The Indian Government has ordered Pfizer India for an immediate ban of a cough syrup, Corex, a prescription drug that have been in the market for more than 30 years.
The ban prompted Pfizer India to abruptly stop the manufacture, sale, and distribution of Corex, which is the combination of chlorpheniramine maleate and codeine syrup. The government's health ministry has perceived this fixed combination that involves "risk" to humans and safer alternatives were available, as reported by The Indian Express.
However, Pfizer appealed to the Delhi High Court, challenging the ban through a written petition, pointing out that the government has not issued the pharmaceutical company a "show cause notice" before banning hte medicine. The court has stayed the government's order, and has given interim injunction on the ban, Reuters stated. Pfizer issued a temporary relief, a stay on the implementation of a ban of cough syrup Corex till March 21, 2016.
Pfizer reported in The Financial Express, that alternative drugs must be prepared six months prior to distribution to give time for new formulations, development, analysis of the product, packaging preparations, and approvals by the authorities under the Act.
Although the pharmaceutical company has heeded the Government's orders, they still felt that the Government moved too drastically, thinking that the medicine has already been widely distributed country-wide. Aside from that, patients and regular consumers would perceive it as a denial of access to medicines.
The ban not only applied to Pfizer India and Corex, but also to other pharmaceutics that produced similar and other 344 fixed-dose combinations (FDCs) like Phensedyl and Benadryl.
Times of India had reported that the health ministry is doing this based on the view that these "...irrational FDCs are causing anti-microbial resistance and in some cases the toxicity is so high that it can even lead to failure of organs. There are also concerns many of these FDCs being available over-the-counter (OTC) without doctors' prescription, which is leading to their misuse."
Pfizer's Indian subsidiary and the other affected companies are expecting a definite plunge in their sales because of the ban.
"The prohibition is likely to have an adverse impact on the revenue and profitability of the company," the company said in a statement. "Corex recorded a sale of Rs 176 crore for the nine months ended December 31, 2015."
In financial year 2014-15, Pfizer Ltd reported a sales turnover of Rs 1,853 crore and net profit of Rs 70 crore, as reported in The Hindu.
