Representative image of medicines.
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The Central Drug Regulatory Authority (CDSCO) has asked companies manufacturing two commonly used cold medicines and one painkiller drug available in fixed-dose combinations (FDC refers to combining two or more drugs in a fixed ratio to develop a single dosage form), to conduct trials ensuring safety and efficacy, the Times of India reported.
These medicines have been on sale in the market for over three decades.
The order is based on the suggestions of a 2021 expert committee that was formed to examine certain pre-1988 FDCs that were given manufacturing approval without the approval of the licensing authority.
Among the drugs suggested for trial are Paracetamol (antipyretic), Phenylephrine Hydrochloride (nasal decongestant) and Caffeine Anhydrous (processed caffeine).
Drugs containing Caffeine Anhydrous, Paracetamol, Hydrochloride (salt) and Chlorpheniramine Maleate (anti-allergic medication) in different compositions are also under the scanner.
Post-marketing surveillance has been advised by the CDSCO 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.
The CDSCO has recommended to continue manufacturing painkillers for mild to moderate headaches with the condition that the said drug shall not be consumed for more than five days.
In an editorial published in the 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'.
Gupta classified 'good' FDCs as the ones having 'strong justification' having a combination of carbidopa, levodopa, sulfonamides and trimethoprim.
'Bad' FDCs were classified as the ones that are formulated primarily with marketing interests adding no value to therapeutic usefulness.
Ones having neither evidence nor theoretical justifications were regarded as 'ugly' FDCs. It includes medication like cough syrup having formulations with two or more antihistamines, longwith decongestants, bronchodilator, cough suppressant, expectorant and antifungal, antibiotic, steroid and topical local anaesthetic.