THE HON’BLE SRI JUSTICE E.V. VENUGOPAL WRIT PETITION No.7057 OF 2025

O R D E R:

This Writ Petition is filed under Article 226 of Constitution of India seeking the following relief/s:-

“… to pass an order, or writ particularly one in the nature of writ of mandamus a) Declaring the seizure Proceedings No.Rc.02/NRKR/DI/SRD/S2/2025 dated 20-02-2025 as illegal, without jurisdiction and ultra vires the Drugs and Cosmetics Act and the Constitution of India b) Consequently direct the release of the seized goods c) Direct the payment of compensation as this Hon’ble Court deems fit and pass such other and further orders …”

2. Heard Mr.Akella Sreenivasa Rao, learned counsel for the petitioner, learned Assistant Government Pleader for Medical and Health appearing for respondent Nos.1 to 3.

3. The brief facts of the case are that the Petitioner is the Managing Partner of M/s.Prosafe Biologicals LLP Company, which was registered as a Limited Liability Partnership firm and manufacturing food supplements from the year 2018 onwards. It is stated that the main ingredients of the food supplements are the Probiotic Bacillus Clausii, duly recognized under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 under Schedule VII but not ‘drug’ as defined under Section 3(b) of the Drugs and Cosmetics Act, 1940. It is stated that the license dated 14-12-2020 is issued by respondent No.4, FSSAI bearing License No.10018047000943, which was extended on 12-01-2025. It is further stated that on 20.02.2025, respondent Nos.2 and 3 came to the premises of the Company along with anti-social elements, within any notice and claimed that the petitioner was manufacturing drugs. Upon inspection, no drugs were found but, respondent No.2 had seized the following goods:-

(i) Bacillus Clausii Gutwell (Quantity – 4988 of 5 ml vials);

(ii) Bacillus Clausii Bakteriya shtammining polirezistent sporalari (Quantity – 5988 of 5 ml vials) and initiated proceedings under the Drugs and Cosmetics Act.

4. It is further stated that respondent No.2/Drug Inspector conducted seizure panchanama and issued notice dated 20-02-2025; that the respondents have no jurisdiction in this matter as there is no “drug” involved in the Company premises and the two items are the Food Supplements as mentioned in the license. Aggrieved by the impugned proceedings dated 20-02-

2025 the petitioner filed the present Writ Petition.

5. Learned counsel for the petitioner submits that the seized products are food with added probiotics and not ‘drugs’; that the seized items are perishable and sensitive goods; that they must be stored in a temperature controlled environment under 15-25 Degrees Celsius; that if the seizure continues, they will become junk/garbage. He states that the products are stocked in Company premises for delivery to Uzbekistan which should commence within a week. Stating thus, he seeks to allow the Writ Petition.

6. On the other hand, learned Assistant Government Pleader submits that the petitioner had already surrendered his license and hence, he is not authorized to manufacture the said drugs. She further states that as per the ‘Central Drugs Standard Control Organisation’, the name of the seized substance is, ‘Bacillus Calusii Spores suspension (2billion/5 ml vial) and it is a drug used for the treatment of the ‘alteration of intestinal bacterial flora’.

7. She further submits that the seized substance was sent to the Government Analyst, Drugs Control Laboratory and the report disclosed that the composition of the said substance is “Bacillus Clausii Spores”, which is a drug as defined under Section 3(b) of the Drugs and Cosmetics Act. For better understanding Section 3(b) of the Drugs and Cosmetics Act, 1940 is extracted as hereunder:-

Section 3(b) The Drugs And Cosmetics Act, 1940 Section 3(b) “drug” includes—(i) all medicines for internal or external use of human beings