THE HON’BLE SRI JUSTICE PULLA KARTHIK WRIT PETITION No.31615 of 2024

ORDER:

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

“…to issue an appropriate Writ, Order, or Direction, particularly in the nature of Writ of Mandamus:

i. To set aside the impugned Proceedings No.19/ph3/ NSQ/Sai Parentrals/2024-25 dated 06-10-2024, issued by 2^nd Respondent, blacklisting the petitioner’s product “Ceftriaxone Injection 1gm [1360] [U],” for a period of three i.e. from 23-10- 2024 to 22-10-2027, as being illegal, arbitrary, and in violation of the principles of natural justice, as well as the procedures prescribed under the Drugs and Cosmetics Act, 1940, apart from being in violation of the Tender conditions contemplated in 10 of 2023,…”

2. The case of the petitioner is that respondent No.2 issued Tender No.10/2022/MW/TSMSIDC dated 10.11.2022, for procurement of medicines under a rate contract, valid for a period of one year. In pursuance thereof, the petitioner Company participated in the tender process and was successfully declared as L1 bidder, later, executed the agreement, which was valid until 08.12.2023. While so, on 08.12.2023, respondent No.2 issued a purchase order No.1360/2K23- Q3-212/759 (10282304663) for the supply of 9,14,832 units of Ceftriaxone Injection 1gm, totaling an amount of Rs.1,51,13,074.20. Thereafter, the petitioner Company, first obtained certification from Sterile India Private Limited and supplied the medicines as requested by respondent No.2. However, the Drug Inspector, who collected the samples of the medicines, alleged that they were of substandard quality and sent them for testing by the CDSCO. Thereafter, the sample was forwarded to the Central Drugs Laboratory, Kolkata, on 19.06.2024, and after testing the sample between 05.07.2024 and 18.07.2024, the Government Analyst submitted his report dated 23.07.2024, in Form 13, under Section 25(1) of the Drugs and Cosmetics Act, 1940, which confirmed that the medicine was ‘not of standard quality’.

3. Thereafter, the petitioner immediately sent the allegedly affected batch of medicines for testing to UMED Pharma Lab, and also conducted an internal analysis themselves, wherein, no deviations, as alleged by the CDSCO and the report dated 23.07.2024, were found. However, while the things stood thus, the CDSCO sent a letter to the petitioner on 05.08.2024, directing to re-call the disputed batch of medicine from the market. Thereafter, on 08.08.2024, a show-cause notice was issued, calling the petitioner to provide an explanation as to why the disputed medicine of the petitioner Company shall not be blacklisted, in accordance with the tender conditions. In response, the petitioner submitted its reply dated 23.08.2024, through e-mail, on 26.08.2024, stating that the product has been previously tested and approved by the empanelled laboratory; indicated their intention to challenge the report in Form-13 dated 23.07.2024, and requested not to take further action until the appellate report is received. However, since the said explanation and request was not considered, the petitioner was constrained to file W.P.No.26757 of 2024, before this Court, challenging the very show-cause notice dated 08.08.2024. This Court, on 15.10.2024, granted an interim order, directing the respondents to consider the petitioner’s reply dated 23.08.2024, submitted on 26.08.2024, and to pass appropriate orders, in conformity with the principles of natural justice. The respondents were also directed not to take any coercive steps till then. However, without conducting an enquiry and without affording the petitioner an opportunity of hearing, respondent No.2 has passed the present impugned order dated 06.10.2024, blacklisting the petitioner’s product for a period of three years. Hence, the present writ petition.

4. Heard Sri Anup Koushik Karavadi, learned counsel appearing for the petitioner, learned Government Pleader for Medical and Health, on be