**Policy Summary: Aceclofenac 100mg/Drotaverine Hydrochloride 80mg FDC Tablet**
This directive, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), addresses the manufacturing and marketing of the Fixed Dose Combination (FDC) of Aceclofenac 100mg and Drotaverine Hydrochloride 80mg tablet.
Originally approved on September 15, 2008, for Ms. Themis Medicare, the FDC was subsequently reviewed by the New Drug Advisory Committee (NDAC) Subject Expert Committee (SEC) following concerns raised in the 59th report of the Parliamentary Standing Committee (PSC) dated May 8, 2012. The review focused on its continued marketing and the need to update the product monograph.
Based on the SEC's recommendations, the FDC's indication was limited to the treatment of colicky pain due to smooth muscle spasm, and manufacturers were initially required to conduct a clinical trial. Ms. Themis Medicare eventually surrendered the product license.
The matter was re-evaluated on August 29, 2019, by the 60th SEC Reproductive Urology. The committee revised its earlier decision, instead recommending that all manufacturers of the FDC conduct Active Post Marketing Surveillance (PMS) on a minimum of 200 patients. The PMS should specifically include patients with primary dysmenorrhea, biliary colic, and ureteric colic, and must be completed within one year. The results are to be submitted to the Directorate for review by the SEC.
All manufacturers of the Aceclofenac 100mg/Drotaverine Hydrochloride 80mg FDC tablet are directed to conduct the Active PMS as per Drugs and Cosmetics Rules and submit the report within one year to the CDSCO.
The Drugs Controller General of India, Dr. V. G. Somani, issued this directive. Copies have been disseminated to all Zonal/Sub-Zonal offices of CDSCO, the Indian Drug Pharmaceuticals Association Forum, and the CDSCO website.
Key Entities Referenced
Aceclofenac 100mg Drotaverine Hydrochloride 80mg tablet: A Fixed-Dose Combination (FDC) drug containing Aceclofenac and Drotaverine Hydrochloride, which is the subject of the policy document.
Themis Medicare: A pharmaceutical company that initially held the approval for the FDC drug Aceclofenac 100mg Drotaverine Hydrochloride 80mg tablet and later surrendered the product license.
Parliamentary Standing Committee PSC: The 59th report of this committee, dated 08.05.2012, influenced the review of the FDC drug.
New Drug Advisory Committee NDACSubject Expert Committee SEC: A committee responsible for the examination, review, and recommendations regarding the continued marketing and product monograph of the FDC drug.
Active Post Marketing Surveillance: A study to be conducted on a minimum of 200 patients to assess the safety and efficacy of the FDC drug for treating colicky pain due to smooth muscle spasm.
Drugs and Cosmetics Rules: The regulatory framework under which the Active Post Marketing Surveillance is to be conducted.
Dr. V. G. Somani: Drugs Controller General India
Central Drugs Standard Control Organization: The Indian regulatory body responsible for drug approval and monitoring, under which the directive for Active Post Marketing Surveillance is issued.
File No. 4-01/2019-DC (Misc. 53) tty No.: 011-23236965
Government of India Fax No. : 011-23236973
Directorate General of Health Services :
Central Drugs Standard Control Organization
(FDC Division)
Subject: Manufacturing and marketing of FDC of Aceclofenac 100mg +
Drotaverine Hydrochloride 80mg tablet-regarding.
Sir,.
The FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet was
initially approved by this office on 15.09.2008 in favour of M/s Themis Medicare. Based
on the 59" report of Parliamentary Standing Committee (PSC) dated 08.05.2012, it was
decided that FDC of Aceclofenac 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 treatment of “colicky pain due to smooth muscle spasm” for its continued marketing.
However, manufacturers of this product shall conduct clinical trial.
As per the recommendations of Subject Expert Committee, M/s. Themis Medicare
was asked to revise the indication and submit the clinical trial protocol for conducting the
study. However, after a series of communications, M/s. Themis Medicare finally
surrendered the product license.
Recently, the proposal was again re-deliberated in 60° SEC (Reproductive &
Urology) dated 29.08.2019 with 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 results of study should placed before the committee for further
review.
In view of above, facts and circumstances, you are requested to direct all the
manufacturers of said FDC under your 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.
Yours faithfully,
Yur
(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to:-
1. All Zonal/Sub Zonal offices of CDSCO.
2. Indian Drug/Pharmaceuticals Association Forum
3. Website of CDSCO