A fixed-dose combination (FDC) contains two or more active pharmaceutical ingredients in a fixed ratio within a single dosage form. Well-designed FDCs, such as antiretroviral, antimalarial and anti-tuberculosis combinations, simplify regimens, improve adherence and can delay the emergence of antimicrobial resistance (AMR). Poorly justified FDCs expose patients to unnecessary ingredients, prevent dose titration of individual components, multiply the risk of adverse drug reactions and interactions, and add cost without therapeutic gain [1,2].

India is among the largest FDC markets in the world. Using national sales data for 2011–2012, McGettigan and colleagues found that 124 NSAID FDC formulations were marketed, of which only 34 (27%) had been approved by the central regulator; 81% of antidepressant/benzodiazepine FDCs were unapproved and accounted for 69% of that segment's sales [3]. Among 118 antibiotic FDC formulations sold in India, 75 (64%) had never been approved by the Central Drugs Standard Control Organisation (CDSCO), and only four were approved in the United States or United Kingdom [4]. More recent longitudinal data show that psychotropic FDC sales rose from 0.8 to 1.4 billion standard units between 2008 and 2020, with unapproved formulations still accounting for 60.3% of those sales [5]. These findings reflect a historical gap between central approval and state-level manufacturing licences documented by Parliament in 2012 [6].

The National List of Essential Medicines (NLEM) is India's reference standard for medicines that satisfy priority health-care needs. NLEM 2022, released in September 2022, lists 384 medicines across 27 therapeutic sections [7,8]. Its inclusion criteria generally exclude FDCs unless the combination offers a proven advantage in efficacy, safety, adherence or resistance prevention over single agents [7]. NLEM listing has direct economic consequences: formulations of NLEM medicines fall under ceiling-price control through the Drugs (Prices Control) Order, 2013 [9]. Because a combination of a scheduled medicine with another ingredient was, in effect, a distinct product outside price control, FDCs have been described as a route by which manufacturers escape price regulation [2,10].

The Government of India has used Section 26A of the Drugs and Cosmetics Act, 1940 to prohibit irrational FDCs in several rounds: 344 FDCs in March 2016 following the Kokate committee review; 328 FDCs (with six restricted) in September 2018 after re-examination by the Drugs Technical Advisory Board (DTAB) under a Supreme Court direction; 14 FDCs in June 2023; and 156 FDCs in August 2024 [10–14]. Each prohibited FDC was, by definition, a licensed product that had been manufactured and sold in India. The published prohibition notifications therefore constitute a verifiable, product-level record of the FDCs that circulated in the Indian market.

Previous analyses of NLEM 2022 have noted that it contains few FDCs and omits the anti-tuberculosis FDCs used by the National TB Elimination Programme [15,16], while market studies have focussed on individual therapeutic classes [3–5,17]. To our knowledge, no study has compared the FDCs of NLEM 2022 directly with a complete, recent set of marketed FDCs. We therefore aimed (i) to enumerate and characterise the FDCs listed in NLEM 2022 and their concordance with the WHO Model List of Essential Medicines (EML) 2023, and (ii) to measure the concordance, therapeutic distribution and formulation complexity of the 156 FDCs removed from the Indian market in August 2024 relative to these essential-medicines standards. We hypothesised that marketed FDCs outside the essential-medicines standard would contain more ingredients and would be concentrated in symptomatic, over-the-counter-type therapeutic areas.

Study design and reporting

This was a document-based (desk) cross-sectional study using publicly available regulatory and policy documents. Reporting follows the STROBE statement for cross-sectional studies, adapted to a document-level unit of analysis [18]. The unit of analysis was a single FDC entry (a unique combination of active ingredients as named in the source document).

Data sources

Reference standard. The National List of Essential Medicines 2022 (Ministry of Health and Family Welfare, Government of India), accessed as the CDSCO-hosted PDF [7], and the WHO Model List of Essential Medicines, 23rd list (2023) [19].

Market-side record. The CDSCO consolidated list of 156 FDCs prohibited for manufacture, sale and distribution under Section 26A of the Drugs and Cosmetics Act, 1940, by Gazette notifications S.O. 3285(E) to S.O. 3440(E) dated 2 August 2024 [14]. This is the most recent complete prohibition round and was used because every entry is a product that held a manufacturing licence and was marketed in India until the notification date; the list is publicly verifiable and item-numbered.

Contextual evidence. Published peer-reviewed analyses of Indian FDC sales and regulatory status (2015–2024) [3–5,17] and official or contemporaneous reports of earlier prohibition rounds [11–13] were extracted for descriptive comparison. All documents were accessed on 23 September 2026.

