Modi Mundipharma Gets SEC Approval to Study Cingal, a Hyaluronic Acid-Steroid Device for Osteoarthritis Knee Pain
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Modi Mundipharma to conduct a post-market clinical investigation of the proposed medical device Cross-linked Sodium Hyaluronate 88 mg with Triamcinolone Hexacetonide 18 mg (Cingal) on the Indian population.
In addition, the expert panel opined to conduct a post-market clinical investigation on the Indian population as per study protocol no. CT-CG-PMS-2023, Version 2.0 dated 20.05.2023.This
This came after Modi Mundipharma presented a proposal for a grant of permission to conduct a post-market clinical investigation on the proposed medical device Cross linked Sodium Hyaluronate 88 mg with Triamcinolone Hexacetonide 18 mg (Cingal) in the country on the Indian population before the committee.
Cingal is a single-injection treatment for knee osteoarthritis pain, combining hyaluronic acid (HA) and a corticosteroid (triamcinolone hexacetonide). It aims to provide both rapid and long-lasting pain relief. The HA component acts as a viscosupplement, lubricating the joint and providing mechanical support, while the corticosteroid offers short-term pain and inflammation reduction.
Cross-linked sodium hyaluronate is a modified form of hyaluronic acid (HA) used in various medical and cosmetic applications. Cross-linking involves chemically bonding HA molecules together, creating a more stable and durable structure than natural, linear HA. This modification enhances its viscoelasticity and persistence, making it suitable for treatments requiring longer-lasting effects.
At the recent SEC meeting for analgesic and rheumatology held on 16th July 2025, the expert panel reviewed the proposal presented by Modi Mundipharma for grant of permission to conduct Post Market Clinical Investigation on proposed medical device Cross linked Sodium Hyaluronate 88 mg with Triamcinolone Hexacetonide 18 mg (Cingal) on Indian population before the committee.
After detailed deliberation the committee recommended the grant of permission to conduct Post Market Clinical Investigation on Indian Population as per Study Protocol no. CT-CG-PMS-2023, Version 2.0 dated 20.05.2023.
