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2025 DIGILAW 2781 (MAD)

Sensa Core Medical Instrumentation Pvt. Ltd. , rep. by its Chairman v. Tamil Nadu Medical Services Corporation Ltd.

2025-07-04

N.ANAND VENKATESH

body2025
ORDER : N.ANAND VENKATESH, J. The petitioner company has challenged the evaluation report result dated 10.5.2025 issued by the respondent pertaining to the e- tender floated on 17.8.2023 and for a consequential direction to the respondent to deal with their representations and to redo the technical evaluation of their products in the presence of the representative of the petitioner company or in the alternative, to permit them to demonstrate the products. 2. Heard the learned counsel for the petitioner company and the learned counsel appearing on behalf of the respondent. 3. The case of the petitioner is as follows : (i) The petitioner company manufactures products with the state of art technology, which includes analytical and diagnostic analyzers and the same are supplied to a large number of hospitals, pathological labs and patients. In the year 2020, the petitioner company was the successful bidder and was awarded a contract by the respondent under a scheme called as 'Makkalai Thedi Maruthuvam Scheme' to supply safety lancets and strips for glucometer and also the glucometers. Previously, the tender was awarded to the petitioner company for a period of two years and thereafter, it was extended for a period of six months. (ii) Later, the respondent issued the e-tender Notification dated 17.8.2023 for the supply of glucometers with lancets and strips. The petitioner company also submitted their bid on 08.10.2024. In the bids so submitted, apart from the petitioner company, five other companies also participated. Thereafter, the petitioner company was called upon by the respondent to produce the glucometer strips for testing and evaluation. The first testing was done from 17.12.2024 to 21.12.2024. Once again, the petitioner company was called upon for the second technical evaluation on 29.1.2025 in the Department of Biochemistry of Rajiv Gandhi Government General Hospital (RGGGH), Chennai. (iii) Finally, the bidders were called for the third technical evaluation on 21.3.2025 in the Department of Biochemistry at the Government Stanley Hospital. Thereafter, the respondent published the result of the technical evaluation report on 10.4.2025 whereby the petitioner company was disqualified as non-responsive by the respondent with the remark "deviation from the target value, which is greater than 10 (>10) and Co-efficient of Variation (CV) is greater than 5% (>5%) across various blood glucose concentration" . Aggrieved by the evaluation report dated 10.4.2025, the petitioner has approached this Court. 4. Aggrieved by the evaluation report dated 10.4.2025, the petitioner has approached this Court. 4. A counter has been filed by the respondent wherein they took the following stand : (i) the open tender was floated for fixing rate contract for the supply of glucometer with strips and lancets in two separate schedules namely glucometer with lancets and strips (low end) - schedule No.1 and glucometer with lancets and strips (high end) - schedule No.2. The technical bids were opened on 10.10.2024 and a total of five companies had participated in the tender for the low end and a total of four companies had participated for the high end. The petitioner company had participated in both the categories. (ii) The technical bids were evaluated by the Specialists from the Department of Biochemistry and the Department of Diabetology in the RGGGH, Chennai from 17.12.2024 to 21.12.2024 through sample evaluation at the Department of Biochemistry from the RGGGH, Chennai. As per the tender specification, the product should have an accuracy of +/- 10% and reproducibility of +/- 5%. The reproducibility is measured in terms of Co-efficient of Variation (CV) and the accuracy is measured in terms of difference between the mean of repeated measurements and a reference or expected value expressed as a percentage (BIAS). (iii) The respondent has tabulated the evaluation reports in both the low end and the high end categories. (iv) Ultimately, the product supplied by the petitioner company was found non-responsive due to exceeding of the threshold limits on the CV and the BIAS values in both the first evaluation and the re- evaluation. Apart from that, one more sample evaluation was carried out and as per the evaluation report dated 07.5.2025, the product of the petitioner was again found non-responsive due to exceeding of the threshold limits on the CV and the BIAS values. Therefore, the petitioner company was disqualified. (v) The evaluation was done by the external experts and the petitioner company, which had undergone the same process during the previous occasion and which was the successful bidder, never questioned the process. This time, since the petitioner company was disqualified, they have chosen to question the evaluation process. Accordingly, the respondent sought for dismissal of this writ petition. 