Eligibility and definitions

An NLEM entry was classified as an FDC if it named two or more active pharmaceutical ingredients combined in a fixed ratio in one product or co-packaged pack (e.g., "Amoxicillin + Clavulanic acid"). Parenteral fluids and electrolyte solutions (e.g., Ringer lactate), oral rehydration salts, and single drugs presented in a diluent (e.g., bupivacaine 0.5% with 7.5% glucose) were excluded because their components are not separate pharmacological agents in the sense relevant to FDC rationality. All 156 prohibited FDCs were included; none were excluded.

Concordance was defined as the identical combination of active ingredients appearing in NLEM 2022 or the WHO EML 2023, irrespective of strength. For NLEM entries, WHO EML status was coded as "listed", "equivalent listed" (a therapeutically interchangeable combination or the same components listed for co-administration, e.g., emtricitabine + tenofovir for lamivudine + tenofovir) or "not listed".

Variables and coding

For each prohibited FDC the following were coded: (a) primary therapeutic area (nine categories, assigned by pharmacological class of the principal active ingredient and the grouping used in the notification); (b) route (oral, topical skin, ophthalmic/otic/nasal, parenteral); (c) number of listed ingredients, counted as the ingredients named in the notification, including excipient-type substances listed as components (e.g., hydroxypropyl methylcellulose); and (d) presence of ten pre-specified component classes: antibacterial/antifungal/antiprotozoal agent; vitamin, mineral, herbal or nutraceutical; sympathomimetic decongestant; naphazoline; first-generation antihistamine; paracetamol; non-salicylate NSAID; proteolytic enzyme; galenical tincture, spirit or chloroform; and probiotic. A broader "any anti-infective" variable additionally counted antiparasitic agents (diethylcarbamazine, gamma benzene hexachloride). Component classes were identified by pre-specified keyword rules applied to the ingredient string and then checked manually item by item. For NLEM FDCs, the number of active ingredients and the number of listed formulation–strength combinations were recorded.

Bias and data quality

Selection bias was minimised by including every entry of both source documents. The complete coded dataset, the extraction rules and the analysis script are provided as supplementary material, so that every figure in this paper can be reproduced. Ingredient strings were transcribed from the official list; spelling errors in the source were corrected only where unambiguous (e.g., "Acelofenac"). Because the prohibited list is a record of FDCs judged irrational, it is not a random sample of all marketed FDCs; this is addressed in the limitations.

Statistical analysis

Categorical variables are presented as n (%) with Wilson score 95% CIs; the number of ingredients is presented as median (interquartile range, IQR) because it was right-skewed. The number of ingredients per FDC was compared between NLEM FDCs and prohibited FDCs with the two-sided Mann–Whitney U test (effect size: rank-biserial correlation, rrb). The proportions with ≥3 ingredients and with an anti-infective component were compared with Fisher's exact test, with odds ratios (OR) and Woolf 95% CIs (Haldane correction). Differences in ingredient count across therapeutic areas within the prohibited set were tested with the Kruskal–Wallis H test. A two-sided p < 0.05 was considered significant. Analyses were performed in Python 3 (pandas, SciPy 1.x, statsmodels) and figures in matplotlib.

Ethical considerations

The study used only publicly available government documents and published aggregate data; it involved no human participants, patient records or animals. Ethics committee approval was therefore not required.

FDCs in NLEM 2022

Of the 384 medicines in NLEM 2022, 19 entries met the FDC definition (4.9%; 95% CI 3.2–7.6) (Figure 1; Table 1). Anti-infectives accounted for 14 of 19 (73.7%; 95% CI 51.2–88.2): nine antiretroviral, three antibacterial (amoxicillin + clavulanic acid, piperacillin + tazobactam, co-trimoxazole) and two antimalarial combinations (Figure 2). The remaining five were lignocaine + adrenaline, ferrous salt + folic acid, ethinylestradiol + levonorgestrel, levodopa + carbidopa and coal tar + salicylic acid. Fifteen (78.9%) were two-drug combinations and four (21.1%) three-drug combinations. The 19 FDCs were listed in 46 formulation–strength combinations (median 2 per FDC; IQR 1–3).

Fourteen NLEM FDCs (73.7%) were listed in the WHO EML 2023 and three (15.8%) had an equivalent listed; only zidovudine + lamivudine + nevirapine and coal tar + salicylic acid had no WHO EML counterpart (Table 1). Conversely, several FDCs of the WHO EML 2023 were absent from NLEM 2022, including the first-line anti-tuberculosis FDCs, antihypertensive FDCs, cardiovascular "polypills", budesonide + formoterol, and the Reserve-group β-lactam/β-lactamase-inhibitor combinations (Table 2).

