1. The present Special Criminal Application under Article 227 of the Constitution of India has been preferred by the petitioners-original accused to quash and set aside the impugned order passed by the learned Metropolitan Magistrate, Ahmedabad dated 11/05/2006 in Criminal Case No. 165/1997 for rejecting the application preferred by the petitioners-original accused to discharge them as well as the impugned judgment and order dated 10/09/2006 passed in Criminal Revision Application No. 299/2006 in dismissing the same and confirming the order passed by the learned Metropolitan Magistrate, Ahmedabad in refusing to discharge them.
2. A Criminal Complaint has been filed by respondent no. 2 against the petitioners-original accused in the Court of learned Chief Metropolitan Magistrate, Ahmedabad, being Criminal Case No. 165/1997 under Sections 18(a)(1) and 18(b) read with Section 27 of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as ‘the Act’). It has been alleged in the Complaint that petitioner no. 1, who is the manufacturer, has manufactured “Framycin Skin Ointment” drug and the said drug was sold to original accused no. 4 and he sold the said drug to original accused no. 6. It is further alleged that petitioners nos. 2 and 3 are the partners of petitioner no. 1 patnership firm. It is alleged that Shri H.G. Koshiya, Drug Inspector, Ahmedabad took the sample of the aforesaid drug, batch no. 1-95 from M/s. Keraline Agency, Ahmedabad and the date of the manufacturing of the said drug was April, 1995 and the expiry date was October, 1996. Its sample was taken on 18/05/1995 by the Drug Inspector and was sent for necessary testing at State Laboratory, Vadodara and the Government Analyst, Vadodara vide report dated 08/08/1995 declared the drug as ‘not of standard quality’. It was alleged that the drug manufactured by the petitioners was misbranded and spurious drug and, therefore, the petitioners-original accused have committed the offence under Section 18(a)(1) of the Act and are liable to be convicted and punished under Section 27(d) and (c) of the Act. It was further alleged that the petitioners- original accused have also committed the breach under Section 18(b) of the Act and, therefore they are liable to be punished under Section 27 of the Act. Thus, it is alleged that the petitioners-original accused nos. 1 to 3 have committed the breach under Sections 18(a)(1) and 18(b) of the Act and under Section 27 of the Act. The petitioners were served with the summons of the aforesaid Complaint on 04/02/2000. Thereafter, the petitioners-original accused gave an application to the learned Magistrate for sending the sample for further test to the Central Drugs Laboratory, Calcutta under Section 25(4) of the Act on 19/02/2000. At the relevant time and thereafter the said application, Exh. 10 was kept pending. Pending the application, Exh. 10, the petitioners submitted another application for discharge, being Exh. 12 dated 07/09/2002 under Section 23(5) of the Act read with Section 24(2) of the Code of Criminal Procedure. It was contended on behalf of the petitioners in the said application that their valuable right to get the drug tested by the Central Drugs Laboratory under Section 25(3) of the Act has been taken away. It was submitted that on 06/12/1995 telegram was received by original accused no. 1 from the Licensing Authority, Food and Drug Administration, M.P., Bhopal that ‘Framcyin Skin Ointment’ Batch No. 1/95 was declared as not of standard quality. It was further alleged that on receipt of the telegram, without waiting for the copy, petitioner no. 1 sent Registered A.D. letter dated 06/12/1995 stating that they do not agree with the report of the Government Analyst and they want to adduce evidence in contravention of the report of the Government Analyst as per Section 25(3) of the Act. It was submitted that despite the Drug Inspector was fully knowing the name and address of the firm, he had given the report of the sample to original accused no. 5 and, therefore, it was submitted that the petitioners are deprived of their rights under Sections 25(3) and 25(4) of the Act and, therefore, it was prayed to discharge them for the offence for which they were being prosecuted. Vide order dated 11/05/2006, the learned Metropolitan Magistrate rejected the said application and refused to discharge the petitioners. Being aggrieved and dissatisfied with the order passed by the learned Metropolitan Magistrate, Ahmedabad dated 11/05/2006 below Exh. 12 in Criminal Case No. 165/1997 the petitioners-original accused nos. 1 to 3 preferred Criminal Revision Application No. 299/2006 before the learned Sessions Judge, Ahmedabad and by impugned judgment and order dated 10/09/2006 learned Additional City Sessions Judge, Court No. 13, Ahmedabad has dismissed the said Revision Application confirming the order passed by the learned Metropolitan Magistrate refusing to discharge original accused nos. 1 to 3. Being aggrieved and dissatisfied with the impugned judgment and order passed by both the Courts below in refusing to discharge the petitioners- original accused nos. 1 to 3 for the offence for which they are being tried, the petitioners-original accused nos. 1 to 3 have preferred the present Special Criminal Application.
