Indian regulations mandate CDSCO approval for fixed-dose combinations (FDCs) before sale, as combining drugs alters how they work in the body, potentially increasing side effects, reducing efficacy, or causing harm
Published Apr 18, 2025 | 10:53 AM ⚊ Updated Apr 18, 2025 | 10:53 AM
(Creative Common)
Synopsis: A new notice from India’s drug regulator, CDSCO, has flagged 35 fixed-dose combination (FDC) medicines being sold without required approval. These unapproved drugs, used for conditions like diabetes, infections, and heart disease, are widely available. The CDSCO warns that many combinations lack clinical trial data or safety evaluations, posing serious health risks due to potential harmful drug interactions
A blistering new notice from India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged 35 fixed-dose combination (FDC) medicines that are being marketed without the mandatory approval from the licensing authority.
These include drugs used for pain relief, cardiovascular disease, diabetes, infections, and gastric issues, many of which are widely available in Indian pharmacies under various brand names.
The list, released in April 2025, reveals a disturbing pattern: combinations of two or more drugs being sold in fixed proportions — sometimes in dangerous or irrational doses — without any clinical trial backing, pharmacokinetic justification, or safety evaluations.
Under Indian drug regulations, every fixed-dose combination (FDC) must be approved by the CDSCO before being marketed. The rationale behind this requirement is simple: combining drugs alters their pharmacodynamics and pharmacokinetics — how they act in the body and interact with each other. These altered profiles can lead to increased side effects, reduced efficacy, or even dangerous outcomes.
“It has come to the notice of this Directorate that certain Fixed Dose Combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy, as per the provisions of the NDCT Rules 2019 under the Drugs & Cosmetics Act, 1940. This poses a serious risk to public health and safety,” said Dr. Rajeev Singh Raghuvanshi, CDSCO head, in a letter to state drug regulators.
He pointed out that the approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation.
“Upon issuing show-cause notices to the manufacturers, they claimed that these licenses were granted by the respective Drug Licensing Authorities and that they had not violated any rules. This has led to a lack of uniform enforcement of the provisions of the NDCT Rules 2019 under the Drugs & Cosmetics Act, 1940, across the country,” he pointed.
“In view of the above, all the State and Union Territory Drug Controllers are requested to review their approval processes for such FDCs and ensure strict compliance with the provisions of the Act and Rules. Public health and safety must remain the top priority,” he added.
CDSCO’s flagged list covers a spectrum of drug categories:
1. Life‑threatening, Multi‑drug‑resistant infections
2. Severe bacterial infections (systemic antibiotics ± probiotics)
3. Cardiovascular & antiplatelet therapy
4. Diabetes mellitus (Type 2)
5. Neuropathic pain, Depression & nutritional support
6. Asthma & COPD
7. Overactive bladder
8. Pain management & muscle spasm
9. Cough, cold & allergic rhinitis
10. Gastrointestinal symptom relief & enzymatic digestion
11. Antifungal & antibacterial skin cream
12. Hormonal, sleep & antioxidant supplements
“While the combination of Ambroxol, Dextromethorphan, and Chlorpheniramine can be effective in managing symptoms of cough and congestion, it is important to be cautious of potential side effects. Ambroxol, a mucolytic agent, may cause gastrointestinal discomfort, while Dextromethorphan, a cough suppressant, can lead to drowsiness or dizziness. Chlorpheniramine, an antihistamine, may also cause sedation and dry mouth. In patients with pre-existing conditions such as asthma or cardiovascular issues, the use of this combination should be carefully monitored to avoid adverse reactions. As with any medication, patient safety must be the top priority,” said a Hyderabad based pharmacologist.
He added that while fixed-dose combinations (FDCs) offer convenience for patients and streamline treatment regimens, it’s crucial that each combination undergoes rigorous evaluation for safety, efficacy, and potential drug interactions.
“The introduction of unapproved FDCs poses significant risks, especially in managing complex conditions like diabetes, hypertension, and infections,” he said.
(Edited by Ananya Rao)