Table 1. Fixed-dose combination entries in the National List of Essential Medicines 2022 and their status in the WHO Model List of Essential Medicines 2023

"Equivalent listed": tenofovir + lamivudine (WHO lists emtricitabine + tenofovir, interchangeable NRTI backbone); darunavir + ritonavir (darunavir listed for co-administration with ritonavir); artesunate + sulphadoxine–pyrimethamine (sulfadoxine + pyrimethamine listed for use with artesunate). DF, disoproxil fumarate. Source: NLEM 2022 [7]; WHO EML 2023 [19].

Table 2. Selected FDCs in the WHO Model List of Essential Medicines 2023 that are absent from NLEM 2022

Source: WHO EML 2023 [19]; NLEM 2022 [7]; Manikandan 2023 [15]; PHRI 2023 [20]. NTEP, National Tuberculosis Elimination Programme; CVD, cardiovascular disease; COPD, chronic obstructive pulmonary disease.

Characteristics of marketed FDCs prohibited in 2024

The 156 prohibited FDCs were distributed across nine therapeutic areas (Figure 3; Table 3). The largest groups were dermatological topical products (31; 19.9%), ophthalmic, otic and nasal preparations (30; 19.2%), analgesic and musculoskeletal products (25; 16.0%) and cough-cold, respiratory and antiallergic products (24; 15.4%). Most were oral (92; 59.0%), followed by topical skin (31; 19.9%), ophthalmic/otic/nasal (30; 19.2%) and parenteral (3; 1.9%: mefenamic acid + paracetamol, diclofenac + thiocolchicoside and methocarbamol + diclofenac injections).

The median number of listed ingredients was 3 (IQR 2–5; mean 3.82 ± 2.02; range 2–15). Fifty FDCs (32.1%; 95% CI 25.2–39.7) had five or more ingredients; the most complex were a 15-enzyme digestive combination, a 12-ingredient glucosamine–chondroitin–vitamin–trace-element product and a 10-ingredient glucosamine product. Ingredient count differed across therapeutic areas (Kruskal–Wallis H = 28.6, df = 8, p < 0.001), being highest in ophthalmic/otic/nasal products (median 5; IQR 4–5) and gastrointestinal/hepatobiliary products (median 4.5; IQR 2.75–6.25) (Table 3).

Component analysis (Figure 5) showed that 50 FDCs (32.1%; 95% CI 25.2–39.7) contained a vitamin, mineral, herbal or nutraceutical ingredient (e.g., silymarin, Ginkgo biloba, glucosamine, aloe). Thirty-four (21.8%) contained a sympathomimetic decongestant, including 22 (14.1%) naphazoline-containing eye or nasal drops, and 29 (18.6%) a first-generation antihistamine. Paracetamol was present in 16 (10.3%) and a non-salicylate NSAID in 13 (8.3%); five combined paracetamol with an NSAID. Seven (4.5%) contained a proteolytic enzyme (serratiopeptidase, bromelain or papain), three (1.9%) a probiotic, and three (1.9%) galenical tinctures or chloroform.

An antibacterial, antifungal or antiprotozoal agent was present in 25 FDCs (16.0%; 95% CI 11.1–22.6); 28 (17.9%) contained any anti-infective. These included systemic antibiotics combined with non-antibiotic adjuncts (cefixime + acetylcysteine; cephalexin + serratiopeptidase; doxycycline + serratiopeptidase; amoxicillin + dicloxacillin + Lactobacillus; erythromycin + lactic acid bacillus; doxycycline + ornidazole + bromelain + two probiotics), an antibiotic–antibiotic combination (tetracycline + colistin), an antibiotic–urinary antispasmodic combination (flavoxate + ofloxacin), topical antibiotic–corticosteroid–antifungal mixtures (miconazole + gentamicin + fluocinolone; beclomethasone + neomycin + clotrimazole + lignocaine) and a veterinary coccidiostat combination (sulfaquinoxaline + diaveridine + vitamin K).

Table 3. Characteristics of the 156 FDCs prohibited in August 2024, by therapeutic area

IQR, interquartile range. Ingredients counted as named in the notification. Any anti-infective includes antibacterial, antifungal, antiprotozoal and antiparasitic agents. Kruskal–Wallis test for ingredient count across areas: H = 28.6, df = 8, p < 0.001.

