IN THE HIGH COURT OF MADRAS
Amreshwar Pratap Sahi, Senthilkumar Ramamoorthy, JJ.
The Chairman, Tamil Nadu Medical Services Corporation Ltd. and Ors. – Appellants
Versus
Jackson Laboratories Private Limited and Ors. – Respondents
W.A. No. 593 of 2020 and C.M.P. No. 8303 of 2020
Decided On : 23-09-2020
Drugs and Cosmetics Act, 1940 - Section 17B - Supply of a spurious drug - Order of black listing - Carbimazole Tablets - Appeal - Appellants are a Government of Tamil Nadu undertaking which is engaged in procurement and supply of drugs and medical equipment to Government Hospitals in State of Tamil Nadu. Pursuant to purchase orders issued to first Respondent herein, first Respondent supplied Carbimazole Tablets I.P. 5 mg. during period 2016 - 2017 - Upon testing, Appellants found that specific batches of aforesaid tablets were not of standard quality. Therefore, a show cause notice was issued to first Respondent - By show cause notice, first Respondent was informed that, as regards Batch, a survey sample was drawn by the Central Drugs Inspector and by testing said survey sample, it was reported that drug is of spurious quality by Central Drugs Testing Laboratory - Held, Court find that learned Judge has relied upon a report from the Central Drugs Laboratory, Kolkata, which is stated to have concluded that drugs were not spurious - Learned counsel for Appellants contended that this report was not made available by first Respondent to Appellants - Accordingly, we permit first Respondent to submit a representation to Appellants within two weeks from date of receipt of a web copy of this judgment requesting for reconsideration of order of blacklisting of first Respondent in light of subsequent developments, including subsequent reports from the Central Drugs Laboratory and other material factors, if any - Directions issued - Writ Appeal is disposed of.
JUDGMENT :
Senthilkumar Ramamoorthy, J.
1. The subject matter of this writ appeal is the order of black listing dated 12.12.2017 whereby the first Respondent herein was black listed for a period of five years from 05.12.2017 to 04.12.2022 for the supply of a spurious drug, namely, specific batches of Carbimazole tablets I.P. 5 mg. The Appellant is the Tamil Nadu Medical Services Corporation Limited which issued the blacklisting order.
2. The facts and circumstances related to the filing of this appeal are as follows. The Appellants are a Government of Tamil Nadu undertaking which is engaged in the procurement and supply of drugs and medical equipment to Government Hospitals in the State of Tamil Nadu. Pursuant to purchase orders issued to the first Respondent herein, the first Respondent supplied Carbimazole Tablets I.P. 5 mg. during the period 2016 - 2017. Upon testing, the Appellants found that specific batches of the aforesaid tablets were not of standard quality. Therefore, a show cause notice dated 02.08.2017 was issued to the first Respondent. By the show cause notice, the first Respondent was informed that, as regards Batch No. T-12701, a survey sample was drawn by the Central Drugs Inspector and by testing the said survey sample, it was reported that the drug is of spurious quality by the Central Drugs Testing Laboratory. Consequently, a statutory sample was taken from the same batch and the report thereon was awaited as of the date of the show cause notice. The first Respondent was informed that, as per Clause 20.2.1(e)(iii) and 20.2.1(f) of the tender condition 2016-17, if the sample fails in the quality test for ASSAY content of less than 50% as per the Government Analyst report and if three batches of a particular drug that are supplied by the supplier are reported to fail in the ASSAY content test, the product of the tenderer would be blacklisted for two years. Accordingly, in terms of clause 20.2.4(i) of tender 2016-17, the first Respondent was called upon to show cause as to why action should not be initiated to blacklist the product as being not of 'standard quality'.
3. In addition, by the same show cause notice, the first Respondent was informed that upon receipt of the report from the Central Drug Testing Laboratory, if it is found that the drug is reported to be a spurious quality, the first Respondent would be liable to be blacklisted as per clause 20.2.1(f) & 20.2.2(c) of the tender conditions for a period of five years. Therefore, the first Respondent was called upon to provide an explanation within 7 days. By reply dated 18.08.2017, the first Respondent stated that the Joint Investigation Report shows that it is of standard quality. The Appellants were informed that these drugs were tested before acceptance and found to be of standard quality, and that it may have deteriorated later because it is a sensitive drug, which is required to be stored at a temperature below 30 degrees Celsius, and, consequently, if the said temperature is not maintained, the drug would deteriorate. The Appellants were requested to decide the case on merits by considering this explanation and also provide a personal hearing.
4. Thereafter, the analytical report dated 11.08.2017 was received from the Central Drugs Laboratory, Kolkatta, stating that the sample does not conform to I.P. with respect to identification and Assay of Carbimazole and that the sample is deemed to be spurious under Section 17B of the Drugs and Cosmetics Act, 1940 (the Drugs Act). By relying upon the aforesaid analytical report, the Appellants issued orders dated 07.12.2017 and 12.12.2017 whereby it was communicated that the first Respondent is blacklisted for a period of five years namely, from 05.08.2017 to 04.08.2022 for the supply of the spurious drug Carbimazole Tablets IP 5 mg (D. Code: 270) as per the tender condition 20.2.2.(c) (2016-17) and for forfeiture of the security deposit. An appeal was filed against the blacklisting order dated 12.12.2017 befor
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