Bombay High Court Allows Writ Petition Challenging Disqualification of Stent Manufacturer from Tender Process. Petitioner's Drug Eluting Stents, Approved by DCGI, Held Eligible for Supply Under Rajiv Gandhi Arogya Yojana.

High Court: Bombay High Court Bench: BOMBAY In Favour of Accused
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Case Note & Summary

The Petitioner, M/s. Vascular Concepts Ltd., a company manufacturing Drug Eluting Stents, filed a Writ Petition before the Bombay High Court challenging the decisions of the Purchase Committee of Respondent Nos. 1 and 2 (State of Maharashtra and Joint Director of Health Services) dated 12th June 2013 and 24th September 2013, and the communications dated 27th June 2013 and 31st December 2013, which disqualified the Petitioner from bidding for supply of stents under the Rajiv Gandhi Arogya Yojana. The Petitioner sought a declaration that its stents, approved by the Drugs Controller General of India (DCGI), were eligible for supply. The court heard arguments from Senior Advocate S.G. Aney for the Petitioner, Senior Advocate A.A. Kumbhakoni for Respondent Nos. 1 and 2, and Mr. G. Hariharan for Respondent Nos. 3 and 4 (Union of India). The court examined the regulatory framework under the Drugs and Cosmetics Act, 1940, and noted that the Petitioner's stents had DCGI approval. The court found that the Purchase Committee's decisions to exclude the Petitioner were arbitrary and without valid justification, as the DCGI approval was sufficient for eligibility. The court held that the impugned decisions and communications were liable to be quashed and set aside, and directed that the Petitioner be considered eligible to bid for and supply stents under the scheme. The judgment was delivered by a Division Bench comprising V.M. Kanade and A.K. Menon, JJ., with the oral judgment pronounced by A.K. Menon, J. on 21st April 2014.

Headnote

A) Constitutional Law - Writ Jurisdiction - Judicial Review of Tender Conditions - The court examined whether the Purchase Committee's decision to disqualify the Petitioner from bidding for supply of Drug Eluting Stents was arbitrary and violative of Article 14 of the Constitution of India. The court held that the Petitioner's stents, being approved by the DCGI, could not be excluded without valid justification, and the impugned decisions were set aside. (Paras 1-10)

B) Medical Devices - Drug Eluting Stents - Approval by Drugs Controller General of India - The court considered the regulatory framework under the Drugs and Cosmetics Act, 1940, and held that DCGI approval is sufficient for eligibility to supply stents under government health schemes. The Purchase Committee's additional criteria were found to be unreasonable. (Paras 3-8)

C) Administrative Law - Purchase Committee - Arbitrariness - The court found that the Purchase Committee's decisions dated 12th June 2013 and 24th September 2013, and the communications dated 27th June 2013 and 31st December 2013, were arbitrary and without proper application of mind, as they excluded the Petitioner despite its DCGI approval. (Paras 2-9)

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Issue of Consideration

Whether the Petitioner's Drug Eluting Stents, approved by the Drugs Controller General of India, are eligible for supply under the Rajiv Gandhi Arogya Yojana, and whether the decisions of the Purchase Committee disqualifying the Petitioner are arbitrary and liable to be quashed.

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Final Decision

The court allowed the Writ Petition, quashed and set aside the decisions of the Purchase Committee dated 12th June 2013 and 24th September 2013, and the communications dated 27th June 2013 and 31st December 2013. The court declared that the Petitioner is eligible to bid for and supply Drug Eluting Stents approved by DCGI to beneficiaries of Rajiv Gandhi Arogya Yojana.

Law Points

  • Eligibility to bid in government tender
  • Drug Eluting Stents
  • Rajiv Gandhi Arogya Yojana
  • Drugs Controller General of India approval
  • Purchase Committee decisions
  • Judicial review of tender conditions
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Case Details

2014:BHC-OS:4306-DB

WRIT PETITION (L) NO.226 OF 2014

2014-04-21

V. M. KANADE, A. K. MENON

2014:BHC-OS:4306-DB

S. G. Aney, K. S. Mohite, Atul Mahajan, S. S. Sanyal, A. A. Kumbhakoni, Ashutosh Kulkarni, G. Hariharan, Y. R. Mishra

M/s. Vascular Concepts Ltd.

The State of Maharashtra, The Joint Director of Health Services, The Union of India, Union of India through the Drugs Controller General of India

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Nature of Litigation

Writ Petition under Article 226 of the Constitution of India challenging decisions of the Purchase Committee disqualifying the Petitioner from bidding for supply of Drug Eluting Stents.

Remedy Sought

Quashing of Purchase Committee decisions dated 12th June 2013 and 24th September 2013, and communications dated 27th June 2013 and 31st December 2013; declaration that Petitioner is eligible to bid for and supply Drug Eluting Stents approved by DCGI to beneficiaries of Rajiv Gandhi Arogya Yojana.

Filing Reason

The Petitioner was disqualified by the Purchase Committee from supplying Drug Eluting Stents under the Rajiv Gandhi Arogya Yojana despite having DCGI approval.

Issues

Whether the Petitioner's Drug Eluting Stents, approved by DCGI, are eligible for supply under the Rajiv Gandhi Arogya Yojana. Whether the decisions of the Purchase Committee disqualifying the Petitioner are arbitrary and liable to be quashed.

Submissions/Arguments

Petitioner argued that its stents are approved by DCGI and thus eligible for supply, and the Purchase Committee's decisions were arbitrary. Respondents argued that the Petitioner did not meet certain criteria set by the Purchase Committee.

Ratio Decidendi

The court held that the Petitioner's Drug Eluting Stents, being approved by the Drugs Controller General of India, are eligible for supply under the Rajiv Gandhi Arogya Yojana, and the Purchase Committee's decisions to disqualify the Petitioner were arbitrary and without valid justification, violating Article 14 of the Constitution of India.

Judgment Excerpts

By the present Writ Petition, the Petitioner seeks an appropriate Writ for quashing and setting aside decisions of the Purchase Committee of Respondents No.1 and 2 dated 12th June 2013 and 24th September 2013 as also impugned communications dated 27th June 2013 and 31st December 2013 from the said Respondents. The Petitioner company carries on business inter alia of manufacturing Drug Eluting Stents.

Procedural History

The Petitioner filed Writ Petition (L) No.226 of 2014 before the Bombay High Court challenging the decisions of the Purchase Committee. The court reserved judgment on 13th March 2014 and pronounced it on 21st April 2014.

Acts & Sections

  • Drugs and Cosmetics Act, 1940:
  • Constitution of India: Article 14
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