Gujarat High Court
Renovision Exports Pvt. Ltd.(Repl) ... vs State Govt. Through M. N. Patel on 17 January, 2023
Author: Gita Gopi
Bench: Gita Gopi
NEUTRAL CITATION
R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023
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IN THE HIGH COURT OF GUJARAT AT AHMEDABAD
R/CRIMINAL MISC.APPLICATION NO. 14367 of 2019
FOR APPROVAL AND SIGNATURE:
HONOURABLE MS. JUSTICE GITA GOPI
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1 Whether Reporters of Local Papers may be allowed
to see the judgment ?
2 To be referred to the Reporter or not ?
3 Whether their Lordships wish to see the fair copy
of the judgment ?
4 Whether this case involves a substantial question
of law as to the interpretation of the Constitution
of India or any order made thereunder ?
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RENOVISION EXPORTS PVT. LTD.(REPL) THROUGH ASHFOOK
RAHMAN (DIRECTOR OF CO.) & 3 other(s)
Versus
STATE GOVT. THROUGH M. N. PATEL
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Appearance:
MR.IBRAR HUSAIN Ld. ADVOCATE WITH MS BHAKTI M JOSHI(3820) for
the Applicant(s) No. 1,2,3,4
NOTICE SERVED for the Respondent(s) No. 1
MR.DHAWAN JAYSWAL APP for the Respondent(s) No. 2
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CORAM:HONOURABLE MS. JUSTICE GITA GOPI
Date : 17/01/2023
COMMON ORAL JUDGMENT
[1] By way of the present petitions under Page 1 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined Section 482 of the Code of Criminal Procedure, 1973 (hereinafter referred to as 'the Code'), the Petitioners have prayed for quashing and setting aside the th Criminal Case No.35325 of 2003 pending before 10 Additional Senior Civil Judge and ACJM, Vadodara and Criminal Case No.44100 of 2005 pending before the learned Chief Judicial Magistrate, Vadodara for the offfence punishable under Sections 2(b), 3(c) and 3(d) read with Sections 7 & 9 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (hereinafter referred to as the 'DMR (Obj. Adv.) Act') as well as other consequential proceedings arising out of the aforesaid complaints qua petitioners.
[2] The Drug Inspector in both the complaint was Mr.T.L.Patel appointed under Section 21 of the Drugs and Cosmetic Act, 1940 and was competent to file complaint under 'DMR (Obj. Adv.), Act. [3] In Criminal Case No.35325 of 2003 before the Chief Judicial Magistrate, Vadodara, the Drug Page 2 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined Inspector had visited the premises of Dr.Parashar Acharya, which is noted as Asst. Pharmacy, near Tapasvasi Classes Shiyapura, Raopura, Vadodara on 14.12.2001, and as per the complaint, Dr.Parashar Acharya is DHMS, with registration No.G-3860 of the Council of Homeopathic System and Medicine Gujarat State. As per the complaint, during the visit, Drug Inspector found homeopathic medicines as Vigoura- 1000, Dayaphone and of Vigoura-1000 Handbills and Vigoura-2000 Handbills with the leaflet of advertisements which as per the Officer, is objectionable, and by order dated 15.12.2001 of Chief Judicial Magistrate, the seized articles were kept in the custody. As per the Drug Inspector, from the letter dated 15.12.2001 of accused No.1, the medicines were purchased from Rushi India Jogeshwari, Mumbai by bill No.RI-00001-369 dated 27.08.2001, with challan no.369. [4] In Criminal Case No.44100 of 2005, the facts suggest that the Drug Inspector visited the premises of accused No.1 -Rajendrabhai Chaturbhuj Page 3 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined Mehta, owner of Trimurti Pharma Distributor at Darshan Apartment, Limda Pole, Raopura, Vadodara on 14.12.2001, and in presence of panchas, he found Homeopathic medicines Vigoura- 1000 of 9/30 ML, and out of the said, he took about 4/2/30 ML in accordance with the Rules for analysis and examination; further noted that outer cartoon of the said medicines label showed manufacturer R.E.P.L, Federal A.N.K.Road, Patna, Bihar, manufacturing in Licence No.86/99, batch No.RV103, manufacturing date February, 2000, MRP Rs.85 (inclusive of all taxes), and 'Homeopathic medicine invented in Germany' was reflected on it, with indication as 'Insufficient Flow Painful menstruation exhaustion' and 'For Vitality and Regulation of Menstrual'. Further on investigation from accused No.1 and under his statement was informed that Vigoura-1000 Batch No.RV-103, 12 numbers and Vigoura-2000, Batch No.RL107 stock of 36 and others medicines, he had purchased from Rushi India Yogeshwari, Mumbai under invoice number R1-00001 on 20.08.2001 under the chalan number 2250 dated 20.08.2001. Page 4 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023
NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined 4.1 The Drug Inspector had found bills and as noted from the bills, medicines were purchased from Rushi India, and therefore, he had initiated the procedure of procuring information regarding the Rushi India manufacturers, and accordingly Drug Inspector, vide communication dated 21.10.2002, forwarded to the Assistant Commissioner, Surat and to Assistant Commissioner, Food & Drug, Vadodara. vide letter dated 28.10.2002 came to the knowledge of Rushi India-accused No.2 being the ownership Firm and Renovision Experts Pvt. Ltd.(REPL)- accused No.3 as a manufacturing Firm with accused No.4 to 6 as the Directors of REPL.
