The main legal point established in the judgment is the significance of timely notification under Section 25(3) and (4) of the Drugs and Cosmetics Act, and the implications of the denial of the opportunity to send the sample for analysis to the Central Drugs Laboratory.

JUDGMENT

(Prayer: This Criminal Original Petition is filed under Section 482 Cr.P.C. to call for the records of the proceedings in S.T.C.No.776 of 2015 on the file of learned Judicial Magistrate No.VII, Coimbatore and quash the complaint.)

1. This petition is filed to call for the proceedings in STC No.776 of 2015 on the file of learned Judicial Magistrate No.VII, Coimbatore and to quash the complaint

2. Respondent filed this complaint against the petitioners for the contravention of the offences under section 18(a)(i) of Drugs and Cosmetics Act, 1940 punishable under Section 27(d) of the Act. The sample of Rabtek, Rabeprazole Tablets IP (20mg) was drawn for analysis by the Deputy Inspector, Coimbatore from ESI Dispensary, Madhukarai. The sealed sample was sent to Government Analyst (Drugs), Drugs Testing Laboratory, Chennai. The test report dated 10.12.2013 declared the sample as not of standard quality for the reason that sample does not confirm to IP specification for Rabeprazole Tablets with respect to the content of cf Rabeprazole Tablets sodium (61.05%) and to the dissolution in buffer medium. The sample medicine disclosed that the subject drug was supplied by Central Medical Stores (ESIS), Coimbatore. It was informed by Central Medical Stores that the drug was acquired from M/s.Zest Pharma (first accused). The quantity purchased was 1,00,000 (One lakh) tablets under the purchase invoice No.ZT/2192 dated 30.01.2013. On 05.02.2014, a show cause memo was sent to M/s.Zest Pharma along with the third portion of the sealed sample calling for the explanation for the contravention of Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 for manufacturing and selling not of standard quality drug. The Investigating Officer sought particulars required under Section 18B of the Drugs and Cosmetics Act, 1940. On 18.03.2014, a reply was received from M/s.Zest Pharma stating that it manufactured and released for sale and distribution only after it was reported as of standard quality by their in-house quality controller. It is also stated that it has re-analysed the said drug batch from their control reference sample and found that as per IP monograph, it complies with the content of Rabeprazole sodium and also in dissolution parameter. It sent sample from it control reference sample to NABL accredited Laboratory for complete analysis as per IP. It has also informed that it has recalled and sent withdrawal letter to all the institutions to whom the drug was sold. On 30.04.2014, the Investigating Officer submitted a report requesting the matter to be referred to the concerned State Drug Controlling Authority, Madhya Pradesh for taking further action, since the manufacturing unit is situated there. On 14.05.2014, the Investigating Officer received a letter from the Director of Drugs Control calling for the proposal for prosecution against M/s.Zest Pharma. On 23.05.2014, Investigating Officer wrote a letter to the Director of Drugs Control requesting the constitution particulars of M/s.Zest Pharma and permission to go to Indore for manufacture level investigation. He received the permission on 29.05.2014. Investigating Officer along with Asok Goyal, Drug Inspector, Indore carried out inspection on 05.06.2014 at the premises of M/s.Zest Pharma at Indore. During the investigation, certified copies of the documents are produced through Jalinder Kakde. The officer of M/s.Zest Pharma informed that the product permission to manufacture and sale in respect of NSQ (Not of Standard Quality) of the said drug was withdrawn. The manufacture of Rabteck Rabeprazole Tablets IP 20 mg is not of standard quality and is in violation of 19(a) of the Drugs and Cosmetics Act, 1940. On 11.05.2014, Investigating Officer sent a detailed report to the Director of Drugs Control to get sanction to prosecute the case. Sanction was accorded by the Director of Drugs Control. Therefore, the complaint.

3. This complaint was taken cognizance by the learned Judicial Magistrate