IN THE HIGH COURT OF JUDICATURE AT PATNA Cr.Misc. No.41578 of 2007 AARON PHARMACEUTICAL PVT.LTD. MUMBAI INDUSTRIES, HOUSE MAHA KALI ROAD, ANDHERI EAST MUMBAI, THROUGH ITS AUTHORISED … MOHAN PD.SINGH ……………………………………….……...Petitioner Versus 1. STATE OF BIHAR 2. SRI B. L. DAS, DRUG INSPECTOR, NAWADA TOWN, DISTRICT- NAWADA ………………………………….Opposite Parties ********** For the Petitioner :- Mr. N. K. Aggrawal, Sr. Advocate For the State :- Mr. U. S. P. Singh, APP ****************** 6 20/05/2010 Heard the parties. 2. This application has been filed for quashing the order dated 12.6.2007 passed in Cr. Revision No. 38 of 2007 by the learned Sessions Judge, Nawada whereby the order taking cognizance dated 21.5.2005 passed by the learned Chief Judicial Magistrate, Nawada in G.O. Case No. 46 of 2005 (Trial No. 3047 of 2005) under Sections 18 (a) (i), 18 (b) and 27 (d) of the Drugs and Cosmetics Act, 1940 was affirmed. 3. The Drugs Inspector, O. P. No. 2 has filed a case in the Court of the learned Chief Judicial Magistrate, Nawada stating, inter alia, that on 22.3.2002 from M/s Laxmi Enterprises, Gola Road, Nawadah sample of medicine, namely, MEBENTH tablet manufactured by M/s 2 Aaron Pharmaceuticals Pvt. Ltd., Mumbai was taken and was sent for analysis to the Analyst, Bihar Drug Control Laboratory, Agamkuan, Patna. The analysis disclosed that on the label of medicine there is no mention whether the medicine is coated or uncoated which was in violation of Schedule V of the Drugs and Cosmetics Rules (hereinafter referred to as the Rules) and it was found that the drug was not of standard quality. 4. The case of the petitioner is that MEBENTH tablet is Mebendazole and this tablet is not a patent or proprietary medicine as defined under section 3 (h) of the Drugs Cosmetics Act (hereinafter referred to as the Act). Section 3 (h) (i) of the Act relates to other system of medicine and in the present case the applicability of Section 3 (h) (ii) is existing, according to which, the medicine which is not included in edition of the Indian Pharmacopoeia or any other Pharmacopoeia authorized in this behalf by the Central Government shall be patent or proprietary medicine under Section 5 of the Act. The sample collected from M/s Laxmi Enterprises, Nawadah manufactured by the petitioner’s company is included in the edition of Indian Pharmacopoeia of 1996 and so it is clear that Mebendazole is not a patent. 5. Under Rule 124B, standards for patent or proprietary medicines has been defined, according to 3 which, the standards for patent or proprietary medicines are those which are mentioned in Schedule V. According to Rule 124, the patent is required as per standard laid down in Schedule V. Schedule V will apply in cases where the medicine is covered within the definition of patent under Section 3 (h) (ii) read with Rule 124 B. The Drug Inspector has lost sight that Mebendazole has already been retained in 1996 edition of Indian Pharmacopoeia and so he was unaware of the legal position. No doubt manufacturer is to follow the standard as mentioned in Schedule V of the Rules but it relates only to the medicines not included in any edition of Indian Pharmacopoeia. The Drug Analyst on analysis has found the potency to be 103.25 per cent whereas the potency should not be less than 92.5 per cent or more than 107.5 per cent. The medicine was not sub- standard. The standard was as per requirement in Indian Pharmacopoeia Edition 1996 which was applicable at the time when the product was manufactured and sample was taken. The Central Government in exercise of powers under Rule 96 (i) clause (3) has clarified that medicines which are included in the Edition of Indian Pharmacopoeia has no requirement to mention on the label whether the medicine is coated or uncoated. The Drug Inspector has taken the sample and it was of 100 mg and the notification issued by the Central Government in exercise of powers 4 under clause (iii) of the Rules 96 (i) of the Rules 1945 gives exemption from application of mentioning the contents of active ingredients or formula in cases of Pharmacopoeia preparations where the composition of such preparations is specified. In the present case the composition is specified in the monogram as 100 mg and under the general monogram of the tablet it is specified that the tablets have to be uncoated and no colour is permitted to be used and so there was no requirement for mentioning whether the tablets were coated or uncoated. 6. On the basis of above mentioned facts it has been submitted that order taking cognizance was without application of mind and the prosecution of the petitioner shall be abuse of the process of the Court. 7. Another fact brought by the petitioner is that the sample was collected on 22.3.2002 and analysis was done on 14.5.2002 and cognizance was taken on 21.5.2005. It has been argued that even if it is accepted that the label was not properly printed then offence shall come under Section 27 (d) of the Act and cognizance was also taken under Section 27 (d) of the Act for which maximum punishment is two years. This is the first case in which the petitioner has been roped in and so even if prosecution case is accepted then the maximum punishment for the offence shall be two years, hence the 5 learned Judicial Magistrate was required to take cognizance within three years from the date of offence which was committed by the petitioner’s company in view of the bar under Section 468 of the Code of Criminal Procedure but cognizance was taken after three years so the entire proceeding is fit to be quashed. 