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Laborate Pharmaceuticals India Ltd. & Ors. (S) v. State Of Tamil Nadu (S)
Factual and Procedural Background
The case arises from criminal proceedings initiated after a drug inspector collected a sample of “Cherry Lab Cough Syrup” on 5 September 2011 from the premises of a retailer. The Government Analyst’s report dated 27 January 2012 declared the sample not of standard quality. A show-cause notice enclosing that report was issued to the appellant-company on 22 March 2012, to which the company replied on 14 May 2012 without contesting the findings or indicating an intention to adduce contrary evidence.
On 10 August 2012, the appellant received one part of the sample from the Drug Inspector and forwarded it to a private laboratory, whose report contradicted the Government Analyst. On 13 September 2012 the appellant requested that the portion of the sample in the court’s custody be sent to the Central Drugs Laboratory, Kolkata, for re-analysis. The request was refused as untimely under Section 25(3) of the Drugs and Cosmetics Act, 1940 (“the Act”), which prescribes a 28-day window from receipt of the show-cause notice.
The complaint was filed on 28 November 2012, but cognizance was taken only on 4 March 2015, by which time the cough syrup’s shelf life had expired. The Madras High Court, by order dated 6 July 2016, declined to quash the proceedings under Section 482 of the Code of Criminal Procedure, 1973. The present appeal challenges that refusal.
Legal Issues Presented
- Whether failure to supply the manufacturer with a portion of the sample at the time of seizure, as mandated by Section 23(4)(iii) of the Act, vitiates the prosecution.
- Whether the appellant’s statutory right under Section 25 of the Act to seek re-analysis by the Central Drugs Laboratory was denied due to delays attributable to the prosecution and the court.
- Whether, in the circumstances, the continuance of the criminal proceedings would constitute an abuse of process warranting quashment under Section 482 CrPC.
Arguments of the Parties
The opinion does not contain a detailed account of the parties' legal arguments.
Table of Precedents Cited
No precedents were cited in the provided opinion.
Court's Reasoning and Analysis
The Court examined the statutory scheme of Sections 23(4) and 25 of the Drugs and Cosmetics Act. Under Section 23(4), when a drug sample is taken from a retailer, it must be divided into four parts, with one part supplied to the manufacturer. In this case, that mandatory step was omitted; only the Government Analyst’s report, not the sample, was forwarded to the appellant on 22 March 2012. Absent the sample, the appellant was incapable of independently verifying the analysis or indicating, within the prescribed 28 days, an intention to adduce contrary evidence.
When the sample was eventually handed over on 10 August 2012, the appellant swiftly requested (on 13 September 2012) that the court-retained portion be sent to the Central Drugs Laboratory. The prosecution refused, citing lapse of the 28-day period. The Court held that strict insistence on the time limit was inequitable because the manufacturer’s delay was caused solely by the prosecution’s failure to supply the sample in the first place.
The Court further noted the substantial delay between filing of the complaint (28 November 2012) and the magistrate’s taking cognizance (4 March 2015). By then, the drug’s shelf life had indisputably expired, rendering any fresh analysis impossible. These cumulative lapses—prosecution’s non-compliance with Section 23(4)(iii) and judicial delay—deprived the accused of the “valuable right” to statutory re-testing. Because the resulting trial would proceed without that critical safeguard, the Court characterized it as a “lame prosecution.”
Holding and Implications
Holding: The Supreme Court quashed C.C. No. 263 of 2015 pending before the XV Metropolitan Magistrate, George Town, Chennai; allowed the appeal; and set aside the Madras High Court’s order dated 6 July 2016.
Implications: The immediate effect is termination of the criminal proceedings against the appellant-company and its officers. The decision underscores that non-compliance with mandatory sampling procedures and prosecution-caused delays that extinguish an accused’s statutory right to re-analysis can justify quashing under Section 482 CrPC. No broader doctrinal precedent is expressly established beyond the facts of this case.
