THE HON’BLE SRI JUSTICE N.RAVI SHANKAR Criminal PETITION No.5274 of 2008 Date: 11th April, 2011 Between: M/s.Parenteral Drugs (India) Limited, Asarwad Post, Dudhia District, Indore, rep. by its Chairman-cum-Managing Director and another …PETITIONERS And The State of Andhra Pradesh, rep. by Public Prosecutor through the Drugs Inspector, Hindupur. …RESPONDENT The Court made the following: ORDER: 1. The petitioners are accused i.e., A-1 and A-3 in C.C.No.159 of 2001 on the file of the Court of Judicial First Class Magistrate, Hindupur (JFCM). The 1st petitioner is a drug manufacturing company at Indore and the 2nd petitioner is a Director of the said company. The said case was registered on a complaint filed by the Drug Inspector, Hindupur. The offences alleged are those punishable under Section 18 (a) (i) r/w. Section 17 (B) r/w. Section 27 (c) of the Drugs and Cosmetics Act, 1940. The said offences relate to manufacture and sale of a drug called Amoxicillin capsule which is alleged to be not of standard quality or a misbranded drug. 2. The JFCM following the procedure prescribed for the trial of warrant cases instituted otherwise than on Police report commenced the case. It appears that PW-1 the complainant-Drug Inspector gave his evidence before the framing of charges. It is not clear whether he gave his evidence in part or completed his evidence. At that stage the petitioners filed a petition i.e., Crl.M.P.No.1210 of 2007 before the JFCM seeking their discharge from the case on the grounds mentioned therein. 3. The JFCM considered that petition and dismissed it by his order dated 11-08-2008 on the ground that a petition for discharge under Section 245 of the Cr. P.C. in a warrant case instituted on a complaint can be considered only after the completion of the evidence of complainant and his witnesses and not before. The petitioners have filed this quash petition challenging that order. 4. It may be noted that Section 244 Cr.P.C. provides for taking of evidence in a warrant case instituted on a complaint before framing of charges. Then Section 245 Cr.P.C. speaks of the stage where the accused can be discharged in such a warrant case. Section 245 Cr.P.C. is now relevant and it reads as follows: “245. When accused shall be discharged:- (1) If, upon taking all the evidence referred to in Section 244, the Magistrate considers, for reasons to be recorded, that no case against the accused has been made out which, if unrebutted, would warrant his conviction, the Magistrate shall discharge him. (2) Nothing in this section shall be deemed to prevent a Magistrate from discharging the accused at any previous stage of the case if, for reasons to be recorded by such Magistrate, he considers the charge to be groundless. 5. It is true that Section 245 (1) Cr.P.C. says that if upon taking all the evidence on behalf of the complainant, if the Magistrate considers for the reasons to be recorded that no case has been made out against the accused, then the accused can be discharged. This Section 245 (1) may apparently suggest that question of discharging the accused under that provision will arise only after completion of the evidence of the complainant and his witnesses which the complainant may let in under Section 244. It appears that the learned Magistrate went more by the tenor of this provision. 6. It should however be noted that Section 245(2) Cr.P.C. which is equally important would show that nothing in Section 245(1) Cr.P.C. shall be deemed to prevent a Magistrate from discharging the accused at any previous stage of the case, if he considers that the charge is groundless. Of course, the Magistrate has to record the reasons for discharging the accused in either case i.e. in a case falling under Sections 245 (1) or under Section 245(2) Cr.P.C. 7. Thus, what emerges from 245 (2) Cr.P.C., is that if the accused makes an application for discharge even before the complainant has completed the evidence from his side, the Magistrate has to consider the said application on merits and he cannot say that he will not consider that application or cannot consider that application unless the complainant is permitted to complete the evidence from his side. 8. Thus, as pointed out by Sri C.Padmanabha Reddy, the learned Senior Counsel appearing for the Advocate on record for the petitioners, the learned Magistrate can be said to have committed an error in passing the impugned order on the ground that the application for discharge cannot be considered unless the complainant leads his entire evidence including that of his witnesses. The impugned order is contrary to Section 245(2) Cr.P.C. It, therefore, follows that this Criminal Petition should be allowed on that ground and impugned order should be set aside and the Criminal Miscellaneous Petition filed by the petitioners before the learned Magistrate should be remanded back to him for fresh disposal on merits. 