Drug Industry to resist ban on 329 fixed dose combinations
Mumbai:The drug industry has decided to join hands to resist the ban imposed by the health ministry on 329 fixed dose combinations. Pharma companies have come together to push for the withdrawal with some even considering 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 opinion in India is against the concept of fixed dose combination as besides being irrational, they have been found to be harmful in the long run. The drugs to be banned are listed in a government March 10 gazette notification
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."
Recommendations of an expert committee have resulted in this notification listing scores of combinations, cited in public interest, prohibiting manufacture, sale and distribution of products.
Trade estimates indicate that the move may shave off at least Rs 3,800 crore from the Indian market impacting 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.
An expert panel audit was conducted in 2014 which analysed as many as 6,000 formulations that proliferated in the Indian market, informed a senior government official in conversation with 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.
Experts were of the opinion that the move was long overdue. Sunil Jain, who practices gastroenterology and hepatology at Indore, told ET that some medicines like 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 were relevant to a country like India.
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 opinion in India is against the concept of fixed dose combination as besides being irrational, they have been found to be harmful in the long run. The drugs to be banned are listed in a government March 10 gazette notification
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."
Recommendations of an expert committee have resulted in this notification listing scores of combinations, cited in public interest, prohibiting manufacture, sale and distribution of products.
Trade estimates indicate that the move may shave off at least Rs 3,800 crore from the Indian market impacting 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.
An expert panel audit was conducted in 2014 which analysed as many as 6,000 formulations that proliferated in the Indian market, informed a senior government official in conversation with 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.
Experts were of the opinion that the move was long overdue. Sunil Jain, who practices gastroenterology and hepatology at Indore, told ET that some medicines like 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 were relevant to a country like India.
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