Submit more Data: CDSCO panel Tells Baxter about balanced salt solution
New Delhi: Based on the justification for the Phase III clinical trial waiver and market the fixed-dose combination (FDC) Calcium chloride dihydrate plus Magnesium chloride hexahydrate plus Sodium Chloride plus Sodium Hydrogen Carbonate plus Potassium Chloride plus Disodium Phosphate Dihydrate solutions, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended Baxter to submit further justification or data.
The expert panel asked the firm to submit data justifying that there is no probability or evidence, on the basis of existing knowledge, of difference in the Indian population or any factor affecting the safety and efficacy of the FDC.
The committee additionally sought information from the firm regarding CDSCO's involvement in a global clinical trial that is currently being conducted in India. The committee also sought information regarding any unmet medical needs.
This came after the firm presented its proposal along with justification for the Phase III clinical trial waiver for the Import and market of the proposed balanced salt solution before the committee.
Calcium chloride dihydrate is a hydrate that is the dihydrate form of calcium chloride. It is a hydrate, a calcium salt, and an inorganic chloride. It contains calcium dichloride.
Magnesium chloride hexahydrate medication is a mineral supplement used to prevent and treat low amounts of magnesium in the blood. Some brands are also used to treat symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion.
Sodium is an electrolyte that regulates the amount of water in your body. Sodium also plays a part in nerve impulses and muscle contractions. Sodium chloride is used to treat or prevent sodium loss caused by dehydration, excessive sweating, or other causes.
Sodium Hydrogen Carbonate formula, also known as Sodium Bicarbonate, formula or Baking Soda formula is explained in this article. It is an inorganic compound that is weakly basic and is composed of cations (Sodium) and anions (Bicarbonate).
Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart. Potassium chloride is used to prevent or treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.
Disodium phosphate is a neutralizing agent. It acts as a buffering solution that helps control pH. Buffering solutions, a type of water-soluble solution known as aqueous solutions, are created by mixing a weak acid and its conjugate base.
At the recent SEC meeting for Cardiovascular and Renal held on the 6th and 7th of June 2023, the expert panel reviewed the proposal along with justification for the Phase III clinical trial waiver for the Import and market of the proposed FDC before the committee.
After detailed deliberation, the committee recommended that the firm should submit justification/data for the below-mentioned points for further review by the committee:
1. Data justifying that there is no probability or evidence, on the basis of existing knowledge, of difference in the Indian population or any factor affecting the safety &efficacy of the FDC.
2. Whether permission to conduct a global clinical trial which is ongoing in India has been taken from CDSCO.
3. Undertaking should be given in writing to conduct Phase IV clinical trials to establish safety and effectiveness as per the design approved by Central Licensing Authority (CLA).
4. Whether there is any unmet medical need.
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