5. (v) The evaluation was done by the external experts and the petitioner company, which had undergone the same process during the previous occasion and which was the successful bidder, never questioned the process. This time, since the petitioner company was disqualified, they have chosen to question the evaluation process. Accordingly, the respondent sought for dismissal of this writ petition. 5. This Court has carefully considered the submissions of the learned counsel on either side and perused the materials available on record and more particularly the impugned evaluation report result. 6. When the matter came up for hearing on 23.6.2025, this Court passed the following order : "Heard Mr.P.Richard Wilson, learned counsel for the petitioner and Mr. Siva Kumar, learned Standing counsel appearing on behalf of the respondent. 2. After hearing the arguments on either side, this Court wanted to understand as to whether the successful bidder viz., SD Bio Sensor had satisfied the requirement as per the tender conditions. The tender specification for the product should have an accuracy of +/- 10% (BIAS) and reproducibility +/- 5% (CV). The tender specification further states that this specification must satisfy across various blood glucose concentration. On going through the documents furnished on the side of the respondent, this Court finds that the product of the successful bidder was found with a CV of 6% at the low end and insofar as the high end is concerned, they have 5%. It is not very clear as to whether the successful bidder has satisfied the tender specification requirement and it requires proper explanation on the side of the respondent. 3. The learned Standing counsel seeks for some time. 4. Post this case on 30.06.2025 at the end of the motion list. The interim order already granted by this Court is extended till 30.06.2025." 7. When the matter was taken up for hearing on 30.6.2025, a clarification was given by the respondent by means of a small note prepared by the experts. 8. At the outset, this Court must remind itself that the matter involves a decision taken by domain experts and this Court, exercising its jurisdiction under Article 226 of The Constitution of India, cannot sit over such opinion of the experts. The law on this issue is now too well settled. 8. At the outset, this Court must remind itself that the matter involves a decision taken by domain experts and this Court, exercising its jurisdiction under Article 226 of The Constitution of India, cannot sit over such opinion of the experts. The law on this issue is now too well settled. Hence, the relief sought for in the above writ petition cannot be sustained since the petitioner company has questioned the evaluation report dated 10.5.2025, which was prepared by the experts and the details of which have been explained to this Court by way of filing a note on 30.6.2025. 9. The petitioner company had undergone the same process during the previous tender and they did not have any grievance in the earlier evaluation report that was submitted since the petitioner was the successful bidder. However, they have turned around and questioned the evaluation report in the present tender since they were not selected in the technical bid. The process and the procedure that were adopted during previous tender were followed in the present tender also and in the absence of any allegations regarding mala fides, the petitioner company cannot be permitted to turn around and question the evaluation report that has been submitted by the experts. 10. This Court, during the previous hearing, had taken into account the particulars furnished regarding the successful bidders in this tender and wanted some clarity to satisfy itself that the successful bidders had fulfilled the requirements. This is in view of the fact that the tender pertains to glucometer with strips and lancets, which are used to ascertain the glucose level in the blood and it is going to be used in the government hospitals. Hence, considering public interest, this Court wanted to satisfy itself regarding the evaluation report that was relied upon in favour of the successful bidders in the present tender. 11. During the course of hearing on 30.6.2025, for the purpose of explaining the query posed by this Court in the earlier order dated 23.6.2025, a detailed note has been presented and the experts were also present before this Court. 