3. Shri Vipul Pancholi, learned advocate appearing on behalf of the petitioners-original accused nos. 1 to 3 has contended that the valuable right available to the petitioners to send the sample to be tested by the Central Laboratory as provided under Section 25(3) of the Act has been taken away. It is submitted by Shri Vipul Pancholi, learned advocate appearing on behalf of the petitioners that both the Courts below have not properly appreciated the fact that the date of the manufacturing was April, 1995 and the expiry date was October, 1996, however, the Complaint has been filed on 15/03/1997 i.e. after a period of six months from the date of expiry of the said drug. Thus, the petitioners have lost the opportunity to request the learned Magistrate to send the sample to the Central Drugs Laboratory, Calcutta for testing. It is submitted by Shri Vipul Pancholi, learned advocate appearing on behalf of the petitioners that both the Courts below have not properly appreciated the fact the petitioners on information from the Lincencing Authority, Food and Drugs Administration, M.P., Bhopal that the drug in question is not of standard quality immediately requested the authority that the drug may be sent for necessary analysis to the Central Drug Laboratory, Calcutta. Thus, the petitioners gave the application within a period of 29 days from the receipt of the information. However, the said sample was not sent to the Central Drug Laboratory, Calcutta by the said authority and thereby they have violated Section 25(3) of the Act. It is submitted that therefore the learned Metropolitan Magistrate ought to have discharged the petitioners for the offence for which they are being tried. It is submitted by Shri Vipul Pancholi, learned advocate appearing on behalf of the petitioners that both the Courts below have not properly appreciated the scope of the valuable right of the petitioners under Sections 25(3) and 25(4) of the Act. Making the above submissions and relying upon the decisions of the Hon’ble Supreme Court in the case of Girishbhai Dahyabhai Shah Vs. C.C. Jani and Anr reported in (2009) 15 SCC 64 as well as the decision in the case of Medicamen Biotech Ltd. and Anr Vs. Rubina Bose, Drug Inspector reported in (2008) SCC 196 it is requested to allow the present Special Criminal Application and allow the application, Exh. 12 submitted by the petitioners to discharge them for the offence for which they are being tried.
4. The present Special Criminal Application is opposed by Shri L.B. Dabhi, learned APP appearing on behalf of the State. It is submitted by Shri L.B. Dabhi, learned APP that in fact the petitioners were aware with respect to the sub-standard drug as they were given the report of the Government Analyst as far back in the year 1995 through the Licensing Authority at Indore and it was requested to withdraw the said drug. Thereafter, there was no request made by manufacturer to the concerned Inspector as provided under Section 25(3) of the Act to send the said sample to the Central Drug Laboratory and, therefore, it is submitted that as such there is no breach under Section 25(3) of the Act as alleged.
4.1. Now so far as the contention on behalf of the petitioners that immediately on receipt of the information dated 06/12/1995 the petitioners disputed the report of the Government Analyst and requested the authority at Indore and opted for remedy under Section 25(3) of the Act is concerned, it is submitted that as such the request was required to be made to the concerned Inspector as provided under Section 25(3) of the Act and, therefore, it cannot be said that at the relevant time the petitioners exercised their rights under Section 25(3) of the Act.
