harma companies are planning to push hard for the withdrawal of an order by the health ministry last week to ban 329 drugs marketed as "fixed dose combinations," with some even looking at legal options.
Drug industry gears up to fight ban on 329 fixed dose combinations
MUMBAI: Pharma companies are planning to push hard for the withdrawal of an order by the health ministry last week to ban 329 drugs marketed as "fixed dose combinations," with some even looking at legal options.
Fixed dose combinations are two separate drugs combined into a single dose. The concept is widely accepted in global markets due to the advantages of lower cost and patient convenience.
However, medical experts in India are of the view that, with the exception of a few products, a large number of these are irrational and possibly harmful in the long term.
The drugs to be banned are listed in a government March 10 gazette notification and include top sellers such as Pfizer's Corex and Abbott's Phensedyl, both cough remedies.
Abbott is reviewing the notification. "We are concerned that patients may not have access to some medicines which have been approved by DCGI (Drug Controller General of India) and safely and effectively used in India for years," a company spokesperson said. "Some of these formulations have been the treatment of choice in specific medical conditions."
The notification that lists scores of combinations was based on the recommendations of an expert committee and cited public interest to regulate and prohibit the manufacture, sale and distribution of the products.
Overall, trade estimates suggest the move may shave off at least Rs 3,800 crore from the Indian market and the jolt may be felt by most companies down to the smallest drug units.
Market research agency PharmaTrac has said that Abbott may take a hit of Rs 485 crore on account of the move while Macleods Pharma will be impacted by Rs 370 crore and Pfizer may suffer a loss of Rs 368 crore. Others like Sun Pharma, Lupin, Wockhardt and Alkem are also among those that will be hit, it said.
The expert panle that was set up in 2014 reviewed as many as 6,000 formulations that had proliferated in the Indian market, according to a senior government official cited by Reuters.
The low threshold for approval of new medicines by state licensing authorities is seen as the root cause of the current situation and has been the subject of debate for years.
Some experts said the move was long overdue. Sunil Jain, who practices gastroenterology and hepatology at Indore, told ET that some medicines such as a proton pump inhibitor and prokinetic agent to treat gastric ulcers was sold as one dose.
"We don't require those products at all and they do not bring any additional value," he said, adding that a few exceptions in fixed dose combinations may be allowed but those should be based on global studies. Others however backed fixed dose combinations, saying they are relevant to a country like India.