The court ruled that mandatory compliance with the statutory provisions in drug testing processes is essential; failure to do so invalidates prosecution.

JUDGMENT :

Chittaranjan Dash, J.

1. By means of this application, the Petitioners seek to invoke the inherent powers of this Court for quashing the proceedings initiated against them in connection with 2(C) CC Case No.55 of 2012 pending before the learned S.D.J.M., Sonepur, for the alleged commission of offences under Section 27 (d) of the Drugs and Cosmetics Act, 1940 .

2. The background facts of the case are that the Drugs Inspector, Subarnapur Range, Subarnapur, lodged a complaint alleging that on 22.08.2007, he collected a statutory sample of the drug “Vigizyme Liquid,” Batch No. VVZ/01, M/D: 06/07, E/D: 08/2008, manufactured by M/s Three B Health Care Ltd., Opp. Dental College, Rampur Road, Paonta Sahib (H.P.) from the sales premises of M/s New Life Medical Store, At/Po-Ullunda, District Subarnapur, through Sri Lalit Kumar Sahu, the then Drug Inspector, Bolangir Range, vide Form-17, for the purpose of test and analysis. One sealed portion of the drug sample (1 × 200 ml) was sent to the Government Analyst, State Drug Testing and Research Laboratory (SDTRI), Bhubaneswar, vide Form-18 of the Drug Inspector, Bolangir, against memorandum No.1586 dated 23.08.2007. The Government Analyst declared the above drug as “NOT OF STANDARD QUALITY” vide Form-13 of the test report.

3. As per Notification No.19110 dated 29.07.2009 issued by the Government of Orissa, Health and Family Welfare Department, the Inspector took charge of the newly created Office of the Drugs Inspector, Subarnapur Range, on 01.10.2009 along with related documents. The portion of the drug sample as required under Section 23(4)(iii) and a copy of the test report in Form-13 as required under Section 25 (2) of the Drugs and Cosmetics Act, 1940 were sent to the manufacturer, M/s Three B Health Care, Paonta Sahib, Himachal Pradesh, by registered post with A.D., vide Drugs Inspector, Bolangir Letter No.933 dated 26.07.2008. In response, the manufacturer furnished a reply vide its letter dated 22.08.2008.

4. During investigation, M/s New Life Medical Store, Ullunda, was directed, vide Drugs Inspector, Bolangir Letter No.935 dated 26.07.2008, to disclose the source of acquisition of the said drug. In response, the firm produced a self-certified copy of purchase Invoice No.364 dated 25.06.2007 of M/s Archana Enterprises, Rugudipada, District Bolangir. Subsequently, vide Drugs Inspector, Bolangir Letter No.1062 dated 14.08.2008, M/s Archana Enterprises was also directed to disclose the source of acquisition of the said drug. In response, the firm furnished a self-certified copy of purchase Invoice No.797 dated 03.07.2007 of M/s Vision Medilink, Ahmedabad. On further inquiry, vide Drugs Inspector, Bolangir Letter No.509 dated 22.04.2009, M/s Vision Medilink, Ahmedabad, was also asked to disclose the source of acquisition of the said drug. In response, the firm furnished a reply dated 08.05.2009, along with a self-attested copy of its drug license and the purchase invoice of M/s Three B Health Care, Paonta Sahib. 

The Drugs Controller, Orissa, vide Letter No.3255 dated 07.04.2009, instructed to establish the supply link between the manufacturer and the wholesaler and accordingly submit a draft prosecution report for approval. For further investigation and effective drug recall, the Drugs Inspector, Cuttack-1 Range, was directed to assist vide Letter No.809 dated 24.07.2009, and in response, a report was furnished vide her letter dated 28.08.2009. Vide Office Letter No.954 dated 05.10.2010, M/s Three B Health Care, Himachal Pradesh, was directed to furnish the Articles of Association and Memorandum of its Board of Directors under intimation to the Drugs Controller, Himachal Pradesh, vide Mem