IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT : THE HONOURABLE MR. JUSTICE THOMAS P.JOSEPH THURSDAY, THE 24TH MARCH 2011 / 3RD CHAITHRA 1933 Crl.MC.No. 4997 of 2010() ------------------------- CC.491/2009 of JUDL. MAGISTRATE OF FIRST CLASS-I, KOZHIKODE .................... PETITIONER NO.1/ ACCUSED NO.3: ----------------------------------------------------- 1. RECKIT BENCKISER (INDIA) LTD. 50/857 CI, CHANGAMPUZHA SAMADHI ROAD, OPP.CRIME BRANCH, EDAPPALLI, KOCHI - 682 024 THROUGH MR.ADITYAS EGHAL MAHALAKSHMI CHAMBERS, M.G.ROAD, BANGALORE. 2. M/S.ANUGRAHA DISTRIBUTORS, 8/86H, KAMMISIATH PARAMBU, CORPORATION OFFICE SOUTH CROSS ROAD, CALICUT - 32, REPRESENTED BY ITS MANAGING PARTNER. MR.ASGAR ALI.A., S/O.H.UMMERKOYA, "ASHA MAHAL", P.O.THIRUVANNUR, CALICUT - 673 029. 3. VIPIN C (PARTNER) S/O.C.VALSAN, CHITTEDATH (HOUSE), FRANCIS ROAD,KOZHIKODE - 673 003. BY ADV. SRI.MADHU RADHAKRISHNAN RESPONDENT(S): --------------------------- 1. STATE OF KERALA, REPRESENTED BY PUBLIC PROSECUTOR. 2. DRUG INSPECTOR, OFFICE OF THE ASST.DRUGS CONTROLLER, CIVIL STATION, KOZHIKODE. R1 & R2 BY PUBLIC PROSECUTOR SRI. K.J.MOHAMMED ANZAR THIS CRIMINAL MISC. CASE HAVING BEEN FINALLY HEARD ON 24/03/2011 ALONG WITH CRM NO. 541 OF 2011, THE COURT ON THE SAME DAY PASSED THE FOLLOWING: Kss 'CR' THOMAS P JOSEPH, J. ---------------------------------------- Crl.M.C.Nos.4997 of 2010 and 541 of 2011 --------------------------------------- Dated this 24th day of March, 2011 ORDER Is exhibiting, stocking, selling or distributing 'Dettol', a product of M/s. Reckitt Benckiser (India) Ltd, the first petitioner herein without a license issued under the Drugs and Cosmetics Act, 1940 (for short, "the Act”) punishable under Sec.27(b)(ii) of the said Act?. The answer depends on whether Dettol is a 'Disinfectant' as contended by petitioners. 2. Short facts necessary for a decision of the question are: Second respondent, the Drug Inspector, Kozhikode searched premises of the second petitioner/first accused, a partnership firm on 18.08.2006 and found Dettol stocked and exhibited for sale in large quantity. The third petitioner/second accused who is the Managing Partner of the said firm could not produce any license issued under the Act for stocking, exhibiting and sale of Dettol. On the premise that Dettol required a license for its stocking, exhibiting and sale, the Drug Inspector filed complaints against accused 1 to 3. It is alleged in the complaints that the first petitioner/third accused manufactured and sold Dettol to Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 2 :- petitioners 2 and 3/accused 1 and 2 (hereinafter referred as accused) who had no license to deal with the same and accused 1 and 2 stocked and exhibited for sale the said product without license under the Act. It is alleged that the accused violated the prohibition contained in Sec.18(c) of the Act and thereby committed offence punishable under Sec.27(b)(ii) of the said Act. Learned Judicial First Class Magistrate-I, Kozhikode took cognizance of the said offence, filed C.C.No.491 of 2009 and 717 of 2009 and issued process to the accused. The complaints, orders taking cognizance and proceedings in the said cases are challenged by the accused in these proceedings under Sec.482 of the Code of Criminal Procedure (for short, "the Code”). Learned counsel for accused 1 to 3 contended that Dettol being a 'Disinfectant' does not require a license under the Act since it came within the exempted category under item No.12 of Schedule K of the Drugs and Cosmetics Rules, 1945 (for short, "the Rules”). Learned counsel has invited my attention to an unreported decision of the Division Bench of this Court in M/s.Reckitt Benckiser (India) Limited Vs. Commissioner (O.T.Appeal.No.6 of 2006) and another unreported decision of the Andra Pradesh High Court in Vijayakumar and Ors. Vs. Drug Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 3 :- Inspector (Crl.Petition.No.3400 of 2005) in support of his contention that Dettol is a 'Disinfectant'. Learned Public Prosecutor would contend that Dettol does not have the characteristics of a 'Disinfectant', it is only an 'Antiseptic' though, it may be used as a 'Disinfectant' also, item No.12 of Schedule K referred above only exempted 'Insecticides' and 'Disinfectants' and hence Dettol is not exempted by the Act and Rules from the necessity to obtain license for its stocking, exhibition and sale. Learned Public Prosecutor has invited my attention to the Complete Drug Reference, 32nd Edition, Page 1097 as to the meaning of 'Disinfectant' and 'Antiseptic'. 3. It is not disputed that accused 1 and 2 are not having license under the Act to stock, exhibit or sell Dettol. Sec.18 coming under Chapter IV of the Act deals with prohibition of manufacture and sale of certain drugs and cosmetics from the date notified by the State Government in the Official Gazette. The said provision says: “18. 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 this behalf- (a) . . . . . . . . . . (b) . . . . . . . . . . Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 4 :- (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 an 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 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”. 