CDSCO directs makers of Aceclofenac, Drotaverine Hydrochloride FDC to conduct Active Post Marketing Surveillance on atleast 200 patients

New Delhi: Through a recent notification, the Central Drugs Standard Control Organisation(CDSCO) has directed all the manufacturers of Fixed-Dose Combination(FDC) of Aceclofenac 100mg and Drotaverine Hydrochloride 80mg tablet, to conduct Active Post Marketing Surveillance on minimum 200 patients for the treatment of colicky pain due to smooth muscle spasm as per Drugs and Cosmetics Rules.

The FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet was initially approved by CDSCO in favour of Themis Medicare. Based on the 59th report of Parliamentary Standing Committee (PSC) it was decided that FDC of Acedofenac 100mg + Drotaverine Hydrochloride 80mg tablet would be referred to New Drug Advisory Committee (NDAC)/Subject Expert Committee (SEC) for examination and review related to its continued marketing and updation of product monograph in light of recent knowledge and regulatory changes in overseas.

Accordingly, the matter was discussed in a series of meetings of the NDAC/SEC. Based on the recommendations of Subject Expert Committee, it was decided that the FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet shall be indicated for the treatment of "colicky pain due to smooth muscle spasm" for its continued marketing. However, manufacturers of this product shall conduct clinical trials.

As per the recommendations of Subject Expert Committee, Themis Medicare was asked to revise the indication and submit the clinical trial protocol for conducting the study. However, after a series of communications, Themis Medicare finally surrendered the product license.

Recently, the proposal was again re-deliberated in 60th SEC (Reproductive & Urology) with a current status. The committee reviewed its earlier decision for conducting the Phase-IV clinical trial on the FDC.

After detailed deliberation, the committee recommended that the firm(s) may be directed to conduct Active Post Marketing Surveillance in minimum 200 patients and the study should include patients of Primary dysmenorrhea, biliary colic and ureteric colic. The study should be completed within one year and the results of the study should be placed before the committee for further review.

In view of above, facts and circumstances, it has been directed to all the manufacturers of said FDC under relevant jurisdiction to conduct Active Post Marketing Surveillance on minimum 200 patients for the treatment of colicky pain due to smooth muscle spasm as per Drugs and Cosmetics Rules. The study should include patients of Primary dysmenorrhea, biliary colic, ureteric colic and report of the same shall be submitted to this Directorate within one year for further review by the Subject Expert Committee.

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