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1. 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.

24. Furthermore, the contention of the learned CGSC that a complaint could not be filed without obtaining an authorisation in writing cannot be accepted. Chapter IV of the Drugs and Cosmetics Act, 1940 deals with manufacture, sale and distribution of drugs and cosmetics. Section 32 of the Drugs and Cosmetics Act, 1940, which provides for cognizance of offences reads as under:

"32 Cognizance of offences. -- [(1) No prosecution under this Chapter shall be instituted except by--

25. A perusal of Section 32 of the Drugs and Cosmetics Act, 1940 shows that prosecution can be instituted by an Inspector or by any gazetted officer of the Central Government or a State Government authorised in writing in this behalf by the Central Government or a State Government by a general or special order made in this behalf by that Government or the person aggrieved or a recognised consumer association whether such person is a member of that association or not. This Section stipulates that sanction has to be obtained under Chapter (IV) of the Drugs and Cosmetics Act, 1940. Admittedly, the petitioner is accused of an offence covered under Chapter (IV) of the Drugs and Cosmetics Act, 1940. Section 32 of the Drugs and Cosmetics Act, 1940 only stipulates as to who is authorised to file a complaint. The complaint in this case is filed by Inspector whose authorisation is not required. Section 32 of the Drugs and Cosmetics Act, 1940 does not require sanction to be obtained from the competent authority for filing the complaint.

26. Chapter IVA of the Drugs and Cosmetics Act, 1940 lays down the provisions relating to Ayurvedic, Siddha and Unani drugs. Section 33M of the Drugs and Cosmetics Act, 1940 which deals with offences falling under chapter IVA of the Drugs and Cosmetics Act, 1940 reads as under:

"33M. Cognizance of offences.--

(1) No prosecution under this Chapter shall be instituted except by an Inspector 1[with the previous sanction of the authority specified under sub-section (4) of section 33G].