Concordance and comparative analysis

None of the 156 prohibited FDCs matched a combination in NLEM 2022 or the WHO EML 2023 (0/156; 95% CI 0–2.4%). Compared with the 19 NLEM FDCs, prohibited FDCs contained more ingredients (median 3 [IQR 2–5] vs. 2 [IQR 2–2]; Mann–Whitney U = 611, p < 0.001; r_rb = 0.59) (Figure 4). The odds of an FDC having ≥3 ingredients were 9.0 times higher among prohibited FDCs (110/156, 70.5% vs. 4/19, 21.1%; OR 8.97, 95% CI 2.71–24.69; p < 0.001). Conversely, anti-infectives made up most NLEM FDCs but a minority of prohibited FDCs (14/19, 73.7% vs. 28/156, 17.9%; OR 12.8, 95% CI 4.1–34.4; p < 0.001) (Table 4).

Table 4. Comparison of NLEM 2022 FDCs with FDCs prohibited in August 2024

*17/19 listed or with a listed therapeutic equivalent in WHO EML 2023 (14 listed; 3 equivalent). †Mann–Whitney U test; r_rb, rank-biserial correlation. ‡Fisher's exact test; OR with Woolf 95% CI (Haldane correction). §Odds of an anti-infective component in NLEM FDCs relative to prohibited FDCs. CI, confidence interval; OR, odds ratio.

Regulatory and market context

Four rounds of Section 26A prohibitions were identified between 2016 and 2024 (Figure 6). These rounds are not additive: the 2018 notification re-examined the 2016 cohort after judicial review, and later rounds arose from expert-committee review of FDCs whose status remained unresolved. Published sales analyses (Table 5) show that unapproved FDCs made up 27–81% of formulations in the classes studied [3–5], that banned antimicrobial FDC sales fell by 75% within a year of the 2018 ban but that overall sales of discouraged FDCs fell by only 8% because of substitution with closely related combinations [17].

Table 5. Published evidence on FDCs in the Indian market, compared with the present study

Unapproved: no record of central (CDSCO) approval. Units are standard units (tablets, capsules, ampoules or equivalent) from national sales audits.

Supplementary Table S1. Complete coded list of the 156 FDCs prohibited by the Government of India on 2 August 2024 (S.O. 3285(E)–3440(E)); S. No. follows the CDSCO consolidated list [15]

Area and route assigned by the author as described in Methods. Ingredient names reproduced from the CDSCO list; minor spelling corrections only. Full coded variables (ten component flags) are provided in datasetB_prohibited_2024.csv.

This analysis produced three principal findings. First, NLEM 2022 contains only 19 FDCs (4.9% of listed medicines), and these are almost all programme-critical anti-infective combinations with a WHO EML counterpart. Second, the 156 FDCs removed from the Indian market in August 2024 had no overlap with either essential-medicines list. Third, the marketed FDCs were structurally different from the essential ones: they had nine-fold higher odds of containing three or more ingredients, one in three contained a vitamin, herbal or nutraceutical component, and they were concentrated in symptomatic therapeutic areas—topical skin products, decongestant eye drops, analgesic–musculoskeletal and cough-cold products—where self-medication and over-the-counter sale are common.

The contrast in composition reflects the different logics by which the two sets of FDCs came into existence. NLEM FDCs satisfy WHO criteria: each component has demonstrated efficacy, the combination has a proven advantage (for example, preventing monotherapy and resistance in HIV and malaria, or peripheral decarboxylase inhibition in levodopa + carbidopa), and the ratio is fixed at clinically appropriate doses [2,19]. By contrast, the prohibited FDCs typically added symptomatic, adjunctive or non-evidence-based ingredients to an established drug—for example, serratiopeptidase, for which a systematic review found no reliable evidence of anti-inflammatory benefit [21], added to cephalexin, doxycycline or etodolac. Naphazoline, an imidazoline vasoconstrictor associated with rebound hyperaemia and, in young children, systemic toxicity, appeared in 22 ophthalmic and nasal products combined with antihistamines, camphor, menthol and boric acid. Such combinations cannot be titrated, expose patients to ingredients they do not need and complicate attribution of adverse reactions [1,10].

