AFD LABORATORIES PVT LTD Vs. UNION OF INDIA, MINISTRY OF HEALTH AND FAMILY WELFARE C/O DRUG CONTROLLER OF HEALTH SERVICES THROUGH DRUGS INSPECTOR SUB ZONE/PORT OFFICE

JUDGEMENT

(1.) The petitioners have assailed the order dated 21.07.2017 passed by the learned JMFC, Vasco, pursuant to which the learned JMFC ordered the issuance of process against the petitioners on the complaint lodged by the respondent under Section 18(i)(a) read with Section 32 of The Drugs and Cosmetics Act, 1940, (Act, for short hereinafter) by invoking the jurisdiction of this Court under Section 482 of the Cr.P.C.

(2.) It was the case of the petitioners that although allegations were made against them, the material on record did not even disclose, prima facie, any case under Sections 18(i)(a) and 27(d) of the the Act. The complaint did not contain any material allegation against the petitioners and that the summons had been issued arbitrarily and in a most perfunctory manner. The respondent had not even followed the procedure established by law in reaching the conclusion to investigate the issue regarding the drug manufactured by the company and, therefore, non following of the procedure rendered both i.e. the complaint as well as the summons issued therein without warrant or authority of law and the same were liable to be quashed. The petitioners have been involved in the process of manufacturing the subject drug Diltiazem Tablets IP (Cardem-30) i.e. the subject drug for brevity's sake from the year 2006-2007 under a loan license obtained by the petitioner no.1 and conforming to the specifications for the subject drug as per the Indian Pharmacopoeia Standards i.e. IP 2007 with only method as Modified Release. However, as per the Indian Pharmacopoeia Standards 2010, the subject drug was given to dissolution methods i.e. Method A (Modified Release) and Method B (Conventional Release) and were continued for IP 2014 as well. The petitioners from the inception and commencing the manufacturing of the said drug used to conform the drug to the Method of Modified Release as per IP 2007 i.e. Method A of Modified Release. The respondent however lodged a complaint against the petitioners herein arraying them as the accused without appreciating the facts and circumstances and the law applicable thereon on the premise that the subject drug was not conforming to the IP Standards prescribed.

(3.) The case of the respondents was that the sample of the subject drug manufactured by the petitioner no.1 was drawn from the Hospital Pharmacy of Goa Medical College for test and analysis under Section 23 of the said Act to the Government Analyst, Central Drugs Testing Laboratory Chennai. The Government Analyst of the said Laboratory found samples of the subject drug non complaint with the IP standards with respect to the tests for dissolution. The respondent informed the pharmacist at the hospital pharmacy of the subject drug not being of standard quality and requested the pharmacist to stop the sale and recall the stock and the investigation revealed that the petitioners were manufacturing the subject drug.