JUDGMENT : 1. Heard Mr. Arun Siwach, learned counsel appearing for the petitioners and Mr. S. Samarjeet, learned CGC for the respondents. 2. The prayer in this criminal petition is as follows : "(b) to quash and set aside the impugned complaint being Criminal (C) Case No. 284 of 2016 pending in the Court of Learned Chief Judicial Magistrate, Imphal West as well as the order dated 21st January, 2017 issuing process against the Petitioners therein and to pass all other incidental and consequential orders as may be deemed fit and proper" FACTS OF THE CASE 3. The brief facts of the case are that the criminal petition has been filed invoking Section 482 of the Code of Criminal Procedure, 1973 to quash the Criminal (C) Case No. 284 of 2016 pending before the Court of Chief Judicial Magistrate, Imphal West. The criminal complaint was filed under Section 16(1)(a) read with Section 18(a)(1) read with Section 34 of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "Act"). The petitioners/accused also challenge the order dated 21.01.2017 passed by the Chief Judicial Magistrate, Imphal West, which is as follows: "Complainant by Ld. Counsel present P.O. is on leave. Issue summons to the accused persons returnable by 17/02/2017. Complainant is to take step." 4. Before the Trial Court, on 05.11.2016, respondent department/complainant presented the criminal complaint. On that day, C.W. No. 3 was examined. After recording the statement of C.W. No. 3 and since no further complainant witness was required to be examined, the Court, satisfied with the materials placed holding that there exists a case to proceed with the Trial, issued summons to the accused persons. Summons were issued to the accused persons returnable on 15.12.2016. The certified copy of the Courts order annexed does not reveal what happened on 15.12.2016. However, in the next order passed by the Court on 21.01.2017, fresh summons were issued against the accused persons returnable by 17.02.2017 with the direction to the complainant to take step. 5. It is after receipt of the summon by the petitioner No.1 on 06.02.2017, by the petitioner No. 2,3,4 on 14.06.2017, the petitioners appeared before the Trial Court through their counsel. Thereafter, the present case has been filed to quash the criminal complaint. 6. 5. It is after receipt of the summon by the petitioner No.1 on 06.02.2017, by the petitioner No. 2,3,4 on 14.06.2017, the petitioners appeared before the Trial Court through their counsel. Thereafter, the present case has been filed to quash the criminal complaint. 6. The petitioner No. 1 is a private limited company, incorporated under the provisions of the Companies Act, having its manufacturing premises at Village-Kumrek, Rangpo, East-Sikkim and its corporate office at Shah & Nahar Industrial Estate, Dr. E. Moses Road, Worli, Mumbai. The petitioner No. 1 is engaged in the business of manufacturing, supply and distribution of pharmaceuticals products in India. 7. On 18.07.2014, the respondent No. 2 visited the premises of M/s. Central Medical Store, Medical Directorate, Imphal-795004 and drew samples of METRON (Metronidazole Tablets IP) (hereinafter referred to as the "offending drug") from batch No. MRT-14003-S, which showed the manufacture batch was the month of March, 2014 and would expire in February, 2017. The drawing of samples was done under Section 23 of the Drugs and Cosmetics Act, 1940. The same is extracted below for reference : "23. Procedure of Inspectors (1) Where an Inspector takes any sample of a drug [or cosmetic] under this Chapter, he shall tender the fair price thereof and may acquire a written acknowledgement therefor. (2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of any drug [or cosmetic] under clause (c) of Section 22, he shall tender a receipt therefor in the prescribed form. (3) Where an Inspector takes a sample of a drug [or cosmetic] for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divide the sample into four portions and effectively seal and suitable mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked. Provided that where the sample is taken from premises whereon the drug [or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only: Provided further that where the drug [or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug [or cosmetic] be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them. (4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:- (i) one portion or container he shall forthwith send to the Government Analyst for test or analysis; (ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug [or cosmetic] and [(iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18-A]" 8. One of the sealed samples was sent to Government Analyst being Central Drugs Laboratory 3, Kyd Street, Kolkata-700016 in a sealed packed with form 18 under memo No. EZ/6-13/GNK/2014/3545 dated 21.07.2014. The Government Analyst at Kolkata vide report bearing No. 32-8/2015-SS/DCA(E)- 164/640 dated 20.07.2015, was of the opinion that the said sample drug was "not of standard quality." 9. The respondent No. 2 called upon the Central Medical Store Keeper from where sample was drawn on 18.07.2014 to furnish the name, address and other particulars of the person from whom the said product was received. The Medical Store Keeper, vide its letter dated 17.08.2015 informed the respondent No. 2 that the subject batch of the said product was procured from M/S. NIM Pharmaceuticals, No. 27, Ground Floor, Shima Plaza, Ulubari Chariali, G.S. Road Guwahati, vide Bill No. 404/IS/NIM dated 11.12.2014. M/S NIM Pharmaceuticals, in turn informed the Respondent No. 2 vide letter dated 05.10.2015, that the subject batch product was procured from M/s Yai Associates, M.G. Avenue, Thangal Bazar, Imphal West, Manipur, vide Bill No. 024 dated 01.12.2014. The communication as aforesaid goes from one dealer to another till the manufacturers name surfaces. M/S NIM Pharmaceuticals, in turn informed the Respondent No. 2 vide letter dated 05.10.2015, that the subject batch product was procured from M/s Yai Associates, M.G. Avenue, Thangal Bazar, Imphal West, Manipur, vide Bill No. 024 dated 01.12.2014. The communication as aforesaid goes from one dealer to another till the manufacturers name surfaces. After series of correspondence, it is evident that the said product has changed several hands. Finally, one M/s Alkem Laboratories Ltd., vide letter dated 30.10.2015 informed respondent No. 2 that subject batch of the said product was manufactured by Petitioner No. 1 at Sikkim. 