The presence of antimicrobials in 16% of prohibited FDCs is directly relevant to AMR containment. Antibiotic FDCs of unproven rationale are classified by WHO as "not recommended" in the AWaRe framework [22], and India has repeatedly been identified as a major consumer of such products [4,17]. Our data show that the 2024 prohibition removed a further set of systemic antibiotic–adjunct and topical antibiotic–corticosteroid combinations, and that one prohibited product was a veterinary coccidiostat combination. The experience after the 2018 ban is instructive: sales of the banned antimicrobial FDCs fell by 75%, but manufacturers substituted closely related, non-banned combinations, so that total sales of discouraged FDCs fell by only 8% [17]. Product-by-product prohibition therefore addresses the symptom rather than the licensing pathway that allows new variants to appear.

Our findings also point to gaps on the NLEM side. NLEM 2022 lists first-line anti-tuberculosis drugs only as single agents, although the National TB Elimination Programme uses 3- and 4-drug FDCs and the WHO EML lists them [15,19]. Antihypertensive FDCs, cardiovascular polypills (added to the WHO EML in 2023) and budesonide + formoterol inhalers are similarly absent [19,20]. These are precisely the FDCs for which there is evidence of improved adherence and outcomes. Their omission means that the most rational FDCs used in Indian practice fall outside the price-control and public-procurement benefits that NLEM listing confers [9], while irrational FDCs historically escaped price control by virtue of not being listed [2,10]. Revising NLEM to include programme-critical FDCs would align the essential-medicines standard with national programmes and with the WHO EML.

Our results are consistent with earlier Indian studies. McGettigan and colleagues showed that most NSAID, psychotropic and antibiotic FDC formulations on the market had never been centrally approved [3,4], and Bogowicz and colleagues found that unapproved formulations still accounted for 60% of psychotropic FDC sales in 2020 and that two of three banned psychotropic FDCs remained on sale [5]. Rao and Hotwani, counting FDC entries in NLEM 2022 with broader inclusion rules, reported 22 FDCs, nine of them antiretroviral [16]; the difference from our 19 is explained by our exclusion of oral rehydration salts, parenteral solutions and drug-in-diluent preparations. Our study extends this literature by providing a complete, item-level comparison of a recent regulatory cohort with the essential-medicines standard.

Clinical and policy implications. For prescribers and pharmacists, the absence of any prohibited FDC from the NLEM/WHO EML provides a simple screening heuristic: an FDC that is not on the essential-medicines list should be prescribed only when each ingredient is independently indicated at the fixed dose. For regulators, the findings support (i) mandatory demonstration of therapeutic justification under the New Drugs and Clinical Trials Rules, 2019 for all FDCs, including those licensed by states before 2019 [23]; (ii) a public, searchable register of licensed FDCs linked to the NLEM; and (iii) post-ban market surveillance to detect substitution. For institutional drug and therapeutics committees and AMR stewardship programmes, hospital formularies should restrict antibiotic FDCs to those in the NLEM/WHO EML.

Strengths and limitations. Strengths include the use of complete, official, publicly verifiable documents; inclusion of every entry without sampling; pre-specified definitions; and full reproducibility of the dataset and code. Several limitations apply. First, the market-side dataset consists of FDCs already judged irrational by an expert committee; it is a verifiable record of marketed FDCs but not a representative sample of all FDCs currently sold, and it cannot provide sales volumes, brand counts or local availability. Findings should not be extrapolated to the proportion of all marketed FDCs that are irrational. Second, we did not conduct a pharmacy-level survey in a defined geographic area, so regional variation in FDC availability could not be assessed. Third, ingredient counts followed the notification text, which lists some excipient-type substances as ingredients; this may slightly overstate complexity for ophthalmic products. Fourth, therapeutic-area coding involved investigator judgement for some multi-purpose products, although the coding rules and the full coded list are provided. Finally, concordance with the WHO EML was assessed at the level of the active-ingredient combination and did not consider strength or formulation.

Future research. Prospective, geographically defined audits of retail pharmacy stock and prescriptions, using NLEM 2022 as the reference standard, are needed to estimate the share of irrational FDCs currently dispensed, to track substitution after prohibitions, and to quantify the proportion of antibiotic FDCs in community use. Linking such audits to AMR surveillance under the national AMR containment programme would allow the effect of FDC regulation on resistance trends to be assessed.

NLEM 2022 includes only 19 FDCs, almost all anti-infective combinations of proven value and concordant with the WHO EML. The 156 FDCs removed from the Indian market in 2024 shared no combination with either essential-medicines list and were significantly more complex, symptomatic and nutraceutical in composition. Using the NLEM and WHO EML as the licensing benchmark for FDCs, adding programme-critical FDCs (anti-tuberculosis, antihypertensive, inhaled corticosteroid–bronchodilator) to the NLEM, and monitoring the market for substitution after prohibitions are practical steps to promote rational use and support AMR containment.

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