4.2. Now so far as the contention on behalf of the petitioners that as the petitioners were not communicated the Government Analyst report by the concerned Inspector and, therefore, it cannot be said that at the relevant time the petitioners did not opt for re-examination of the sample by the Central Laboratory is concerned, it is submitted by Shri L.B. Dabhi, learned APP that as such petitioner no. 1 was served with the xerox copy of the Government Analyst report through the licensing authority at Indore and, therefore, merely because the Inspector did not send the Government Analyst Report to the manufacturer and instead of that some other authority has sent, no prejudice is caused to the petitioners and they could have requested the concerned Inspector to send the sample to the Central Drugs Laboratory as provided under Section 25(4) of the Act and, therefore, it is submitted that the impugned Complaint is required to be quashed and set aside. Making the above submissions and relying upon the decisions of the Hon’ble Supreme Court in the case of Glaxo Smith Kline Pharmaceuticals Ltd. & Anr. Vs. State of Madhya Pradesh reported in AIR 2011 SC 2998 and in the case of State of Haryana Vs. Brij Lal Mittal and Ors reported in (1998) 5 SCC 343, it is requested to dismiss the present Special Criminal Application.
5. Heard the learned advocates appearing on behalf of the respective parties at length. At the outset, it is required to be noted that the petitioners and others are being prosecuted for the breach of provisions of the Act, more particularly, under Sections 18(a)(1) and 18(b) read with Section 27 of the Act.
5.1. Having served with the summons of the Criminal case, the petitioners submitted an application, Exh. 12 to discharge them mainly on the ground that there is no breach under Section 25(3) and 25(4) of the Act as their valuable right to send the sample to the Central Drugs Laboratory, Calcutta has been taken away. It was mainly contented on behalf of the petitioners that immediately on receipt of the telegram dated 06/12/1995 from the Licencing Authority, Food and Drug Administrator, M.P. Bhopal that ‘Framycin Skin Ointment’ Batch No. 1/1995 has been not declared of standard quality, immediately on the next date the petitioners disputed the said report and challenged the same under Section 25(a) of the Act and requested that one of the sample portion be sent to the Central Drugs Laboratory, Calcutta for testing, which was not sent to the Central Drugs Laboratory, Calcutta and, therefore, the valuable right of the petitioners under Section 25(4) of the Act has been taken away and by the time the Complaint was filed that the validity period of the drug has expired. However, it is required to be noted that considering Section 25(3) of the Act, such a request was required to be given in writing to the Inspector. Thus, admittedly, no request was made to the Inspector to sent the sample to the Central Drugs Laboratory, Calcutta and, therefore, it cannot be said that at the relevant time petitioner no. 1 opted for the right under Section 25(3) of the Act. Now so far as the contention on behalf of the petitioners that as the petitioner no. 1 was not communicated the Government Analyst Report by the concerned Inspector and, therefore, it cannot be said that at the relevant time the petitioners did not opt for re-examination by the Central Drugs Laboratory is concerned, it is required to be noted that as such petitioner no. 1 was sent with the xerox copy of the Government Analyst Report through the Licencing Authority at Indoor and, therefore, merely because the Inspector did not send the Government Analyst Report to the manufacturer instead of that the some other authority has send, no prejudice is caused to the petitioner and he could have requested the concerned Inspector to send the sample to the Central Drugs Laboratory, Calcutta as provided under Section 25(4) of the Act. Under the circumstances, on the aforesaid ground the impugned Complaint is not required to be quashed and set aside and/or petitioners are not required to be discharged for the offence for which they are being prosecuted. Under the circumstances and in the facts and circumstances of the case, the decisions relied upon by the learned advocate appearing on behalf of the petitioners in the case of Girishbhai Dahyabhai Shah Vs. C.C. Jani and Anr (Supra) and Medicamen Biotech Ltd. and Anr (Supra) would not be of any assistance to the petitioners. On the contrary the issue raised in the said petition is squarely covered by the decision of the Hon’ble Supreme Court in the case of Glaxo Smith Kline Pharmaceuticals Ltd. & Anr.