10. Respondent No. 2, on receipt of information of name of manufacturer, forwarded the said report of the Government analyst by his letter bearing Reference No. EZ/6-13/GNK/NSQ/METRON/2015/6342 dated 05.11.2015 along with one sample portion of the offending drug/product to the petitioner No. 1 with a request to furnish comments on the test report along with supportive documents within 28 days. This letter dated 05.11.2015 (Annexure-A-10), which is relevant to the case is extracted below : "No. EZ/6-13/GNK/NSQ/METRON/2015/6342 Dated 05 Nov. 2015 To M/s Indchemie Health Specialities Private Limited, Village-Kumrek, Dist Rangpo, East Sikkim -737132 Sub:-METRON (Metronidazole Tablets IP) B.No.MRT-14003- SD/M:03/2014 D/E:02/2017 Manufactured by: M/s Indchemie Health Specialities Pvt. Ltd. Village Kumrek, Rangpo, East Sikkim 737132 declared "Not of Standard Quality" Reg. Sir, With reference to the above subject this is to state that the subject batch sample was drawn from the premises of Central Medical Store, Medical Directorate, Imphal by the undersigned Drugs Inspector on 18.07.2014 under the provision of Drugs & Cosmetics Act 1940 and Rules 1945 there under. The sample on test has been declared as "Not of Standard Quality" by Government Analyst, Central Drugs Laboratory, Kolkata vide report No. 32- 8/2015-SS/DCA (E)-164/640, Dt. 20.07.2015 for the reason as the sample does not conform to I.P. with respect to the test of "dissolution". The Medical Store Keeper, Medical Directorate informed vide letter No. MSK-I/DHS/Ds-2015 dated 17th August 2015 that the subject drug is procured from NIM Pharmaceuticals vide Bill No. & Date 404/IS/NIM of 11th Dec 2014 (Copy enclosed). M/s NIM Pharmaceuticals informed vide letter No. 1245/IS/NIM/2015 dated 05/10/2015 that the subject drug is procured from Yai Associates, MG Avenue, Manipur. M/s Yai Associates had purchased the drug form M/s International Departmental Store vide inv. No. 12314 dated 26/06/2014 (Copy enclosed). M/s NIM Pharmaceuticals informed vide letter No. 1245/IS/NIM/2015 dated 05/10/2015 that the subject drug is procured from Yai Associates, MG Avenue, Manipur. M/s Yai Associates had purchased the drug form M/s International Departmental Store vide inv. No. 12314 dated 26/06/2014 (Copy enclosed). M/s International Departmental Store informed that the subject drug is procured from M/s Alkem Laboratories Limited, Guwahati vide bill No. 5040304245 dt. 31/05/2014(copy enclosed). M/s Alkem Laboratories Limited informed that the subject drug is procured from you vide invoice no. Fg/90/1314 dated 28/03/2014 (copy enclosed). Therefore, as per the provisions of Sec. 23(4)(iii) and 25(3) as per the provisions of Drugs and Cosmetics Act, test report in original (red colour) of said batch of drug and one sealed portion is being sent to you by registered post with Acknowledgement. You are requested to furnish your comments within 28 days from the receipt of this letter. Under Section 18 of Drugs and Cosmetics Act 1940 and Rules 1945 manufacture for sale and distribution of "Not of standard quality" drug is prohibited, hence you are requested to take appropriate measures on the subject batch drug as per provisions of Drugs and Cosmetics Act. This is to be treated as most urgent as matter is of the "Not of Standard Quality" Drug. Yours faithfully, (G. Narendrakumar) Drugs Inspector C.D.S.C.O. East Zone, Kolkata" 11. The petitioner No. 1 on receipt of the above letter dated 5.11.2015, responded to the department by its letter bearing Reference No. IS/FDA/033/16 dated 08.12.2015, which is extracted below. "Date : 8th December, 2015 Ref. No. IS/FDA/033/15 To, Drugs Inspector CDSCO, East Zone, O/o Dy. Drugs Controller (I) Nizam Palace, 1st MSO Building 7th Floor (Eastern Side) 234/4, A.J.C. Bose Road Kolkata 700020 Subject : Response for CDSCO notice for the product Metronidazole Tablets IP 200 mg (Metron) Batch no. MRT- 14003S Mfg. date March 2014, Exp. Date Feb 2017 manufactured by M/s Indchemie Health Specialities Private Limited, Village Kumrek, Rangpo, East Sikkim-737132 declared as Not of Standard quality. Reference: 1 CDSCO Notice dated 5 Nov 2015 received dated 20 Nov 2015 Dear Sir, We write in response to notice issued dated 05 Nov 2015 for the product Metronidazole Tablets I.P. 200 mg (METRON) Batch no. MRT-14003S Mfg. date March 2014, Exp. Date Feb 2017 manufactured by M/s. Indchemie Health Specialities Private Limited, Village-Kumrek, Rangpo, East Sikkim- 737132. Reference: 1 CDSCO Notice dated 5 Nov 2015 received dated 20 Nov 2015 Dear Sir, We write in response to notice issued dated 05 Nov 2015 for the product Metronidazole Tablets I.P. 200 mg (METRON) Batch no. MRT-14003S Mfg. date March 2014, Exp. Date Feb 2017 manufactured by M/s. Indchemie Health Specialities Private Limited, Village-Kumrek, Rangpo, East Sikkim- 737132. Copy of the Notice is enclosed as Enclosure-1 for your reference. We would like to inform your kind office that we have been manufacturing this product for quite a good time and there has been no concern raised in house and from market related to any parameters for the mentioned product. However, we are also in process of root cause analysis with our respective in house team for the said product. We have postponed our further commercial production of said brand since receipt your letter. Further, we have investigated your complaint by analyzing our control sample of same batch and conducted analysis at Government Approved Analytical Laboratory also. The results comply with IP specification. We conclude that there may be some erratic handling of our product during storage which may lead this disqualification. We are requesting you to consider our case sympathetically once again. As per the CDSCO guidance for recall of drug we have initiated the necessary steps of recall for the said batch there by abiding to the rules laid per Schedule M and conditions of license as per Drugs & Cosmetics Act. Hence we would humbly request your kind office not to suspend or cancel the product license based on the necessary and corrective action taken by us. We hope you find the above mentioned documents and necessary action in order and would actively co-operate for any further assistance required. We are committed to provide our customer with the highest level of service and product quality. Thanking you. Yours Sincerely, Authorized Signatory Encl: As above." 12. Along with this letter dated 08.12.2015, the certificate of analysis issued by Oscar Analytical Pvt. Ltd. which is duly approved by approval No.HPTL/07/01 dated 28.11.2015 was enclosed. The certificate of M/s Oscar Analytical Pvt. Ltd. states that the sample which was handed over by the petitioner was analysed and found to be of standard quality. This, according to the petitioners is the evidence in controversion of the report of the Government Analyst. 13. The certificate of M/s Oscar Analytical Pvt. Ltd. states that the sample which was handed over by the petitioner was analysed and found to be of standard quality. This, according to the petitioners is the evidence in controversion of the report of the Government Analyst. 