1 BEFORE THE MADURAI BENCH OF MADRAS HIGH COURT DATED : 29.07.2011 CORAM THE HONOURABLE MS.JUSTICE R.MALA Crl.O.P.(MD).No.2680 of 2011 and M.P.(MD) No.2 of 2011 M/s.SBL Private Limited, A3, Site IV, Sahibabad Ghaziabad – 20100 represented by Rajesh Gupta : Petitioner/A5 -Vs- 1.The State of Tamilnadu, Rep. by the Inspector of Police, Prohibition Enforcement Wing, Thuckalay, Kanyakumari District. 2.The Drugs Inspector, Nagercoil Range, Kanyakumari District. :Respondents/Complainant and Defacto Complainant PRAYER: Petition is filed under Section 482 of the Code of Criminal Procedure praying to call for the records of the First Information Report in crime No.210 of 2010 on the file of the Inspector of Police, Prohibition Enforcement Wing, Thuckalay, Kanyakumari District and quash the same. For Petitioner : Mr.V.P.Raman For Respondents : Mr.A.P.Balasubramani, G.A. (Crl. Side) O R D E R This petition is filed to call for the records of the First Information Report in crime No.210 of 2010 on the file of the Inspector of Police, Prohibition Enforcement Wing, Thuckalay, Kanyakumari District and quash the same. 2.The learned counsel appearing for the petitioner would submit that the petitioner is a private company, holding a valid license under the Drugs and Cosmetics Act for the manufacture and distribution of Sativol. The ownership of the share can be changed by mere sale or purchase or by succession. The petitioner is a leading homoeopathic medicines manufacturer company and holding valid licence of Mother Tinctures/Dilutions which contain Alcohol upto 90 per cent and are consumed as medicines not only in India but also all over the world. 3.He would further submit that the petitioner had manufactured a homeopathic drug by the name of Sativol labeled to contain 40% alcohol and had distributed the same to various distributors including M/s.Sooriya Homeo Medicals, Nagercoil. On 08.12.2010, the Drugs Inspector, Nagercoil Range along with the Drugs Inspector, Tuticorin II Range, Drugs Inspector Tuticorin I Range and the Inspector of Police, Prohibition Enforcement Wing, Nagercoil had inspected the premises of M/s.Sooriya Homeo Medicals and seized the homeopathic medicines i.e. 'Sativol' and after obtaining a report, he filed the complaint for the offence under Sections 4(1)(aaa), 4 (1)(i) and 4(1)(h) of the Tamil Nadu Prohibition Act read with Section 328 of the Indian Penal Code and Section 27(d) and 27(b)(ii) of the Drugs and Cosmetics Act 1940. https://hcservices.ecourts.gov.in/hcservices/ 2 4.He would further submit that there is no specific allegation in the F.I.R. and the petitioner's company has been registered under the Indian Companies Act 1956. The main object is the business of raw drugs and prepared homeopathic medicines including manufacture and marketing of homeopathic medicines and hence, the offence under Section 328 I.P.C. is not made out. Sections 27(d) and Section 27(b)(ii) of the Drugs and Cosmetics Act read with Section 18(c) of the said Act read in consonance with Rule 106 (B) would clearly state that no person shall manufacture, distribute or sell any drug except under and in accordance with the conditions of a licence issued for such purpose. The petitioner has obtained licence bearing Ref.No.20F/1634/4109 dated 03.04.2008 valid from 01.01.2008 to 31.12.2012. He would further submit that as per the order of High Court of Uttat Pradesh at Lucknow Bench, the 'Sativol' can be packed and sold in packs of 60 ml., 100 ml. and 200 ml.. In the F.I.R., it has been stated that the medicine 'Sativol' was being packed and distributed in 200 ml., which is an alleged contravention to the local laws which are prevalent in the State of Tamil Nadu. 5.He would further submit that in respect of Rule 106(B) of the Drugs and Cosmetics Rules, 1945 is concerned, the petitioner has obtained a stay order against the implementation of Rule 106(B) of the Drugs and Cosmetics Rules, 1945 and hence, the allegations in the F.I.R. is not substantiate to rope the petitioner in the criminal case and no prima facie case is made out against the petitioner and hence, he has come forward with the application to quash the proceedings against the petitioner. 