Akums Drugs and Pharma Gets CDSCO Panel Nod to study Aceclofenac plus Drotaverine Hydrochloride tablet

New Delhi: The drug major Akums Drugs and Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the active post-marketing surveillance (PMS) studies of the fixed-dose combination (FDC) Aceclofenac plus Drotaverine Hydrochloride 80 mg tablet.

This came after Akums Drugs and Pharmaceuticals presented the proposal along with the active post-marketing surveillance (PMS) protocol before the committee.

Drotaverine plus Aceclofenac is a combination of two medicines: Drotaverine and Aceclofenac, which relieve abdominal pain and cramps. Drotaverine is an anti-spasmodic medicine that relieves contractions (spasms) associated with smooth muscles in the abdomen. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking the release of certain chemical messengers that cause abdominal pain and inflammation (swelling).

Aceclofenac, a phenylacetic acid derivative, is a non-steroidal, anti-inflammatory drug (NSAID). It shares structural similarities with another NSAID, diclofenac. The drug was designed to improve tolerance and bioavailability. It has anti-inflammatory, analgesic, and antipyretic properties. Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Drotaverine is a phosphodiesterase-4 inhibitor used to alleviate gastrointestinal and genitourinary smooth muscle spasms. Drotaverine is a selective inhibitor of phosphodiesterase 4 (PDE4), which is an enzyme responsible for the degradation of cyclic adenosine monophosphate (cAMP). Inhibition of PDE4 leads to elevated levels of cAMP, leading to smooth muscle relaxation.

At the recent SEC meeting for reproductive held on July 4, 2024, the expert panel reviewed the proposal presented by the drug major Akums Drugs and Pharmaceuticals along with the active post-marketing surveillance (PMS) study protocol before the committee.

After detailed deliberation, the committee recommended conducting the Active PMS study.

In addition, the expert panel suggested that the result of the study should be submitted to CDSCO for review by the committee.

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