[5] Advocate Mr.Ibrar Husain submits that on 15.05.1999, the licensing Authority of Bihar had granted licence for manufacture and sale of the Drugs. The petitioners in both the petitions, are Managing Director and Directors of the Company, Renovision Exports Pvt. Ltd. which manufactures drugs with valid licence adhering strictly to the conditions. The drugs are manufactured as per the Page 5 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined norms of authoritative standard book of Ayurved and Homeopathic Arshad Jamal Pharmacopoeia. Mr.Husain further submitted that the Company of the petitioners is GMP certified and has also been granted certificate of Pharmaceutical Products confirming to the format recommended by the World Health Organization, which is given to a manufacturer of International Standard Quality Medicines.
5.1 Advocate Mr.Husain submits that the complaints itself are totally misconceived, frivolous, abounds in ambiguities and mistakes and is in violation of DMR (Obj Adv.) Act, 1954 and Rules, 1955. Mr.Husain further submits that the label and mono cartoons do not contain any objectionable printed materials. There is compliance of Section 106(a) of Drugs and Magic Rules, 1945, for the labelling and packaging of these subject drugs. Packing inserts/leaflets or literature in the packaging of drugs are as per serial no.One, Column 1 & 2 of the table of the Schedule of DMR (Obj Adv.) Rules, Page 6 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined 1955 substituted vide GSR843. Mr.Husain submits that packing itself contains words as ''Information for Registered Medical Practitioners/Hospital/Laboratory only' which itself means, that it is not meant for self medication of people and the information are for the guidance of medical practitioner with regard to therapeutic indication of drugs, its administration, its dosage, its side effect and the precaution to be observed with the drugs, further stated that all these, are based on the materials with regard to the ingredients explained in the standard books of medicines acknowledged all over world. 5.2 Advocate Mr.Husain submits that the drugs seized by the Drug Inspector is in contravention of Section 8(1)(b) of the DMR Act, 1954, and without following the provisions of scrutiny under Rule 3 of DMR Rules, 1955, the criminal complaints are instituted. Mr.Husain submits that the Drug Inspector has not hold any inquiry about the composition and permission about the approval of label, cartoon and leaflets from the applicants, which Page 7 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined according to advocate Mr.Husain, do not have any objectionable printed material to consider it as contravention of the provisions of DMR (Obj Adv.) Act and Rules.
5.3 Advocate Mr.Husain submits that the licencing authority of Bihar had granted the licence to manufacture and sell the drugs. The drugs were seized by the Drug Inspector with panchanama on 04.12.2001, and thereafter criminal case No.35325 of 2003 and criminal case No.44100 of 2005 were filed on 10.11.2003 and 19.01.2005 respectively before the Chief Judicial Magistrate, Vadodara. 5.4 Advocate Mr.Husain submits that in both the matter, Drug Inspector has informed that the drugs were purchased from the owner of accused No.2 Rushi India under invoice and challan. After investigation, the Drug Inspector found that the manufacturer of subject drugs is REPL - accused No.3 and accused No.4 to 6 are Directors. Therefore, all of them have been made accused in the alleged Page 8 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined offence. He further submits that the Drug Inspector has not averred in the complaint that accused No.4-6 are persons incharge and responsible for day to day affairs of the Company as provided under Section 9 of the DMR (Obj Adv.) Act.
