Indian court grants Pfizer temporary relief on cough syrup ban (updated)

Abbott India

14/03/2016 16:23

* India banned 344 drug combinations over the weekend 
    * Next Pfizer case hearing slated for March 21 
    * Abbott also challenged ban on cough syrup combination -TV 
    * Pfizer says banned syrup brought in $26 mln in Apr-Dec 
 
 (Adds statement from Pfizer's India unit) 
    By Zeba Siddiqui and Aditya Kalra 
    MUMBAI/NEW DELHI, March 14 (Reuters) - An Indian court 
granted U.S. drugmaker Pfizer  PFE.N   PFIZ.NS  an interim 
injunction on a ban on its popular cough syrup Corex, days after 
the government ordered it to be prohibited citing a potential 
risk to humans. 
    India's health ministry banned the combination of 
chlorpheniramine maleate and codeine syrup, which Pfizer sells 
as the cough syrup Corex, in a notice over the weekend. 
    Pfizer's Indian subsidiary appealed the ban through a writ 
petition in the New Delhi High Court, which granted the company 
a stay on Monday, pending the next court hearing, Pfizer said in 
a statement. 
    Pfizer's Indian business said earlier on Monday it had 
stopped selling Corex, and expected its profit to be hit, as the 
brand generated sales of about $26 million in the nine months 
through December. Pfizer shares closed down 9 percent in Mumbai, 
before the stay order was issued. 
    The court said the government had not issued Pfizer a "show 
cause notice" before banning the medicine, two lawyers for the 
drugmaker told Reuters, declining to be named. 
    The next hearing by on Pfizer's plea is slated for March 21. 
    The ban also applied to Abbott Laboratories'  ABT.N  
Phensedyl cough syrup and Abbott's Indian subsidiary also filed 
a writ petition at the same court, which will come up for 
hearing on Tuesday, local television channels said.  
    Sanjay Jain, a lawyer representing the health ministry, 
wasn't immediately available to comment. 
    Abbott's Phensedyl commands around a third of India's cough 
syrup market and makes up over 3 percent of the company's $1 
billion in revenue in India. The shares of Abbott's Indian arm 
fell about 3 percent after it said it would comply with the ban. 
    Abbott declined to comment on its case. 
    As the cough syrup contains the narcotic codeine, India has 
been privately pressuring manufacturers to better police supply 
chains to tackle smuggling and addiction, Reuters reported last 
year.  urn:newsml:reuters.com:*:nL3N12E1W6 
    Akun Sabharwal, drugs controller for the southern state of 
Telangana which last year detected an "illegal diversion" of 
Phensedyl worth about $8.5 million, said he believed the ban 
would end the syrup's abuse. 
     
    PATCHY REGULATION 
    The medicine was among 344 fixed-dose combination drugs 
India banned, saying a panel of experts found the drugs lacked 
"therapeutic justification".  urn:newsml:reuters.com:*:nL3N16M1SX 
    Market researcher AIOCD AWACS estimated it could cut sales 
in the local pharmaceutical industry by up to $522 million, with 
Pfizer and Abbott among the worst hit. 
    The sale of fixed dose combination medicines in India 
requires the approval of the central government. But several 
drug combinations have entered the market over the years based 
solely on approval from individual states.  urn:newsml:reuters.com:*:nL4N16K0CV 
    India has made intermittent efforts to shut this avenue, but 
success has been limited. In 2007 it ordered states to recall 
about 300 such combination drugs, but drugmakers challenged it 
in court and the order was stayed. (http://reut.rs/1J9azFo) 
    In 2014, India set up a panel of experts to review over 
6,000 such drug combinations, and asked companies to submit data 
to prove safety and efficacy of their drugs. 344 of those have 
been banned. 
    OPPI, a lobby group for multinational drugmakers, criticised 
the move, saying codeine-based combinations under the ban have 
the approval of India's drug controller, and companies were 
never made aware that these were being reviewed. Pfizer's India 
unit also said its Corex had the central government's approval. 
    Drug Controller General G.N. Singh was not immediately 
available to comment. 
    The Indian Pharmaceutical Alliance, which represents Indian 
drugmakers, said the review process was not transparent.  
    Health ministry official K.L. Sharma told Reuters he 
disagreed, saying, "we are not prepared to tolerate anything 
that will (adversely) affect patients." 
 
 (Additional reporting by Suchitra Mohanty in NEW DELHI; Editing 
by Mark Potter and Susan Fenton) 
 ((zeba.siddiqui@thomsonreuters.com; +91-9769624550; Reuters 
Messaging: zeba.siddiqui.thomsonreuters.com@reuters.net)) 
 
Keywords: INDIA PFIZER/MEDICINE