6.Repudiating the same, the 1st respondent has filed the counter affidavit stating that in the chemical analysis report, it is opined that the Homeopathy Medicine by name 'Sativol' is not of standard one. Since the petitioner has manufactured a homeopathic medicine, which is not of standard quality as defined in Drug and Cosmetics Act, 1940 and rules thereunder and distributed to A2, prima facie case has been made out. Rule 106 (B) of Drugs and Cosmetics Rules 1945 clearly state that no homeopathy medicine containing more than 12% alcohol shall be packed and sold in packing or more than 30 ml. except that it may be sold to hospitals/dispensaries in packing or bottles of not more than 100 ml. The respondent has seized the said 'Sativol' in 200 ml. Bottles. As per Section 8 and 9 of Tamil Nadu Spiritues Preparation (control) rule 1984, the petitioner has not obtained license for export, transport for homeopathy medicine to Tamil Nadu. Since the petitioner himself admitted that he is a valid license holder, he is responsible for the above said violation of Rules framed by Government of India and the Government of Tamil Nadu. 7.In the chemical analysis report, it is very clear that 'Sativol' contains 38% alcohol as against the petitioner claims that the contains of 40% alcohol and the 'Sativol' is not of standard quality as defined in Drugs and Cosmetics Act 1940 and rules there under. As per rule 8 and 9 of TNSP rules (control) 1984, the petitioner has to obtain licence for export and transport of the said medicine to Tamil Nadu. More over, he has distributed to A2, who is not having valid license for import, transport wholesale and retail sale as per sections 7,9 and 11 of TNSP rules (control) 1984. 8.Rule 106 (B) of Drug and Cosmetics Rule 1945 was amended to prevent of the misuse of homeopathy medicine containing alcohol in the year 1994, which says that no homeopathy medicine containing more than 12% alcohol shall be packed and sold in packing or more than 30 ml. except that it may be sold to hospitals/dispensaries in packing or bottles of not more https://hcservices.ecourts.gov.in/hcservices/ 3 than 100 ml. and this rule was amended for the purpose of preventing lose of human lives. Some of the manufactures challenged this rule and obtained stay order from the High Court of Allahabad and Delhi and finally, the writ, challenging the rule was dismissed by the High Court of Delhi. Hence, no person shall manufacture homeopathy medicine containing more than 12% in 200 ml. Package. The report received from the homeopathic pharmacopoeia laboratory, Ghaziabad is clearly proved that the medicine, which is not of standard quality surely cause hurt and dangerous to human lives and the same comes within the definition of Poison. There is no motive between the petitioner and the respondent and only in the interest of enforcing law and preventing lose of human lives, action has been taken against the petitioner. 9.Even though the petitioner has stated that he has obtained stay order, questioning the validity of Rule 106 (B) of Drugs and Cosmetics Rules, 1945, which was finally dismissed by the High Court of Delhi and the Supreme Court of India. Hence, the rule 106( B) of Drugs and Cosmetics Rules, 1945, prohibits the manufacturer to pack and sale of homeopathic medicine containing more than 12% alcohol in more than 30 ml. package and in case of hospital and dispensary, more than 100 ml. In the present case, 'Sativol' containing 40% alcohol in 200 ml. bottles were seized and hence the petitioner has violated the said Act and Rule and local laws of the State of Tamil Nadu. Hence, the learned Government Advocate (criminal side) prayed for the dismissal of the application. 10.I have heard the submissions made on either side and perused the records available on record. 11.Considering the rival submissions made on either side, this Court has to decide as to whether the offence has been prima facie made out against this petitioner. 12.It is an admitted fact that the petitioner/A5 herein is the manufacturer of 'Sativol', which was seized on 08.12.2010 from M/s.Sooriya Homeo Medicals, Nagercoil/A2. The case has been registered against the petitioner for the offence under Sections 4(1)(aaa), 4(1)(i) and 4(1)(h) of the Tamil Nadu Prohibition Act read with Section 328 of the Indian Penal Code and Sections 27(d) and 27(b)(ii) of the Drugs and Cosmetics Act 1940. 