Telangana High Court
Suzikem Drugs Private Ltd. vs The State Of Telangana on 15 July, 2022
Author: B. Vijaysen Reddy
Bench: B. Vijaysen Reddy
THE HON'BLE SRI JUSTICE B. VIJAYSEN REDDY
WRIT PETITION No.24009 OF 2022
ORDER:
Heard learned counsel for the petitioner, learned Government Pleader for Medical & Health appearing for respondent Nos.1, 3 and 4 and Mr. P. Kishore Rao, learned Standing Counsel appearing for respondent No.2.
2. This writ petition is filed to declare the action of the 2nd respondent in passing orders dated 11.05.2022 vide letter No.08/ph3/QC/GM/Suzikem/NSQ/2022-22/431, blacklisting the petitioner's product namely "Telmisartan Tablet 40 mg (1964) (U)"
for a period of three years from 11.05.2022 to 10.05.2025, without considering the explanation of the petitioner firm and also the report issued by the Drugs Control Administration (DCA), dated 15.03.2021, whereunder the said product has been declared as of 'Standard Quality', as being illegal, arbitrary and consequently to set aside the impugned order.
3. The petitioner firm was registered with Government of Telangana and had been supplying medicines to the 2nd respondent- Managing Director, Telangana State Medical Services & Infrastructure Development Corporation. Pursuant to e-tender notification No.3(A)/TSMSIDC/MW/Medicines/2019 dated BVR,J 2 WP.No.24009_2022 24.09.2019 issued for supply of medicines to the Government Hospitals, Primary Health Centres in Telangana State, the petitioner submitted tender and was declared as successful bidder. In respect of the product "Telmisartan Tablet 40 mg (1964) (U)" of the petitioner firm, the 4th respondent -Drugs Inspector, Jagityal sent a sample to the 3rd respondent - Government Analyst, DCA, seeking opinion with regard to the quality of the said product by conducting lab analysis. The said sample was received by the 3rd respondent on 02.12.2020. After conducting lab analysis, the 3rd respondent sent analysis report to the 4th respondent on 18.01.2021, declaring the sample sent for analysis as 'Not of Standard Quality'. In pursuance thereof, the 2nd respondent issued show-cause notice dated 22.02.2021 to the petitioner calling for explanation as to why the product "Telmisartan Tablet 40 mg (1964) (U)" should not be blacklisted. On verification of the report dated 18.01.2021, the petitioner requested the Drugs Inspector, Malkajgiri, to send the said sample for re-testing and, accordingly, the same was sent to the Drugs Control Laboratory (DCL), Hyderabad, for analysis. Thereafter, the 3rd respondent issued a report dated 15.03.2021 declaring the subject sample of the petitioner as of 'Standard Quality'. The petitioner submitted explanation to the 2nd BVR,J 3 WP.No.24009_2022 respondent on 15.03.2021 enclosing a copy of the report dated 15.03.2021 and requested the 2nd respondent not to blacklist the said product. The explanation of the petitioner was received by the 2nd respondent on 25.03.2021.
4. The grievance of the petitioner is that despite the report dated 15.03.2021 issued by the 3rd respondent declaring the product as of 'Standard Quality', all of a sudden, the 2nd respondent passed the impugned order, dated 11.05.2022, blacklisting the product "Telmisartan Tablet 40 mg (1964) (U)" for a period of three years from 11.05.2022 to 10.05.2025.
5. Learned counsel for the petitioner submitted that the impugned order is in violation of the terms and conditions of the tender notification dated 24.09.2019. Learned counsel has referred to clause 12.07 of the said notification which prescribes the procedure for blacklisting of an item. Learned counsel further contended that as per the said clause, if supplier challenges the report issued by the concerned DCL and requests for re-testing the sample, the sample shall be tested at Government DCL or reputed Government Institute like National Institute of Pharmaceutical Education and Research (NIPER) and the test report of DCL or NIPER will be final and will be binding on the supplier.
BVR,J 4 WP.No.24009_2022
6. On the other hand, Mr. P. Kishore Rao, learned Standing Counsel appearing for respondent No.2, submitted that as there was variation in two reports, clarification was sought by respondent No.2 from the Joint Director, DCA, who, vide his letter dated 02.05.2022, clarified that the possibility of two different test reports i.e., Standard & Not of Standard from a batch cannot be ruled out in case of a non-homogenous batch due to poor GMP practices by the manufacturer/ lack of adequate stability data in the container-closure system intended for marketing of the subject product and, finally, opined that the report dated 18.01.2021 of the 3rd respondent declaring the subject drug as 'Not of Standard Quality' shall be considered in this case. Acting upon such opinion of the Joint Director, the impugned blacklisting orders have been issued against the petitioner firm.
7. Clause 12.07 of the terms and conditions of the e-tender notification dated 24.09.2019 provides for the procedure to be adopted for blacklisting of an item. As per the said clause, the supplier had a chance of requesting for re-testing the sample at Government DCL or NIPER. In case of conflict in two analysis reports, the test report of DCL or NIPER will be final. By report dated 15.03.2021, the product of the petitioner was held to be of BVR,J 5 WP.No.24009_2022 'Standard Quality'. When the tender conditions provide for a particular procedure to be followed, the question of again taking the opinion of the Joint Director would not arise. It is also not in dispute that the report dated 15.03.2021 is issued by DCL which is a Government Laboratory and the same is in favour of the petitioner. Therefore, the action of the 2nd respondent in accepting the earlier report dated 18.01.2021 of the 3rd respondent in preference to the subsequent report dated 15.03.2021 issued by the very same authority is arbitrary and unreasonable and, as pointed out above, is contrary to the terms and conditions of the tender document, more particularly clause 12.7 therein.
8. In view of the above observations, the writ petition is allowed setting aside the impugned orders dated 11.05.2022 passed by the 2nd respondent vide letter No.08/ph3/QC/GM/Suzikem/ NSQ/2022-22/431, and all consequential proceedings initiated pursuant to the impugned orders shall be withdrawn forthwith. No order as to costs.
Pending miscellaneous petitions, if any, shall stand closed.
______________________ B. VIJAYSEN REDDY, J 15-07-2022 vv