IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT : THE HONOURABLE MR. JUSTICE V.GIRI TUESDAY, THE 10TH FEBRUARY 2009 / 21ST MAGHA 1930 Crl.Rev.Pet.No. 893 of 2001() ----------------------------- {CR.A.77/1996 OF THE SESSIONS COURT, TRIVANDRUM IN C.C.NO.77/1993 OF THE JUDICIAL MAGISTRATE OF FIRST CLASS COURT-II, NEDUMANGAD} .................... REVN. PETITIONER(S)/APPELLANT/ACCUSED: ------------------------------------------------------------------------- J.HAREENDRAN NAIR, XIII/169, POOVACHAL, THIRUVANANTHAPURAM (PROPRIETOR SREE DHANWANTHARY AYURVEDICS). BY ADV. SRI.G.GOPALAKRISHNAN NAIR SRI.R.BINDU (SASTHAMANGALAM) SRI.R.JAYAKRISHNAN RESPONDENT(S)/RESPONDENT/COMPLAINANT: ----------------------------------------------------------------------------- STATE OF KERALA BY THE PUBLIC PROSECUTOR, HIGH COURT OF KERALA, ERNAKULAM. BY PUBLIC PROSECUTOR SMT.PUSHPALATHA THIS CRIMINAL REVISION PETITION HAVING BEEN FINALLY HEARD ON 10/02/2009, THE COURT ON THE SAME DAY PASSED THE FOLLOWING: V.GIRI, J. ------------------------- CRL.R.P.No.893 of 2001 ------------------------- Dated this the 10th day of February, 2009. O R D E R The accused in C.C.No.77/93 on the file of the Judicial Magistrate of the First Class-II, Nedumangadu, who was prosecuted, convicted and sentenced for offences punishable under Rule 158(a) of the Drugs and Cosmetics Rules, 1945 {for short 'the Rules'} and Section 33(EEC) (a) (iii) read with and 33 I (2) of the Drugs and Cosmetics Act, 1940 {for short “the Act”} and under Rule 161(1) of the Rules and Section 33(EEC)(a) (iii) read with and 33 I (2) of the Act, is the petitioner. Thus, the petitioner has come up with this Criminal Revision Petition. 2. The petitioner is duly licensed under the Act. He is carrying on the business of manufacture and sale of Ayurvedic Medicines in the premises Sree Dhanwanthari Ayurvedic House in Building No.XIII/169 and 170, Poovachal, Thiruvananthapuram District. He is licensed to manufacture the proprietary Ayurvedic Medicine, 'Pankaja Kasthuri'. On 27.1.1992 PW.1 Drugs Inspector CRL.R.P.No.893 of 2001 :: 2 :: inspected the manufacturing premises, took a sample of 'Pankaja Kasthuri' and also seized the records, which were to be maintained and which were maintained for the purpose of manufacture and sale of Ayurvedic Medicines. Further inspection was conducted in Sree Dhary Ayurvedic Stores on 28.1.1992 and yet another sample was collected. These samples were sent to the Government Analyst, Drugs Testing Laboratory, Thiruvananthapuram. Records seized at the time of inspection revealed that the accused has not maintained the proper records relating to the details of the manufacture of the drugs and that this is in contravention of Rule 158(a) of the Rules. It was further alleged that the labels on the container of the medicine 'Pankaja Kasthuri' did not contain the details of the quantities of each ingredient used for the manufacture of the drug. This amounted to a contravention of Rule 161(1) of the Rules. It was on these allegations that the complaint was laid. 3. Though initially there was an allegation that the drugs manufactured are spurious, the same was later CRL.R.P.No.893 of 2001 :: 3 :: given up in the light of Ext.P17 report of the Central Drugs Laboratory. It was found that there are no undisclosed substances in the medicine. Ultimately, the petitioner was prosecuted for contravention of Rules 158 (a) and 161 of the Rules, which, in turn, would amount to contravention under Section 33(EEC)(a) (iii) of the Act and 33 I (2) thereof. The contravention of the aforementioned provisions were found by the trial court and the petitioner was sentenced to undergo simple imprisonment for 10 days and to pay a fine of Rs.2,500/-, with a default sentence of imprisonment for 15 days under Section 33(EEC)(a) (iii) read with and 33 I (2) of the Act and under Rule 161(1) of the Rules and for similar sentence, for the offence under Rule 158(a) of the Rules. The conviction and sentence were confirmed by the appellate court and hence this revision. 4. I heard Mr.Bindu Sasthamangalam, learned counsel for the petitioner and learned Public Prosecutor. 5. Learned counsel for the petitioner essentially confined his challenge to the validity of sanction for prosecution, Ext.P22 issued in that behalf by PW.4, the CRL.R.P.No.893 of 2001 :: 4 :: Drugs Controller and the Licensing Authority. Reference in this behalf was made to Section 33(M) of the Act. “(1) No prosecution under this Chapter shall be instituted except by an Inspector (with the previous sanction of the authority specified under sub- section (4) of Section 33G). (2) No court inferior to that of a Metropolitan Magistrate of a Judicial Magistrate of the First Class try an offence punishable under this Chapter.” 