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Anti-diabetic drug finally banned in India: The Deccan Herald
New Delhi, Dec 01: Apparently taking a cue from the classic story of Rip Van Winkle, the Health Ministry wakes up after 25 years, to ban a drug that is prohibited almost in the entire world since 1977.
New Delhi, Dec 01: Apparently taking a cue from the classic story of Rip Van Winkle, the Health Ministry wakes up after 25 years, to ban a drug that is prohibited almost in the entire world since 1977.
The anti-diabetic, Phenformin, is banned since 1977 world over, due to serious adverse side effects like development of lactic acidosis disease and ill effects on kidney and heart functions.
Developed in late 1950s, the drug was banned by the US Food and Drug Administration in early 1970s and in most countries by 1977, since it was found that risks associated with the drug did not outweigh the benefits. An American study in 1970s showed that the users of the drug has 25 per cent more chance of suffering from heart diseases.
ORDER TOO LATE? Interestingly sources told Deccan Herald, that as late as in 2001, the Drug Technical Advisory Board at the office of Drugs Controller General of India (DCGI) has certified Phenformin as a safe drug. But in the wake of Nimesulide controversy, DCGI decided to ban the drug in 2002 and the notification finally came a year late and put into effect only from October 2003.
In India, Phenformin was manufactured and marketed by Mumbai-based USV Ltd. under the brand name of DBI and DBI-TD. According to a pharma industry publication, the two brands were enjoying an annual sale of around Rs 7 crore and approximately 10,000 patients were using it when the ban came.
“Patients over 60 years may still be using the drug, as it was earlier prescribed to diabetics more than 40 years of age and those who were overweight. But the government should have banned it much earlier,” Dr A K Jhingon, a private practitioner who heads Delhi Diabetes Research Centre, said.
STILL AVAILABLE: However, experts alleged that till October, the drug was available in the market. “The message did not percolate to the doctors and chemists. I bought it from the market on October 28,” said Dr C M Gulhati, a former World Health Organisation (WHO) consultant on drugs.
When asked Dr Ashwini Kumar, the DCGI, admitted that it might take some time to withdraw the drugs from the market. “Overnight it will not turn into a poison?” he told Deccan Herald.
Since the drug has a shelf life of three years, a batch prepared in September, 2003 can be kept at the medicine shops till 2006, unless the company or the chemist made a conscious effort to stop sale of the two products, Dr Gulhati who edits Monthly Index of Medical Specialties (MIMS), said.
Developed in late 1950s, the drug was banned by the US Food and Drug Administration in early 1970s and in most countries by 1977, since it was found that risks associated with the drug did not outweigh the benefits. An American study in 1970s showed that the users of the drug has 25 per cent more chance of suffering from heart diseases.
ORDER TOO LATE? Interestingly sources told Deccan Herald, that as late as in 2001, the Drug Technical Advisory Board at the office of Drugs Controller General of India (DCGI) has certified Phenformin as a safe drug. But in the wake of Nimesulide controversy, DCGI decided to ban the drug in 2002 and the notification finally came a year late and put into effect only from October 2003.
In India, Phenformin was manufactured and marketed by Mumbai-based USV Ltd. under the brand name of DBI and DBI-TD. According to a pharma industry publication, the two brands were enjoying an annual sale of around Rs 7 crore and approximately 10,000 patients were using it when the ban came.
“Patients over 60 years may still be using the drug, as it was earlier prescribed to diabetics more than 40 years of age and those who were overweight. But the government should have banned it much earlier,” Dr A K Jhingon, a private practitioner who heads Delhi Diabetes Research Centre, said.
STILL AVAILABLE: However, experts alleged that till October, the drug was available in the market. “The message did not percolate to the doctors and chemists. I bought it from the market on October 28,” said Dr C M Gulhati, a former World Health Organisation (WHO) consultant on drugs.
When asked Dr Ashwini Kumar, the DCGI, admitted that it might take some time to withdraw the drugs from the market. “Overnight it will not turn into a poison?” he told Deccan Herald.
Since the drug has a shelf life of three years, a batch prepared in September, 2003 can be kept at the medicine shops till 2006, unless the company or the chemist made a conscious effort to stop sale of the two products, Dr Gulhati who edits Monthly Index of Medical Specialties (MIMS), said.