Pfizer and Abbott cut production on their popular cough medicines in India last year after officials imposed new regs to fight the smuggling of opiates into Bangladesh. Now regulators have banned the products altogether, leaving Pfizer to scramble to court Monday for an order staying the action as it tries to sort out the matter.
The cough syrups, Corex from Pfizer ($PFE) and Phensedyl from Abbott ($ABT), dominate the $103 million market in India, Reuters reports. But they were included among 344 fixed-dose drugs the government banned over the weekend, claiming they did not have approval from the central government and lacked therapeutic justification. Reuters reports many meds have been sold for years after getting approvals from local states.
On Tuesday, Proctor & Gamble said its Vicks Action 500 Extra was also hit by the ban, the Economic Times reported.
Pfizer and Abbott both initially said they would comply with the ban, but Pfizer quickly followed that up with court action, getting a stay, Reuters said, citing Indian television. Abbott told the Economic Times that it had reviewed the order and was concerned by the "unilateral approach" taken by the Drug Controller General of India (DCGI). It also said it was looking at its options to counter the ban.
Phensedyl holds about a third of the Indian cough syrup market, and its sales there account for about 3% of Abbott's $1 billion revenues in India, Reuters reports. In a statement, Pfizer told the news service that Corex had Indian sales of about $26 million in the 9 months ended December 2015. It said Corex had a "well-established efficacy and safety profile in India for more than 30 years."
The government has been pressuring drugmakers for several years to limit their manufacture and sales of the codeine-based drugs because of concerns about opiate addiction in the country and smugglers diverting codeine for illegal use, Reuters reported last year. Both Pfizer and Abbott reduced their capacities to meet government demands that drugmakers limit 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.
Abbott at one point found itself in a fight with one state regulator that posted a notice that a couple of batches of an Abbott cough syrup were defective because they contained twice the level of codeine allowed by law. Abbott claimed it retested its retained samples of the product and found them to be within specs. The company said it couldn't get the state to provide samples of the confiscated bottles.
According to the news service, Indian drugmaker Cipla gave up on the codeine cough med market altogether, after "considering the business environment … and the fact that this product was regulated by multiple agencies."