13. After receipt of this letter dated 08.12.2015 along with the Certificate of analysis by Oscar Analytical Pvt. Ltd dated 28.11.2015, the department wrote letter to the petitioner company asking for details of the Directors and other particulars. The department did not respond to the petitioners letter dated 08.12.2015. The department thereafter filed CRIL (C) Case No. 284 of 2016 on 28.06.2016 before the Trial Court. It is pertinent to mention that the report of the Government Analyst was issued on 20.07.2015 and the complaint was filed on 28.06.2016 (i.e.) after a lapse of nearly 1 year. 14. After some adjournments, the case was taken up on 28.06.2016 and after hearing the counsel for the department and after perusing documents (1)-(12), the case was taken on file. The criminal case was fixed for further hearing on 01.07.2016. The certified copy of the Courts order however, does not say what happened thereafter. It is only on 05.11.2016 that the complainant witness No. 3 was examined, the document taken on file, and summons were issued returnable by 15.12.2016. There is no entry as to what happened on 15.12.2016. However, from the order, it is evident that the summons in this case was once again issued on 21.01.2017 returnable by 17.02.2017. After step was taken, the petitioners herein were served on various dates as already mentioned above and they appeared. 15. It will be appropriate to mention that in February 2017, the samples of the offending product seized on 18.07.2014 had expired. Even as per the seizure memo, the date of manufacture of the said product is March, 2014 and date of expiry is February, 2017. On the above facts, the petitioners have filed this case for quashing the impugned proceeding, pleading that the case of the respondents department pending before the Chief Judicial Magistrate, Imphal West has to be quashed for failure to comply with the requirement under Section 25(4) and other provisions of the Drugs and Cosmetics Act, 1940. It is pleaded that the exercise of a trial is meaningless and a farce. In view of inherent defect, the complaint deserves to be quashed. It is pleaded that the exercise of a trial is meaningless and a farce. In view of inherent defect, the complaint deserves to be quashed. LEGAL SUBMISSION 16. According to the learned counsel for the petitioners, in terms of section 23(4) of the Act, which has been already set out above, a portion of the sample taken was sent to the Government analyst for test and another sample was sent to the manufacturer, petitioner No. 1 as required under Section 18-A of the Act. After receipt of the report of the government Analyst in terms of Section 25(1) and as required by Section 25(2), a copy of the report of the Government Analyst was sent to the petitioner No. 1 on 5.11.2015. On receipt of the report, the petitioner No. 1 responded the same within 28 days as required under Section 25(3) of the Act, evincing their intention to adduce evidence in controversion of the report vide its letter dated 08.12.2015 which has already been extracted above. Therefore, what is required by law has been complied. 17. The petitioners" contention is that they have responded to the Government Analyst report within its time line of 28 days prescribed indicating their intention to adduce evidence by way of the analytical report of approved laboratory which was enclosed with the letter dated 8.12.2015. The petitioners plead that in terms of Section 25(4) of the Act, the Court should have forwarded the samples to the Central Drug Laboratory in time (i.e.) before expiry of the drug. The petitioners have notified their intention to adduce evidence in controversion of the Government analyst report. Hence non compliance of Section 25(4) of the Act is fatal to the prosecution. 18. Section 25 (1), (2), (3), & (4) of the Act is as follows : "25. Reports of Government Analysts. (1) The Government Analyst to whom a sample of any drug [or cosmetic] has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form. Reports of Government Analysts. (1) The Government Analyst to whom a sample of any drug [or cosmetic] has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form. (2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken [and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18-A], and shall retain the third copy for use in any prosecution in respect of the sample. (3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken [or the person whose name, address and other particulars have been disclosed under section 18-A] has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report. (4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion of a Government Analysts report, the Court may, of its motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug [or cosmetic] produced before the Magistrate under sub-section (4) of section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the fact stated therein." (emphasis supplied) 19. According to the learned counsel for the petitioners, failure to have the sample submitted to the Court tested again in the laboratory specified in Section 25 (4) would be fatal to the case of the department. According to the learned counsel for the petitioners, failure to have the sample submitted to the Court tested again in the laboratory specified in Section 25 (4) would be fatal to the case of the department. That petitioners cannot be forced to undergo a farce trial in view of the failure on the part of the prosecution to get the sample tested by the competent laboratory namely Central Drug Laboratory which is Specified in Section 25(4) of the Act. DECISIONS RELIED UPON 20. To buttress his argument, learned counsel for the petitioner relied upon the decision of Supreme Court in the case of Medicamen Biotech Limited & Anr. v. Rubina Bose, Drug Inspector reported in (2008) 7 SCC 196 . Relevant para No. 3, 4, 5, 5 & 7 are as under: "3. The Drugs Inspector, Central Drugs Standard Control Organisation, Kolkata visited Government Medical Stores Depot at Belvedere, Kolkata on 14-6-2000 and collected samples of the drug and after dividing the sample into four equal parts, sent one portion to Central Drugs Laboratory, Kolkata under Clause (i), sub-section (4) of Section 23 of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Act") for test/analysis. The sample portion of the drug was received in the laboratory at Kolkata on 23-6-2000. The Drugs Inspector received the test report from the Drugs Laboratory on 6-7-2001 declaring the drug as not conforming to the prescribed standards. 4. A show-cause notice was issued to the appellants on 14-8-2001 on which the appellant once again carried out an in-house test and also obtained an analysis report from another approved laboratory. Both the reports opined that the sample satisfied the prescribed norms. The appellant also received a show-cause notice dated 14-8-2001/17-8-2001 from the Ministry of Health and Welfare from Government Medical Stores Depot, Kolkata informing the appellant that the drug in question had been declared substandard. 