High Court of KeralaDivision BenchWrit Appeal dismissed.

Peekay Mediequip Limited v. Kerala Medical Services Corporation Limited and The Chief Government Analyst, Drug Testing Laboratory

Case / Petition Number:W.A.No.650 of 2012

Case Details & Bench

Court
High Court of Kerala
Hon'ble Judges
  • Manjula Chellur
  • A. M. Shaffique
Judgment Date
2012-09-24
Court Decision / Holding
Writ Appeal is dismissed; Ext.P5 order upheld; no interference with the Single Judge's decision.
Final Disposition
Writ Appeal dismissed.

Parties to the Case

Appellants / Petitioners

  • M/S. PEEKAY MEDIEQUIP LIMITED

Respondents

  • The Kerala Medical Services Corporation Limited
  • The Chief Government Analyst, Drug Testing Laboratory

Legal Representation & Advocates

Counsels for Petitioners

  • • K. Ramakumar (Sr.)
  • • S. M. Prasanth
  • • Smt. Smitha George

Counsels for Respondents

  • • M. Ajay
  • • Girija Gopal

Case Synopsis & Summary

Peekay Mediequip Limited, a supplier, challenged Ext.P5 which blacklisted the firm for five years from 2010 to 2015, barring participation in tenders for the item 2cc disposable syringe without needle. The appellant argued the order ignored due process, noting no proper notice and non-compliance with Sections 23(3) and 25(4) of the Drugs and Cosmetics Act, 1940 for sampling and testing. It invoked Amery Pharmaceuticals v. State of Rajasthan to support procedural protections, and contended that blacklisting infringed Article 21 of the Constitution. The learned Single Judge dismissed the petition, holding Ext.P5 was issued after notice and based on test reports. The court examines the contract between the Kerala Medical Services Corporation and the appellant, especially Clause 7(d), which authorizes blacklist if two batches fail assay and if three batches fail quality tests apart from assay content. The appellant argues Ext.P4 certificate of analysis shows high quality, but Ext.P5 relies on lab findings that four batches failed. The government laboratory reports indicate non-standard quality; Ext.P4 cannot override the lab. The court holds that Sections 23(3) and 25(4) do not apply to contract-based blacklisting, as misbranding/adulteration testing is not at issue here. It concludes the blacklist was justified for the specific item during the contract period and declines to interfere with the lower court's order. The decision upholds the writ petition dismissal and sustains Ext.P5.

Provisions of Law Cited

Drugs and Cosmetics Act, 1940 - Section 23(3)Drugs and Cosmetics Act, 1940 - Section 25(4)Constitution of India - Article 21

Submissions & Arguments

Contentions of Appellants / Petitioners

The appellant contends that Ext.P5 was issued without proper notice and without compliance with Sections 23(3) and 25(4) of the Drugs and Cosmetics Act, 1940 for sampling and testing. It relies on Amery Pharmaceuticals v. State of Rajasthan to argue due process concerns and alleges a potential Article 21 violation through blanket blacklisting. The contract provisions (Clause 7(d)(i)-(ii)) are argued to be misapplied or overbroad, and Ext.P4’s Certificate of Analysis cannot override government lab findings. It is argued that prior show-cause communication (13.5.2009) received no response, undermining claims of due process, and that the lab results indicate high quality in the appellant’s products.

Contentions of Respondents

The respondents defend Ext.P5 as a proper exercise of contractual rights under Clause 7(d), supported by government laboratory findings showing four batches not of standard quality. They emphasize that 23(3) and 25(4) of the Drugs and Cosmetics Act are inapplicable to contract-based blacklisting, which concerns tender integrity rather than misbranding or adulteration. They argue that the blacklisting is limited to a specific item and period, and that Article 21 rights are not violated by a five-year restriction. They also contend that a lab-based assessment and the show-cause process justify the decision, and that this Court should not reassess findings of fact under Article 226.

Cited Precedents (1)

Case NameCitationTreatmentExplanation
Amery Pharmaceuticals v. State of Rajasthan2001 (4) SCC 382DistinguishedThe court distinguished this decision as not applicable to the contract-based blacklisting nature of Ext.P5; the factual context involves sampling for misbranding/adulteration, which is different from the contract-violation context in this case.

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Extracted Judgment Text

Exact text extracted from official judgment records.

IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT: THE HON'BLE ACTING CHIEF JUSTICE MRS.MANJULA CHELLUR & THE HONOURABLE MR.JUSTICE A.M.SHAFFIQUE MONDAY, THE 24TH DAY OF SEPTEMBER 2012/2ND ASWINA 1934 WA.No. 650 of 2012 () IN WPC/20814/2011 ---------------------------------------AGAINST THE JUDGMENT IN WPC.20814/2011 DATED 05-08-2011 APPELLANT/PETITIONER: ----------------------- M/S. PEEKAY MEDIEQUIP LIMITED REPRESENTED BY ITS MANAGING DIRECTOR,G.SANKER, NO.16 VNS GARDEN,RAMAKRISHNAPURAM,THANJAVUR TAMIL NADU. BY ADVS.SRI.K.RAMAKUMAR (SR.) SRI.S.M.PRASANTH SMT.SMITHA GEORGE RESPONDENTS/RESPONDENTS: -------------------------- 1. THE KERALA MEDICAL SERVICES CORPORATION LIMITED REPRESENTED BY ITS MANAGING DIRECTOR KERALA STATEINSTITUTION FOR HEALTH AND FAMILY WELFARE CAMPUS, THYCAUD,THIRUVANANTHAPURAM-695014. 2. THE CHIEF GOVERNMENT ANALYST, DRUG TESTING LABORATORY,THIRUVANANTHAPURAM-695011. R1 BY ADV. SRI.M.AJAY,SC,KERALA MEDICAL SERV.CORPN R2 BY ADV. GOVERNMENT PLEADER SMT.GIRIJA GOPAL THIS WRIT APPEAL HAVING COME UP FOR ADMISSION ON 24-09-2012, THE COURT ON THE SAME DAY DELIVERED THE FOLLOWING: ## **MANJULA CHELLUR, Ag.C.J. & A.M.SHAFFIQUE, J. ---------------------------------------------------W.A.No.650 of 2012 ---------------------------------------------------Dated this the 24[th] day of September, 2012** ## **Judgment** ## **Shaffique, J.** The appellant filed the writ petition challenging Ext.P5 order passed by the first respondent. By virtue of Ext.P5 order, the appellant was blacklisted for a period of five years from 2010 to 2015 thereby declaring that the appellant-firm is ineligible to participate in any of the tenders floated by the Kerala Medical Services Corporation for the particular item of disposable syringe without needle 2cc during the said period. Learned Single Judge dismissed the writ petition finding that Ext.P5 order was passed after issuing notice to the petitioner and relying on the test reports as stated in Ext.P5. 2. It is the contention of the appellant that before passing Ext.P5 order, proper notice was not given and that no steps were taken for complying with the statutory provisions under Sections 23(3) and 25(4) of the Drugs and Cosmetics Act, 1940 in relation to taking sample as well as testing. Mr.K.Ramakumar, learned W.A.No.650/2012 2 Senior Counsel appearing for the appellant also relied upon the decision of the Supreme Court in **Amery Pharmaceuticals v. State of Rajasthan** [ (2001) 4 S.C.C. 382]. It is also argued that blacklisting the firm amounts to infringement of Article 21 of the Constitution of India. 3. We have gone through Ext.P5 order as well as terms of Ext.P1 agreement. Clause 7(d)(i) of the agreement clearly indicates that during the contract period if two batches of a particular item supplied by the firm fails in ASSAY content, then that product of that particular firm will be blacklisted. Clause 7(d) (ii) of the agreement also indicates that during the contract period if three batches of the particular item supplied by the firm fails in quality test in any parameters other than ASSAY content mentioned in pharmacopoeia, then that product of that particular firm will be blacklisted. It is the argument of the learned counsel for the appellant that Ext.P4 Certificate of Analysis issued by the lab indicates that the items supplied by the appellant was of very good quality and the same was not taken into consideration while passing Ext.P5 order. A reading of Ext.P5 indicates that the products were sent for lab analysis to the Government laboratory W.A.No.650/2012 3 on receipt of certain complaints and it was found that four batches were declared as not of standard quality. Ext.P4 is a report obtained by the appellant themselves which cannot be relied upon to negative the lab report from Government agencies. 4. It is also relevant to note that when a letter dated 13.5.2009 was sent to the appellant as a show cause for not blacklisting the product as per the agreement conditions, the appellant did not respond. Hence, it cannot be contended that prior notice was not issued to the appellant before issuing Ext.P5. 5. On a reading of Sections 23(3) and 25(4) of the Drugs and Cosmetics Act, 1940, it can be seen that the said provisions have no application to the facts of the present case. The sample and testing procedure contained in the above provisions will not apply in a case where there is violation of agreement conditions. Those provisions apply only when sampling and testing is done to find out any misbranding, adulteration etc. In this case, admittedly, the reports issued by the Government Laboratory clearly indicates that the sample of the syringes was not of standard quality. In that view of the matter, the respondentCorporation was justified in blacklisting the firm in respect of that W.A.No.650/2012 4 particular item alone. The argument that the firm itself has been blacklisted and therefore they are unable to supply other products does not seem to be correct. A reading of Ext.P5 shows that the appellant-firm is ineligible to participate in any of the tenders floated by the Kerala Medical Services Corporation for the particular item of disposable syringe without needle 2cc for a period of five years which apparently does not apply to other items manufactured by them. ## 6. In respect of the decision in **Amery Pharmaceuticals's** case (supra) the Supreme Court was considering a case where the Drug Inspector purchased a drug formulation from a retail medical shop for the purpose of sampling it under the provisions of the Drugs and Cosmetics Act and prosecution was initiated finding that the sample is misbranded, adulterated and spurious. The said decision has no application to the case on hand. The facts of this case is entirely different. Here the subject matter is blacklisting of the supplier in terms of a contract between by the respondent-Corporation and the appellant. The respondentCorporation has blacklisted the appellant-firm as per the agreement conditions. Such findings of fact in Ext.P5 cannot be W.A.No.650/2012 5 examined by this court while exercising powers under Article 226 of the Constitution of India. No materials are produced to substantiate that such a decision is perverse or illegal. 7. The argument that Ext.P5 amounts to deprivation of the right to live under Article 21 of the Constitution of India is also baseless as the blacklisting is only for five years and in respect of a particular item, and that too for violating the contract conditions. 8. In view of what is stated above, we find no reason to interfere with the judgment of the learned Single Judge. The Writ Appeal is dismissed. **MANJULA CHELLUR Ag. Chief Justice** **A.M.SHAFFIQUE Judge** srd W.A.No.650/2012 6 W.A.No.650/2012 7