The right of the accused to challenge the Government Analyst report and the expiration of the drug's shelf life are crucial factors in determining the maintainability of proceedings under the Drugs and Cosmetics Act.

ORDER :

1. This Criminal Petition is filed under Section 482 Cr.P.C. seeking to quash the proceedings in P.R.C. No. 2 of 2015 on the file of the Additional Judicial Magistrate of First Class, Khammam. A complaint came to be filed by the Drugs Inspector, Khammam Urban (hereinafter referred to as “the complainant”) under Section 32 of the Drugs and Cosmetics Act, 1940 (for short “the Act”) against the petitioners/A-1 to A-3, for contravening the provisions of Sections 18(a)(i) read with Section 16 of the Act punishable under Section 27(d) of the Act and Section 17B(d) of the Act punishable under Section 27(c) of the Act.

2. The gist of the averments in the complaint would show that on 15.06.2019, the Assistant Director, Drugs Control Administration, Karimnagar District (hereinafter referred to as “Assistant Director”) visited the shop of G. Purna Chandra Rao (LW-2) by name M/s. Sri. Venkata Durga Pharmaceuticals, D. No. 10-2-93/1, Bus Depot Road, Khammam and lifted 200 tablets of Asek-3D, B. No. DAD-0818, Mfg. dated 01/2009, Exp. dated 06/2010, Mfg. by M/s. Everest Formulations, Solan-173211 (H.P.) for test/analysis as per the procedure laid down under Section 23 of the Act. On 16.06.2019, the Assistant Director, forwarded one sealed portion of the sampled drug to the Government Analyst, Drugs Control Laboratory, Hyderabad along with original memorandum in Form-18 through registered parcel, as per the provisions and procedures laid down under Drugs and Cosmetics Act, 1940 and Rules made thereunder, with a request to cause test or analysis of the said drug as per the standards of label claim. On 17.05.2010, the Assistant Director received the certificate of test or analysis in Form-13 in triplicate vide report No. 398/DCL/2010 from the Government Analyst and the Government Analyst declared that the drug i.e. Asek-3D tablets, B. No. DAD-0818 as of “Not of Standard Quality” for the reason that “the sample does not meet the labeled claim in respect of serratiopeptidase content found 5.0 mg. against labeled claim 10.0 mg. (limit is 9 mg. to 11 mg.)” i.e. 50% of the label claim. On the same day, the Assistant Director served a notice under Section 18-A and 22(1)(cca) of the Act to the Proprietor-cum-competent person of M/s. Sri Venkata Durga Pharmaceuticals, Khammam (LW-2), in person under acknowledgment, with a direction to disclose the source of supply and produce the registers and records of said drug along with copy of Government Analyst Report in Form-13 as required under Section 25(2) of the Act. On 26.05.2010, the Assistant Director received a reply stating that the said drug was purchased from M/s. Pravallika Medi needs, Pharmaceutical Distributors, D. No. 1-10-9/7, Sattenapalli Road, Narsaraopet, Guntur District vide Invoice Nos. VS 587, dated 11-04-2009, VS 2911, dated 08.06.2009 and VS 3906 dated 02.07.2009. It is also stated that they were not having stocks of the said drug and also with retailers to whom they have supplied. On the same day, the Assistant Director forwarded a notice under Section 18-A and 22(1)(cca) of the Act to M/s. Pravallika Medi Needs, Narsaraopet, Guntur District, by registered post, to disclose the source of supply of the said drug along with copy of Form-13 and one sealed sampled drug portion as required under Section 23(4)(iii) of the Act and further instructed not to sell the said drug since it is declared as of “Not of Standard Quality” and instructed to call back the stock sold. On 07.06.2010, the Assistant Director received reply from M/s. Pravallika Medi Needs, Narsaraopet, Guntur District, stating that the said drug was purchased from M/s. De-Cross Labs (India) Private Limited, D. No. 2-4-80/4, Medical Complex, Rajagarikota, Narsaraopet, Guntur District, vide Invoice No. DCL 78, dated 20.02.2009. They also stated that they were not having stock of the said drug. On the same day, the Assistant Director forwarded a notice under Section 18-A and 22(1)(cca) of the Act to M/s. De-Cross Labs (India)