13.The first limb of the argument advanced by the learned counsel appearing for the petitioner is that there is no averment for implicating the petitioner as an accused. At this juncture, it is appropriate on the part of this Court to refer the First Information Report, wherein, it has been specifically mentioned that “'Sativol' Homeopathic Medicine, 200 ml packing manufactured by SBL Private Limited., A3, Site IV, Sahibabad, Ghaziabad – 201 010 (Quantity 9 x 30 x 200 ml.) and hence the above drugs were seized from Thiru.C.Thiraviyam under form 16 No.4875 dated 08.12.2010 and mahazer dated 08.12.2010 for the contravention of Section 18(c) of the Drugs and Cosmetics Act, 1940 for having stocked for sale and distribution without valid licenses.” It would clearly show that the petitioner is the manufacturer of the drug viz., 'Sativol'. 14.On perusal of the affidavit and petition filed by the petitioner, nowhere, he has stated that he has not manufactured, supplied and distributed the drugs seized to Ms.Sooriya Homeo Medicals and it is an admitted fact that the drugs seized by the respondent on 08.12.2010 has been manufactured by the petitioner herein. In such circumstances, the arguments advanced by the learned counsel appearing for the petitioner that no https://hcservices.ecourts.gov.in/hcservices/ 4 allegation has been made against the petitioner for the commission of offence does not merit acceptance. 15.It is appropriate to consider the decision relied upon by the learned counsel appearing for the petitioner in R.Jayaprakash and another Vs. State rep. By the Women Inspector of Police, All Women Police Station, Thanjavur and another reported in 2008(6) CTC 888, wherein, it has been held that since there is no allegation against A6 and A5 made in the complaint and their names alone have been referred in the F.I.R and the F.I.R was closed as being clear case of abuse of process of law. The relevant portion of the said judgment in paragraph No.8 is extracted hereunder: “At the outset, this Court is constrained to state that a perusal of the F.I.R. in this case discloses that there is absolutely no allegation whatsoever made against the petitioners constituting the offences alleged in the F.I.R. much less any other offence. It is pertinent to be noted that in first para of the First Information Report, only the names of these petitioners and their relationship with the first accused is mentioned, as the petitioners are paternal uncle and maternal uncle of the first accused/husband of the defact complainant. It is well settled that even if the entire allegations contained in the F.I.R. to be taken as true, if there is n offence made out in the F.I.R., as against the petitioners and the same is liable to be quashed. Therefore, in view of the settled principles of law, as already pointed out by this Court that there is no whisper made against these petitioners wither for the allegation of demand dowry and or for the allegation of cruel treatment, this Court is of the considered view that allowing the further proceedings to continue in pursuance of the F.I.R. registered in crime No.16 of 2006 would amount to a clear case of abuse of process of law and as such, this Court is constrained to quash the F.I.R., insofar as the petitioners herein are concerned. However, it is made clear that the investigating officer shall proceed with the investigation in respect of the husband and others, who have been arrayed as accused No.1 to 4 in this case. It is open to the parties viz., the accused well as the defacto complainant to work out amicable settlement through Mediation and Conciliation Centre.” 16.Perusal of the above said judgment along with the facts of the present case, here, the petitioner has manufactured the drug viz., 'Sativol' and hence, the above said decisions is not applicable to the facts of the present case. 17.At this juncture, it is appropriate to consider that Rule 106 (B) of the Drugs and Cosmetic Rules, 1945, wherein, it has been specifically mentioned that no homeopathy medicine containing more than 12% alcohol shall be packed and sold in packing or more than 30 ml. except that it may be sold to hospitals/dispensaries in packing or bottles of not more than 100 ml. Admittedly, as per the complaint 200 ml. bottles of 'Sativol' has been seized from M/s.Sooriya Homeo Medicals and hence, it is clear that there is violation of Rule 106 (B) of Drugs and Cosmetic Rules, 1945. https://hcservices.ecourts.gov.in/hcservices/ 