Western drugmakers often complain about what sometimes seems like the capricious nature of Indian drug regulation. Now Pfizer ($PFE) has asked an Indian court to get involved after a regulator included popular cough syrups from it and Abbott ($ABT) in a broad ban of fixed-dose drugs over the weekend.
Pfizer's Corex and Abbott's Phensedyl cough syrups with codeine were among 344 fixed-dose drugs the government banned saying they lacked "therapeutic justification" and had never been approved by the central government. Reuters reports that many of the meds have been sold for years after getting approvals from local states. Pfizer and Abbott both initially said they would comply with the ban by the Drug Controller General of India (DCGI), but Pfizer quickly followed that up with court action, getting a stay on the ban, while the matter is sorted out.
Abbott's Phensedyl holds about a third of the Indian cough syrup market, and sales account for about $30 million of Abbott's $1 billion revenues in India, Reuters reports. Pfizer told the news service in a statement that Corex had sales of about $26.3 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."
Abbott told the Economic Times that it had reviewed the order and was concerned by the "unilateral approach" taken by the DCGI. It also said it was looking at its options to counter the ban.
The government has been pressuring drugmakers for several years to better control their manufacture and sales of codeine-based drugs over concern about opiate addiction in the country and smugglers diverting codeine for illegal use, Reuters reports. Both Pfizer and Abbott last year had to reduce their capacities to meet government demands that they limit sales to one batch per buyer.
Western drugmakers have a long history of fighting India's multilayered state and federal drug pharma regulations over issues like price caps on drugs and denied or revoked patents on expensive meds