EVEREST FORMULATION Vs. STATE OF A.P.

JUDGEMENT

(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 I-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 17 B (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. dt. 01/2009, Exp.dt: 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 Analysit 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) Limited, Narsaraopet, Guntur District, by registered post, to disclose the source of supply of the said drug and further instructed not to sell the drug since it is declared as of "Not of Standard Quality" and instructed to call back the stock sold. On 22.06.2010, the Assistant Director received reply from M/s. De-Cross Labs (India) Private Limited, Narsaraopet, Guntur District, stating that the said drug was purchased from accused No.1 vide Tax Invoice No.786, dated 30.01.2009. They also stated that they were not having stocks of the said drug. On the same day, the Assistant Director, forwarded notice under Section 18-B and 22 (1) (cca) of the Act to accused No.1, by registered post, with an instruction to confirm the manufacture and sale of the said drug and produce information regarding the manufacturing records, analytical records and distribution particulars and also instructed to produce attested photo copies of Drug Licences, name and address of the responsible person of the firm. On 09.07.2010, the Assistant Director received reply from accused No.1, stating that they would like to challenge the Government Analyst report as per Section 25 (4) of the Act and requested to send the said sample to Central Drugs Laboratory, Kolkata.

(3.) It is also stated in the complaint that as per the provisions of Section 25 (3) of the Act, "Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence to the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken or the person whose name, address and other particulars have been disclosed under Section 18-A of the Act has, within twenty eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in contravention of the report". The person from whom the sample was taken or the person whose name, address and other particulars have been disclosed under Section 18-A of the Act were not challenged the Government Analyst report, where as the manufacturer challenged the Government Analyst report after the twenty eight days from the date of receipt of a copy of Government Analyst report along with one sealed sampled drug portion by the person whose name, address and other particulars have been disclosed under Section 18-A of the Act. It is also stated that as per Section 18 (a) (i) of the Act "No person shall himself or by any other person on his behalf, manufacture for sale or for distribution, or for sell, or stock or exhibit or offer for sale, or distribute any drug which is Not of Standard Quality, or is Misbranded, Adulterated or Spurious". Thus, the petitioners/A1 to A3 are responsible for manufacturing of "Not of Standard Quality" drug ie. Asek-3D Tablets, B.No.DAD-0818, Mfg. dt. 01/2019, Exp.dt: 06/2010. Hence, violated Section 18 (a) (i) read with Section 16 of the Act, punishable under Section 27 (d) of the Act. As per Section 17-B(d) of the Act "A drug shall be deemed to be spurious, if it has been substituted wholly or in part by another drug or substance". Thus, the petitioners/A1 to A3 have violated this provision by manufacturing the above drug by substituting wholly or in part by another drug or substance, because the content of Serratiopeptidase is only 50% of the labeled claim, hence, punishable under Section 27 (c) of the Act. Basing on the above allegations a complaint came to be filed. By an order dated 03.01.2015, the learned I Additional Judicial Magistrate of First Class, Khammam, has taken cognizance of the complaint against the petitioners/A1 to A3 for the offences punishable under Sections 27 (d) and Section 27 (c) of the Act; registered as P.R.C.No.2 of 2015 and ordered for issuance of summons to the petitioners/ A1 to A3. Challenging the said order, the petitioners/A1 to A3 filed the present Criminal Petition.