The Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulator, has identified at least 90 unapproved fixed-dose combination (FDC) medicines in circulation and asked states to move against those involved in their manufacture and sale. The directive follows a review of lab testing data for 2025.
The communication was issued last week, according to News18 reports. It calls for immediate checks and action on companies linked to these products.
CDSCO flags unapproved FDC drugs: What triggered the crackdown
The findings came from scrutiny of samples uploaded on the Sugam portal, the government’s online system for drug testing data. Several of these samples were found to fall under the ‘new drug’ category but lacked approval from the central authority, the News18 report stated.
That is where the issue begins.
Under existing rules, no new drug can be manufactured or sold without prior clearance from the Central Drugs Standard Control Organisation (CDSCO).
The Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, described the presence of such medicines in the supply chain as a serious concern. The note, cited by News18, also pointed to violations of the Drugs and Cosmetics Act, 1940.
Categories of unapproved FDC drugs: Vitamins, anti-diabetic, cough syrups
The list is spread across common treatment segments.
Cough and cold combinations:
The biggest segment with around 14-16 entries, including multi-ingredient syrups combining dextromethorphan, ambroxol, guaiphenesin, chlorpheniramine, phenylephrine, terbutaline and menthol. Some paediatric formulations were also listed.
Vitamins, minerals and supplements:
Roughly 18-20 products, including multivitamin capsules, iron-folic acid syrups, calcium with vitamin D3 and K2, and combinations like methylcobalamin-based formulations used in neuropathy care.
Antifungal and dermatological creams:
Close to 10 entries. Mostly topical creams combining steroids with antifungal agents – a category that has seen regulatory concern earlier as well.
Anti-diabetic combinations:
Around 5-6 drugs were flagged in this category. These include fixed-dose combinations such as glimepiride with metformin and glimepiride with pioglitazone.
Other formulations:
A smaller set includes magnesium tablets, iron supplements, and mixed mineral formulations that fall under the ‘new drug’ category without approval.
State action and compliance checks on unapproved medicines are requested
State drug regulators have been asked to verify whether any approvals were granted locally and to check if manufacturers had submitted mandatory permissions under Rule 83 of the NDCT Rules, 2019.
If such documents exist, copies must be shared. If not, action is expected.
The DCGI has also asked states to submit an action taken report at the earliest. The matter, the letter notes, should be treated as a priority.
Background and next steps
Concerns around unapproved FDCs are not new. A parliamentary committee had flagged similar lapses in 2012, noting that some state authorities issued licences without central clearance.
The current review brings the issue back into focus. This time with fresh data.
Further action will depend on state-level enforcement and follow-up reports. For now, regulators are looking to remove these products from circulation and tighten compliance checks across the supply chain.
