The high court (HC) in Delhi granted an interim order on the government ban on Pfizer’s cough syrup, Corex, which has an average monthly sale of Rs 20 crore. The company decided to move the HC after the government on Thursday notified a ban on about 300 fixed dose combination drugs. This includes the combination of codeine and chlopheniramine maleate, sold by Pfizer and Abbott under the respective brand names of Corex and Phensedyl. Abbott, too, has challenged the government order and its petition is to be heard on Tuesday.
Corex, one of the top selling drugs of Pfizer, generated sales of Rs 176 crore in the nine months ending December 2015. Phensedyl has an average annual sale of Rs 180 crore.
“We have received an interim injunction suspending the operation of the said notification banning the manufacture for sale, sale and distribution of fixed dose combination of Chlopheniramine Maleate + Codeine Syrup till the next date of hearing. We are awaiting the order from the honourable Delhi High Court,” the company said in a statement.
Corex has a well-established efficacy and safety profile in India for more than 30 years and has both Central and State licenses and approvals. Pfizer makes every effort to maintain the highest standards of regulatory and quality compliance in the manufacture and distribution of Corex”
“We are concerned about the unilateral approach in prohibiting the manufacture, sale and distribution of certain fixed dose combinations that have already been approved for use by DCGI (the sector regulator). We are evaluating the notification and exploring all available options,” an Abbott India spokesperson said.
The pharmaceutical industry – both Indian and multinational companies – has criticised the government's ban as unfair and non-transparent. S V Veeramani, president, Indian Drug Manufacturers Association, has asked the government to reconsider and said the ban was imposed without hearing the manufacturers.
“The Indian Pharmaceutical Association is not against a ban of irrational combinations. However, a ban must follow the due process of law laid down under the Drugs and Cosmetics Act. The current list (of banned drugs) includes some items not examined by the expert committee,” said D G Shah, secretary general of Indian Pharmaceutical Alliance.
“It is a big concern that, with this sweeping action, patients are to be denied access to some medicines that are approved as safe and efficacious in India and globally," said Ranjana Smetacek, director general, Organisation of Pharmaceutical Producers of India, a consortium of multinational drug makers.
A circular was issued by the Drugs Controller General of India (DCGI) in January 2013 to all state counterprats that all fixed drug combination drugs which do not have its approval needed to get it within 18 months. The central controller said if any of these failed to get its approval in 18 months, it would be banned.
The decision follows the recommendations of the Kokate committee, established in October 2014. Its report had a list of ‘approved’ and ‘irrational’ fixed dose combinations, opining that the combinations recommended as irrational should not be manufactured and sold in India.
According to industry sources, a DCGI notification of June 2014 had said any fixed dose combination drug whose production began before September 1988, will not need to take the controller’s approval, being deemed as approved. “Many of the drugs deemed approved as per this notification – have also been banned now,” said a source.