UNICURE ( INDIA ) LIMITED Vs. STATE OF KERALA

JUDGEMENT

(1.) Petitioner is a licensed drugs manufacturer. It is stated that they have been supplying drugs to various Governments including the Government of Kerala for the last so many years. The second respondent, the Kerala Medical Services Corporation Limited (the Corporation) is the undertaking of the State Government procuring and supplying drugs to various Government Hospitals. On 18.11.2016, the Corporation invited tenders for supply of various drugs, and in response to the said invitation, the petitioner offered to supply drugs including Telmisartan Tab IP 40mg. The bid submitted by the petitioner for the said drug was accepted and on receipt of purchase order, the petitioner supplied the said drug to the Corporation.

(2.) On 26.10.2018, the petitioner was issued Ext.P2 communication by the Corporation stating that the drug, Telmisartan Tab IP 40 mg of Batch No.TSHT519 manufactured and supplied by the petitioner, was declared as "Not of Standard Quality" by the Government Analyst in the Drugs Testing Laboratory of the State Government and the Corporation has, therefore, issued directions to all District Drug Warehouses and hospitals where the said drug has been supplied, to stop the distribution/use of the same and also to transfer the remaining stock to the quarantine area. Along with Ext.P2, a copy of the Test Report of the Government Analyst referred to therein was also forwarded to the petitioner. Ext.P3 is the copy of the Test Report enclosed along with Ext.P2 communication. The petitioner sent a reply to Ext.P2 communication taking the stand that since the control sample of the drug has passed through all the prescribed parameters, the exposure of the drug to heavy moisture might have been the reason for the adverse report.

(3.) Later, on 28.12.2018, the Corporation issued Ext.P5 communication to the petitioner on the same lines of Ext.P2 communication, stating that the same drug of Batch No.TSHT515 manufactured and supplied by the petitioner was also declared as "Not of Standard Quality" by the Government Analyst in the Drugs Testing Laboratory. Ext.P6 is the Test Report enclosed along with Ext.P5 communication. The petitioner sent Ext.P7 reply to Ext.P5 communication taking the stand that the sample of the drug tested might not have been the drug manufactured and supplied by the petitioner.