The main legal point established in the judgment is the scrupulous adherence to the procedural requirements of the Drugs and Cosmetics Act, particularly regarding the drawing and analysis of samples, as well as the distribution of sample portions as required by the Act.

JUDGMENT :

John Michael Cunha, J.

1. Petitioners are accused Nos. 2 and 3 in C.C. No. 103/2006 registered for the offences punishable under Sections 18(a) (i) and 27 (d) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as ‘the Act’ for brevity).

2. Heard learned counsel for the petitioners and learned Additional State Public Prosecutor appearing for the respondent.

3. The Drug Inspector, Bengaluru Circle-I lodged a private complaint under Section 200 of Cr.P.C. against seven accused persons alleging violation of Section 18(a)(i) of the Drugs and Cosmetics Act and Rules punishable under Section 27(d) of the said Act. According to the complainant, accused No. 1 is a Private Limited Company, which runs under the name and style M/s. V.V.S. Pharmaceuticals and Chemicals (P) Ltd. situated at D-125 and 128, Phase-III, IDA, Jeedimelta, Hyderabad; accused Nos. 2 and 3 are the Directors; accused No. 4 is the Managing Director; accused Nos. 5 and 6 are the Manufacturing Chemists and accused No. 7 is Analytical Chemist of accused No. 1-Company.

On 24.02.2013, Sri Shankar Jyothi, Drugs Inspector, Bengaluru Circle-I, Bengaluru, (for short ‘Drugs Inspector’) drew sample of drugs from M/s. Durga Sales Corporation and sent one portion for test analysis to the Government Analyst, Drugs Testing Laboratory, Bengaluru under Form No. 18 dated 25.02.2003. On 17.4.2003, a test report was received in Form No. 13 declaring that the drugs examined by the Analysts were "Not of Standard Quality." The Drugs Inspector addressed a letter to the Director, Drugs Control Administration, Vengal Rao Nagar, Hyderabad since the manufacturer of the referred drugs was located in their jurisdiction to take action as per the provisions under law. On 21.04.2003, Drugs Inspector sent a notice under Section 18A and 18B of the Act to M/s. Durga Sales Corporation No. 16/1, 3rd Cross, Ground Floor, Malleswaram, Bengaluru-03 (which is the new address since the firm was shifted). On 23.04.2003, Drugs Inspector sent a letter along with the copy of the test report in Form No. 13 dated 10.4.2003 to M/s. V.V.S. Pharmaceuticals and Chemicals (P) Ltd. No. D-125 & 128, Phase-III, IDA, Jeedimelta, Hyderabad. On 24.04.2003, Drugs Inspector submitted his report to the Drugs Controller for the State of Karnataka for information and necessary action. On 3.5.2003, Drugs Inspector received a letter dated 23.04.2003 from Sri. Ramadas K. Shet, proprietor of M/s. Durga Sales Corporation, No. 1, 6/1, 3rd Cross, Malleswaram, Bengaluru. In the said letter, he disclosed that the drug Lupical-500 tablets, B. No. 171022V was purchased from M/s. Hira Drug House, No. 211-214, Shankar Complex, Sultanpet Cross, Bengaluru under invoice No. 73455 dated 6.2.2003 with its copies. On 20.05.2003, Drugs Inspector received a letter addressed to the Drugs Controller for the State of Karnataka bearing No. VVS/035/2003-04, dated 10.05.2003 from Sri. Sandeep Varalwar, Executive Director of accused No. 1 requesting to re-analyze the batch in question along with the copy of the certificate of analysis report related to Lupical-500 tablets, B. No. 27023V instead of B. No. 17102V and a copy of the same was marked to the Director, Drugs Control Administration, Andhra Pradesh for information.

On 7.6.2003, Drugs Inspector served a notice under Section 25(2) and Section 23(4)(iii) of the Drugs and Cosmetics Act, 1940 and Rules thereunder to M/s. Hira Drug House, Sultapet Cross, Bengaluru along with sealed 3rd portion of the drug and original test report in Form No. 13 dated 10.04.2003 under acknowledgment in person. On 7.7.2003, Drugs Inspector addressed a letter to accused No. 1 with a request to state whether it had manufactured the said drug which was "Not of Standard Quality." Accused No. 1 failed to reply to the letter dated 7.7.2003 and also did not challenge the test report of the Lupical tablets, B. No. 17102V. On 8.9.2005, the Drugs Controller for the State of Karnataka directed the complainant to complete