1. Leave granted.
2. We have heard the learned counsels for the parties.
3. This appeal is directed against the order of the High Court of Madras dated 6 July, 2016 by which the criminal proceeding against the appellant-company and its directors (appellant nos. 1 to 5) and appellant no. 6 - Vice President (Operations), person responsible for conduct of business has been refused to be interdicted by the High Court in exercise of its power under Section 482 of the Code of Criminal Procedure, 1973.
4. The facts lie in a short compass and have to be noticed as the same would be determinative of the legal issues that having been raised in the present appeal.
5. A sample of Cherry Lab Cough Syrup was taken on 5 September, 2011 from the medical shop of one S. Serumathi, a retailer. One part of the said sample was sent for analysis by the Government Analyst who submitted a report dated 27 January, 2012 to the effect that the sample did not conform to the standard quality.
6. A show cause notice was sent to the appellant no. 1-Company on 22 March, 2012 along with a copy of the report of the Government Analyst. The appellant sent its reply on 14 May, 2012. In the said reply, the appellant-Company did not contest the findings of the Government Analyst and also did not indicate that it was proposing to adduce evidence contrary to the report of the Government Analyst. While the matter was so situated, on 10 August, 2012 the appellant received a part of the sample from the Drug Inspector which was sent by it to a private laboratory for analysis. On receipt of the report from the private laboratory which was inconsistent with the report of the Government Analyst the appellant indicated that it would like to adduce contrary evidence and to have the sample in the custody of the Court retested and re-analysed by the Central Drug Laboratory, Kolkata. This was on 13 September, 2012. The said request was refused on the ground that under the provisions of Section 25(3) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as “the Act”), the manufacturer was required to exercise the aforesaid option within 28 days from the date of receipt of the show cause notice i.e 22 March, 2012 and that the request made in the present case was belated. The High Court took the view that such exercise of option by the appellant was beyond the time contemplated by the provisions of the Act and there is no infirmity in the prosecution which has to be brought to its logical conclusion. Aggrieved this appeal has been filed.
7. A reading of the provisions of Section 23(4) and 25 of the Act would indicate that in the present case the sample having been taken from the premises of the retailer had to be divided into four portions; one portion is required to be given to the retailer; one portion is required to be sent to the Government Analyst and one to the Court and the last one to the manufacturer whose name, particulars, etc. is disclosed under Section 18A of the Act. In the present case, admittedly, one part of the sample that was required to be sent to the appellant (manufacturer) under Section 23(4)(iii) of the Act was not sent. Instead, what was sent on 22 March, 2012 was only the report of the Government Analyst. When the part of the sample was not sent to the manufacturer, the manufacturer could not have got the same analyzed even if he wanted to do so and, therefore, it was not in a position to contest the findings of the Government Analyst. In the present case, the sample was sent to the appellant-manufacturer on 10 August, 2012 and on 13 September, 2012 the appellant had indicated its desire to have another part of the sample sent to the Central Laboratory for re-analysis. This was refused on the ground that the aforesaid request was made much after the stipulated period of 28 days provided for in Section 25(3) of the Act.
8. The cognizance of the offence(s) alleged in the present case was taken on 4 March, 2015 though it appears that the complaint itself was filed on 28 November, 2012. According to the appellant the cough syrup had lost shelf life in the month of November, 2012 itself. Even otherwise, it is reasonably certain that on the date when cognizance was taken, the shelf life of the drug in question had expired. The Magistrate, therefore, could not have sent the sample for reanalysis by the Central Laboratory.
9. All the aforesaid facts would go to show that the valuable right of the appellant to have the sample analyzed 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 March, 2015 though the same was filed on 28 November, 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 re-analysis 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.
10. Consequently and for the reasons alluded we are of the view that the present would be a fit case to interdict the criminal trial against the accused appellants. We order accordingly. Therefore, C.C No. 263 of 2015 pending on the file of the XV Metropolitan Magistrate, George Town, Chennai is hereby quashed. The appeal is allowed and the order of the High Court is set aside.
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