11. During the course of hearing on 30.6.2025, for the purpose of explaining the query posed by this Court in the earlier order dated 23.6.2025, a detailed note has been presented and the experts were also present before this Court. For proper appreciation, the note is extracted as hereunder : "Method of testing the samples : (a) Actual human blood samples from the patients having glucose level lowest to highest level will be taken and same will be tested in the samples of all the models submitted by the bidders with the same human blood samples simultaneously and the result will be noted down. The same human blood sample will be simultaneously checked in the auto analyser. The values from the auto analyser will be taken as the reference to compare the variations of the results of the samples of the glucometer of the bidders for assessment. (b) In case human blood samples are not readily available and or the bidders will be able to supply control samples (chemicals with fixed quantity of glucose concentration prefilled by the manufacturer for testing) and the results of the samples of the glucometer of the respective manufacturer will be compared with the prefixed glucose level of the control samples to arrive at the variation for assessment. (c) The threshold limit prescribed are CV (repeatability) as +/- 5% and accuracy (BIAS) as +/- 10%. When the result of samples of the glucometer are analysed, the extent of variations in CV and BIAS with respect to the above threshold limits will be taken to determine the substantial responsiveness of the strips and the instruments. (d) Further, the variations in normal level of glucose in the human blood like 80 mg/dl, minor variations beyond the threshold limits will be considered as tolerable variations and based on such tolerable variations, the product will be considered as substantially responsive to the parameter whereas the variations in higher level of glucose in the blood like 380 mg/dl, the variations are expected to be either within the threshold limit or lesser. (e) While analysing the CV and BIAS values with respect to the threshold limits, if BIAS is found lesser and within the limit, it could be considered as substantially responsive even if CV is marginally higher than the threshold limit whereas if the BIAS is higher than the threshold limit, it will be considered as non responsive even if CV is within or lesser than the limit. Glucometer with lancets and strips (low end) - Schdule No.1 : With the above points, the results indicated in our report dated 20.1.2025 for the sample evaluation of the glucometers of the bidders done at RGGGH, Chennai, the following are submitted : (i) In low level glucose (80 mg/dl), the CV of M/s.Sensa Core sample is 2% against the limit of 5% whereas the BIAS of this sample is -16% which is 6% higher than the limit of 10%. On the other hand, in case of the samples of selected bidder M/s.SD Biosensor, the CV is 6% which is exceeding only by 1% over the limit of 5% and BIAS is 6.3% which is lesser by 3.7% over the limit of 10%. Hence, the model of M/s.SD Biosensor is considered as responsive. (ii) With respect to the result of the above two models for the higher glucose level at 380 mg/dl, it may be seen that the CV of M/s.Sensa Core model is 7% which is 2% higher than the 5% limit and also the BIAS for the model is 10.6% i.e. 0.6% higher than the limit of 10% i.e both the CV and the BIAS are exceeding the limits and hence, the model is considered as non responsive. (iii) On the other hand, the results of the selected bidder M/s.SD Biosensor, the CV is only 3%, 2% lesser than the 5% limit and BIAS is only 2.3%, 7.7.% lesser than the limit of 10%. Since for the model of M/s.SD Biosensor, both CV and BIAS are much lesser than the threshold limit, it is considered as responsive. (iii) On the other hand, the results of the selected bidder M/s.SD Biosensor, the CV is only 3%, 2% lesser than the 5% limit and BIAS is only 2.3%, 7.7.% lesser than the limit of 10%. Since for the model of M/s.SD Biosensor, both CV and BIAS are much lesser than the threshold limit, it is considered as responsive. Glucometer with lancets and strips (high end) - Schedule No.2 : For the lower glucose value of 72 mg/dl of human blood samples, the CV of selected bidder M/s.Justa Medical System is 7% i.e. 2% is higher than 5% limit but the BIAS is only 1.16% which is 8.84% lesser than the 10% limit whereas in the case of M/s.Sensa Core, CV is 4% i.e. 1% lesser than the 5% limit, but the BIAs is 20.37% which is 10.37% higher than the 10% limit. Further, it may also be seen that the Schedule 2 the model of M/s. SD Biosensor, the CV value is 5%, which is within the limit but the value of BIAS is 13.6% which is 3.6% is higher than the 10% limit. Based on the above, the model of M/s.Justa Medical System has been considered as responsive due to lesser value of BIAS even though the CV is higher by 2% whereas the model of M/s.Sensa Core is considered as non responsive due to BIAS value of 20.37% even though the CV is within 5%. Similarly, the model of M/s.SD Biosensor is considered as non responsive due to higher value of BIAS at 13.6% even though the CV value is 5%. Hence, M/s.Justa Medical System was considered as responsive based on lesser BIAS value whereas the models of other two bidders are considered as non responsive due to higher BIAS. In case of glucose level of human blood of 278 mg/dl, the CV of M/s.Justa Medical System is only 3% i.e. 2% lesser than 5% limit and the BIAS is also only 6.95%, which is 3.05% lesser than 