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The US Food and Drug Administration on June 18 warned brand-name drug and generic companies against data researched by an Indian company.
It has been alleged that the company manipulated the data used in key research to get approval for the drugs it manufactured. The data from researchers Synapse Labs may have been used in hundreds of drugs and such drugs are still available for sale in the market.
Last year, European regulators told the FDA to be cautious about Synapse. The European regulator later told US companies that rely heavily on Synapse studies for approval of their drugs that they will now have to look for another option for the job.
The FDA said that companies that have used Synapse data will have a year to prepare new data on the drugs. Because, without fresh data studies, it is difficult to know whether currently available drugs are safe or not. Masood Motamed, who is an FDA inspector until January 2023 and has a doctorate in biochemistry, said the entire episode raises many questions about the effects of drugs available in the market.
Motamed said his biggest concern is that the drugs from Synapse Labs may contain too much or too little of the active ingredient. Too much could lead to dangerous toxicity. Drugs that don't have enough of the ingredients run the risk of not working.
Of course, the FDA has not told patients, doctors and pharmacists which of the thousands of drugs may have been approved based on the fraudulent data. Because, it is also possible that the drug company hired a specific company to do the research and such information was kept secret. However, the FDA is monitoring the entire incident and if any safety concerns emerge, the agency will certainly take action, said FDA spokeswoman Cheri Duvall Jones.
The Bloomberg study identified several generic drugs that have now lost their brand name value despite having brand names earlier this year. These include Viagra and Cialis generics manufactured by India's Umedica Laboratories. The list also includes Lupin's cholesterol-lowering drug Lipitor and Aurobindo Pharma's risedronate sodium. In particular, the FDA often protects corporate information, including the company where the drug is manufactured, for fear of violating trade secret laws.
Security Concerns
Synapse Labs-related medicines may contain too much or too little of the active ingredient
According to Bloomberg research, the affected drugs include Umedica's Viagra and Cialis generics, Lupin's Lipitor, Aurobindo Pharma's risedronate sodium.
The FDA has so far seen no indication in its side effect data that the drugs have serious safety concerns
This problem can lead to very serious toxicity problems, with drugs that do not contain enough of the element running the risk of not working
However, without accurate data, it is difficult to know the true results of the study and whether such medicines are safe or not
Generic versions of the erectile dysfunction drugs Viagra and Cialis are believed to have been approved for the US market using potentially fraudulent data, raising serious questions about their safety and efficacy.