7 months ago
Delhi High Court Restores Ban on Diabetes FDCs
The Delhi High Court has recently restored a ban on two diabetes medicines that combine multiple drugs, including one called pioglitazone.
These medicines, known as fixed dose combinations (FDCs), mix several drugs into one pill.
The court's decision was made to protect public health, as some experts believe these combinations are not always safe or necessary.
Pioglitazone, one of the drugs in these FDCs, has been linked to heart problems, bone issues, and even bladder cancer.
Some doctors argue that these FDCs are not crucial and that there are other, safer options available.
The court's ruling has sparked discussions among health professionals and the pharmaceutical industry.
Delhi High Court restored a ban on two diabetes FDCs containing pioglitazone, upholding public health interests.
The ban was previously lifted by a single judge but was reinstated after a caveat was filed in the Supreme Court.
Pioglitazone is associated with risks such as heart failure, bone density loss, and bladder cancer.
Experts argue that these FDCs are not crucial and there are safer alternatives available.
The court's decision has sparked discussions among medical practitioners and public health workers.
- Who
- Delhi High Court, Micro Labs, Intas Pharmaceuticals, Lupin, Eris Lifesciences, All India Drug Action Network (Aidan)
- What
- Restoration of ban on two diabetes FDCs containing pioglitazone
- Where
- Delhi, India
- When
- January 2026
- Why
- In the interest of public health and rationality of products
Key facts
- Court
- Delhi High Court
- Drugs Banned
- Two diabetes FDCs containing pioglitazone
- Companies Involved
- Micro Labs, Intas Pharmaceuticals, Lupin, Eris Lifesciences
- Date of Judgement
- January 2026
- Expert Opinion
- Pioglitazone poses risks like heart failure, bone density loss, and bladder cancer
Quotes
Anurag Bhargava
Professor in the Department of Medicine at Mangalore’s Kasturba Medical College
“Evidence considered for regulatory approval of all drugs including FDCs should be accessible to consumers and professionals, along with its full prescribing information, and updates and advisories emerging out of new concerns on old drugs”
thehindubusinessline.com
“Often physicians may not be aware of the dose and constituent medicines in dual or triple drug FDCs, which also have the disadvantage of not allowing individualisation of drug doses”
thehindubusinessline.com
S.Srinivasan
Member of the All India Drug Action Network (Aidan) and co-founder of Locost
“The judgement is in the 'interest of rationality of products in this country'”
thehindubusinessline.com
Ambrish Mithal
Group Chairman of Max Healthcare (Department of Endocrinology and Diabetes)
“Irrational combinations are a challenge in India. And it’s not going to make any major difference to the patients or ….industry… there are lots of other options, which can be used. And they don’t necessarily have to be three drug combinations”
thehindubusinessline.com
Sources
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