5 18.As per the contention of the learned counsel appearing for the petitioner, he filed a writ petition questioning the validity of Rule 106(B) of Drugs and Cosmetic Rules 1945 and obtained an order of stay. Whereas, as per the contention of the learned Government Advocate (criminal side), questioning the validity of Rule 160(B) of Drugs and Cosmetics Rules, 1945, writ petition has been filed by some of the manufactures before the High Court of Delhi, where the same were dismissed. The same was reported in 2008(2) Drugs Cases (DC) 509, wherein, the Delhi High Court has held as follows in paragraph No.25: “In the light of the above pronouncements of the Supreme Court, we have no hesitation in holding that the restriction placed upon the use of containers for sale of homeopathic medicines with more than 12% alcohol content in the same is a reasonable restriction and is intended to prevent misuse of such preparations by those who purchase the same across the countries. The experience of such preparations having been misused in the past leading to loss of valuable human lives was, in our view, sufficient for the rule making authority to act in public interest and regulate the sale of such medicines by stipulating that they would not be sold in containers more than 30 ml capacity. The rule, it is noteworthy, does not require such small containers to be used in case the supply is meant for hospitals and dispensaries in which event the packing of bottles could be of 100 ml also. Having regard to the purpose sought to be achieved by the Act and the Rules framed thereunder, the restriction contained in Rule 106 B qua homeopathic medicine with more than 12% alcohol content cannot be said to be either unreasonable or otherwise violative of the right guaranteed to the petitioners under Article 19(1)(g) of the Constitution. Our answer to question No.3 is in the negative.” 19.In such circumstances, I am of the view that the incorporation of Rule 106(B) is not unconstitutional and hence, said writ petition has been dismissed. But, even though, the petitioner herein has stated that he had obtained stay at Lucknow Bench of Allahabad High Court, he has not given any document to show that whether finality has been arrived or not? 20.The learned Government Advocate (criminal side) would rely upon the order of this Court dated 01.02.2010 made in W.P.(MD) No.11971 of 2008 in Dr.G.P.Hahnemann Vs. The Drug Controller of Tamil Nadu and 3 others, which was filed for issuance of a writ of Mandamus to forbear the respondents and their subordinate officials from interfering with the right of the petitioner to keep homeopathic dilutions in 500 millilitres pound pack and the same has been dismissed after considering the decision of the Apex Court reported in AIR 1981 SC 1863 (Southern Pharmaceuticals and Chemicals, Trichur and others Vs. State of Kerala and Others) and also 2008 (2) Drugs Cases (DC) 509 (R.S.Bhargava Pharmacy Vs. Union of India). In such circumstances, I am of the view that after such finding, the inclusion of Rule 106(B) of the Drugs and Cosmetics Rules is a constitutional and hence, the petitioner herein is not entitled to manufacture the drug viz., 'Sativol' in contravening the provisions of Rule 106(B) of the Drugs and https://hcservices.ecourts.gov.in/hcservices/ 6 Cosmetics Rules, 1945. 21.The learned counsel appearing for the petitioner would submit that he has obtained proper license and on that basis only, he has manufactured the same, and he relied upon the copy licence produced before this Court, wherein, it has been mentioned that his licence has been renewed upto 31.12.2012. But, the petitioner has given licence to manufacture homeopathy medicine. Even though he has stated that he has obtained stay, it has been granted only on 17.12.2004, but the occurrence has been taken place on 18.12.2010 and the High Courts have come to the conclusion that the inclusion of Rule 106(B) of the Drugs and Cosmetics Rules, 1945 is not an unconstitutional. Hence, I am of the view that the petitioner herein is not entitled to manufacture the drugs contrary to the Rule 106(B) of the Drugs and Cosmetics Rules, 1945. 22.Now this Court has to decide as to whether the ingredients of the offence mentioned in the F.I.R has been prima facie made out against the petitioner. 