6. Ext.P22 order of sanction reads as follows: “Sanction is hereby accorded to the Drugs Inspector (Ayurveda) Office of the Regional Drugs Inspector, Kollam for launching prosecution against person(s)/ Firm(s) involved in the manufacture for sale and sale of spurious Ayurvedic drugs in violation of Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder detected at M/s.Dhanwanthari Ayurvedics, Undappara, Poovachal P.O., Thiruvananthapuram district vide paper Ist cited.” CRL.R.P.No.893 of 2001 :: 5 :: 7. It is contended that the sanction for prosecution was given by PW.4 to prosecute the petitioner for offences relating to the manufacture and sale in contravention of the provisions of the Act. In the light of Ext.P17 report, the petitioner cannot be prosecuted for the said offence. In fact, the accused was discharged of the said offence. Contravention of Rules 158(a) and 161 (1) of the Rules arises on allegations relating to the non- maintenance of the registers and non-supply of details regarding the ingredients of the medicines on the label of the container, which was used for the sale of the drug. These are independent offences and the order of sanction does not specifically refer to the same. Learned counsel for the petitioner, therefore, contends that the prosecution of the petitioner for the aforementioned violation was not supported by a valid order of sanction. 8. Learned Public Prosecutor submits that the order of sanction cannot be subjected to such a strict interpretation especially, at any rate, since the sanction order refers to the manufacture and sale of the drugs. The requirements of Rules 158(1), 158(a) and 161(1) of CRL.R.P.No.893 of 2001 :: 6 :: the Rules relate to the stages of manufacture for sale and sale of the drug. Therefore, the order should be treated as sufficient. 9. I have already extracted the relevant portion of Ext.P22 order. PW.4, the author of Ext.P22, has issued the order of sanction for prosecuting the petitioner for sale of a spurious drug and that the sanction related to ancillary matters as well. In my view, the order of sanction relates to the stages of manufacture and sale of drugs. Though ultimately the petitioner was not prosecuted for manufacture and sale of spurious drug, it cannot be said that the order of sanction, does not, in any manner, relate to the manufacture for sale and sale as such. Rule 158 of the Rules deals with the conditions of licence and Rule 158(a) obliges the licensee to keep proper records of the details of manufacture and of the tests, if any, carried out by him or by any other person on his behalf of the raw materials and finished products. Rule 161(1) obliges the licensee to conspicuously display on the label of the container or package of an Ayurvedic (including Siddha) or Unani Drug, the true list of all the CRL.R.P.No.893 of 2001 :: 7 :: ingredients used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein. Obviously, Rule 161(1) of the Rules is an obligation, which will have to be discharged by the licensee, for the purpose of sale of an Ayurvedic product. Thus, the rules mentioned above contemplates conditions that have to be fulfilled at the stage of manufacture of Ayurvedic drug for sale and at the time of sale. These two stages are contemplated and comprehended by the order of sanction, Ext.P22. It cannot be said that the prosecution launched against the accused for the offence aforementioned rules, therefore, did not have sanction as contemplated by the Rules. In my view, the courts below have, therefore, correctly come to the conclusion. Since the provisions are mandatory, the conviction of the petitioner, for the aforementioned offences, does not warrant any interference. 10. Learned counsel for the accused submits that as a matter of fact, though not in the proper form, the labels packed along with the containers of the drug Ext.P4, details the ingredients. He submits that the CRL.R.P.No.893 of 2001 :: 8 :: sentence of substantial imprisonment as imposed by the trial court is too harsh. 11. I heard learned Public Prosecutor on this aspect. In my view, imprisonment till the rising of the court will suffice, along with a larger amount of fine. 12. In the result, Criminal Revision Petition is allowed in part. The conviction of the petitioner for offences under Rule 158(a) of the Rules and Section 33 (EEC)(a) (iii) read with and 33 I (2) of the Act and under Rule 161(1) of the Rules and Section 33(EEC)(a) (iii) read with and 33 I (2) of the Act is upheld. The sentences imposed on the accused is modified to the following extent: (1) The accused shall suffer a sentence of imprisonment till the rising of the court and to pay a fine of Rs.7,500/- and in default to undergo simple imprisonment for 15 days under Rule 158(a) of the Drugs and Cosmetics Rules, 1945 and Section 33(EEC)(a) (iii) read with and 33 I (2) of the Drugs and Cosmetics Act. 1940. CRL.R.P.No.893 of 2001 :: 9 :: (2) The accused is again sentenced to imprisonment till the rising of the court and to pay of Rs.7,500/- and in default to undergo simple imprisonment for 15 days under Rule 161(1) of the Drugs and Cosmetics Rules, 1945 and Section 33(EEC)(a) (iii) read with and 33 I (2) of the Drugs and Cosmetics Act. 1940. (3) The substantive term of imprisonment under each of the above counts need be suffered only concurrently. (4) The accused shall be given two months' time to pay the fine. He shall appear before the court below on 23.03.2009 to suffer the imprisonment. Lower Court Records shall be transmitted to the trial court forthwith. Sd/- (V.GIRI) JUDGE sk/ //true copy// P.S. to Judge CRL.R.P.No.893 of 2001 :: 10 ::