Some banned FDCs have US FDA approval

The Indian’s government sudden decision to ban codeine combinations along with 300 other fixed-dose combinations (FDCs) last month has a curious twist. The Drug Controller General of India (DCGI) tends to follow the lead of the US Food and Drugs Administration (FDA) lead when it comes to banning or approving drugs or medical devices; but this time, the regulator has gone ahead and banned drugs that the US FDA has approved in the past.
Incidentally, cough syrups such as Corex and Phensedyl that contain cough drug codeine in combination with chlorpheniramine maleate, were cleared for sale in India about three decades ago. The Drug Controller General of India banned them, citing them as “irrational’’ and prone to misuse and addiction.
Yet, more often than not, Indian authorities look up to the US FDA approvals as the gold standard as far as drugs and medical devices are concerned. So, a drug or device with an US FDA approval has it easier with the Indian authorities, or so has been the practice for decades.
Even as recent as June 2015, the US FDA had approved a pharmaceutical company’s application for codeine-chlorpheniramine maleate combination. Browsing through the US FDA database (https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm), shows several codeine combinations.
A few doctors whom TOI spoke to said that some patients with tuberculosis or chronic obstructive pulmonary disorder respond better to Corex-type combinations than plain codeine syrup. ``We have seen this time and again over the last two decades,’’ said chest specialist Dr A Mahasur from Mumbai who is puzzled with the ban on codeine-chlorpheniramine maleate combination.
Incidentally, both Pfizer and Abbott, manufacturers of Corex and Phensedyl respectively, moved the Delhi High Court and got a stay on the government ban. In recent months, the Indian authorities had been vocal against codeine’s addictive nature and the vast scale smuggling of the drug.
Codeine and its combinations are rarely given to children. In fact, the US FDA has mentioned that the combination shouldn’t be given to children. A research paper written by chest specialist Dr Agam Vora and published in JAPI (Journal of Association of Physicians of India) in 2015 said, ``Codeine in combination with other medicines has been a mainstay for the effective short-term symptomatic relief of dry or nonproductive cough in clinical practice.’’ It mentioned that codeine is one of the centrally acting narcotic opioids approved for use as an anti-tussive (a cough suppressant), and is metabolised into morphine in the liver.
``Codeine is one of the most frequently used anti-tussive in clinical practice and has been widely regarded as the standard cough suppressant against which newer drugs are being evaluated. Codeine has an advantage as an anti-tussive because of its multifaceted effect as an analgesic and sedative along with cough suppression. However, codeine may have efficacy to suppress cough in humans only in specific situations. Caution is also needed to limit its use only when and as long as it is clinically necessary, particularly in children,’’ the paper concluded.