ORDER : G. Jayachandran, J. The petitioners herein are M/s Gopal Life Sciences, Solan, Himachala Pradesh, its Partner and Authorised Signatory-cum-Manager. 2. A complaint by the Drug Inspector, Vellore Zone under Section 32 of The Drugs and Cosmetics Act, 1940(hereinafter referred to “the Act”), for contravention of Section 18(a)(i) and punishable under Section 27(d) of the said Act laid before the Judicial Magistrate, Chengam, Tiruvannamalai District and taken on file as S.T.C.No.183 of 2022. 3. The gist of the complaint is that, on 30/07/2019, a sample of 4x100ml TERBOT-G syrup (Terbutaline sulphate, Bromhexine, Guaiphenesin and Menthol Syrup), B.No.GLL-8036, M/D:7/18, E/D:6/20, Mfd by Gopal Lifesciences, Hill top Industrial Estate, Near Export Zone, Jharmajri, Baddi (H.P)-173205(marked as 45/MSA/19/TVM-II) was drawn for analysis from M/s Vasuki Medicals situated at No.223, Nadu Street, Mothakkal Post, Tiruvannamalai-II Range, under Form-17 dated 30.07.2019 and sent for analysis to the Government Analyst under Form-18 dated 30.07.2019. The said drug has been declared as Not of Standard Quality drug by the Government Analyst, Drug Testing Laboratory, Chennai-6 for the reason that the sample does not conform to Label claim with respect to the content of Terbutaline Sulphate (70.83%) and Bromhexine Hydrochloride(68.13%), thereby for having manufactured for sale, stocked for sale and sold the said Not of Standard Quality drug, the Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 has been contravened. 4. M/s Vasuki Medicals was issued a show cause memo under Section 18-A of the Act for stock and selling the subject drug. In response, Vasuki Medicals, the seller/stockist, vide its letter dated 18/09/2019 disclosed that he purchased the drug from M/s Radha Medical Stores, Harur. 5. A show cause memo dated 20/09/2019 was issued to M/s Radha Medical Stores, Harur, to disclose the name, address and other particulars of the person from whom they had acquired the stock of the subject drug. In response to the memo, M/s Radha Medical Stores, Harur informed that they purchased the subject drug from M/s Cosmic Pharma, Trichy. To the show cause memo sent to M/s Cosmic Pharma on 15/10/2019, they replied that the subject drug was purchased from its manufacturer M/s Gopal Lifesciences (Unit II), Panchkula, Haryana under invoice No: GST/INV-1775 dated 13/11/2018 and GST /INV-1826 dated 19/11/2018. 6. To the show cause memo sent to M/s Cosmic Pharma on 15/10/2019, they replied that the subject drug was purchased from its manufacturer M/s Gopal Lifesciences (Unit II), Panchkula, Haryana under invoice No: GST/INV-1775 dated 13/11/2018 and GST /INV-1826 dated 19/11/2018. 6. Since M/s Gopal Life Sciences, Panchkula, is being the manufacturer of the subject drug, a show cause notice for contravention of Section 18(a)(i) of the Act was caused along with the copy of the test report. They were called to furnish the documents and particulars, such as, the drug licences, product endorsement, constitution details, batch manufacturing records, etc. They were also instructed to recall the subject drug from the persons to whom they sold /supplied and to furnish the details of those recalled stocks of drugs. 7. In response to the notice, the Manufacturer, M/s Gopal Life Sciences, controverted the lab result and claimed that the subject drug was delivered only after ensuring all the parameters checked and no discrepancies observed. On getting the information, they tested their control sample of subject drug and no discrepancies observed. Though they enclosed the copies of product endorsement, recall letter, invoice copy, etc., they did not enclose the required documents such as constitution details, drug licences, Batch Manufacturing records, etc., Since, the reply of the Manufacturer was not satisfactory, after getting sanction from the Director of Drugs Control on 11/06/2020, the complaint was lodged. 8. The Learned counsel for the petitioners contended that the complaint is liable to be quashed on the ground that the complainant failed to forward the third sample to the Manufacturer along with the show cause memo. Though in the complaint it is stated that the third sample was sent to the manufacturer through registered post separately as per Section 23(4)(iii) of the Act, nothing was sent as claimed. This was brought to the notice of the complainant immediately in the comprehensive reply dated 30/11/2019. However, the complainant did not respond to the specific and positive stand of the manufacturer regarding non-receipt of the sample portion. 