5.5 Advocate Mr.Husain submits that the seizure of Drugs is not in conformity with Section 8 of DMR (Obj Adv.) Act, since seizure could only take place if the advertisement is in contravention to any of the provisions of the Act; while in the present case, medicines seized by the respondent are certainly not prohibited advertisement in any meaning of the Act.
5.6 Advocate Mr.Husain submits that the alleged banner or hoarding was recovered from the premises of the dispensary of accused Doctor, who is a registered medical practitioner, thus the provisions of the DMR (Obj Adv.) Act, could not be invoked since he would be protected by Section 14 of the Act, and the DMR (Obj Adv.) Act & Rules would not be Page 9 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined applicable to him. Mr.Husain submits that the respondent Drug Inspector did not follow the provisions of Rule 3 of DMR (Obj Adv.) Rules 1955, and has not issued show cause notice, nor, has given any opportunity of personal hearing to the petitioners towards the seized Drugs.
[6] Mr.Dhawan Jayswal, learned APP submitted that the case which has been noted against the accused is under Sections 3(c) and 3(d) of the DMR (Obj Adv.) Act. Mr.Jayswal submits that the DMR (Obj Adv.) Act prohibits the advertisement of certain drugs for treatment of certain diseases and disorders, and no person can take any part in publication of any advertisement referring to any drugs in terms which suggests or are calculated to lead to the use of that drug for the maintenance or improvement of the capacity of human beings for sexual pleasure as provided under Section 3(b) & 3(c) is prohibition of advertisement for the correction of menstrual disorder in women.
6.1 Mr.Jayswal submits that any such Page 10 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined advertisements are prohibited and such objectionable advertisements and printing of advertisement gets included as an Act prohibited under Section 3 in terms of meaning of expression 'taking any part in publication of any advertisement' defined under Section 2(d) of the Act which includes the printing of the advertisement, and the publication of any advertisement outside the territories to which DMR (Obj Adv.) Act extends by or at the the instance of a person residing within the said territories, thus the petitioners being the Directors and the people holding the position in the Company have to be prosecuted under Section 9 of the Act. Learned APP has also relied the judgment in the case of Institute of Indian Therapies Vs. State of Kerala declared on June 12, 2019 in Criminal Miscellaneous Case 880 of 2015, [7] Section 2(b) of the DMR (Obj. Adv.) Act defines 'drug' includes -
(i) a medicine for the internal or external use of human beings or animals;
(ii) any substance intended to be used for Page 11 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals;
(iii) any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals;
(iv) any article intended for use as a component of any medicine, substance or article, referred to in sub-clauses (i), (ii) and (iii).
[8] It is required to be noted that accused No.1 in Criminal Case No.35325 of 2003 is a registered Homeopathic Doctor, protected under the Savings Clause of Section 14 of the DMR (Obj Adv.) Act. The protection accorded by way of the saving clause of DMR (Obj Adv.) Act, provides that act would not apply to any signboard or notice displayed by a registered medical practitioner on his premises, for the disease, disorder or condition specified in Section 3, the Schedule or Rules under DMR (Obj Adv.) Act. Page 12 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023
NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined Section 14 of the Act reads as under:
"14. Savings. Nothing in this Act shall apply to-
(a) any signboard or notice displayed by a registered medical practitioner on his premises indicating that treatment for any disease, disorder or condition specified in section 3, the Schedule or the rules made under this Act is undertaken in those premises; or
(b) any treatise or book dealing with any of the matters specified in section 3 from a bona fide scientific or social standpoint; or
(c) any advertisement relating to any drug sent confidentially in the manner prescribed under section 16 only to a registered medical practitioner; or
(d) any advertisement relating to a Page 13 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined drug printed or published by the Government; or
(e) any advertisement relating to a drug printed or published by any person with the previous sanction of the Government granted prior to the commencement of the Drugs and Magic Remedies (Objectionable Advertisements) Amendment Act, 1963 (42 of 1963);
Provided that the Government may, for reasons to be recorded in writing, withdraw the sanction after giving the person an opportunity of showing cause against such withdrawal.
