Point of Law: Act provides furnishing of the copy of the government analyst report by the Drug Inspector alone. Initiating any other action, by any of the officer of the Food and Drugs Administration will not be presumed to be compliance under sub-section (2) of Section 25 of the Act.

JUDGMENT :

Umesh Trivedi, J.

1. Since common question of law is involved in both these matters, they are being disposed of together by this common judgment.

2. The question of law raised in these applications is concerning about the valuable right of the accused, as envisaged under Section 25(4) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Act"), requesting the Court to send the sample of drug produced before it to the Central Drugs Laboratory, where the complaint against the accused is filed much after the shelf life of the sample expired.

Facts of Special Criminal Application No. 2985 of 2017

3. In this case, the petitioners as Directors of one M/s. Divine Life Care Pvt. Ltd., Ahmedabad along with the Company itself prosecuted for manufacturing of a Drug named "Rabivin-20 Tablets" found to be spurious Drugs making them liable for prosecution under Sections 18(a)(i), 18(a)(vi) punishable under Section 27 of the Act. One Mr. L.R. Patel, Drug Inspector, empowered under the Act to act as Drug Inspector in the Ahemedbad City, took a sample of aforesaid tablets from M/s. Clavin Life Sciences, Naroda, Ahmedabad for the purpose of test by Government Analyst after following the due procedure prescribed under the Act and Drugs and Cosmetics Rules, 1945 (hereinafter referred to as "the Rules"). The said sample was drawn on 13.02.2014 and sent for the purpose of analysis to the Government Analyst, Vadodara on 21.02.2014.

The Government Analyst, Vadodara vide its report dated 07.10.2014 declared the sample of drug to be spurious as the sample did not indicate the presence of Rabeprazole Sodium.

4. The Drug Inspector on 17.10.2014 received the said report from Government Analyst, Vadodara. Therefore, in compliance with the provisions of the Act, a copy of Government Analyst's report was sent to M/s. Clavin Life Sciences vide letter dated 17.10.2014 as the sample was drawn from it demanding details about the purchase of the said drugs. Since till 13.11.2014 M/s. Clavin Life Sciences, from whom sample was drawn, did not respond, the complainant - Drug Inspector personally visited it. On inquiry from the person in charge of M/s. Clavin Life Sciences, it was revealed that it has been purchased from M/s. Divine Life Care Pvt. Ltd., on 22.02.2013 in bulk and evidencing the same, it produced purchase bill.

5. Therefore vide letter dated 14.11.2014 M/s. Divine Life Care Pvt. Ltd., who happens to be a Manufacturer of the Drugs in question, provided with one sealed pack sample along with original copy of Government Analyst Report under Sections 23(4)(iii) and 25(2) of the Act respectively through Registered Post A.D. It is averred in the complaint that Drug Inspector-original complainant received the said Registered Post A.D. on 28.11.2014 returned back as the premises found closed. Therefore, the complainant - Drug Inspector on 4.12.2014 obtained the telephone number of the Directors of M/s. Divine Life Care Pvt. Ltd., which is available in the records of the Head Office, informed him about the report as also the sealed pack sample drawn and asked applicant No. 1 to get it from the office of the Drug Inspector. Pursuant thereto, the petitioner No. 1 herein - Rajesh Ramanlal Shah as Director of Manufacturer Company being M/s. Divine Life Care Pvt. Ltd., visited the office of Drug Inspector - complainant on that very day i.e. 04.12.2014 and obtained the original test report and one sealed pack sample and passed on the receipt thereof.

6. It is further averred in the complaint that the Manufacturer being M/s. Divine Life Care Private Limited vide its letter dated 28.12.2014 represented that they do not agree with the report of the Government Analyst, Vadodara and they intend to challenge the test report. Therefore, vide letter dated 05.01.2015, the Drug Inspector-complainant informed the accused, which includes the petitioners along with manufacturer Company, that if they do not agree with the test report of Government Analyst, Vadoda