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NEW DELHI: The central drug regulator has asked companies manufacturing two commonly prescribed cough and cold medications and one painkiller drug available in fixed dose combinations (FDCs), which have been on sale for more than 30 years, to carry out trials to review their safety and efficacy. FDC refers to combining two or more drugs in a fixed ratio to develop a single dosage form.
One of the cough and cold medications suggested for a fresh trial to assess safety includes drugs containing Paracetamol (antipyretic), Phenylephrine Hydrochloride (nasal decongestant) and Caffeine Anhydrous (processed caffeine).
The other one contains Caffeine Anhydrous, Paracetamol, Hydrochloride (salt) and Chlorpheniramine Maleate (anti-allergic medication) in different compositions.
Central Drug Regulatory Authority (CDSCO) has advised post-marketing surveillance to generate safety and efficacy data on a third FDC that belongs to a class of painkillers called non-steroidal anti-inflammatory drugs. It contains Paracetamol, Propyphenazone (an analgesic and antipyretic) and Caffeine.
In the case of the painkiller drug, the committee recommended continued manufacturing and marketing of the FDC for mild to moderate headache with the conditions that it should not be taken for more than five to seven days.
The CDSCO order is based on the suggestions of an expert committee formed in 2021 to examine certain pre-1988 FDCs that were given fresh approval for manufacturing for sale without due approval from the licensing authority.
FDCs are justified when they demonstrate clear benefits in terms of potentiating the therapeutic efficacy, reducing the incidence of adverse effects of drugs, better compliance by reducing the pill burden and decreasing development of resistance among others.In an editorial published in Indian Journal of Pharmacology, Dr Y K Gupta, former head of pharmacology at All-India Institute of Medical Sciences & Dr Suganthi S Ramachandra, classified the available FDCs in India as ‘The Good, the Bad and the Ugly’.
The ‘Good FDCs’ were defined as the ones having strong justification, for example, combination of carbidopa, levodopa, sulfonamides and trimethoprim. The ‘Bad FDCs’ were the ones formulated primarily with marketing interests and do not add any value to the therapeutic usefulness and whose justification is debatable.
The ‘Ugly FDCs’ were defined as ones that have neither evidence nor theoretical justifications like formulations having cough syrups with two or more antihistamines alongwith decongestant, bronchodilator, cough suppressant, expectorant and antifungal, antibiotic, steroid and topical local anaesthetic.
One of the cough and cold medications suggested for a fresh trial to assess safety includes drugs containing Paracetamol (antipyretic), Phenylephrine Hydrochloride (nasal decongestant) and Caffeine Anhydrous (processed caffeine).
The other one contains Caffeine Anhydrous, Paracetamol, Hydrochloride (salt) and Chlorpheniramine Maleate (anti-allergic medication) in different compositions.
Central Drug Regulatory Authority (CDSCO) has advised post-marketing surveillance to generate safety and efficacy data on a third FDC that belongs to a class of painkillers called non-steroidal anti-inflammatory drugs. It contains Paracetamol, Propyphenazone (an analgesic and antipyretic) and Caffeine.
In the case of the painkiller drug, the committee recommended continued manufacturing and marketing of the FDC for mild to moderate headache with the conditions that it should not be taken for more than five to seven days.
The CDSCO order is based on the suggestions of an expert committee formed in 2021 to examine certain pre-1988 FDCs that were given fresh approval for manufacturing for sale without due approval from the licensing authority.
FDCs are justified when they demonstrate clear benefits in terms of potentiating the therapeutic efficacy, reducing the incidence of adverse effects of drugs, better compliance by reducing the pill burden and decreasing development of resistance among others.In an editorial published in Indian Journal of Pharmacology, Dr Y K Gupta, former head of pharmacology at All-India Institute of Medical Sciences & Dr Suganthi S Ramachandra, classified the available FDCs in India as ‘The Good, the Bad and the Ugly’.
The ‘Good FDCs’ were defined as the ones having strong justification, for example, combination of carbidopa, levodopa, sulfonamides and trimethoprim. The ‘Bad FDCs’ were the ones formulated primarily with marketing interests and do not add any value to the therapeutic usefulness and whose justification is debatable.
The ‘Ugly FDCs’ were defined as ones that have neither evidence nor theoretical justifications like formulations having cough syrups with two or more antihistamines alongwith decongestant, bronchodilator, cough suppressant, expectorant and antifungal, antibiotic, steroid and topical local anaesthetic.
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