**Summary:**
This policy directive, issued by the Central Drugs Standard Control Organization (CDSCO), FDC Division, on December 8, 2023, addresses concerns regarding the promotion of FDC (Fixed Dose Combination) products containing tranexamic acid and Prophylactic Literature 5mg of Dropping insert. The directive, addressed to all State/UTs Drugs Controllers, references File No.: 04012022DC Misc.47.
The policy decision stems from deliberations and recommendations of the Subject Expert Committee (SEC) . Specifically, the policy concerns promotion of tranexamic acid 500 mg + Prophylactic Literature 5 mg of insert dropping insert Pack 21707.20015. The recommendation of the SEC has been considered by this office.
State/UT Drugs Controllers are instructed to take appropriate action in response to concerns regarding the promotion of the aforementioned FDC drug and intimate the CDSCO office of actions taken.
Copies of the directive are distributed to all Zonal/Sub-Zonal offices of CDSCO, the Indian Drug Pharmaceuticals Association Forum, and are available on the CDSCO website.
Key Entities Referenced
SEC: Subject Expert Committee, recommendation of SEC considered by this office.
Directorate General of Health Services: An organization under the Government of India, involved in health services.
Central Drugs Standard Control Organization: National Regulatory Authority (NRA) of India, responsible for regulating pharmaceuticals and medical devices.
FDC Division: Division within the Central Drugs Standard Control Organization (CDSCO).
All StateUTs Drugs Controllers: Drugs Controllers of all States and Union Territories of India.
Indian DrugPharmaceuticals Association Forum: Association related to the Indian Drug and Pharmaceuticals industry.
All ZonalSub Zonal offices of CDSCO: Zonal and Sub-Zonal offices of the Central Drugs Standard Control Organization.
File No.: 04-01/2022-DC (Misc.-47)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
| 8DEC 2023
To,
All State/UTs Drugs Controllers,
S Cu hb lj oe rc pt h: e niT ro a miu np ed a Mt ae l eap ta ec k Ia Pg e 2 mgin s +e rt P/ hP er no ym lo et pi hon ra il n e L Hi Cte Ir a It Pu re 5 mgof drF oD pC /m ! of -
regarding.
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policy decision.
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insert.
The recommendation of the SEC has been considered by this office.
u bn ed le or w yA 4oc uc yro e r j ad ui rrn sig s l d oy i fc, t i ay o go n e u ”t oa or m ne e n lr t ae i bq eou lne s awt nae drd n i pt no a g c d ki “ ar F gec D et C i al nsl s h et o rh u te /l Pdm r a onn mo ou tf t ia obc nt e au lr u e s Lr ies td e ro af i t n u s ra c ei h d i o l fF d rD te hC n e
drug.
Action taken in this regard may be intimated to this office.
Copy to:-
4. All Zonal/Sub Zonal offices of CDSCO
2. Indian Drug/Pharmaceuticals Association Forum
3. Website of CDSCO