5. On 28-8-2001, the appellant sent a detailed reply to the show-cause notice to the Medical Stores Department with copies to the Drugs Inspector disputing the report of the Government Analyst and requesting for a retesting of the drug. 6. On 31-8-2001 the appellant received a letter dated 22-8-2001 from the Drugs Inspector once again pointing out that the sample seized was not of the prescribed standard and also called for the comments of Appellant 1 within 10 days. 7. 6. On 31-8-2001 the appellant received a letter dated 22-8-2001 from the Drugs Inspector once again pointing out that the sample seized was not of the prescribed standard and also called for the comments of Appellant 1 within 10 days. 7. The appellant received yet another letter dated 7-9-2001 from the Drugs Inspector seeking certain information to which the appellant gave a reply on 13-9-2001 giving the necessary information and also disputing the test report of Central Drugs Laboratory, Kolkata and requesting for reanalysis." 21. In that case, the Supreme Court held that since the accused person appellant had categorically stated that he wanted reanalysis not agreeing with the Government analysis report and having exercised it within 28 days from the date of receipt of the show cause notice, the failure on the part of the prosecution to get the sample tested in terms of the Section 25(4) of the Act is fatal to the prosecution and held that it is a deprivation of valuable right under section 25(3) and 25 (4) which would result in quashing of the impugned proceeding. Relevant para No. 18, 19 & 20 in the case of Medicamen Biotech Limited & Anr. (supra) are as below: "18. In Unique Farmaid case which was a case under the Insecticides Act which has provisions analogous to Section 25(4) of the Act, the Court found that the accused had indeed made a request to the Inspector for sending the sample for retesting within the prescribed time-limit and as this request had not been accepted an important right given to an accused had been rendered ineffective on which the proceedings could be quashed. This is what the Court had to say : (SCC p.197, paras 12-13) "12. It cannot be gainsaid, therefore, that the respondents in these appeals have been deprived of their valuable right to have the sample tested from the Central Insecticides Laboratory under sub-section (4) of the Section 24 of the Act. Under sub-section (3) of Section 24 report signed by the Insecticide Analyst shall be evidence of the facts stated therein and shall be conclusive evidence against the accused only if the accused do not, within 28 days of the receipt of the report, notify in writing to the Insecticides Inspector or the court before which proceedings are pending that they intend to adduce evidence to controvert the report. In the present cases the Insecticides Inspector was notified that the accused intended to adduce evidence to controvert the report. By the time the matter reached the court, the shelf life of the sample had already expired and no purpose would have been served informing the court of such an intention. The report of the Insecticide Analyst was, therefore, not conclusive. A valuable right had been conferred on the accused to have the sample tested from the Central Insecticides Laboratory and in the circumstances of the case the accused have been deprived of that right, thus, prejudicing them in their defence. 13. In these circumstances, the High Court was right in concluding that it will be an abuse of process of court if the prosecution is continued against the respondents, the accused persons. The High Court rightly quashed the criminal complaint. We uphold the order of the High Court and would dismiss the appeals." We find that this judgment helps the case of the appellant rather than that of the respondent because in spite of two communications from the appellant that it intended to adduce evidence to controvert the facts given in the report of the Government Analyst, the fourth sample with the Magistrate had not been sent for reanalysis. The observations in Amery Pharmaceuticals case are also to the same effect. We find that the aforesaid interpretation supports the case of the appellants inasmuch they had been deprived of the right to have the fourth sample tested from the Central Drugs Laboratory. It is also clear that the complaint had been filed on 2-7-2002 which is about a month short of the expiry date of the drug and as such had the appellant-accused appeared before the Magistrate even on 2-7-2002, it would have been well-nigh impossible to get the sample tested before its expiry. 19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9-5-2005. This is begging the question. 19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9-5-2005. This is begging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for retesting of the drug had been made by the appellant in August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the complaint could not have been filed earlier and the fourth sample sent for retesting well within time. We are, therefore, of the opinion that the facts of the case suggest that the appellant shave been deprived of a valuable right under Sections 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them. 20. The appeal is allowed accordingly and the proceedings against the appellants are quashed." 22. The Supreme Court in this case of Medicamen Biotec Limited & Another (supra) also relied upon the decision in the case of Amery Pharmaceuticals and Another v. State of Rajasthan, reported in (2001) AIR (SC) 1303 which is also relied upon by the respondent department. 23. In Amery Pharmaceuticals and Another (Supra), the contention of the appellant was that one portion of the sample was not given to the accused thereby the mandatory provision contained in Section 23(4)(iii) of the Act was not complied with. However, the Supreme Court in the case of Medicamen Biotec and Another (supra) drew inspiration from Amery Pharmaceuticals and Anr. (supra) in paragraph No. 25 which is extracted below: 25. In our view the court should lean to an interpretation as would avert the consequences of depriving an accused of any remedy against such evidence. He must have the right to disprove or controvert the facts stated in such a document at least at the first tier. (supra) in paragraph No. 25 which is extracted below: 25. In our view the court should lean to an interpretation as would avert the consequences of depriving an accused of any remedy against such evidence. He must have the right to disprove or controvert the facts stated in such a document at least at the first tier. It is possible to interpret