9. The learned counsel apart from other infirmities in the complaint, particularly claimed that the valuable right of the manufacturer to subject the Court sample for test by Central Lab been deprieved. However, the complainant did not respond to the specific and positive stand of the manufacturer regarding non-receipt of the sample portion. 9. The learned counsel apart from other infirmities in the complaint, particularly claimed that the valuable right of the manufacturer to subject the Court sample for test by Central Lab been deprieved. Though the complaint is alleged to have been presented in the Court on 22/06/2020 few days before the expiry of the shelf life of the subject drug, the same was returned by the Court for curing the defects in the complaint. The complaint was represented after one and half years and taken cognizance only on 14/12/2021, long after the expiry of shelf life of the subject drug. Relying on Section 23(4) and Section 25 of the Act, it is contended that the complaint cannot sustain, in view of the patent deprivation of the valuable right vested with the manufacturer . 10. The Learned Government Advocate (Crl.Side) referring the sanction order given by the Director of drug control on 11/06/2020 and the complaint, submitted that the third sample was sent to the manufacturer separately under registered post. The denial of the manufacturer regarding non receipt of the sample is a disputed fact which has to be tested in the trial. As far as the contention of filing the complaint after the shelf life of the drug, the Learned Government Advocate contended that, the complaint was filed well before the expiry of the shelf life of the subject drug. The complaint was filed along with the e-mail print out of the sanction order. For non furnishing the original sanction order of the Director Drug Control, the complaint was returned by the Court. Therefore the complaint was represented along with the original sanction order on 14/12/2021. The delay is explained and that cannot be a reason to quash the complaint made for manufacturing drug of non standard quality. 11. Heard the Learned Counsels. 12. The seizure of the subject drug from M/s Vasuki Medicals, Thandarampattu was on 30/07/2019. Though the seized drugs contain the details of the manufacturer, the complainant had not caused notice to the manufacturer immediately on receiving the lab report. 13. The complainant out of three samples drawn, had sent one sample to the State laboratory and received the report dated 12/09/2019, which has declared the drug as not of standrard quality. Though the seized drugs contain the details of the manufacturer, the complainant had not caused notice to the manufacturer immediately on receiving the lab report. 13. The complainant out of three samples drawn, had sent one sample to the State laboratory and received the report dated 12/09/2019, which has declared the drug as not of standrard quality. The opinion of the expert is as below:- “In the opinion of the undersigned the sample referred to above is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 and rules thereunder for the reasons given below: The sample does not conform to the label claim with respect to the content of Terbutaline Sulphate and Bromhexine Hydrochloride”. 14. Only after sending show cause memo to the seller M/s Vasuki Medicals, his supplier M/s Radha Medicals, then to its supplier M/s Cosmic Pharma, one after another at last, the manufacturer been asked to give his explanation under Section 18 A of the Act, atleast two months lost in this process, which is apparently against the spirit and purpose of the Act. While the Laboratory report received on 12/09/2019 and the name of the manufacturer is well known even on the date of seizure of the subject drug, the drug inspector has called for explanation from the manufacturer only on 18/11/2019. 15. Further, regarding complainance of Section 23 (4) of the Act, it is to be noted that the Inspector is empowered to conduct a search of the premises and seize of any samples of drugs or cosmetics and has to draw 3 set of samples sealed. One to be sent to the State Laboratory for analysis and the second set for the Court. The third set of sample must be sent to the Manufacturer, while calling for his explanation. 16. In this case, the complainant states that the third sample was sent to the manufacturer separately under registered post. However, no further detail is available to vouchsafe the said claim. Particularly, when the manufacturer denies the receipt of sample, the complainant could not be able to place contra proof. That apart, the specfic case of the manufacturer is that their valuable right to send the Court sample for second opnion by the Central Laboratory been deprived due to belated filing of the complaint. Particularly, when the manufacturer denies the receipt of sample, the complainant could not be able to place contra proof. That apart, the specfic case of the manufacturer is that their valuable right to send the Court sample for second opnion by the Central Laboratory been deprived due to belated filing of the complaint. This defence gains very much significance since right from inception the manufacturer claims that the control sample in their custody tested and found no discrepancies. 