9. It may, however, be noted that at the time of arguments in this Criminal Petition, the learned Senior Counsel argued for quashing of the criminal case i.e. C.C.No.159 of 2001 itself on two grounds which were raised in the above Criminal Miscellaneous petition filed before the learned Magistrate for the discharge of the petitioners. It may be noted here that the relief sought for in the present Criminal Petition is stated in para 10 of the petition and it is only for setting aside the impugned order dated 11.8.2008 passed in Crl.M.P.No.1210 of 2007 and not for quashing the Criminal case. The said relief has to be granted to the petitioners and it is already granted as stated supra remanding the said Criminal Miscellaneous Petition to the J.F.C.M. Court for fresh disposal for the reasons already recorded supra. 10. The advocate on record was specifically asked as to how the scope of the Criminal Petition can be enlarged for quashing the case especially in view of the order passed in an earlier criminal petition i.e., Criminal Petition 5130 of 2004 filed by these two petitioners along with the 2nd accused therein. There was no convincing reply, but he tried to put forward his case basing on the contention which is raised as second ground that the analysis of the drug was made on the basis of the standards prescribed in Indian Pharmacopoeia (IP) of 1985, which was already superseded by the Indian Pharmacopoeia of 1996, which was in force on the date of taking sample and the analysis report. The learned Counsel for the petitioners argued the two grounds also and since the learned Public Prosecutor also argued the matter opposing the same the said grounds are now taken up as all the points or grounds argued in the petition should be answered. 11. The first ground raised for quashing the criminal case is that the sample of the drug called Amoxicillin capsule was lifted from the retailer shop M/s. Ashwath Medicals, Hindupur on 11.3.1997 and the laboratory analysis report was obtained on 30.6.1997 and a copy of the said report was served on the 1st petitioner’s company on 8.7.1997, but the complaint was filed on 15.5.2000 in the J.F.C.M. Court and this delay in filing the complaint has prejudiced the rights of the petitioners in getting the second sample analysed as by that time the shelf life or the expiry date of the drug was over. The expiry date of the drug is mentioned as November, 1998. 12. It must be mentioned here that this ground was specifically raised in the earlier Criminal Petition 5130 of 2004 which was filed by the petitioners earlier for quashing the criminal case. This Court rejected that contention by observing as follows: “As seen from the record, the sample was duly taken and sent to the analyst and the analyst opined that the sample was not of standard quality. The copy of the said report was served on A-1’s company on 8.7.1997 and in spite of the service of the report, A-1 did not challenge the said report within 28 days. The shelf life period of the drug was expired only in the month of November, 1998. So it is clear that much before the expiry date, the copy of analyst report was served on A-1. In spite of service of copy of analyst report, A-3 did not choose to challenge the analyst report. Therefore, no prejudice is caused on account of the delay in filing the complaint.” 13. With the observations and reasons, this Court already rejected the plea of petitioners for quashing the case against them on the ground of delay. In the said criminal petition, the case against A-2 was quashed for reasons recorded therein and these two petitioners were directed to face the trial. Hence, I am of the opinion that it is not open for the petitioners to raise the ground of delay in filing complaint again in this second criminal petition, which is filed only to quash the order of the JFCM dismissing an application for discharge. 14. The learned Counsel for the petitioners relied upon two decisions of our Supreme Court one given in Medicamen Biotech Limited Vs. Rubina Bose, Drug Inspector[1] and another given i n State of Haryana Vs. Unique Farmaid (P) Limited[2] in support of his contention based on the delay in filing the complaint and the expiry of the shelf life or the expiry of the expiry date of the drug. The first case relates to a prosecution under the Act whereas the second case relates to a prosecution under the Insecticides Act, 1968. In view of the Judgment of this Court already given in Criminal Petition No.5130 of 2004, which went against the petitioners on the ground of delay in filing the complaint, I am of the opinion that this