(Supra) in which the Hon’ble Supreme Court has relied upon its earlier decision in the case of Brij Lal Mittal and Ors (Supra). In the case before the Hon’ble Supreme Court in the case of Glaxo Smith Kline Pharmaceuticals Ltd. & Anr. (Supra) the manufacturer did not give any option to adduce the evidence in contravention of the Analyst’s report and subsequently the Complaint was filed after expiry period. Criminal Complaint/proceedings were sought to be quashed on the ground that his right under Section 25(3)of the Act to get the sample re-examined by the Central Laboratory has been taken away the Hon’ble Supreme Court has negatived the same. In the said decision, the Hon’ble Supreme Court has also considered the decision in the case of Medicamen Biotech Ltd. and Anr (Supra), which has been relied upon by the learned advocate appearing on behalf of the petitioners. In the case of Glaxo Smith Kline Pharmaceuticals Ltd. & Anr. (Supra) in paragraph nos. 7 to 12, Hon’ble Supreme Court has observed as under;
“7. The issue involving herein is no more res integra matter. The issues have been examined time and again. It is a settled legal proposition that report of the analyst is conclusive. It means that no reasons are needed in support of conclusion given in the report, nor it is required that the report should contain the mode or particulars of the analysis (See Dhian Singh v. Municipal Board, Saharanpur & Anr., AIR 1970 SC 318) However, law permits the drug manufacturer to controvert the report expressing his intention to adduce evidence to controvert the report within the prescribed limitation of 28 days as provided under Section 25(3) of the Act, 1940. In the instant case, the report dated 27/08/1997 was received by the statutory authorities who sent the show cause notice to the appellants on 29/09/1997 and the appellants replied to that notice on 03/11/1997. The case of the statutory authorities is that option/willingness to adduce evidence to controvert the analyst’s report was not filed within the period of 28 days i.e. limitation prescribed for it. The appellants are the persons who knew the date on which the show cause notice was received. For the reasons best known to them, they have not disclosed the said date. It is a company which must be having Receipt and Issue department and should have an office which may inform on what date it has received the notice, and thus should have made the willingness to controvert the report. In fact, such application had only been made on the technique adopted for analysis. It has been the case that instead of testing the medicine under the I.P. 1985, it could have been done under I.P. 1996 because the I.P. 1996 had come into force prior to the date of taking the sample on 09/12/1996.
8. In view of the fact that the appellants did not express an intention to adduce evidence to controvert the analyst report within the statutory limitation period of 28 days, further delay in filing the complaint becomes immaterial. Even otherwise, expiry date of the medicine was March, 1998 i.e. only after 4 months of submission of the reply by the appellants, and they did not fulfill their burden of expressing intention to adduce evidence in contravention of the report. Therefore, they cannot raise the grievance that the complaint had been lodged at a much belated stage. So far as the application of I.P. 1985 or I.P. 1996 is concerned, such an issue can be agitated at the time of trial.
9. The judgment in Medicamen Biotech Limited & Anr. Rubina Bose, Drug Inspector (2008) 7 SCC 196: (AIR 2008 SC 1939; 2008 AIR SCW 2201), was heavily relied on by Shri R. Raamachandran, learned senior counsel appearing for the appellants. Nevertheless, the facts of the said case are quite distinguishable. In that case, the complaint had been filed about a month short of expiry date, and the accused therein had expressed their option to lead evidence in contravention of the analyst’s report within limitation time but were not able to do so as shortly thereafter the medicine expired.
10. We agree with Ms. Makhija that the case is squarely covered by the judgment of this Court in State of Haryana v. Brij Lal Mittal & Ors. (1998) 5 SCC 343; (AIR) 1998 SC 2327; 1998 AIR SCW 2240) where this Court has held as under;
“....Sub-section (4) also makes it abundantly clear that the right to get the sample tested by the Central Government Laboratory (so as to make its report override the report of the Analyst) through the court accrues to a person accused in the case only if he had earlier notified in accordance with sub-section (3) his intention of adducing evidence in controversion of the report of the Government Analyst. To put it differently, unless requirement of sub-section (3) is complied with by the person concerned he cannot avail of his right under sub- section (4).”