4. Sec.3(b) of the Act defines 'drug' as under: (i). . . . . . . . . . . . . . . . . . . . . . . . . (ii) such substance (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of (vermin) or insects which cause disease in human Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 5 :- beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette are also includes in the definition of “drug”. As per the said definition, any substance intended to be used for the destruction of vermin or insects which cause disease in human being or animals as may be specified from time to time by the Central Government by notification in the Official Gazette is also brought within the definition of 'drug'. A 'Disinfectant' is therefore, a 'deemed drug' as Sec.3(b)(ii) of the Act would say and should normally come within the prohibition contained in Sec.18 of the Act. 5. Now the question is whether 'Dettol' is a 'Disinfectant' and hence exempted from Sec.18 of the Act as contended by the accused. Part XI of the Rules deals with exemptions. Rule 123 falling in the said part says: “123-- The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule”. In Schedule K, item 12 is, Class of Drugs Extent and Conditions of Exemption “12. Substances intended to be “The provisions of Chapter IV of the Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 6 :- used for destruction of Act (taking in sec.18 of the Act) vermin or insects which and Rules thereunder, which cause disease in human require them to be covered by a being or animals, viz sale license (subject to the Antiseptics and condition that provision of Disinfectants”. condition (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945 are complied with by the persons stocking or selling such substances” Condition No.17 of Rule 65 relates to stocking or sale of the drug after the date of expiration of potency recorded on its containers, label or wrapper or in violation of statement or direction recorded on such container label or wrapper. Prosecution of the accused in these cases is not based on any violation of condition No.17 and hence that question is not required to be adverted to in these proceedings. 6. I referred to item 12 of Schedule K of the Rules where the expression used is substances intended to be used for destruction of vermin or insects which cause disease in human beings or animals viz, Insecticides and Disinfectants. The expression 'viz' means “namely”, “that is to say” (See Law Lexicon by P.Ramanatha Aiyar). The word “namely” is a term which imports interpretation that is it includes what is included in the previous term. That word imports enumeration of what is comprised in the preceding clause. It ordinarily serves the purpose of equating what Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 7 :- follows with the clause described before (See State of Bombay Vs. Bombay Education Society & Ors. (AIR 1954 SC 561 at 565). If Dettol is a 'Disinfectant', it falls in item 12 of Schedule K in which case by virtue of Rule 123 of the Rules, Dettol should be held to be exempted from Sec.18 of the Act which comes under Chapter IV of the said Act. 7. Learned counsel for the accused has given me a copy of label of the product in question - Dettol where it is stated that it is an Antiseptic germicidal and the following are its use mentioned. i. Pre-operative Preparation of Patient's Skin ii. Antisepsis in Obstetrics and Midwifery iii. Cuts and Wounds (Also bites, scratches and insect stings) iv. Instrument Sterilisation v. General Disinfection: Wards and Theatre, Hands, Face, Masks, Soiled Hospital Linen, etc. vi. Bathing and Irrigation of Abscesses and Boils vii. Epidemics viii. Dandruff ix. Gargle x. Bath Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 8 :- It is cautioned that the product is meant “for external use only”. The active ingredients of Dettol are: i. Chloroxylenol I.P.4.8% w/v ii. Terpineol B.P. 9.0% v/v iii. Alcohol Absolute (Denatured) 13.1% v/v It Contains Caramel I.P. as colour. 8. In “Infection Control” relied on by the accused, use of Disinfectant and Antiseptic is given as below:- “Disinfectant used on inanimate objects to kill or prevent the growth of micro- organisms”. “Antiseptic- used on living tissue to kill or prevent the growth of micro-organisms”. The unreported decision of Andra Pradesh High Court referred above held that 'Savlon' is a Disinfectant. In the unreported decision of the Division Bench of this Court referred above though dealing with the question regarding liability under the Kerala Value Added Tax, 2003 it is observed in paragraph 7: “ Appellant has no case that the above Disinfectant, that is Dettol, is able to prevent or cure any disease. It externally kills germs and is used for various purposes referred to in the leaflet Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 9 :- attached to it which includes even washing.” (emphasis supplied) In the view of the Division Bench, Dettol is a Disinfectant. 