Cracking Down on Banned Codeine Based Cough Syrups

India has recently taken a bold step to ban several well-known cough syrups, including Phensedyl and Corex, due to their banned codeine phosphate content and the addictive risks associated with them. This move is part of a larger crackdown on fixed dose combinations (FDCs) that pose significant health risks to the population.

India Bans Codeine-Based Cough Syrups: The Hidden Dangers of Fixed Dose Combinations - iTervis
Cough syrup is marked with CC0 1.0.

Understanding Fixed Dose Combinations (FDCs):

Fixed dose combinations (FDCs) involve blending two or more drugs into a single pill. The FDA has issued stern warnings about the potential harm posed by FDCs, leading the Health Ministry to ban 344 such combination products in India. In essence, an FDC is a cocktail of therapeutic ingredients conveniently packed into a single dose.

The 2016 Ban on FDCs:

On March 10, 2016, the Indian government issued a notification prohibiting the manufacture, sale, and distribution of 344 FDC drugs, including popular names like Vicks Action 500, Phensedyl, and Corex.

The Mechanics of Cough Syrups:

Coughing is the body’s natural defense mechanism to expel foreign particles, including germs and dust. Cough syrups, while intended to relieve this discomfort, can actually hinder the body’s innate protection. They work by reaching the lungs and, in some cases, can even increase heart rates, particularly in children. All cough syrups contain sedatives and carry the risk of addiction.

The Legal Battle Against Cough Syrups:

Various high courts in India have recognized the dangers of banned codeine-based cough syrups, but they are still prescribed by physicians, including pediatricians. It’s worth noting that in most developed countries, cough syrups are banned, and doctors do not recommend their use.

Why Corex Cough Syrup was Banned:

Corex and similar codeine-based cough syrups have been banned in India due to their highly addictive nature. Although effective in suppressing coughs, these syrups are frequently misused, leading to narcotic dependence. Codeine, a key ingredient, falls within the opioid class of drugs, known for their potential for addiction.

Phensedyl’s Ban in Bangladesh:

Phensedyl, another notorious cough syrup, containing codeine, was already banned in Bangladesh due to its high codeine content and addictive properties. Nevertheless, it has been frequently smuggled from India into Bangladesh, where its sale carries legal consequences.

Safety Concerns for Children:

Cough syrups pose a particular threat to children with rapid metabolisms. In many developed countries, medicines containing codeine have been banned for children under 12. However, in India, popular cough syrups like Benadryl, Corex, Phensedyl, and Teddy cough continue to be sold without age restrictions.

Drugs and Companies Affected:

The ban on cough syrups is not limited to Phensedyl and Corex. Numerous other drugs have faced similar restrictions in many countries. Some notable examples include:

  • Cough Syrup Phensedyl (Manufacturer: Abbott)
  • Ascoril range of cough syrups (Manufacturer: Glenmark)
  • Zedex cough syrups (Manufacturer: Wockhardt)
  • Vicks Action 500 Extra (Manufacturer: Procter and Gamble, P&G)

Conclusion: India’s decision to ban codeine-based cough syrups is a crucial step towards curbing the risks of banned codeine-based cough syrups and other related products. While the country is one of the world’s largest pharmaceutical markets, it faces challenges in effectively regulating the safety of drugs, allowing many banned substances to circulate unchecked. This recent action underscores the importance of prioritizing public health over profit in the pharmaceutical industry.

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