In the said case, like the present case, the manufacturer did not notify the Inspector within the prescribed period that he intended to adduce evidence in contravention of the report. Also, akin to the case at hand, the manufacturer’s right under sub-section (3) of Section 25 expired few months before expiry of shelf life. Holding for the directors of the manufacturing company on different grounds, the court opined that the right to get drugs tested by Central Drugs Laboratory does not arise unless requirement of sub-section (3) is complied with.
11. It is pertinent to mention herein that the present appellants had earlier also been informed by the Drug Inspector of various cities on many occasions that the aforesaid medicine was i.e. Betnesol Tablet, was not of standard quality and the authorities had been making an attempt to initiate proceedings against them. As is evident from the pleadings taken by the appellants themselves and the letter dated 01/07/1996 (Annexure P- 9) wherein the appellant company wrote a letter to the Controller, Food and Drug Administration, Madhya Pradesh. The relevant part thereof reads as under;
“During the past one month we have received requests from Drug Inspectors of Dhar, Rewa, Seoni and Ambikapur all under your kind control, to provide Memorandum of Articles of Association, constitution etc. of our company to initiate action for manufacturing Betnesol Tablets B.NO. NA 660, Mfd. Dec. 92, Exp May 94, NB 290, Mfd Nov. 94, Exp. Apr. 96, NB 538, Mfd. May 95, Exp. Dec.96 and NB 656, Mfd. Sep. 95, Exp. Feb. 97, which were earlier declared as not of standard quality by Government Analyst, Bhopal for facing analytical difficulties during the determination of uniformity of content by the IP 1985 method.”
(Emphasis added) In that letter also the appellant company does not make its intention clear to adduce any evidence to controvert the Government Analyst’s report rather made the following request;
“Under these circumstances, we respectfully reiterate that our product Betnesol Tablets referred above are of standard quality and request you to kindly treat all the matter as closed.”
12. As explained hereinabove, the appellants and other co-accused did not give any option to adduce evidence in contravention of the analyst’s report within statutory limitation period. Even if there was inordinate delay in launching the criminal prosecution or filing the complaint, it is thereby of no consequence. We do not find any ground to interfere with the well reasoned judgment of the High Court. The appeal lacks merits and is, accordingly, dismissed.”
6. In the present case as such the Licensing Authority, Bhopal on receipt of the report of the Government Analyst informed the manufacturer that the drug in question is not of standard quality and it was directed/requested to withdraw the drug and infact the petitioner and the manufacturer withdrew the drug in question, more particularly, batch no. 1-95 from M/s. Keraline Agency, Ahmedabad, however, did not request the Inspector to send the report to the Central Drug Laboratory, Calclutta under Section 25(3) of the Act and thereby did not exercise the option, which was available under Section 25(3) of the Act, and, therefore, as such, it cannot be said that any valuable right of the petitioners has been taken away. Under the circumstances, as such no case is made out to discharge the petitioners for the offence punishable under the Act and both the Courts below have rightly refused to discharge the petitioners.
6.1. Now so far as challenge to the order passed by the learned Metropolitan Magistrate below Exh. 10 is concerned considering the fact that the order passed by the learned Metropolitan Magistrate below Exh. 12 refusing to discharge the petitioners confirmed by the revisional Court is further being confirmed by this Court, the challenge to the order passed below Exh. 10 also fails. In the facts and circumstances of the case, this Court is of the opinion that no error has been committed by the Courts below in refusing to discharge the petitioners, which calls for the interference of this Court under Article 227 of the Constitution of India.
7. In view of the above and for the reasons stated hereinabove, the present Special Criminal Application fails and the same deserves to be dismissed and is accordingly dismissed. Rule is discharged. Ad-interim relief granted earlier stands vacated forthwith.
(M.R.SHAH, J.) Siji