Under Scrutiny: The Safety Evaluation of 3 Widely Used Pain, Cough and Cold Drugs

The unique combination of this Cough and Cold Drug prompts a reevaluation to ensure the well-being of users.

February 6, 2024

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CDSCO Central Drug Standard Control Organisation — CDSCO

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Last Updated on February 19, 2024 by The Health Master

Cough and Cold

In a significant move, the Central Drugs Standard Control Organisation (CDSCO) has mandated companies manufacturing two widely used cough and cold Drugs and a painkiller drug, available in fixed dose combinations (FDCs) for over 30 years, to conduct trials reviewing their safety and efficacy.

FDCs involve combining two or more drugs in fixed ratios to create a single dosage form.

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Cough and Cold Drugs under Scrutiny

Cough and Cold Drug 1

The first Cough and Cold Drug under review includes drugs containing Paracetamol (antipyretic), Phenylephrine Hydrochloride (nasal decongestant), and Caffeine Anhydrous (processed caffeine).

The call for a fresh trial highlights the need to reassess the safety and efficacy of these components of this Cough and Cold Drug.

Cough and Cold Drug 2

The second Cough and Cold Drug contains Caffeine Anhydrous, Paracetamol, Hydrochloride (salt), and Chlorpheniramine Maleate (anti-allergic medication) in different compositions.

The unique combination of this Cough and Cold Drug prompts a reevaluation to ensure the well-being of users.

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Painkiller Drug – A Non-Steroidal Anti-Inflammatory Drug (NSAID)

The third painkiller FDC, classified as an NSAID, comprises Paracetamol, Propyphenazone (an analgesic and antipyretic), and Caffeine.

While the committee recommends continued manufacturing for mild to moderate headaches, specific conditions limit its usage to five to seven days.

CDSCO’s Recommendations and Insights

The CDSCO emphasizes post-marketing surveillance to generate crucial safety and efficacy data.

This directive stems from an expert committee’s findings in 2021, examining pre-1988 FDCs that lacked necessary approvals for manufacturing and sale.

Click for Guidance documents for industry

Justification for FDCs

Fixed dose combinations (FDCs) prove beneficial by enhancing therapeutic efficacy, reducing adverse effects, ensuring better compliance, and decreasing the development of resistance.

Dr Y K Gupta and Dr Suganthi S Ramachandra, in an editorial published in the Indian Journal of Pharmacology, categorize FDCs into ‘The Good, the Bad, and the Ugly.’

Editorial Insights

The ‘Good FDCs’: These have strong justifications, such as the combination of carbidopa, levodopa, sulfonamides, and trimethoprim.
The ‘Bad FDCs’: Formulated primarily for marketing interests, lacking therapeutic value, and with debatable justifications.
The ‘Ugly FDCs’: Lack both evidence and theoretical justifications, including formulations with multiple antihistamines, decongestants, bronchodilators, and more.

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