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2023 Supreme(AP) 1307

IN THE HIGH COURT OF ANDHRA PRADESH AT AMARAVATI
Duppala Venkata Ramana, J.
J.P.N.Singh - Appellant
Versus
State of Andhra Pradesh - Respondent
Criminal Petition No. 13022 of 2014
Decided On : 26-09-2023

Advocates appeared:
T.S.Anirudh Reddy, Advocate

The main legal point established in the judgment is the conclusive nature of the State Analyst Report and the requirement to exercise the statutory right to request re-analysis by the Central Drugs Laboratory within the prescribed time.

Headnote:

DRUGS AND COSMETICS ACT - Criminal Petition - Sec. 18(a)(i), Sec. 16, Sec. 27(d) - The court discussed the provisions of Sec. 25 of the Act, emphasizing the conclusive nature of the Government Analyst's report and the right to request re-analysis by the Central Drugs Laboratory. The court also highlighted the responsibility of the accused for the day-to-day affairs of the firm and the requirement to exercise the statutory right within the prescribed time. The decision was based on the failure of the accused to avail the statutory right and the conclusive nature of the State Analyst Report.

Fact of the Case:

The Drugs Inspector filed a complaint against the petitioner/A.2 for manufacturing and selling a 'Not of Standard Quality Drug' under Sec. 18(a)(i) read with Sec. 16 of the Drugs and Cosmetics Act, 1940. The petitioner/A.2 sought to quash the proceedings, arguing that the complaint was not maintainable due to the expiry of the drug's shelf-life and non-compliance with statutory provisions.

Finding of the Court:

The court found that the petitioner/A.2 failed to exercise the statutory right to request re-analysis of the drug by the Central Drugs Laboratory within the prescribed time, and the State Analyst Report was conclusive evidence. The court also determined that the petitioner/A.2 was responsible for the day-to-day affairs of the firm, based on the affidavit submitted by the petitioner/A.2.

Issues: The issues revolved around the maintainability of the complaint due to the expiry of the drug's shelf-life, non-compliance with statutory provisions, and the responsibility of the petitioner/A.2 for the firm's affairs.

Ratio Decidendi: The court held that the failure to exercise the statutory right within the prescribed time and the conclusive nature of the State Analyst Report were pivotal in the decision to dismiss the criminal petition.

Final Decision: The criminal petition seeking quashing of the proceedings was dismissed, allowing the petitioner/A.2 to raise all contentions before the trial court.

JUDGMENT

1. This Criminal Petition has been filed by the Petitioner/A.2 under Sec. 482 of the Code of Criminal Procedure, 1973 (for short "Cr.P.C") for quashing the proceedings in C.C.No.405 of 2012 on the file of the Court of II Additional Munsif Magistrate, Ongole, registered for the offence under Sec. 18(a)(i) read with Sec. 16 punishable under Sec. 27(d) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Act").

2. Heard Sri T.Pradyumna Kumar Reddy, learned Senior Counsel instructed by Sri T.S.Anirudh Reddy, learned counsel for the petitioner and learned Assistant Public Prosecutor for the respondent.

3. The brief facts of the case are as follows:

(i) A.1-firm, namely, M/s.Galpha Laboratories Limited, Thana, possessed drug manufacturing licence bearing No.L/06/256/MB, dtd. 27/6/2006, to manufacture the drugs for sale. The petitioner/A.2 is the responsible Director of the firm and A.3-O.N.Vaishy is the responsible person for the manufacturing activities of the firm at Baddi.

(ii) On 12/5/2009, the-then Drugs InspectorN.Ramamoorthy(L.W.1) inspected Central Drug Stores, APHMHIDC, Ongole, in the presence of Pharmacist under Form No.17 as required under Sec. 23 of the Act and picked up the drug, namely "Amoxycillin" and Potassium Clavulanate Oral Suspension I.P., Clanoxy-200 Batch No.CNSF-90071B, Manufacturing Date 4/2009, Expiry Date 3/2011, manufactured by A.1 firm, seized four samples(drugs) separately under seal, and immediately sent one sealed portion of the said drug sample - Clanoxy 200, to the Government Analyst, Drugs Control Laboratory, Hyderabad vide Form No.18, through Registered Post for analysis. He also sent one copy of Form No.18 to the Government Analyst, Drugs Control Laboratory, Hyderabad, separately through Registered Post. (iii) On 26/5/2010 the Drugs Inspector(L.W.1) received the Government Analyst Report dtd. 20/5/2010, declaring the sample drug is "not of standard quality" as defined under the Act and Rules framed thereunder for the reason that the sample does not meet the labelled claim in respect of the Clavulanic Acid content(found 3.59 mg/28.5 mg).

(iv) On receipt of the Government Analyst's Report, the Drug Inspector addressed a letter dtd. 26/5/2010 to the Executive Engineer, Central Drug Stores, APHMHIDC, Ongole, under Sec. 18A of the Act with a request to disclose the source of acquisition of the sample drug along with a selfattested copy of purchase invoice. On 10/6/2010, the Drugs Inspector received a reply from the Executive Engineer stating that the sample drug was received vide Bill No.0911NS/11, dtd. 25/4/2009. On 30/6/2010 the Drugs Inspector addressed a letter to M/s.Galpha Laboratories Limited, Hyderabad(A.1) under Sec. 18A of the Act requesting to disclose the source of the acquisition of the drug and to furnish the self-attested Xerox copy of the purchase invoice. The Drugs Inspector received a reply dtd. 14/7/2010 from A.1-firm stating that "they have manufactured, sold and distributed a standard quality drug namely Clanoxy-200 Suspension and the findings of the Government Analyst can be attributed to error in testing or improper storage". In view of the above, they requested the Drug Inspector to take into consideration their submission and the background submitted above and not to take any action against them. In another letter dtd. 26/7/2010 received from the Authorized Signatory of A.1 Firm, it was stated that "they have manufactured, sold and distributed standard quality of drug namely Clanoxy 200 dry syrup and the findings of the Government Analyst can be attributed to error in testing or improper storage" and requested not to take any action against them.

(v) On 16/9/2010 the Drugs Inspector addressed another letter to M/s.Galpha Laboratories Limited, Zirakpur requesting to disclose the source of supply and to furnish a selfattested Xerox copy of their purchase invoice. On 18/4/2011 the complainant received a reply from A.1-firm along with the manufacturing and

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