9. In 'Complete Drug Reference' relied on by the learned Public Prosecutor, it is stated at page 1097:: “There is often confusion between the terms disinfectant and antiseptic. The term Disinfectant is applied to a chemical agent which destroys or inhibits the growth of pathogenic micro-organisms in the non-spoting or vegetative state, Disinfectants do not necessarily kill all micro-organisms but reduce them to a level which is harmful neither to health not the quality of perishable goods. The term is applicable to agents used to treat inanimate objects and materials and may also be applied to agents used to treat the skin and other body membranes and cavities.” “An Antiseptic is a Disinfectant which is used on skin and other living tissues thereby limiting or preventing infection”. Learned Public Prosecutor argues that Dettol is basically an Antiseptic though, it may be used as Disinfectant also. 10. It is appropriate to refer to the meaning of the words Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 10 :- in the Medical Dictionary. In Legal Medical Dictionary by Erskine Pollock and E. Raymond Clutterbuck the word “Sepsis” ( the word 'Septic' is its adjective) is defined as under: “The presence of pus-forming bacteria in, e.g, a wound which is festering. The index of the presence of such bacteria is the train of symptoms known as inflammation. Adj, Septic”. 'Antiseptic' therefore must be something which prevents sepsis. The word “Infectious” is defined as, “capable of being transmitted from one person to another”. The word “Antiseptic” is defined as, “germ-destroying”. In Dorland's Pocket Medical Dictionary the word “Antiseptic” is defined as: “i. Preventing sepsis. ii. a substance that inhibits the growth and development of microorganisms but does not necessarily kill them.” “Disinfectant” is defined thus: “i. Freeing from infection. ii. An agent that disinfects, Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 11 :- particularly one used on inanimate objects”. In Mosby's Medical Dictionary, the word “Antiseptic” is defined as, “i. tending to inhibit the growth and reproduction of microorganisms. ii. a substance that tends to inhibit the growth and reproduction of microorganisms.” The word “Disinfectant” is defined as, “a chemical that can be applied to objects to destroy micro organisms”. “Disinfection” is defined as “the process of killing pathogenic organisms or of rendering them inert” The above descriptions persuades me to hold that the function of a 'Disinfectant' which is a chemical or mixture of chemicals of appropriate percentage is destruction or making inert micro organisms particularly on inanimate objects. But that does not mean that a Disinfectant could be used only on inanimate objects and the moment it could be used on animate objects also, it ceases to be a 'Disinfectant' and became an 'Antiseptic'. Its use on animate objects is only external with the same purpose – destruction or making inert micro organisms. 11. I stated from the label of 'Dettol' the uses to which the Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 12 :- said product can be put to. It includes sterilisation of instruments and g eneral disinfection of wards and theatre, hands, face, masks, soiled hospital linen, etc (ie, on inanimate objects). It can also be used for bathing and irrigation of abscesses and boils, not to say about its use to prevent dandruff. 'Dettol' can be used for bathing as well. It is stated (on the label) that a little Dettol added to bath water is pleasant, refreshing and deodorising. A deodorant is a substance that destroys or masks odors (smell). The mere fact that 'Dettol' can also be used for pre-operative preparation of patient's skin or as antisepsis in obstetrics and midwifery, on cust and wounds (also bites, scratches and insect sting), all externally, and all for the purpose of destruction or making inert micro organisms in my view does not make 'Dettol' anything other than a 'Disinfectant'. 'Dettol' is a mixture of the chemicals I have mentioned above, from its label. Thus, going by the definition of the word 'Disinfectant' and the use for which Dettol is manufactured I hold that Dettol is a 'Disinfectant' used to treat inanimate objects and materials though it may also be applied to agents used to treat the skin and other body membranes and cavities (externally). Dettol contains some chemicals which are antiseptic but does not loose its character as Crl.M.C.Nos.4997 of 2010 and 541 of 2011 -: 13 :- a Disinfectant for the said reason or that it can be used to treat skin and other body membranes and cavities. 'Dettol' thus comes under item 12 of Schedule K of the Rules and hence is exempted from Chapter IV of the Act by virtue of Rule 123 of the Rules. Hence for stocking, exhibiting and sale of 'Dettol' a license under the Act is not required. Prosecution against petitioners/accused have to fail. Resultantly these criminal miscellaneous cases are allowed. The complaints preferred against petitioners/accused, cognizance taken thereon and proceedings against them before learned Judicial First Class Magistrate-I, Kozhikode in C.C.Nos.491 and 717 of 2009 are quashed. (THOMAS P JOSEPH, JUDGE) Sbna/- The words “Antiseptics and Disinfectants” occurring in the extracted portion of Schedule K, item No.12 of rule 123 in paragraph 5 of the order dtd 24/03/2011 under the heading “Class of Drugs” are corrected and substituted as “Insecticides and Disinfectants” as per common order dtd.24/05/2011 in Crl.M.C.Nos.4997/2010 and 541/2011. Sd/- Registrar (Judicial)