Indian regulators over the weekend included some popular cough syrups containing codeine in a drug ban in what was deemed an effort to tighten up the nation's supply chain of opiates to fight smuggling and drug addiction. But the action by the Drug Controller General of India (DCGI) has unleashed a firestorm from Western drugmakers that dominate that market.
Abbott ($ABT) joined Pfizer ($PFE) in turning to the Indian Supreme Court for a stay on the ban, and Procter & Gamble ($PG) has said it was looking into that option. The DCGI over the weekend banned 344 fixed-dose drugs, claiming they did not have approval from the central government and lacked therapeutic justification. But the meds have been sold for years after getting approvals from local states.
Pfizer's Corex and Abbott's Phensedyl each control roughly a third of the $103 million market in India for cough suppressants with codeine. P&G sells Vicks Action 500 Extra, which is a fixed-dose combination of paracetamol, phenylephrine and caffeine, Reuters reports.
The government has been talking about a ban and has taken steps over the last few years to limit the manufacture and sales of the codeine-based drugs. They have said the steps were needed to make it harder for smugglers to divert codeine for illegal use and to fight the country's opiate addiction issues, Reuters reported last year. Both Pfizer and Abbott previously reduced their manufacturing runs after government rules limited sales to one batch per buyer. They also changed labeling to indicate on the label where products were to be sold to help regulators better track the meds.