Hyderabad: A total of 344 fixed dose combination drugs have been recalled by the Telangana Drugs Control Authority as these drugs do not have any therapeutic justification and are stated to be nonviable for human consumption.
The decision will affect 80 big and 100 small companies, with losses ranking to more than Rs 3,000 crore per week.
Market research agency PharmaTrac has stated that Abbott Healthcare Private Ltd will take a hit of Rs 485 crore. Macleods Pharma will lose Rs 370 crore and Pfizer, Rs 368 crore.
Others like Sun Pharma, Lupin, Wockhardt and Alkem will also suffer losses. According to sources, the worst-hit will be small manufacturers who may even be forced to shut shop or shift completely to single dose drugs.
A senior pharma official said, “Some of the companies in the state manufacture only three to four drugs. If these combinations are a part of their list than they are in for huge losses.” To recall all these drugs from the market will take two to three months.
Two top selling cough syrups, Corex of Pfizer and Phensedyl of Abbott Heal-thcare Private Limited, are in the list of fixed dose combinations which have been constantly tracked by drug controllers.
Dr Akun Sabharwal, director of the Drug Control Authority, said, “The expert committee set up by the government scrutinised 6,000 fixed dose combinations and they have found these 344 to be non-viable for human consumption. There have been constant complaints against cough syrups, combinations of antibiotics and diabetic drugs which are not found to work.”
The antibiotic combination of cefixime and azith-romycin under the Zimnic AZ brand is marketed by Abbott and 15 other companies but it is not found to be not of much use.
Combination drugs flood market
Combination drugs were started to improve the patient’s compliance levels but it has proliferated to such an extent that half the market is filled with combinations. Drug firms added ingredients to existing drugs so they can promote a new product and increase market share.
The ban on the drugs comes into immediate effect. “We have tried to bring objectivity to the issue by roping in the best of scientists to study the effects. Show cause notices were issued to more than 344 companies that were given time to make further representations after the expert committee gave its recommendations,” a senior Health Ministry official said.
“Some did not even care to respond. It was done after much examination,” the official said.
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