CDSCO Panel Denies Trial Waiver for Atropine, Asks Sun Pharma to Conduct Phase III Study
New Delhi: Rejecting the proposal for a clinical trial waiver for Atropine Sulphate Ophthalmic Solution IP 0.025% w/v, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has opined that the published clinical data presented by Sun Pharmaceuticals is not adequate to prove the efficacy of the applied product, and the firm should conduct the Phase III clinical trial.
This came after Sun Pharmaceuticals presented their proposal for granting permission for the manufacturing and marketing of the product Atropine Sulfate Ophthalmic Solution IP 0.025% with a clinical trial waiver.
Atropine is an alkaloid originally synthesized from Atropa belladonna. It is a racemic mixture of d-and l-hyoscyamine, of which only l-hyoscyamine is pharmacologically active. Atropine is generally available as a sulfate salt and can be administered by intravenous, subcutaneous, intramuscular, intraosseous, endotracheal, and ophthalmic methods. Oral atropine is only available in combination products. Atropine is a competitive, reversible antagonist of muscarinic receptors that blocks the effects of acetylcholine and other choline esters. It has a variety of therapeutic applications, including pupil dilation and the treatment of anticholinergic poisoning and symptomatic bradycardia in the absence of reversible causes. Atropine is a relatively inexpensive drug and is included in the World Health Organization List of Essential Medicines.
At the recent SEC meeting for ophthalmology, the firm stated that the product Atropine Sulfate Ophthalmic Solution 0.025% (Rejucea Mini Ophthalmic Solution 0.025%) is approved in Japan on 27.12.2024 for the inhibition of myopia progression.
After detailed deliberation, the committee opined,
"The published clinical data presented by the firm are not adequate to prove the efficacy of the applied product. Accordingly, the committee recommended that the firm conduct the Phase III clinical trial."