8. In the present case cognizance has been taken under Section 18 (a) (i) and 18 (b) read with Section 27 (d) of the Act which prescribes for prohibition of manufacture and sale of certain drugs and cosmetics which is being quoted herein below:- “18. Prohibition of manufacture and sale of certain drugs and cosmetics- From such date as may be fixed by the State government by notification in the Official Gazette ion 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 6 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[for cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder; ( c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug [or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter: Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small 7 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.” 27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter:- (a) xx xx xx (b xx xx xx (c) xx xx xx (d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine: 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.” 9. Emphasis has been laid by the learned counsel for the petitioner that the delay in taking cognizance has 8 not been condoned so the learned court below has violated the mandatory provision of Section 468 Code of Criminal Procedure (hereinafter referred to as the Code) which is being quoted herein below: “468. Bar to taking cognizance after lapse of the period of limitation.- (1) Except as otherwise provided elsewhere in this Code, no Court, shall take cognizance of an offence of the category specified in sub-section (2), after the expiry of the period of limitation. (2) The period of limitation shall be – (a) six months, if the offence is punishable with fine only; (b) one year, if the offence is punishable with imprisonment for a term not exceeding one year; © three years, if the offence is punishable with imprisonment for a term exceeding one year but not exceeding three years. [(3) For the purpose of this section, the period of limitation, in relation to offences which may be tried together, shall be determined with reference to the offence whichis punishable with the more severe punishment or, as the case may be, the most severe punishment.]” 10. Section 468 of the Code prescribes a bar to take cognizance after lapse of a period of limitation. Under repealed code of 1998 no period of limitation was 9 prescribed for launching a prosecution and the Court had no authority to throw away a private complaint or a police report on the ground of delay. Now the Parliament has prescribed period of limitation to put pressure on the organs who are associated with the criminal prosecution and every efforts have to be taken that the case is instituted within reasonable time. When the offence is punishable with imprisonment for a term exceeding three years the time of limitation as laid down under Section 468 of the Code is not applicable and on the ground of any delay the proceeding cannot be quashed. The delay matters when the punishment is up to three years. The power of “except as otherwise provided” is mentioned in Section 468 of the Code which covers the provision under Section 473 of the Code. The court has discretion to take cognizance after expiry of period of limitation but for that the Court has to be satisfied that the delay has been properly explained and it is necessary to take cognizance in the interest of justice and at that stage an opportunity is required to be given to the accused. Power of condoning the delay can be exercised and it has to be done considering the facts involved in the occurrence. 11. Learned counsel appearing on behalf of the State has submitted that no doubt cognizance has been taken beyond the period of limitation but in view of the 10 gravity of the offence the prosecution cannot be allowed to be quashed. 12. The mandate of Section 468 of the Code is to the effect that all the prosecution wing must work cohesively to bring the accused to the dock within reasonable time. This provision is in the terms of the right guaranteed under Article 21 of the Constitution of India. If there is period of limitation prescribed then the parties responsible for causing the delay must explain what was the cause of delay and if it is properly explained then the Court has discretion to consider as to whether the cognizance can be taken even after expiry of period prescribed under Section 468 of the Code. 13. In the present case, there is no mention at all that as to why the cognizance was taken beyond the period of limitation. In this view of the matter, the impugned order is fit to be quashed. 14. Considering the defence of the petitioner that the Drug seized from the petitioner was found to be having full potency and there was no apparent violation of any of the provisions, the impugned order taking cognizance against the petitioner dated 21.5.2005 passed by the learned Chief Judicial Magistrate, Nawada in G.O. Case No. 46 of 2005 (Trial No. 3047 of 2005) under Sections 18 (a) (i), 18 (b) and 27 (d) of the Drugs and Cosmetics Act is 11 quashed. 15. In the result, this application is allowed. avin (Shyam Kishore Sharma, J.)