8.1 The DMR (Objectionable Advertisements) Act, 1954 had come into force on 01.04.1955 with an object to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected Page 14 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined therewith.
8.2 Section 14 of the DMR (Obj Adv.) Act, thus through Clause (a) protects the registered medical practitioner as the Act does not apply to signboard or notice displayed by the registered medical practitioner on his premises which indicates the treatment for any disease, disorder or condition specified in Section 3, the Schedule or the rules made under the DMR Act undertaken in his premises; clause (b) provides that act shall not apply to any treatise or book dealing with any of the matters specified in Section 3 from a bonafide scientific or social standpoint; clause (c) makes provision for protection of advertisement relating to any drug sent confidentially in the manner prescribed under Section 16, only to a registered medical practitioner; Clause (d) is for any advertisement relating to a drug printed or published by the Government; or (e) any advertisement relating to a drug printed or published by any person with the previous sanction of the Government granted prior to Page 15 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined the commencement of the Drugs and Magic Remedies (Objectionable Advertisements) Amendment Act, 1963 (42 of 1963), with express proviso, that the Government may withdraw the sanction to the reasons recorded in writing, after giving the person an opportunity to show-cause against such withdrawal.
[9] Here, in this case, the signboard, leaflets found at the premises of Dr.Parashar Acharya would get exempted from the application of the DMR (Obj Adv.) Act. Hence, any display of signboard or advertisements at the premises regarding the drugs sent to the Registered Medical Practitioner would not be offence under the DMR (Obj Adv.) Act, 1954. [10] It is also required to refer to the provisions of Section 15 of the DMR (Obj.) Act, which is with regard to the power of the Central Government to exempt the application of Act. Section 15 of the DMR (Obj.) Act reads thus:
"15 Power to exempt from application of Act. -
Page 16 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined If in the opinion of the central
Government public interest requires that the advertisement of any specified drug or class of drugs [for any specified class of advertisements relating to drugs] should be permitted, it may, by notification in the Official Gazette, direct that the provisions of Sections 3, 4, 5 and 6 or any one of such provisions shall not apply or shall apply subject to such conditions as may be specified in notification to or in relation to the advertisement of any such drug or class drugs [or any such class of advertisements relating to drugs].
10.1 Section 15 of the DMR (Obj.) Act, empowers the Central Government to permit the advertisement of any specified drug or class of drugs by issuance of notification in the Official Gazette and the Government may declare that the provisions of Sections 3, 4, 5 and 6 or any one of such provisions Page 17 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined shall not apply or shall apply subject to such conditions as may be specified in the notification or in relation to the advertisement of any such drug or class or drugs or any such class of advertisements relating to drugs.
[11] The petitioner No.1, in both the matter, is Renovision Exports Pvt. Ltd. (REPL), Patna Bihar and the petitioner Nos. 2, 3 & 4, are the Directors.
The Company is permitted a licence from the State Drugs Controller-cum-Chief Licensing Authority, Bihar Patna, under Licence No.86/99 granted on 15.05.1999.
The licence is for manufacture and sale of the homeopathic mother tincture/potentised preparation at rd the premises situated at 'Repl Plaza, 3 Floor, Federal Colony, A & K Road, Phulwari Shariff, Dist.-
Patna, Bihar which was renewed from 01.01.2013 to 31.12.2017. The licence also covered list of homeopathic medicines which are allowed. Further, the documents produced on record, the communication dated 10.01.2013 says that the licencee would be required to follow the Rule 106A and 85E of The Page 18 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined Drugs and Cosmetics Act, 1940 and Rules, 1945.
[12] Rule 106A of the Drugs and Cosmetics Act, 1940 and Rules, 1945, read as under:
"106A. Manner of labelling of Homoeopathic medicines-
(A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed:-
(i) The words 'Homoeopathic medicine".
(ii) The name of the medicine-
[(a) For drugs included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.]
(b) For other drugs, the name descriptive of the true nature of the drugs.
Page 19 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023
NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined
(iii) The potency of the Homoeopathic medicine- For this purpose, the potency shall be expressed either in decimal, centesimal or millesimal systems.
(iiiA) In case of a Homoeopathic medicine containing two or more ingredients, the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label.