the provisions in such a way as to make a remedy available to him. When so interpreted the position is thus: The conclusiveness meant in section 25(3) of the Act need be read in juxtaposition with the persons referred to in the sub-section. In other words, if any of the persons who receives a copy of the report of the Government Analyst fails to notify his intention to adduce evidence in controversion of the facts stated in the report within a period of 28 days of the receipt of the report, then such report of the Government Analyst could become conclusive evidence regarding the facts stated therein as against such persons. But as for an accused, like the manufacturer in the present case, who is not entitled to be supplied with a copy of the report of the Government Analyst, he must have the liberty to challenge the correctness of the facts stated in the report by resorting to any other modes by which such facts can be disproved. He can also avail himself of the remedy indicated in sub-section (4) of Section 25 of the Act by requesting the court to send the other portion of the sample remaining in the court to be tested at the Central Drugs Laboratory. Of course, no court is under a compulsion to cause the said sample to be so tested if the request is made after a long delay. It is for that purpose that a discretion has been conferred on the court to decide whether such sample should be sent to the Central Drugs Laboratory on the strength of such request. However once the sample is tested at the Central Drugs Laboratory and a report is envisaged in Section 25(4) of the Act is produced in court the conclusiveness mentioned in that sub-section would become incontrovertible." The decision of the Supreme Court in Amery Pharmaceuticals & Anr. (supra) buttresses the petitioners" plea of intention to lead evidence in controversion which the petitioners plead as having done. 24. (supra) buttresses the petitioners" plea of intention to lead evidence in controversion which the petitioners plead as having done. 24. Learned counsel for the petitioners further submitted that the report of the Government analyst dated 20.07.2015 has been issued in form No. 13 Rule 46 under Section 25 (1) (Certificate of Test or Analysis by Government Analysis under Section 25(1) of the Drugs Act, 1940), signed by the Government Analyst), whereas the certificate that has to be issued by the Central Drug Laboratory, Director or other authorised Officer in terms of Section 25 (4) should be as per rule 6. Form no. 2, which is set out as below : "FORM 2 [See Rule 6] Certificate of test or analysis by the Central Drugs Laboratory Certified that the samples, bearing number…..purporting to be a sample of received on…..with memorandum No…...dated from…...has been tested/analysed and that the result of such test/analysis is as stated below. 2. The condition of the seals on the packet on receipt was as follows: *3. In the opinion of the undersigned the sample is of standard quality as defined in the Drugs and Cosmetics Act, 1940, and Rules thereunder is not of standard quality as defined in the Drugs and Cosmetics Act, 1940, the Rules thereunder for the reasons given below:- Date…. Director, Central Drugs Laboratory, or other authorized Officer Details of results of test or analysis with protocols of test applied Director, Date….. Central Drugs Laboratory or other authorized Officer If opinion is required on any other matter, the paragraph should be suitable amended." 25. It is pleaded that the Act and Rules makes it very clear that the certificate issued under section 25(1) is by an analyst whereas the certificate issued under 25(4) is by the Director or his authorized person. In the present case, despite a specific request by adducing evidence in controversion to the report and expressing their intention of controversion by letter dated 08.12.2015, the prosecution has failed to refer the samples to the authority specified in terms of section 25(4). Therefore, there is a failure on the part of the prosecution to comply with the requirement of Section 25(4) and that has greatly prejudiced the right of the petitioners. Therefore, the proceeding in the criminal case is bad. 26. Therefore, there is a failure on the part of the prosecution to comply with the requirement of Section 25(4) and that has greatly prejudiced the right of the petitioners. Therefore, the proceeding in the criminal case is bad. 26. It is further contended that the option exercised by the petitioners in letter dated 08.12.2015 which is faulted by the respondent by saying that it is not very specific about retesting is countered by learned counsel for the petitioners stating that language of section 25(3) and 25(4) is that on receipt of the copy of the report of the Government analyst, the accused has to give its response within 28 days his intention to adduce evidence in controversion of the report. And that has been done in the 8.12.2015 letter along with evidence in controversion namely, Certificate of Analysis by Oscar Analytical Pvt. Ltd, which gives the result as follows: "In the opinion of the undersigned, the sample referred to above is of standard quality as defined in the Act and the rules made thereunder for the reasons given below. Samples complies as per I.P. W.R.T. to Above Test Only" 27. To buttress his argument, petitioners" counsel relies upon the decision of the High Court of Bombay, Bench at Aurangabad in the case of M/s. United Phosphorus Ltd. & Ors. v. The State of Maharashtra in Criminal Writ Petition No. 145 of 2007 dated 15.01.2009. In that case, the report of the test of Government Analyst and the show cause notice dated 28.7.1997 was replied on 20.8.1997. In that reply, the petitioners accused made it clear that they have informed the Research and Development Scientist to analyse the counter sample of the same batch, and test report confirms that the product satisfies ISI specification in all aspects. They forwarded a copy of the certificate of analysis issued by the R &D scientist. In effect they furnished evidence showing their desire to dispute the correctness of the report of the government analyst given in terms of section issued on 25 (1). 28. Another argument placed was that the complaint has been filed after expiry of shelf life of the sample drawn. The said Court was of the view that the intention to adduce evidence in controversion of the report would satisfy the requirement of sub clause 3 of Section 24. 