Ensure continuity of life-saving blood product biz, argues HC, allows biotech firm to take part

Ensure continuity of life-saving blood product biz, argues HC, allows biotech firm to take part

Calcutta High Court

The company’s earlier manufacturing licence was valid till March 31, 2026. They applied for renewal in November 2025, and it was renewed by the state licensing authority on June 22, 2026 with effect from April 1, 2026 to March 31, 2031. This renewal was forwarded to the Central Licence Approving Authority for approval but was kept pending and on July 24 the company’s technical bid was marked ‘not qualified technically’ by the state. On Oct 8, the division bench held: “If the Rules permit the appellant to continue with such business, then there is no reason why the appellant cannot participate in a fresh tender process, which is an integral part of its business activity.

Kolkata: Calcutta High Court recently allowed a biotechnology company to participate in a state government bid, observing, “blood, blood products, plasma derived products have limited shelf life…Continuity in the business is essential so that such rare products required to save human lives do not go to waste”. The licence renewed by the state licensing authority did not have approval of the central authority, which is a requirement, according to the state. The single judge was of the opinion that without approval from the central authority, which is also the approving authority, the rejection of the bid was justified.

ICHOR Biologics Private Limited had appealed before the division bench of justices Shampa Sarkar and Arjun Ray Mukherjee against a single judge’s decision of dismissing their petition challenging rejection of its technical bid in a state tender for collecting excess or surplus screened fresh frozen plasma from blood component separation units attached to state’s blood centres.

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“The license of the appellant does not become invalid because it is pending approval before the Approving Authority and shall be deemed to be a validly issued by virtue of operation of the second proviso of sub-Rule 1 of Rule 122F, till it is either cancelled or revoked or suspended by the authorities,” division bench held. Download the TOI App.

The company’s case was that the licensing authority issued the certificate of renewal of license for manufacture of blood products and the rules permitted them to continue the business during the pendency of the application awaiting approval. The notice inviting tender provided that the participant should have a valid license for manufacturing plasma derived products. Advocate General Surajit Nath Mitra argued it would be an absurd proposition that although the legislature contemplated approval by the approving authority, such approval was not a mandatory requirement under the law and a renewed license could be treated as a valid one without such approval. It was submitted that the other bidders had a valid license with the approval from the approving authority (central).

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