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2015 Supreme(Mad) 2803

IN THE MADURAI BENCH OF MADRAS HIGH COURT
R.MALA, J.
Time Pharmaceuticals and Ors. – Petitioner
Vs.
State represented by The Drug Inspector – Respondents
Criminal Original Petition(MD) No.21860 of 2014 and M.P.(MD)Nos.1 and 2 of 2014
Decided On : 03.09.2015

Advocates:
Advocate Appeared:
For Petitioners: Mr.M.Saravanan
For Respondent:Mr.K.Anbarasan, Government Advocate (Crl. Side)

The main legal point established in the judgment is the significance of the statutory limitation period for adducing evidence to controvert the analyst's report, as provided under Sections 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940.

Headnote:

Drugs and Cosmetics Act - Prosecution under Section 18(a)(i) of Drugs and Cosmetics Act, 1940 - Section 27(d) - Section 25 - Section 23(4) - Section 25(3) - Section 25(4) - [SUMMARY] The court discussed the contravention under Section 18(a)(i) of Drugs and Cosmetics Act, 1940, punishable under Section 27(d). It emphasized the importance of Sections 25, 23(4), 25(3), and 25(4) in providing safeguards and procedures for testing and analysis of drug samples, and the right to adduce evidence to controvert the report of the analyst within the statutory limitation period.

Fact of the Case:

The petitioners sought discharge from prosecution under Section 18(a)(i) of Drugs and Cosmetics Act, 1940, for contravention related to the quality of a cough syrup. The complaint was filed after the expiry of the medicine's shelf life, raising questions about the right to send the sample for analysis.

Finding of the Court:

The court found that the complaint was filed after the expiry of the medicine's shelf life, depriving the accused of the right to send the sample for analysis, as provided under Section 25(4) of the Act.

Issues: The key issue was the timing of the complaint in relation to the expiry of the medicine's shelf life and the right to send the sample for analysis under Section 25(4) of the Drugs and Cosmetics Act, 1940.

Ratio Decidendi: The court's decision was based on the interpretation of Sections 25(4) and 25(3) of the Act, emphasizing the importance of the statutory limitation period for adducing evidence to controvert the analyst's report.

Final Decision: The court set aside the order and quashed the charges, discharging the petitioners from the prosecution.

ORDER :

This Criminal Original Petition is directed against the order dated 09.04.2014 passed in Crl.M.P.No.5575 of 2012, whereby and whereunder, the learned Judicial Magistrate, Uthamapalayam, dismissed the application filed by the petitioners to discharge them from the prosecution.

2. Heard both sides.

3. The learned counsel for the petitioners would submit that the respondent, as a complainant, filed a complaint for contravention under Section 18(a)(i) of Drugs and Cosmetics Act, 1940, which is punishable under Section 27(d) of the said Act. He would further submit that the first petitioner is the Pharmaceutical Firm. The petitioners 2 to 5 are the partners. The petitioner No.6 is the purchaser of medicine and the petitioner No.7 is the Managing Director of petitioner No.6.

4. Adding further, he would submit that on 23.01.2007, one Panneerselvam, the then Drugs Inspector of Theni Range had drawn for analysis the drug samples of Gropex-Dx Cough Formula 100 ml, Batch No.GIL-602, and it has been manufactured in June, 2006 and the expiry date is May, 2009. The sample was sent for analysis to the Government Analyst (Drugs), Chennai and the report has been received on 29.12.2008, in which, it was declared that the sample does not conform to label claim with respect to the content of Phenylephrine Hydrochloride and the sample deemed to be "Not of Standard Quality", as it is found to contain only 0.53 mg (21.2%) phenylephrine hydrochloride instead of the label claim of 2.5 mg. On receipt of the report, a show cause memo was issued to the concerned parties and called for explanation for the contravention of Section 18(a)(i) of Drugs and Cosmetics Act, 1940, and to disclose the details of the person from whom the said drug was purchased and lastly, a memo dated 23.03.2009 was issued to the first petitioner herein to offer their explanation for having manufactured and sold the not of standard quality cough syrup formula 100 ml bearing its Batch No.GIL-602 and to furnish other required particulars, for which, the first petitioner sent a reply on 31.03.2009 stating that they have manufactured only 998 bottles of the said batch (GIL-602) and out of which, 3 were kept as control sample and 995 bottles were supplied to the M/s.Great Indian Remedies and M/s.Kronie Health Care (P) Ltd. The complaint has been filed only on 13.05.2010 after the expiry of the expiry date of the medicine in the sample. Thus, the right of the first petitioner to send the sample to Central Drugs Laboratory is curtailed under Section 25(4) of the Act. Hence, the learned counsel prayed for discharging the petitioners from the prosecution.

5. To substantiate his argument, he relied upon the decisions reported in Medicamen Biotech Ltd. v. Drug Inspector [2008(7) SCC 196] and M/s. Unicure (India) Pvt. Ltd., & another vs. State rep. by M.N.Sridhar, Drug Inspector [2010(2) Drugs Cases (DC) 297.

6. Resisting the same, the learned Government Advocate (Criminal side) would submit that after taking sample, it was sent for analysis to the Government Analyst (Drugs), Chennai and the report has been received on 29.12.2008 and memo has been issued on 23.03.2009 to the first petitioner, but the date of expiry of cough syrup is May 2009 and as such, they are having a period of two months to send the sample for Central Drugs Laboratory for analysis. Therefore, the right to send the sample for Government Analyst has not been deprived, as alleged by the petitioners.

7. In support of his contention, he relied upon a decision of Karnataka High Court, Circuit Bench at Dharwad in Criminal Petition No.8006 of 2010 [M/s.Agron Remedies PVT Ltd., and another vs. State by Drug Inspector] and a decision of the Supreme Court in Criminal Appeal No.1489 of 2011 [Glaxosmithkline Pharmaceuticals Ltd., v. State of Madhya Pradesh] and prayed for dismissal of this petition.

8. I have considered the rival submissions made on both sides and perused the typed-set of papers.

9. A perusal of the complaint wo
































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