"[(iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer - the name and address of the seller;] [Provided that where such medicines are imported, the name and address of the importer shall also be mentioned on the label.]
(v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by Page 20 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined volume in terms of ethyl alcohol shall be stated on the label:] [Provided that in case that the total quantity of the pharmacopoeia Homoeopathic medicine in the container is 30 milliliters or less, it will not be necessary to state the content of alcohol in the label.] (B) In addition to the above particulars the label of a Homoeopathic mother tincture shall display the following particulars:-
(i) a distinctive batch number, that is to say, that number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the words "Batch No." or "Batch" or "Lot Number" or "Lot No. or "Lot"
or any distinguishing prefix;
(ii) manufacturing licence number, the Page 21 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined number being preceded by the words "Manufacturing Licence Number" or "Mfg. Lic No." or "M.L.".
[Explanation. This clause shall not apply to a Homoeopathic mother tincture manufactured outside India.
(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label.] [13] Rule 85E of the Drugs and Cosmetics Act, 1940 and Rules, 1945, read as under:
85E. Conditions for the grant or renewal of a licence in Form 25C.- Before a licence in Form 25C is granted or renewed the following conditions shall be complied with by the applicant:-
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee and Page 22 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined who is-
(a) a graduate in Science with Chemistry as one of the subjects with three years' experience in manufacture of Homoeopathic medicines; or
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or
(c) holds qualification as defined under sub-clause (g) of clause (1) of section 2 of the Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines:
Provided that the persons who are already in employment with five years' experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any licence granted in Form 25C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the Page 23 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined purpose of this rule.
(2) The factory premises shall comply with the requirements and conditions specified in Schedule M1:
Provided that where the licensing authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing.
(2A) Certificate of Good Manufacturing Practice- The certificate of Good Manufacturing Practice to manufacturers, who comply with the requirements of Good Manufacturing Practices of Homeopathy drugs, as specified in Schedule M-1, shall be issued up to the date of validity of licence] (3) The applicant for manufacture of Page 24 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined Homoeopathic mother tinctures shall either (i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or (ii) make arrangements with some institution approved by the licensing authority under Part XV (A) of these rules) for some tests, wherever possible, to be regularly carried out on his behalf by that institution.
(4) The premises where Homoeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes.
(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine. (6) The applicant shall make arrangements for proper storage of Homoeopathic medicines manufactured by him:
Provided that in case potentised preparations Page 25 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined are made in a Pharmacy holding licence in Form 20C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the licensing authority that the products manufactured by it, conform to the claims made on the label.] [14] The allegations are that the medicines such as vigoura-1000, dayaphone and vigoura-1000 handbill and vigoura-2000 handbill, and leaflets of advertisements were found with the objectionable advertisements, while as noted hereinabove, any advertisement relating to any drug sent confidentially in the manner prescribed under Section 16 to the register medical practitioner would not invoke the provisions of DMR (Obj Adv.) Act as exempted under Section 14, of the DMR (Obj Adv.) Act.
[15] Section 16 of the DMR (Obj Adv.) Act, is regarding the power of the Central Government to make Rules to carry out the purpose of the DMR (Obj.) Act. Such Rules are notified in the official Gazette. It has been brought to notice the Page 26 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined provisions of GSR843, the relevant part of GSR843 is hereunder:
"G.S.R.843- Whereas the Central Government is of opinion that public interest requires that certain classes of advertisements relating to drugs should be permitted;
Now, therefore, in exercise of the powers conferred by Section 15 of the Drugs and Magic Remedies (Objectionable Advertisements) Act. 1954 the Central Government hereby directs that the provisions of clause (c) and (d) of Section 3 of the said Act shall not apply to the classes of advertisement specified in column (1) of the said Table below, if the conditions specified in the corresponding entries in column (2) of the said table are fulfilled.
Class of advertisement Conditions (1) & (2) Page 27 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined
1. Leaflets or literature accompanying packaging of drugs (1) The advertisement contains only such information as is required for the guidance of registered medical practitioners in respect of matters relating to (a) therapeutic indications of the drug, (b) its administration, (c) its dosage, (d) its side-effects and (e) the precautions to be observed in treatment with the drug.
