18(a) which is punishable under Section 27(d) of the Act. 18. The sum total of the submission of learned counsel for the appellants was that the very fact of dealing with sildenafil citrate drug and distributing the same after making a different component of Ayurvedic drug itself constitutes an offence. 18. The sum total of the submission of learned counsel for the appellants was that the very fact of dealing with sildenafil citrate drug and distributing the same after making a different component of Ayurvedic drug itself constitutes an offence. Therefore, it is erroneous to say that since the accused is dealing with Ayurvedic drugs therefore, only the Inspector who is authorized under Chapter IVA could launch the prosecution and not the Inspectors appointed under Chapter IV. 19. The accused has used sildenafil citrate which is an allopathic drug. Sildenafil citrate is a white to off-white crystalline power with a solubility of 3.5 mg/ml in water and molecular weight of 666.7. Viagra (sildenafil citrate) is formulated as blue, film-coated rounded-diamond shaped tablets equivalent to 25mg, 50 mg and 100 mg of sidenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients; microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide,lactose, triacetin and FD & C Blue No.2 aluminum lake. The brand name is Viagra and generic name is sildenafil citrate. This is an allopathic drug and by no stretch of imagination it can be said as an Ayurvedic drug. Therefore, learned counsel for the appellants appears to be justified that since it is an allopathic drug and it cannot be used by anybody else unless a person who holds the licence for it. It is an admitted position that the accused does not possess the licence. Therefore, the very fact of selling this drug as one of the ingredients in the Ozomen capsule and not displaying the name in the prescribed manner in the drugs will also constitute an offence under Section 18 (a), (b) & (c) punishable under Section 27(b) (ii). The submission of learned counsel for the appellants is justified and we are of opinion that the view taken by learned Single Judge of the High Court is not correct and the High Court should not have proceeded to quash the whole proceedings under Section 482 of the Code of Criminal Procedure when serious issues were involved in the matter. 20. In the result, we allow this appeal and set aside the order passed by the High Court and direct that the Inspector appointed under Chapter IV is competent to launch prosecution for the aforesaid sections against the accused. 20. In the result, we allow this appeal and set aside the order passed by the High Court and direct that the Inspector appointed under Chapter IV is competent to launch prosecution for the aforesaid sections against the accused. We have also been informed in the alternative prosecution has also been launched against the accused under Chapter IVA. Both the prosecution can be tagged together and the learned trial court should proceed with the matter. However, any observations made by us in disposing this appeal will not prejudice the rights of either parties.” 14. Having regard to the aforesaid position emerging from the judgment of the Apex Court (supra), the controversy raised by the petitioner in the instant petition pales into insignificance. The petition thus, entails dismissal and, is accordingly, dismissed.