CDSCO Committee Asks Elevate Scientific To Prove Back Pain Gel In Indian Trial
New Delhi: With an aim to demonstrate the safety and efficacy on lower back pain, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has opined that Elevate Scientific should conduct the clinical investigation of Radiopaque Gelified Ethanol (Absolute Gel) on the Indian population.
In addition, the expert panel suggested that the firm needs to submit the Clinical Investigation Protocol with a statistically significant sample size for taking further necessary action in the matter.
This came as Elevate Scientific presented clinical study data generated globally (Iran, Italy, etc.) along with post-marketing data on Radiopaque Gelified Ethanol (Absolute Gel) for the waiver of one of the conditions of the permission for manufacturing obtained under Form MD27 and proposed to allow them to market the product for domestic use.
Radiopaque gelified ethanol, also known as Absolute Gel, is a minimally invasive treatment for disc herniations using a substance injected into the disc under imaging guidance. It's a gelified ethanol solution with tungsten particles, designed to be more viscous than pure ethanol and to allow for tracking during the procedure. The gel, upon contact with the nucleus pulposus, dehydrates it, leading to a retraction of the herniated disc and potential pain relief.
At the recent SEC meeting for analgesic and rheumatology (Medical Devices Division) held on 16th July 2025, the expert panel reviewed the clinical study data generated globally (Iran, Italy, etc.) along with post-marketing data on radiopaque gelified ethanol (absolute gel) presented by Elevate Scientific for the waiver of one of the conditions of the permission for manufacturing obtained under Form MD27.
After detailed deliberation, the committee observed that the clinical study data presented by the firm does not demonstrate the safety and efficacy of pain outcomes of the patients.
Therefore, the committee recommended that the firm should conduct the clinical investigation on the Indian population with the objective of demonstrating the safety and efficacy on lower back pain.
In accordance with the above, the expert panel stated that the firm needs to submit the Clinical Investigation Protocol with a statistically significant sample size for taking further necessary action in the matter.
