The failure to comply with mandatory provisions regarding sample handling and report disclosure under the Drugs and Cosmetics Act vitiates the prosecution against manufacturers, ensuring their right to a fair defense.

JUDGMENT

Amit Sharma, J.

1. The present petition under Section 482 of the Code of Criminal Procedure, 1973 (hereinafter referred to as 'CrPC`) seeks quashing of CC no. 45/04 titled 'State through K.T Raghu Kumar Drugs Inspector vs. M/s Ishwar Pharma & Ors.` and all other consequential proceedings emanating therefrom, pending before the Court of the learned Metropolitan Magistrate, Rohini, Delhi, including the order dated 06.12.2010 (hereinafter referred to as 'impugned order`) by which the learned Metropolitan Magistrate has taken cognizance of offences under Sections 18(a)(i) and 27(d) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'the Act`) and summoned the accused persons including the petitioners herein.

1.1. It is noted that by separate judgments of the same date, this Court has disposed of similar petitions filed on behalf of the petitioners herein, in relation to separate complaints filed by the respondent with respect to different batches of drugs. The facts and circumstances of the said petitions are similar to the present petition and the same contentions have been raised on behalf of the parties. Details of the said petitions are as under:

i. CRL.MC. 3424/2011 pertaining to CC No. 46/04 arising out of complaint dated 06.12.2010.

ii. CRL.MC. 4332/2011 pertaining to CC No. 46/04 arising out of complaint dated 06.12.2010.

iii. CRL.MC. 4334/2011 pertaining to CC No. 47/04 arising out of complaint dated 06.12.2010.

iv. CRL.MC. 4335/2011 pertaining to CC No. 48/04 arising out of complaint dated 06.12.2010.

Background

2. Petitioner no. 1 is the Joint Managing Director of M/s Cipla Ltd -a leading pharmaceutical company and petitioner no. 2 is its Chairman and Managing Director. The subject complaint dated 06.12.2010 was instituted at the instance of Sh. K.T. Raghu Kumar, Drugs Inspector, Drugs Control Department, Government of NCT of Delhi, seeking initiation of prosecution against the accused persons named therein, including the petitioners, for commission of offences under Sections 18(a)(i) and 27(d) of the Act. Briefly stated, the facts of the case are as under:

i. As on November 2007, M/s Cipla Ltd. (accused no. 6) was a company within the meaning of Section 34 of the Act. The drug namely, 'Ibugesic` Ibuprofen Oral Suspension B.P. (hereinafter referred to as 'the Drug`), which is a drug within the meaning of Section 3(b) of the Act was manufactured by M/s Mistair Health and Hygiene Pvt. Ltd. (accused no. 10) on the basis of a loan license granted to M/s Cipla Ltd. At the relevant point in time, petitioner no. 1 (accused no. 7) was the Joint Managing Director and petitioner no. 2 (accused no. 8) was the Chairman and Managing Director of M/s Cipla Ltd. and were in- charge of the conduct of day to day business of the said company.

ii. It was stated that on 25.06.2008, a sample of the Drug from batch no. CM 8030, Mfd. 01/08, Exp. 12/10, manufactured by M/s Cipla Ltd. was taken by the complainant for test/analysis from the premises of M/s Ishwar Pharma (accused no. 1, hereinafter referred to as 'vendor`) as per the procedure laid down in Section 23 of the Act. Intimation on Form-17 and one sealed portion of the sample was handed over to the vendor.

iii. On 26.06.2008, a portion of the sampled drug was forwarded to the government analyst, as per the procedure laid down in Rule 57 of the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as 1945 Rules`).

iv. Vide test report no. F.2/(24)/TR/DTL-314/08 dated 02.02.2009, the government analyst declared the sample as 'not of standard quality' as it did not "conform to claim as per BP with respect to test for assay (content of ibuprofen)" inasmuch as it was found to contain 33.09% of Ibuprofen as against the claim of 100 mg/5 ml.

v. On 17.02.2009, a copy of the report of the government analyst was supplied to the vendor.

vi. On further enquiry made on 18.02.2009, Mr. Nand Lal, a partner in the vendor firm informed the complainant that the said batch of the Drug was suppl