(2) It shall be the responsibility of the advertiser to prove that any claim made in the advertisement in respect of the drug is not false, exaggerated or misleading."
2. Advertisement of drugs in medical, pharmaceutical, scientific and technical journals.
(1) The advertisement contains only such in formation as is required for Page 28 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined the guidance of Registered Medical Practitioners in respect of matters relating to (a) the therapeutic indications of the drug, (b) its administration (c) its dosage (d) its side-effects and (e) the precautions to be observed in treatment with the drug.
(2) It shall be the responsibility of the advertiser to prove that any claim made in the advertisement in respect of the drug is not false, exaggerated or misleading.
[16] The handbill attached with a thread as advertisements, as allegedly recovered from the premises of Dr.Prashar Acharya, who is a registered medical practitioner, would be protected under the said provisions, and therefore, petitioners would not be liable for any advertisement materials found, such as banner and hoardings at the premises of Registered Medical Practitioner. Similarly the drugs and the materials on the cartoons described as Page 29 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined advertisement of drugs at pharmaceutical agency, would be for the guidance of registered medical practitioners thus would stand protected. [17] Rule 3 of DMR (Obj Adv.) Rules, 1955 lays down that no publisher or advertising agency of any medium shall be deemed to have contravened the relevant provisions of the Act, merely by reasons of dissemination of any advertisement relating to a drug, unless has failed to comply with any discretion made by authorized person, calling him to furnish the details of the name and address of the manufacturer, packer, distributor, seller or advertising agency who or which has caused such advertisement to be disseminated. Regarding the information in connection to the drug, for holding the scrutiny of the advertisement, and when such order is made, it shall be the duty of the manufacturers, packers, distributors or sellers of the drug to which the advertisement relates to comply with the order and any failure to comply with the order shall, for the purposes of Section 7 of the Act be deemed to be Page 30 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined the contravention of the provisions of Section 4. 17.1 Section 4 of the DMR (Obj Adv.) Act, is regarding the prohibition of misleading advertisements relating to drugs, publication of any advertisement relating to a drug, if the advertisement contains any matter which directly or indirectly gives a false impression regarding the true character of the drug; or makes a false claim for the drug; or is otherwise false or misleading in any material particular. [18] Here, in this case, it appears that the petitioners were not called by an order to give any information or instruction relating to the advertisement of the seized drugs. Further, if the Drug Inspector had reason to believe that the advertisements for seized drugs, were in contravention to the provisions of the Act, further he was required to verify with the documents, articles or things, which contain any such advertisement including the contents of such documents, articles or things, whether such advertisements were separable Page 31 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined lest for reason of its being embossed or otherwise from such documents, articles or thing without affecting the integrity, utility or saleable value. In the present case, it has been observed that the drugs have been seized with separable labels, leaflets and mono cartons. The advertisement leaflet was found attached with a string. While in the case of Trimurti Pharm Distributor, accused No.1 in Criminal Case No.44100 of 2005 outer cartoons and labels were found with literature indication of drug, with information of manufacturing license number, batch number, manufacturing date and MRP. 18.2 The Notification dated 29.01.1967 issued by Ministry of Health & Family Planning (Department of Health), New Delhi by GSR843 allows the Central Government, if is of the opinion, in the public interest, to permit certain classes of advertisements relating to drugs, and, in exercise of powers conferred by Section 15 of the DMR (Obj Adv.) Act, 1954, the Central Government, therefore, by GSR843 had directed that the provisions of Clause (c) and (d) Page 32 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined of Section 3 of the said Act, shall not apply to the classes of advertisements specified in Column (1) of Table, if the condition specified in the corresponding entries in column (2) of the said table, are fulfilled. [19] It is also required to be noted that the penal provisions under Section 7 of the Act, for punishment in case of first conviction, is with imprisonment, which may extend to six months with fine or with both. In view of the provisions of Section 468 of the Criminal Procedure Code, 1973 (in short Cr.P.C.), the period of limitation for filing the complaint would be one year. In these cases, on inspection on 14.12.2001, after considerable long period, the criminal complaints were filed on 10.11.2003 and 19.01.2005 respectively, thus both the complaints are hit by the provisions of limitation as provided under Cr.P.C.
