**Executive Summary**
The Union Ministry of Health and Family Welfare has prohibited the manufacture, sale, and distribution of 16 Fixed Dose Combinations (FDCs) for human use under Section 26A of the Drugs and Cosmetics Act, 1940. This decision, effective immediately as of June 20, 2026, follows a Supreme Court-mandated review which found these combinations to be irrational and lacking therapeutic justification. The action aims to safeguard public health by ensuring only scientifically validated and safe medicines remain available in the market.
**Key Points / Main Content**
* **Regulatory Framework and Authority**
* The prohibition is issued under Section 26A of the Drugs and Cosmetics Act, 1940.
* The decision follows directions from the Hon’ble Supreme Court of India for a comprehensive review of available FDCs.
* The Drugs Technical Advisory Board (DTAB) formed an Expert Committee to identify irrational or risky drug combinations.
* **Scientific Findings**
* The 16 identified FDCs were found to lack therapeutic justification.
* Continued use of these combinations was deemed not beneficial relative to the potential risks posed to human health.
* The action reinforces the government's commitment to evidence-based healthcare and patient safety.
* **Prohibited Categories and Scope**
* The ban covers the manufacture for sale, sale, distribution, and supply of the listed FDCs across the country.
* Affected therapeutic categories include dermatological preparations, analgesics, antispasmodics, and antibiotic-based formulations.
* Specific prohibited combinations include various Aloe Vera-based mixtures, Gliclazide + Chromium Picolinate, and several Amoxicillin or Cefuroxime combinations with Serratiopeptidase.
**Impact Analysis**
**State Drug Controllers, Regulatory Authorities, and Enforcement Agencies**
**Impact:** These bodies are responsible for the legal oversight and field-level execution of the ban.
**Action Required:** They must ensure strict implementation of the notifications and monitor compliance across their respective jurisdictions.
**Manufacturers, Importers, and Distributors**
**Impact:** These stakeholders are legally prohibited from producing, importing, or selling any of the 16 identified FDCs.
**Action Required:** They must immediately cease all prohibited activities and take necessary corrective measures to comply with the law.
**General Public**
**Impact:** Public health is safeguarded by the removal of irrational and potentially harmful drug combinations from the market.
**Action Required:** Patients and consumers should ensure they are using only scientifically validated medicines as the availability of these 16 FDCs is discontinued.
Key Entities Referenced
Section 26A of the Drugs and Cosmetics Act, 1940: The legal provision under which the Ministry of Health and Family Welfare issued notifications to prohibit the manufacture, sale, and distribution of irrational drug combinations.
Drugs Technical Advisory Board (DTAB): The statutory body that constituted an Expert Committee to review and identify harmful or irrational Fixed Dose Combinations (FDCs) following judicial directions.
16 Fixed Dose Combinations (FDCs): The specific group of drug formulations, including certain dermatological and antibiotic-based medicines, prohibited from public use due to lack of therapeutic justification.
Expert Committee: A specialized body formed to conduct scientific assessments and provide recommendations on the safety and efficacy of existing drug combinations.
Supreme Court: The judicial authority that mandated a comprehensive review of all Fixed Dose Combinations available in the country to safeguard public health.
Ministry of Health and Family Welfare
Union Ministry of Health and Family Welfare
Prohibits Manufacture, Sale and Distribution of
16 Fixed Dose Combinations (FDCs) in Public
Interest
Decision aimed at safeguarding public health and ensuring
availability of only scientifically justified drug combinations
प्रव तथ: 20 JUN 2026 12:42PM by PIB Delhi
In a significant step towards safeguarding public health and promoting the rational use of medicines, the
Ministry of Health and Family Welfare has issued notifications under Section 26A of the Drugs and
Cosmetics Act, 1940, prohibiting the manufacture for sale, sale and distribution for human use of 16 Fixed
Dose Combinations (FDCs). The notifications have come into force with immediate effect.
The decision follows directions of the Hon’ble Supreme Court, which had mandated a comprehensive
review of Fixed Dose Combinations available in the country. In compliance with these directions, the
Drugs Technical Advisory Board (DTAB) constituted an Expert Committee to examine various FDCs and
identify those that are irrational, lack therapeutic justification, or may pose risks to human health.
Based on the scientific assessment and recommendations of the Expert Committee, the Government has
taken action against 16 FDCs that were found to lack therapeutic justification and whose continued use
was not considered beneficial in relation to the potential risks involved. The prohibited FDCs belong to
various therapeutic categories, including certain dermatological preparations, analgesic and antispasmodic
medicines, and antibiotic-based formulations.
The Ministry noted that this action is in line with the Government’s continuing efforts to ensure that only
safe, effective and scientifically validated medicines are available to the public. In previous instances as
well, several irrational FDCs were prohibited following detailed scientific review, reinforcing the
commitment of the Government towards patient safety and evidence-based healthcare.
Accordingly, the manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human
use shall stand prohibited with immediate effect across the country.
All State Drug Controllers, regulatory authorities and enforcement agencies have been directed to ensure
strict implementation and compliance with the notifications. Manufacturers, importers, distributors and
other stakeholders have also been advised to take necessary corrective measures to comply with the
provisions of the law.
The e-Gazette regarding the same can be accessed through this link: https://egazette.gov.in/WriteReadDat
a/2026/273649.pdf
The detailed list of the prohibited Fixed Dose Combinations are as follows:S.No. Composition of the FDC Recommendations
1 Acetyl Salicylic acid + Ethoheptazine Recommended for prohibition under
Section 26A of Drugs & Cosmetics Act,
2 Aloe Extract + Allantoin + 1940
Alphatocopherol Acetate +D-Penthenol
+ Vitamin A
3 Aloe Extract +Vitamin E + Dimethicone
+ Glycerine
4 Aloe Vera +Jojoba Oil +Vitamin E
5 Aloe vera + Orange oil
6 Aloe vera + Jojoba oil + Wheat germ oil
+ Tea tree oil
7 Aloe vera + Vitamin E + Herbal
8 Dicyclomine + Paracetamol + Clidinium
Bromide
9 Dicyclomine +Paracetamol + Clidinium
Bromide + Chlordiazepoxide
10 Gliclazide + Chromium Picolinate
11 Paracetamol + Lignocaine
12 Amoxicillin + Serratiopeptidase+
Lactobacillus Sporogenes
13 Amoxicillin + Cloxacillin + Lactic acid
bacillus + Serratiopeptidase
14 Amoxicillin + Serratiopeptidase
15 Cefadroxyl + Probenecid
16 Cefuroxime + Serratiopeptidase
*****SR
(रलीज़ आईडी: 2275595) आगंतुक पटल : 1334
इस वज्ञ को इन भाषाओ ंम पढ़: Urdu , Marathi , ही , Tamil , Telugu , Malayalam