The central legal point established in the judgment is the importance of adhering to the prescribed limitation period for filing a complaint under the Drugs and Cosmetics Act, 1940, and the consequences of delay in filing a complaint. The court's decision emphasizes the necessity of providing a valid explanation for any delay and the power of the trial court to extend the period of filing the complaint.

JUDGMENT

1. This Criminal Petition has been filed by the petitioners/A.1 to A.4 under Sec. 482 of the Code of Criminal Procedure, 1973, (for short "Cr.P.C") for quashing the proceedings in C.C.No.316 of 2013 on the file of the Court of II Additional Munsif Magistrate, Ongole, for the offence under Ss. 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"), against them.

2. Heard Sri Challa Ajay Kumar, learned counsel instructed by Sri Sunil Gawasane, learned counsel for the petitioners, and learned Assistant Public Prosecutor for respondent No.1-State.

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

(i) On 20/9/2004, the Drugs Inspector-P.Rambabu (L.W.1) picked up the drug sample "Atenolol Tablets IP", Batch No.4007, Manufacturing Dated 05/2004 and Expiry Date 04/2007, manufactured by M/s.Zest Pharma, Indore(A.1) for analysis from the premises of A.P.H.M.H.I.D.C. Central Drug Stores, M.C.Hospital Campus, Ongole, in the presence of Pharmacist Grade-II (L.W.2) under intimation in Form No.17, as per Sec. 23 of the Act. On the same day, the Drug Inspector (L.W.1) sent one sealed portion of the sample drug (Atenolol Tablets IP) to the Government Analyst, Drugs Control Laboratory, Hyderabad, along with Form No.18 through registered post, for analysis.

(ii) The State Analyst submitted his report dtd. 31/12/2004 to the effect that "the samples were not of standard quality", as defined under the Act, as the sample does not meet the IP specifications for disintegration test for uncoated tablets and the said report was received by the Drugs Inspector (L.W.1) on 5/1/2005. On receipt of the said report, on 6/1/2005 the Drugs Inspector (L.W.1) addressed a letter to L.W.2 - Pharmacist, Grade-II with a request to disclose the name, address and other particulars of the person from whom the drugs had been purchased/acquired, enclosing the attested copies of purchase invoice bill. In compliance, on 18/2/2005 Drugs Inspector (L.W.1) received a reply from L.W.2 - Pharmacist Grade-II, APHMHIDC Central Drug Stores, Government Hospital Campus, Ongole stating that they had purchased the sample drug (Atenolol Tablets IP) Batch No.4007, Mfg.5/2004, Exp.4/2007, manufactured by M/s.Zest Pharma, Indore(A.1) vide Invoice No.700 dtd. 24/6/2004 with purchase Order No.37/2K4-Q1/135D, dtd. 10/5/2004 of Managing Director, APHMHIDC, Hyderabad, dtd. 18/2/2005.

(iii) Before getting the above information, on 17/2/2005, a letter was received by the Drug Inspector(L.W.1) from M/s.Zest Pharma stating that they disagreed with the findings and the opinion of the Senior Scientific Officer and requested that the sample portion also be sent to the Central Drugs Laboratory, Calcutta for the test/analysis. On 21/2/2005 a letter was sent to A.1- Drug Manufacturing Firm by L.W.1-Drug Inspector stating that one sealed portion of the drug sample would be sent to the Central Drugs Laboratory, as requested by the Firm(A.1) and also requested to furnish (a) manufacturing records for the above subject batch drug, (b) complete sale particulars of the drug, (c) names and addresses of technical persons responsible for the manufacturing the subject drug and constitutional particulars of the Firm along with attested Xerox copies of manufacturing licence held by the Firm as required under Sec. 18-B of the Drugs and Cosmetics Act. (iv) On 13/4/2005, A.1-Firm gave a reply stating that they sent the batch manufacturing records of the subject drug and did not send constitution particulars. On 26/4/2005 the Drugs Inspector (LW1) sent another letter to M/s.Zest Pharma(A.1) requesting to pay the analysis fee.

(v) On 19/9/2005 the Drugs Inspector (LW1) produced the sealed portion of the seized drug before the learned II Additional Munsif Magistrate, Ongole, with a request to send the same to the Director, Central Drugs Laboratory, Calcutta for analysis and the said samples were received by the Court in C.P.R.No.57 of 2005 dt