19.1 Section 9 of the DMR (Obj Adv.) Act provides that if the person contravening any of the provisions of this Act, is a company, every person Page 33 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined who, at the time the offence was committed, was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company shall be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly. Here, in this case, all the persons, shown as accused No.4 to 6, are referred as Managing Director, and Directors. The Drug Inspector has failed to verify the fact regarding the person-in-charge, responsible to the Company business.
19.2 The judgment referred by learned APP of Institute of Indian Therapies (supra) would not be applicable to the facts of the present case, where, the referred case is in connection to the advertisement published in the 'Mathrubhumi Daily', highlighting the medicinal benefits of a drug manufactured by the petitioners. [20] Here, in this case, the petitioners are licence holders, and, the inquiry has not been made Page 34 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined in accordance to the provisions of the Act by the Drug Inspector, while under order of the competent authority, the petitioner company has been granted license to manufacture and sell the drugs. The drugs and advertisement material was found at the premises of registered medical practitioner and at the pharmaceutical agency.
[21] Here, the complainant has failed to prove any such case against the petitioners. The raid which was conducted at the premises of accused No.1 of both the cases, does not disclose any contravention of the provisions of the Act by the doctor or the pharmacist and even the petitioners as licence holder. Thus, this Court find no reason to permit the continuation of criminal proceedings against the petitioners.
[22] In case of State of Haryana V. Bhajan Lal and others, AIR (1992) SC 604, the Apex Court formulated as many as seven categories of cases, wherein the extraordinary power under Section 482 Page 35 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined could be exercised by the High Court to prevent abuse of process of the court. It was clarified that it was not possible to lay down precise and inflexible guidelines or any rigid formula or to give an exhaustive list of circumstances in which such power could be exercised. The Apex Court made the following observations:-
"8.1. In the exercise of the extra- ordinary power under Article 226 or the inherent powers under Section 482 of the Code of Criminal Procedure, the following categories of cases are given by way of illustration wherein such power could be exercised either to prevent abuse of the process of any Court or otherwise to secure the ends of justice, though it may not be possible to lay down any precise, clearly defined and sufficiently channelised and inflexible guide in myriad kinds of cases wherein such power should be exercised:Page 36 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023
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(a) where the allegations made in the First Information Report or the complaint, even if they are taken at their face value and accepted in their entirety do not prima facie constitute any offence or make out a case against the accused;
(b) where the allegations in the First Information Report and other materials, if any, accompanying the F.I.R. do not disclose a cognizable offence, justifying an investigation by police officers under Section 156(1) of the Code except under an order of a Magistrate within the purview of Section 155(2) of the Code;
(c) where the uncontroverted
allegations made in the FIR or
complaint and the evidence collected in support of the same do not disclose the commission of any offence and make out a case against the accused;Page 37 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023
NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined
(d) where the allegations in the FIR do not constitute a cognizable offence but constitute only a non-cognizable offence, no investigation is permitted by a police officer without an order of a Magistrate as contemplated under Section 155(2) of the Code;
(e) where the allegations made in the FIR or complaint are so absurd and inherently improbable on the basis of which no prudent person can ever reach a just conclusion that there is sufficient ground for proceeding against the accused;
(f) where there is an express legal bar engrafted in any of the provisions of the Code or the concerned Act (under which a criminal proceeding is instituted) to the institution and continuance of the proceedings and / or Page 38 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023 NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined where there is a specific provision in the Code or the concerned Act, providing efficacious redress for the grievance of the aggrieved party;
(g) where a criminal proceeding is
manifestly attended with mala fide
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."
[23] Resultantly, the present applications are allowed and the impugned Criminal Case No.35325 of th 2003 pending before 10 Additional Senior Civil Judge and ACJM, Vadodara and Criminal Case No.44100 of 2005 pending before the learned Chief Judicial Magistrate, Vadodara are quashed and set aside as well as all other consequential proceedings arising out of the aforesaid complaint, are also quashed and set aside qua the present petitioners. Page 39 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023
NEUTRAL CITATION R/CR.MA/14367/2019 JUDGMENT DATED: 17/01/2023 undefined Office to keep copy of this order in Criminal Misc. Application No.7321 of 2019.
(GITA GOPI,J) MANOJ Page 40 of 40 Downloaded on : Sun Sep 17 20:54:40 IST 2023