IMPORTANT POINTS
(1) Seizure of drug of sub-standard quality – A person cannot be made liable unless, at material time, he was incharge of and was also responsible to company for conduct of its business – There is no universal rule that a Director of a company is in charge of its everyday affairs.
(2) Order of issuance of process is not an empty formality – Magistrate is required to apply his mind as to whether sufficient ground for proceeding exists in the case or not.

JUDGMENT :

B.R. Gavai, J.

1. Leave granted.

2. This appeal arises out of the judgment and order dated 25th June 2015 passed by the learned Single Judge of the High Court of Judicature of Bombay, at Aurangabad, in Criminal Writ Petition No.288 of 2015, thereby dismissing the said criminal writ petition filed by the appellants herein and upholding the order of issuance of process dated 30th March 2009 passed by the learned Chief Judicial Magistrate, Beed (hereinafter referred to as “the learned CJM”) and the order passed by the learned Sessions Judge, Beed dated 25th November 2014 dismissing the Criminal Revision being Criminal Revision Petition No.115 of 2013 filed by the appellants thereagainst.

3. The facts, in brief, giving rise to the present appeal are as under:

3.1 The Appellants are the Directors of M/s Cachet Pharmaceuticals Private Ltd. (hereinafter referred to as “CPPL”). CPPL was granted permission to manufacture ‘Hemfer Syrup’ which falls under Schedule C & C(1) to the Drugs & Cosmetics Rules, 1945 (hereinafter referred to as “the said Rules”).

3.2 On 30th August 2006, Sh. N.A. Yadav, the then Drugs Inspector, Food and Drugs Administration, Beed, Maharashtra, visited the premises of M/s. Priya Agencies at Beed and purchased ‘Hemfer Syrup’, from which he had drawn samples of the drug. On 31st August 2006, he sent one such sample to the Government Analyst, Maharashtra State Drug Control Laboratory Mumbai so as to have the drug tested. On 26th February 2007, he received a test report dated 13th February 2007 from the Government Analyst stating that the sample was not of standard quality as the content of Cyanocobalamin was less than the permissible limit, i.e., 39% of the label amount. On the same day, the manufacturer of the drug, i.e., CPPL, was informed by a registered post about the test report.

3.3 On 29th March 2007, Sh. Vijay Jain, Deputy Manager, QA of CPPL requested the Drug Inspector to send the samples again for analysis. Pursuant to an application filed by M/s Alkem Laboratories, the distributor of CPPL, the learned CJM, Beed sent the samples of ‘Hemfer Syrup’ for re-analysis on 24th April 2007. On 10th July 2007, the Learned CJM, Beed received the test report from the Central Drug Laboratory, Calcutta stating therein that the sample was not of standard quality as it did not conform to the accepted limits of Cyanocobalamin content.

3.4 Vide letter dated 21st August 2008, the Drug Inspector called upon CPPL to furnish the particulars of Directors, Articles of Association, Memorandum of Association, copies of License to manufacture and sell drugs, particulars of technical persons, and all such information as was needed to be provided under the Drugs & Cosmetics Act, 1940 (hereinafter referred to as “the said Act”). In reply to this letter, CPPL informed the Drug Inspector that the report dated 10th July 2007 was signed by “In-Charge Director” and not the Director of Central Drugs Laboratory and thus requested him to send a proper report signed by the Director of the Central Drugs Laboratory.

3.5 Vide letter dated 12th January 2009, the Drug Inspector again called upon CPPL to furnish particulars that were previously sought. Vide letter dated 12th February 2009, CPPL provided the information and documents requested by the Drug Inspector and it was categorically stated therein that the ‘Hemfer Syrup’ was manufactured under the supervision and technical guidance of Sh. Ashok Kumar, the FDA approved manufacturing chemist for liquid orals.

3.6 Mr. Ashok Kumar (Accused No. 9) wrote an individual letter dated 13th February 2009 to the Drug Inspector stating therein that the said batch of ‘Hemfer Syrup’ was manufactured under his supervision and that the drug complied with the requisite standards. Similarly, Mr. Naresh Roy (Accused No. 10) also wrote a letter dated 13th February 2009 to the Drug Inspector stating therein that the said batch of the ‘Hemfer Syrup’ was tested under his supervision and from the test results it app