28. Another argument placed was that the complaint has been filed after expiry of shelf life of the sample drawn. The said Court was of the view that the intention to adduce evidence in controversion of the report would satisfy the requirement of sub clause 3 of Section 24. Relevant para No. 7 in the case of M/s. United Phosphorus Ltd. & Ors (supra) is extracted below : "7. The law makes it mandatory that the Insecticide Inspector shall deliver a copy of the report to the person from whom the sample was taken. The relevant provision contained in Section 24(3) of the Insecticides Act, 1968, would make it amply clear that the report signed by the Insecticide Analyst shall be the conclusive evidence of the facts stated therein. There is deeming effect about its conclusive nature unless the same is disputed within 28 (twenty eight) days of the receipt of the copy of the report by the concerned person from whom the sample was collected, or the same is challenged after filing of the complaint and the concerned person would express intention to adduce evidence to show inaccuracy of the report. A plain reading of sub clause (3) of Section 24 would make it manifest that the concerned person from whom the sample is collected, is not under obligation to immediately ask for sending of the another sample to the Director of the Central Insecticide Laboratory. What is required under the law is that he shall express intention to adduce evidence in contravention of the report. By filling their reply dated 20.8.1997, within the stipulated period of 28 (twenty eight) days, the petitioners expressed intention to adduce evidence in contravention of the report. Nay, they filed copy of the internal report of analysis. It is true that they could have asked the Insecticide Inspector to send another copy to the Central Insecticide Laboratory. However, such choice was available to them under sub clause (4) of Section 24 of the Insecticides Act, 1968, even after filing of the complaint in the Court." (Emphasis supplied) 29. The Single Judge Bombay High Court in the above case was of the view that delay in filing prosecution after expiry of the drug was fatal to the prosecution. 30. In the present case, the prosecution was lodged earlier to expiry of the drug. The drug expired before summons were issued and received. The Single Judge Bombay High Court in the above case was of the view that delay in filing prosecution after expiry of the drug was fatal to the prosecution. 30. In the present case, the prosecution was lodged earlier to expiry of the drug. The drug expired before summons were issued and received. The principle that is pleaded here is that the requirement of sub clause 3 of Section 25 of the Act would be satisfied if the intention to adduce evidence in controversion of the Government analysis report would by itself require the prosecution to forward the samples to the Central Drug Laboratory in accordance with Sub Section 4 of Section 25 of the Act which has not happened in the present case and therefore, it is bad. RESPONDENTS 30. Contra, Mr. S. Samarjeet, learned CGC appearing for the department submits that in the case of GlaxoSmithKline Pharmaceuticals Ltd. & Anr. v. State of Madhya Pradesh in Criminal Appeal 1489 of 2011, the Supreme Court had taken a view that until and unless the manufacturer takes a stand in accordance with Sub Section 3 of Section 25, the question of controverting the evidence of the Government analysis does not arise. In that case, what was controverted by the accused company was a simple letter stating that their product is of standard quality and therefore, matter should be closed. They did not give document to show their intention to adduce evidence in controversion of the report of the Government analyst. 31. The learned counsel contended that since retest was not requested, the question of sending the sample to further test in terms of Section 25(4) does not arise. The letter of petitioners/accused is not in terms of Section 25(3). The ingredients are not satisfied. He prayed for dismissal of the petition. ANALYSIS 32. The case of GlaxoSmithKline Pharmaceuticals Ltd. & Anr (supra), refers to Medicamen Biotec Limited & Anr. (supra) but distinguishes the same on the plea that the accused have not expressed their opinion to lead evidence in controversion. Therefore, this decision of GlaxoSmithKline Pharmaceuticals Ltd. & Anr. (supra) cannot be made applicable to the facts of the present case because on 08.12.2015, a specific letter has been written to the respondent No. 2 with supporting certificate of an approved analytical laboratory controverting the report of the Government Analysis. Therefore, the case of GlaxoSmithKline Pharmaceuticals Ltd. & Anr. Therefore, this decision of GlaxoSmithKline Pharmaceuticals Ltd. & Anr. (supra) cannot be made applicable to the facts of the present case because on 08.12.2015, a specific letter has been written to the respondent No. 2 with supporting certificate of an approved analytical laboratory controverting the report of the Government Analysis. Therefore, the case of GlaxoSmithKline Pharmaceuticals Ltd. & Anr. (supra) may not apply to the facts of the present case. 33. In fact, in the case of GlaxoSmithKline Pharmaceuticals Ltd. & Anr. (supra), the reliance is placed on the decision in the case of State of Haryaa v. Brij Lal Mittal &Ors. Reported in (1998) 5 SCC 343 . Relevant para 10 of GlaxoSmithKline Pharmaceuticals Ltd. & Anr. (supra) is extracted below: "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 wherein 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 Lab oratory (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 subsection (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 manufacturers right under 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-division (3) is complied with." 34. Reading of the above makes it clear that what is required under Sub Section 3 of Section 25 is the intention to adduce evidence in controversion of the report of the Government analyst. Reading of the above makes it clear that what is required under Sub Section 3 of Section 25 is the intention to adduce evidence in controversion of the report of the Government analyst. In the present case, petitioners have given a supporting document showing their intention to adduce evidence in controversion of the report of the Government Analyst. The said certificate has been received by the respondents department but curiously, as is evident from criminal complaint, that the letter dated 08.12.2015 has not been placed before the trial court as a document in support of the prosecution. Surprisingly, in paragraph 13 of the complaint, the complainant states as follows : "13. The manufacturer vide letter no. IS/FDA/033/15 dated 8th December 2015 forwarded their comments/explanations which seem to be unsatisfactory" The respondent department summarily dismissed the letter dated 8.12.2015 as unsatisfactory. This Court fails to understand whether such a power can be exercised by the authority at the stage of filing the complaint. In any event, the document letter dated 08.12.2015 should have been placed before the Court. The trial court should decide in terms of Section 25 (4) on the letter dated 8.12.2015 and its enclosures. When there is an analytical report submitted by the accused to controvert the evidence of the Government analyst, failure to submit the same before the Court may cast a gloom over the nature of prosecution or to draw adverse inference on the intention behind the suppression of the document by the prosecuting department. 