CDSCO denies approval for Akums Acid reflux FDC in Capsule form

New Delhi: In order to expand its portfolio, Akum Drugs & Pharmaceuticals Ltd. presented before the Subject Experts Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to seek permission for Fixed Dose Combination (FDC) of Rabeprazole Sodium and Levosulpiride in a capsule dosage form. However, the committee turned down the proposal stating that the capsule dosage form is not required as it will not have any added advantage.

Akums Drugs brought an in-depth presentation before the SEC Committee for the FDC of Levosulpiride in the strength of 75 mg and Rabeprazole Sodium in the strength of 40 mg capsules.

FDC of Levosulpiride and Rabeprazole is indicated for the treatment of gastroesophageal reflux disease (acid reflux), intestinal ulcers and irritable bowel syndrome.

Levosulpiride is a prokinetic which works by increasing the release of acetylcholine. This increases the movement of the stomach and intestines and prevents reflux while Rabeprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in the relief of acid-related indigestion and ulcers.

Presently, a combination of Rabeprazole Sodium and Levosulpiride is available in the market in various strengths under different brand names including a generic combination of Rabeprazole 20mg and Levosulpiride(SR) 75mg under the brand name Rabekind Plus (20mg/75mg). Rabekind Plus is manufactured by Mankind Pharma while another notable drugmaker Zydus Cadila manufactures the same under the brand name Happi-L (20mg/75mg).

Akums' recent proposal to manufacture the said drug in capsule form was rejected by the committee. The committee noted that FDC of Rabeprazole 40mg (Enteric coated) + Levosulpiride 75 mg (sustained release) tablet is already declared rationale by Kokate committee. However, the present proposal is with respect to the capsule dosage form of the same FDC which contains individual tablets of both the drugs.

Deliberating the matter, the committee said, "The applied dosage form of the FDC i.e. capsule dosage form is not required as it will not have any added advantage. Hence the committee didn't recommend for approval."

Also Read: NPPA fixes retail price of 20 drugs including FDCs for Blood pressure control, dual antiplatelet