17. The learned Government Advocate(Crl.Side) appearing for the complainant refer the letter dated 18.11.2019 emanated from the Drugs Inspector Tiruvannamalai II Range, which says that the third portion of the sample drawn for analysis sent separately by registered post, as required under Section 23(4) of the Act. Except this letter, no material apart from this letter is available on record to indicate that the third sample has been sent through registered post. In the said circumstances, atleast if the complaint is filed in time and oppotunity given to the manufacturer to seek second opinion from the Cetral Laboratory by forwarding the Court sample(Second sample) the manufactuer could not have been put to any prejudice. However, in this case, the complaint taken cognizance more than one year after the expiry of the shelf life of the subject drug. In this regard, it is appropriate to refer the following judgments of the Hon'ble Supreme Court requires reference and reliance. (i) State of Haryana v. Brij lal Mittal and others reported in [ (1998) 5 SCC 343 ], wherein it was held that: “5. From a bare perusal of sub-section (3) of Section 25, it is manifest that the report of the Government Analyst 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 or other particulars have been disclosed under Section 18-A (in this case the manufacturers) has within 28 days of the receipt 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. 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).” (ii) State of Haryana v. Unique Farmaid (P)Ltd., reported in [ (1999)8 SCC 190 ] wherein it was held that: “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 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 Insecticide Inspector or the court before which proceedings are pending that they intend to adduce evidence to controvert the report. In the present cases the Insecticide 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. 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.” (iii) Medicamen Biotech Limited and another v. Rubina Bose, Drug Inspector reported in [ (2008) 7 SCC 196 ], wherein the Hon'bel Supreme Court held that: “19......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 appellants have 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.” 18. From the records, it could be seen that soon after the receipt of the show cause notice along with lab report, which opines as below:- “In the opinion of the undersigned the sample referred to above is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 ad Rules thereunder for the reasons given below: “The sample does not conform to the label claim with respect to the content of Terbutaline Sulphate and Bromhexine Hydrochloride”. 19. The manufacture has given a reply as below:- “1.At the time of Batch release, all parameters were checked, there was no any discrepancy is observed in assay of Terbutaline Sulphate and Guaiphenesin of Terbot-G Syryp. COA is attached for your rference. 19. The manufacture has given a reply as below:- “1.At the time of Batch release, all parameters were checked, there was no any discrepancy is observed in assay of Terbutaline Sulphate and Guaiphenesin of Terbot-G Syryp. COA is attached for your rference. 2.When we get information that our sample is withdrawn by you, then we got tested our Control sample of Terbot G Syrup in our Internal Lab and outside NABL Approved Laboratory, No discrepancy was observed in assay of Terbutaline Sulphate and Guaiphenesin of Terbot-G COA is attached for your reference.” 20. The complaint was taken cognizance, obviously after expiry of the shelf life of the said drug. In the said circumstances, the valuable right of the manufacturer to get second opinion from the Central Laboratory has been deprived and the complainant is responsible for the said deprivation, due to belated filing of the complaint. The dictum laid down by the Hon'ble Supreme Court in Medicamen Biotech Limited and another v. Rubina Bose, Drug Inspector reported in [ (2008) 7 SCC 196 ], squarely applies to the case in hand. Hence, this Criminal Original Petition is allowed. The case in S.T.C.No.183 of 2022 on the file of the Judicial Magistrate Court, Chengam is hereby quashed. Consequently, connected Miscellaneous Petitions are closed.