23.The case has been registered for the offence under Sections 4(1) (aaa), 4(1)(i) and 4(1)(h) of the Tamil Nadu Prohibition Act read with Section 328 of the Indian Penal Code and Section 27(d) and 27(b)(ii) of the Drugs and Cosmetics Act 1940. It is useful to extract the above said provisions of law: “4.Prohibition of the manufacture of, traffic in, and consumption of liquor and intoxicating drugs - (1) whoever - (aaa) imports, exports, transports or possesses liquor of one hundred litres and above, (i) sells liquor or any intoxicating drug - (h) bottles any liquor for purposes of sale; 328 I.P.C. - Causing hurt by means of poison, etc. with intent to commit an offence. - Whoever administers to or causes to be taken by any person any poison or any stupefying, intoxicating or unwholesome drug, or other thing with intent to cause hurt to such person, or with intent to commit or to facilitate the commission of an offence or knowing it to be likely that he will thereby cause hurt, shall be punished with imprisonment of either description for a term which may extent to ten years, and shall also be liable to fine. “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 Gfazette 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 https://hcservices.ecourts.gov.in/hcservices/ 7 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 license 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 Gfazette, 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. “27.Penalty for manufacture, sale etc., of drugs in contravention of this Chapter. - (b) any drug - (ii) without a valid license as required under clause (c) of Section 18, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than five 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 and of fine of less than five thousand 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 ear but which may extend to two years and with fine. provided that the court may for any adequate and special reasons to be recorded in the judgment impose a https://hcservices.ecourts.gov.in/hcservices/ 8 sentence of imprisonment for a term of less than one year. “ 24.As per the report of the chemical laboratory, it has been stated in clause 3 that the sample is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 and the reasons has also been assigned. It is not the case of the petitioner that the petitioner has manufactured the homeopathic medicine containing below 12% alcohol. His contention is that even though, Rule 106(B) has been incorporated that has been challenged and he obtained an order of stay. But, as already stated, the provision has been declared as not an unconstitutional and the writ petition has been dismissed. In such circumstances, I am of the view that the drugs seized from M/s.Sooriya Homeo Medicals has been containing 38% of alcohol, which is contra to the provision of Rule 106(B) of Drugs and Cosmetics Act. 25.The learned Government Advocate (criminal side) would submit that the petitioner herein has violated the provisions of Rules 8 and 9 of Tamilnadu Spiritues Preparation (control) Rule 1984. But, no case has been registered for violation of Rules 8,9 and 11 of TNSP (control) Rule 1984 and hence, the arguments advanced by the learned Government Advocate (criminal side) is not relevant. 26.As already stated, on 08.12.2010, the drugs manufactured by the petitioner herein had contains 40% alcohol, which is contra to Rule 106(B) of Drugs and Cosmetics Rules, 1945. In the F.I.R. itself, it has been mentioned that the seized drugs were manufactured by the petitioner. In that circumstances, the validity of Section 106(B) of Drugs and Cosmetics Rules, 1945 has been upheld by the High Court of Delhi and hence, the offence against the petitioner has been prima facie made out. Therefore, I find no reason for quashing the proceedings and thus the petition deserves to be dismissed. 27.Accordingly, this criminal original petition is dismissed. Consequently connected miscellaneous petition is dismissed. SD ASST REGISTRAR ( CO ) /TRUE COPY/ SUB ASST REGISTRAR To 1.TheInspector of Police,Prohibition Enforcement Wing, Thuckalay, Kanyakumari District. 2.The Drugs Inspector, Nagercoil Range, Kanyakumari District. 3.The Addl. Public Prosecutor, Madurai Bench of Madras High Court, Madurai. DM:2011:AUGUST:04:: Crl.O.P.(MD).No.2680 of 2011 29.07.2011 8P:4C:: https://hcservices.ecourts.gov.in/hcservices/