Hyderabad: The expert committee report of the CDSCO which revealed the ill-effects of combination drugs was chaired by C.K. Kokate, VC of KLE University, Belgaum, and with experts on internal medicine and each field of pharmacology as members.
The committee evaluated replies, clarifications received by CDSCO in response to the show-cause notices issued to the pharma companies in respect to FDCs considered as irrational by the committee.
The committee noted that products were available in the market which had been licensed by state level authorities without following due procedures as laid down under drugs and cosmetics rules.
These had not been evaluated by the state drug administration which exposed patients to unnecessary risks of adverse drug reactions, and injudicious use of antibiotics could lead to resistance.
For instance, the committee found that Alex P syrup of Glen Pharma containing fixed dose combination of Dextromethorphon hydrobromide, Paracetamol, Phenylephrine, Chlorophenaramine maleate dosing schedule had incompatible ingredients and would have adverse affects of sedation and drowsiness and would interfere with the reflexes and centrally acting anti-tussive (drug that suppresses cough), and should not be combined with anti histamine (allergic) drugs.
Likewise, the anti diabetic drug combination of Glimepiride + Metformin HCL SR 4mg + 100 mg, widely used by several combinations, would lead to confusion, prescription error, dispensing error and increase risk of hypoglycemia (less sugar levels).
Regarding the Vicks Action 500 containing Paracetamol, Phenylephrine and caffeine, the committee said this was “pharmaco dynamically” irrelevant, made misuse and overuse of one of the ingredients of FDC in case it was not indicated.
In case of Kofcure syrup that use the FDC of Dextromethorphon, Phenylephrine and Guaiphenesin, the committee said that it was pharmaco dynamically irrelevant and Guaiphenesin was a mucolytic which increased mucus secretion and should not be given in combination with anti histaminic with anti cholinergic properties that causes the mucus secretions are dried up.
It also said Detromethrophon decreased the cough impulses, so expulsion of secretions would be hampered. It said in this drug, patients may need only one ingredient and FDC may lead to misuse....