JUDGMENT

Subramonium Prasad, J. - These writ petitions under Article 226/227 of the Constitution of India have been filed for quashing of summoning orders dated 30.09.2019 and 13.01.2020 as well as Order dated 16.01.2021, issuing notice against the petitioner, and for quashing of Criminal Complaint being CC No. 16817/2019.

2. The facts, in brief, leading to the present case are as follows:-

i. It is stated that in June 2015, the Petitioner Company manufactured the drug Combiflam, i.e. Batch No. A150682 (hereinafter, "batch in question") and a test analysis result of this batch was conducted by Shagun Testing Laboratories as well as Devansh Testing & Research Laboratory Pvt. Ltd., both being contracted labs for the Government Medical Store Depot, New Delhi. It is stated that both were found to be duly complying with the Disintegration Test parameters. Both the laboratories termed Batch No. A150682 as "Standard Quality".

ii. It is stated that on 24.02.2016, a sample of the same batch was drawn by the then Drug Inspector, Central Drug Standards Control Organisation (CDSCO) North Zone, Ghaziabad, for testing analysis. The sample portion was sent to Government Analyst, Regional Drugs Testing Lab, Chandigarh for testing and analysis as well.

iii. On 06.04.2016, vide test report of the Government Analyst, the sample was termed as "Not of Standard Quality". It is stated that the sample had been tested as per the old method of analysis in Indian Pharmacopeia.

iv. On 03.05.2016, a Show Cause Notice (hereinafter, "SCN") was issued by the Drug Inspector under Section 18A and 18B of the Drugs and Cosmetics Act, 1940 to the Chief Medical Officer, CGHS Wellness Centre, Pragati Vihar, Delhi-58, directing them to stop usage/distribution and to disclose the name/address of the firm/person from whom the drug had been obtained. The Drug Inspector, CDSCO, also sent an SCN under Section 18A and 18B of Drugs and Cosmetics Act, 1940, along with the test report. An SCN was also sent to the Petitioner-Company along with the test report, but the same was without the sealed sample portion.

v. On 28.05.2016, the Petitioner-Company filed a response to the SCN dated 03.05.2016 informing CDSCO that the SCN had been issued without any sealed sample portion. Further, the response stated that a recalling process of the batch in question had already been initiated and that the probable root cause for the failure in the Disintegration Test could be related to storage conditions in the market as well as formulation aspects. It was further stated that the Petitioner-Company would implement corrective measures in order to avoid such issues in the future.

vi. On 05.07.2016, the Food and Drugs Control Administration (FDCA) sent an SCN to Petitioner No.1 in W.P. (Crl.) 645/2021 with respect to same batch and it was issued without any sealed sample portion. In response to this SCN, the Petitioner-Company filed a reply dated 19.07.2016 wherein it informed FDCA that it had received a similar notice from CDSCO and it had already initiated the recall process of the batch in question.

vii. Thereafter on 23.08.2016, the Petitioner-Company issued a recall closure letter to CDSCO wherein it informed them that it had duly recalled all the samples of the batch in question. A similar recall closure letter was issued to FDCA.

viii. It is stated that on 22.03.2017, a License Suspension Order was issued by the FDCA against the Petitioner-Company for three days, i.e. from 24.04.2017 to 26.04.2017, under Rule 85(2) of the Drugs and Cosmetics Rules, 1945.

ix. It is stated that on 31.12.2017, Managing Director ,i.e. Petitioner No.1 in W.P.(CRL) 646/2021, ceased to be Managing Director of the petitioner/company.

x. Pursuant to the suspension order, on 11.04.2018, the Deputy Drugs Controller (I), CDSCO, Ghaziabad, requested the Deputy Drugs Controller, Ahmadabad to conduct an investigation at the premises of the Petitioner-Company.

xi. In May 2018, the batch in question expired. It is stated that on 06