10% limit whereas in case of M/s.Sensa Core, the CV is 10% i.e. 5% higher than the 5% limit and again the BIAS is 17.99% which is 7.99% higher than 10% limit. With respect to M/s.SD Biosensor, CV value is only 3% i.e. 2% lesser but the BIAS value is 33.75%, which is 23.75% higher than 10% limit. With respect to M/s.SD Biosensor, CV value is only 3% i.e. 2% lesser but the BIAS value is 33.75%, which is 23.75% higher than 10% limit. Hence, the model of M/s.Justa Medical System was considered as responsive and that of the two other bidders as non responsive due to higher BIAS value. With respect to glucose value of human blood of 385 mg/dl for M/s.Justa Medical System, the CV is only 4% i.e. 1% lesser than 5% limit and the BIAS is also only 3.03% which is 6.97% lesser than the 10% limit. Whereas for M/s.Sensa Core, the CV is 3% i.e. 2% lesser than the 5% limit but the BIAS is 11.47% which is 1.47% higher than 10% limits. In case of M/s.SD Biosensor, the CV value is 4% which is 1% lesser than the limit of 5% but the BIAS is 14.94% which is 4.94% is higher than 10% limit. Based on the above, the product of M/s.Justa Medical System has been considered as responsive whereas that of the other two bidders as non responsive based on higher BIAS. From the above, it may be seen that the acceptance or rejection of a particular model is either based on both CV and BIAS as within the limits and in case of CV is more than the limit, the BIAS value is considered for acceptance/rejection." 12. The main ground that was raised by the learned counsel for the petitioner company is that the successful bidder namely M/s.SD Biosensor did not achieve the requisite percentage in the low end since the CV value was 6%. Similarly, M/s.Justa Medical System did not fulfill the requirement at the high end since their CV value was 7%. To substantiate this submission, he relied upon the tender qualification criteria, which mandated that the CV value cannot go beyond 5% and that the BIAS value cannot go beyond 10%. 13. In the considered view of this Court, the present evaluation report cannot be understood with the mere numbers that have been mentioned against each column and it has to be understood as a whole as is explained in the detailed note that was submitted before this Court on 30.6.2025. 13. In the considered view of this Court, the present evaluation report cannot be understood with the mere numbers that have been mentioned against each column and it has to be understood as a whole as is explained in the detailed note that was submitted before this Court on 30.6.2025. When the result of the samples of the glucometer is analysed, the extent of variation in the CV and the BIAS values with respect to the threshold limits of 5% and 10% will be taken to determine the substantial responsiveness of the strips and instruments. The experts have also taken into consideration the tolerable variations where the product will be tested if it is substantially responsive to the parameter. However, in the higher level of glucose in the blood like 380mg/decilitre, the variations are expected to be either within the threshold limit or lesser. 14. The most important criterion is that while analysing the CV and the BIAS values with respect to the threshold limits, if the BIAS value is found lesser and within the limit, it can be considered as substantially responsive even if the CV value is marginally higher than the threshold limit. 15. On the other hand, if the BIAS value is higher than the threshold limit, it will be considered as non-responsive even if the CV value is within or lesser than the limit prescribed. Therefore, just by pointing out to the CV percentage of the successful bidders, this Court cannot conclude that they have not fulfilled the requirements. How the evaluation was done and how the successful bidders were selected as responsive have been explained before this Court. Therefore, this Court is of the considered opinion that those bidders, who have cleared their technical bids, have satisfied the requirements. Even otherwise, without they being parties to this writ petition, their selection in the technical bid cannot be questioned. 16. The above discussions go far beyond the relief sought for in the above writ petition. However, this Court wanted to undertake such an exercise considering the fact that instruments are being procured for analysing blood sugar levels of poor patients, who are knocking the doors of general hospitals. Hence, apart from holding that the relief sought for by the petitioner lacks merits, this Court is also satisfied with the evaluation done by the experts for choosing the successful bidders in the technical bid. 17. Hence, apart from holding that the relief sought for by the petitioner lacks merits, this Court is also satisfied with the evaluation done by the experts for choosing the successful bidders in the technical bid. 17. For the foregoing reasons, the writ petition is dismissed. No costs. Consequently, the connected WMPs are also dismissed.