35. The Supreme Court, in the case of Laborate Pharmaceuticals India Limited and Others v. State of Tamil Nadu reported in (2018) 15 SCC 93 , was of the view that the right to exercise option under section 25(4) for reanalysis by the Central Government Laboratory under 25 (4) is valuable right and the non supply of sample to the manufacturer under Section 24 (3) was fatal to the prosecution. Relevant para 8 of the said case is as follows : "8. Relevant para 8 of the said case is as follows : "8. All the aforesaid facts would go to show that the valuable right of the appellant to have the sample analysed in the Central Laboratory has been denied by a series of defaults committed by the prosecution; firstly, in not sending to the appellant manufacturer part of the sample as required under Section 23(4)(iii) of the Act; and secondly, on the part of the Court in taking cognizance of the complaint on 4-3-2015 though the same was filed on 28-11-2012. The delay on both counts is not attributable to the appellants and, therefore, the consequences thereof cannot work adversely to the interest of the appellants. As the valuable right of the accused for reanalysis vested under the Act appears to have been violated and having regard to the possible shelf life of the drug we are of the view that as on date the prosecution, if allowed to continue, would be a lame prosecution." 36. In the present case, we are concerned with right of the petitioners/accused to have the sample tested which is scuttled by not following the procedure prescribed under Section 25 (4) when it is once established that the petitioners have exercised their option under Section 25 (3) to adduce evidence in controversion. 37. In the present case, from the narration of the facts as above, it is clear that the only objection raised by the prosecution appears to be that the letter dated 5.12.2015 does not state in clear terms that they are controverting the evidence of the Government analyst. This plea is not correct because, it has been clearly spelt out in the result of the Government approved analytical laboratory dated 28.11.2015 relied upon by the petitioners/accused that the product sample tested complies with IP specification. The certificate is in controversion to the Government analyst report. It is not in dispute that the petitioners have exercised their option within 28 days by submitting it to the department. It is the tenor of letter dated 08.12.2015 which appears to be the interdict of the respondent to state that no case is made out to invoke Section 25(3) and 25(4) of the Act. INTERPRETATION OF STATUTE 38. It is not in dispute that the petitioners have exercised their option within 28 days by submitting it to the department. It is the tenor of letter dated 08.12.2015 which appears to be the interdict of the respondent to state that no case is made out to invoke Section 25(3) and 25(4) of the Act. INTERPRETATION OF STATUTE 38. A reading of the provision section 25(3) and 25(4) of the Act, it is clear that the intention of the legislature is to enable the accused to adduce evidence in controversion of the report. There is no need to ask for a re-testing as suggested by the respondents counsel. 39. The interpretation of Section 25(3) has to be on the plain language of the words used in the Section. The word used in the statute has to be understood in its plain meaning. The Court should not add more or subtract to the meaning of the word. The Honble Supreme Court in several decisions held as follows : (A) Union of India v. Deoki Nandan Aggarwal reported in AIR 1992 SC 96 . Relevant para 14 reads as follows : "14. We are at a loss to understand the reasoning of the learned Judges in reading down the provisions in paragraph 2 in force prior to November, 1, 1986 as "more than five years" and as "more than four years" in the same paragraph for the period subsequent to November, 1, 1986. It is not the duty of the Court either to enlarge the scope of the legislation or the intention of the legislature when the language of the provision is plain and unambiguous. The Court cannot rewrite, recast or reframe the legislation for the very good reason that it has no power to legislate. The power to legislate has not been conferred on the Courts. The Court cannot add words to a statute or read words into it which are not there. Assuming there is a defect or an omission in the words used by the legislature the Court could not go to its aid to correct or make up the deficiency. Court shall decide what the law is and not what it should be. The Court of course adopts a construction which will carry out the obvious intention of the legislature but could not legislate itself. Court shall decide what the law is and not what it should be. The Court of course adopts a construction which will carry out the obvious intention of the legislature but could not legislate itself. But to invoke judicial activism to set at naught legislative judgment is subversive of the constitutional harmony and comity of instrumentalities." (B) Satheedevi v. Prarsanna, reported in AIR 2010 SC 2777 . Relevant para 10 reads as follows: "10. Before proceeding further, we may notice two well recognized rules of interpretation of statutes. The first and primary rule of construction is that the intention of the legislature must be found in the words used by the legislature itself. If the words used are capable of one construction, only then it would not be open to the courts to adopt any other hypothetical construction on the ground that such hypothetical construction is more consistent with the alleged object and policy of the Act. The words used in the material provisions of the statute must be interpreted in their plain grammatical meaning and it is only when such words are capable of two constructions that the question of giving effect to the policy or object of the Act can legitimately arise Kanai Lal Sur v. Paramnidhi Sadhukhan, 1958 SCR 360 : ( AIR 1957 SC 907 ). The other important rule of interpretation is that the Court cannot rewrite, recast or reframe the legislation because it has no power to do so. The Court cannot add words to a statute or read words which are not therein. Even if there is a defect or an omission in the statute, the Court cannot correct the defect or supply the omission." (C) Kanai Lal Sur v. Paramnidhi Sadhukhan, reported in AIR 1957 SC 907 . Relavant para 6 reads as follows : "However, in applying these observations to the provisions