Court cannot entertain one Criminal Petition after another when the matter is decided by this Court against the petitioners in the earlier one. Further, in the earlier Criminal Petition, this Court considered the aspect of delay and also the failure of the petitioners No.1 and 3 to challenge the report within 28 days before the Drug Inspector or make a request before him for a second analysis as contemplated under Section 25(3) of the Act. In any event, this question has now to be decided by the JFCM Court only. 15. Then turning to the second ground, this was not raised in the earlier Criminal Petition No.5130 of 2004, though it was available even then, but is raised now. A copy of the analysis report dated 30.6.1997 of the Government analyst of Drugs Control Administration, Hyderabad, made available would no doubt show that the said analyst in analysing the drug went by the standards prescribed in Indian Pharmacopoeia of 1985. The analyst report shows that the average net content of the capsule weighed 0.283 grams and that the assay of amoxicillin showed that it contained 135.2 mg. of amoxicillin in a disintegration time of two minutes. 16. Copies of the Pharmacopoeia of 1985 and 1995 for amoxicillin drug have been filed by the petitioners themselves in their paper book and they commence from page 13 of the said paper book. The Pharmacopoeia of 1985 prescribes that amoxicillin content in a capsule should be not less than 92.5% and not more than 110%. Similarly, the Pharmacopoeia of 1995 prescribes that amoxicillin drug contents should be not less than 90% and not more than 100% in a capsule i.e. the stated amount. A perusal of the standards would show that the standards prescribed in Pharmacopoeia of 1985 with regard to the minimum content is more stringent than the standard prescribed in the Pharmacopoeia of 1995. 17. In the analysis report as already mentioned supra, the average net content of the capsule taken as sample is shown as 0.283 grams and the amoxicillin content is shown as 133.2 mg. It would thus be clear that the minimum amoxicillin content is as per both the standards prescribed in Pharmacopoeia of 1985 and Pharmacopoeia of 1995 is less. The learned public prosecutor pointed out that going by the standards prescribed in the Pharmacopoeia of 1985 and the Pharmacopoeia of 1995, the drug can be said to be not of standard quality and it can be said to be a substandard drug even going by Pharmacopoeia of 1995 and no prejudice will be caused to the petitioners in either case and therefore, the proceedings cannot be quashed on that ground. 18. The learned Senior Counsel in the course of arguments, pointed out that the testing method prescribed by the Pharmacopoeia of 1995 is different and more harsh than the one prescribed in the Pharmacopoeia of 1985 and therefore, the analyst report which was not given in accordance with the Pharmacopoeia of 1995 standards cannot be accepted and the proceedings should be quashed. In my opinion, it is difficult to accept this contention in this petition. 19. It may be noted that ultimately whether the contention raised on behalf of the petitioners under the second ground is to be accepted or not vis-à-vis the arguments of the learned public prosecutor is a question to be decided in the enquiry in the discharge petition or in trial and I am of the opinion that this Court cannot go into these aspects under Section 482 Cr.P.C. It is open for the petitioners to raise this ground or any other ground in the discharge petition, which is now remanded back to the JFCM Court. 20. Accordingly, for the aforesaid reasons, the grounds raised by the petitioners for quashing the criminal case, are rejected. However, in so far as the impugned order passed in Criminal M.P.1210 of 2007 by the JFCM is concerned, this petition is allowed and that order is set aside and the Cr.M.P.No.1210 of 2007 is remanded back to the JFCM for fresh disposal in accordance with law. This criminal petition is allowed only to the extent indicated above. This order shall not be understood to place any restriction on the power of the learned Judicial Magistrate of First Class to deal with it in accordance with Law. 21. Copies of this order are ordered to be communicated to Drugs Controller General (India), New Delhi and Director, Drug Control Administration, Andhra Pradesh, Hyderabad, for necessary action at their end for educating the Government Analysts regarding the Pharmacopoeia standards to be followed in analysing the alleged misbranded or substandard drugs. ______________________ N. RAVI SHANKAR, J 11th April, 2011 Pn/Tjmr HON’BLE SRI JUSTICE N. RAVI SHANKAR CRIMINAL PETITION No.5274 of 2​008 11th April, 2011 Pn [1] (2008) 7 Supreme Court Cases 196 [2] (1998) 8 Supreme Court Cases 190