The court's decision emphasized the importance of considering the actual quality of the product, the timing of the launch of prosecution, and the availability of administrative measures for minor defects under the Drugs and Cosmetics Act.

JUDGMENT :

1. By way of this present application under Article 226 and 227 of the Constitution of India and under section 482 of the Code of Criminal Procedure 1973, the writ applicants herein have prayed for quashing and setting aside the complaint being Criminal Case No. 4547 of 2015 lodged by the respondent No. 2 before the Chief Judicial Magistrate Court, Viramgam for alleged offences under section 16(1)(a), 18(1)(i) r/w section 34 and punishable under section 27 of the Drugs and Cosmetics Act, 1940 and the order passed by the learned Chief Judicial Magistrate, Viramgam issuing summons to the petitioners.

2. The facts giving rise to the filing of the present petition reads as under:-

2.1 The petitioner No. 1 is a company incorporated under the provisions of Company’s Act, 1956 and is engaged in the manufacturing and sale of Soda Ash, Linear Alkaline Benzene, Soaps and Detergents and Cement at various locations in the State of Gujarat and in India.

2.2 The petitioner No. 1 was also engaged in manufacturing drugs and pharmaceuticals at village Sachana Taluka Viramgam, Gujarat. The petitioner No. 2 is the accused No. 2 in the complaint being Criminal Case No. 4547 of 2015 and is the Managing Director of petitioner No. 1 – Company.

2.3 The petitioner No. 1 was manufacturing drugs and pharmaceutical products under a license bearing No. G/28/1221 granted by the Food and Drugs Control Administration, Gujarat to manufacture for sale (or for distribution) of drugs specified in Schedule thereto for a period of 5 years from 20.06.2006 to 19.06.2011. The same came to renewed on 29.12.2011 for a period of another 5 years from 20.06.2011 to 19.06.2016.

2.4 The petitioner No. 1 was manufacturing Ceftriaxone and Sulbactam for Injection 1.5 gm with Sterile Water for injection in combi-pack sold under brand Nirixone-S. The same was also added in the list of approved produces as per the Form-28 after issuance of license. The Healthcare Division of petitioner No. 1 was demerged and transferred into Aculife Healthcare Private Limited vide order of this Court dated 20.04.2015. After the demerger of the Healthcare Division, the license under Form 8 dated 29.12.2011 was canceled on 05.10.2015 by Food and Drugs Control Administration, Gujarat and pursuant to which the petitioner stopped manufacturing Drugs and Pharmaceutical products.

2.5 The impugned complaint came to be filed against the writ applicants by the respondent No. 2 on 02.11.2015. It is stated that before or after the impugned complaint filed by the respondent No. 2 – Drug Inspector being Criminal Case No. 4547 of 2015, there is no such incident which had occurred after the strict warning given by the Food and Drugs Control Department, Gujarat vide letter dated 03.10.2015.

3. It is the case of the complainant – respondent No. 2 that the accused No. 1 manufactured drugs not of standard quality being Nirixone-S (Ceftriaxone and Sulbactam for injection) B. No. 6C30037, D/M. 03/2013, D/ E. 02/2015 along with Sterile Water for Injection Batch No. 7501978, D/M. 08/2012, D/E-07/2017 Manufactured by M/s Nirma Limited (Healthcare Division) Sachana Gujarat. It is also the case of the complainant that the accused No. 1 had supplied the said batch of drug as per the list submitted. The samples of the aforesaid drugs along with the other samples were drawn by Shri Virendra Singh, Drugs Inspector on 28.09.2013 from the custody of Mr. Deepak Bhatt – accused No. 3 under the provisions of Drugs and Cosmetics Act. The said collected drug were divided into three equal portions (under section 23 of the Act) and it was effectively sealed packed and suitably marked. The intimation in writing was duly filled up relevant Form No. 17 and Form No. 17-A along with one sealed potions of the sample which was handed over to accused No. 3 and the same was acknowledged and signed. Out of the two samples which were retained by Shri Virendra Singh – Drug Inspector one portion of sealed sample was sent for test/analysis