In a major relief to Pfizer Limited, the Delhi High Court Monday ordered a stay on the ban on its Corex cough syrup. Abbott India, the makers of Phensedyl cough syrup that has been banned by the government, also approached the Delhi High Court challenging the government order.
The health ministry's notification issued March 10 said examination by an expert committee showed over 300 combination drugs risked the lives of humans and are prohibited from manufacture, sale and distribution under Section 26(A) of the Drugs and Cosmetics Act (1940).
The combination drugs include two or more active pharmaceutical ingredients combined in a single-dosage form, manufactured and distributed in fixed doses.
"The company has challenged the government notification dated March 10, 2010 before the Delhi High Court. The court has granted an interim injunction to us, suspending the operation of the said notification, banning the manufacture for sale, sale and distribution of fixed dose combination of Chlopheniramine Maleate and Codeine Syrup(Corex) till the next date of hearing. We are awaiting the order from the Delhi High Court," said an official statement from Pfizer.
The counsels, Kapil Sibal and Rajiv Nayyar who represented the Pfizer, said the Corex has been available in Indian markets for 25 years and the same drug is available elsewhere in the world being sold by other companies. The counsels said the expert committee which has recommended the ban on combination drugs to centre was set up three years ago.They argued, the health ministry did nothing and has suddenly impose the ban, according to the Economic Times
The court hearing on the Corex ban has been scheduled for March 21.
The company earlier said in a Bombay Stock Exchange (BSE) filing the Corex drug recorded a sale of Rs 176 crore for the nine-month period ending Dec. 31, 2015.
Meanwhile, another drug company, Abbott India, has also moved Delhi High Court challenging the government order, the Hindustan Times reported.
"We are evaluating the notification and exploring all the available options we are concerned about the unilateral approach in prohibiting the manufacture, sale and distribution of combination drugs that were earlier approved by the Drug Controller General of India (DCGI)," Abbott spokesperson was quoted by the HT as saying.
Phensedyl, which is Abbott's cough syrup, reportedly accounts for one-third of the India's cough-syrup market. Phensedyl contributes to 3 percent of the company's market revenue in India.
Market research agency PharmaTrac, meanwhile, was quoted as saying by the Economic Times that Abbott may take a hit of Rs 485 crore and Pfizer Limited of Rs 368 crore as a result of the government move.