of any statute, it must always be borne in mind that the first and primary rule of construction is that the intention of the Legislature must be found in the words used by the Legislature itself. If the words used are capable of one construction only then it would not be open to the Courts to adopt any other hypothetical construction on the ground that such hypothetical construction is more consistent with the alleged object and policy of the Act. If the words used are capable of one construction only then it would not be open to the Courts to adopt any other hypothetical construction on the ground that such hypothetical construction is more consistent with the alleged object and policy of the Act. The words used in the material provisions of the statute must be interpreted in their plain grammatical meaning and it is only when such words are capable of two constructions that the question of giving effect to the policy or object of the Act can legitimately arise. When the material words are capable of two constructions, one of which is likely to defeat or impair the policy of the Act whilst the other construction is likely to assist the achievement of the said policy, then the Courts would prefer to adopt the later construction. It is only in such cases that it becomes relevant to consider the mischief and defect which the Act purports to remedy and correct. Indeed Mr. Chatterjee himself fairly conceded that he would not be justified in asking the Court to put an undue strain on the words used in the section in order that a construction favourable to the thika tenants should be deduced. It is in the light of this legal position that we must now consider s.5, Sub-s (1) of West Bengal Act, II of 1949, amended by West Bengal Act VI of 1953." (D) Shyam Kishori Devi v. Patna Municipal Corporation AIR 1966 SC 1678 . Relevant Para 8 reads as follows : "8. The question is whether he could have validly done so. It is not disputed that S. N. Sarkar had jurisdiction to take action under S. 107(c) of the Act, but what is contended is that he had no jurisdiction to dispose of the review petition under Section 117(1) of the Act. If the Committee under S.117 of the Act could have been validly constituted even after the supersession of the Municipality, S.N. Sarkar would not have jurisdiction to hear the review petition, for under that section it was the function of the Committee to do so. Mr. If the Committee under S.117 of the Act could have been validly constituted even after the supersession of the Municipality, S.N. Sarkar would not have jurisdiction to hear the review petition, for under that section it was the function of the Committee to do so. Mr. Varma contends that after the order of supersession passed by the Government all the Commissioners vacated their offices and thereafter it was impossible for the Commissioners to function as members of the Committee or to nominate or elect two other tax-payers to that Committee within the meaning of Section 117(1) of the Act and that, therefore, the Government validly appointed the Assistant Special Officer to exercise the powers and perform the functions of the Committee under the said section. If this construction be accepted, all the sections whereunder certain powers were conferred and certain duties were imposed on the said Commissioners would cease to be operative after the order of supersession. Only to avoid this contingency S.386(1)(b) of the Act in express terms says that all the powers and duties which may under the provisions of the Act be exercised and performed by the Commissioners, whether at a meeting or otherwise, shall be exercised and performed by such person or persons as the State Government may direct. The effect of that clause is that all the powers and duties of the Commissioners conferred and imposed on them under the various sections of the Act, whether to act in a body or in committees or individually, would be exercised by such person or persons as the State Government might direct thereunder. If that be the interpretation of S. 386(1), the person or persons appointed by the State Government thereunder would take the place of the Commissioners in the various sections of the Act. So too, in S. 117(1) of the Act, which would run thus : If that be the effect of S. 386 on S. 117, the Committee under S. 117, the Committee under S. 117 could have been constituted with one or more of the three persons nominated by the Government under S. 386(1)(b) of the Act and two tax-payers nominated by them and a Deputy Magistrate nominated by the Government. This construction will give full effect to S. 117 of the Act, whereas the construction suggested by the learned counsel for the respondents and accepted by the High Court would make it unworkable. It is well known rule of construction that a Court must construe a section, unless it is impossible to do so, to make it workable rather than to make it unworkable. In the words of Lord Bramwell, the words of a statute never should in interpretation be added to or subtracted from, without almost a necessity. " 40. Tested on the above principles laid down by the Honble Supreme Court, in the present case, the petitioners have adduced evidence to controvert the report of the Government Analyst. And therefore, the requirement of under section 25 (3) and 25 (4) is satisfied. The consequence is that the prosecution ought to have sent the report to the Government drug laboratory for test by the competent authority, namely, the director or his duly authorized person specified in rule 3 and 6 r/w Form 2 extracted above. The failure to place the report in controversion before the Court, is a violation of provision of law. The breach will entitle the petitioners in this case to plead for quashing the proceedings which is inherently defective. RESULT 41. In view of the above legal analysis, this Court has no other option except to conclude that the petitioners accused have been deprived of their valuable right under section 25(4) of the Act though they have exercised their option in terms of Section 25(3) of the Drugs and Cosmetics Act, 1940. A denial of such right deprives the petitioners accused of their right to effective defence and the proceedings against the petitioners would be a mere formality, because the test report of the Government analyst which is controverted by the petitioners based on the analytical report of the Government approved analyst remains uncontroverted. The requirement of Section 25 (3) has been complied by the petitioners and the department has breached the mandate of Section 25(4). Hence, the proceeding in the criminal complaint case is not lawfully justified and therefore, deserves to be quashed. 42. As a result, the proceeding in Criminal (C) Case No. 284 of 2016 before the Court of Chief Judicial Magistrate Imphal West stands quashed.