UPSC Prelims Practice Questions — Union Ministry of Health and Family Welfare Prohibits Manufacture, Sale and Distribution of 16 Fixed Dose Combinations (FDCs) in Public Interest

Q1. The power of the Central Government to prohibit, by notification in the Official Gazette, the manufacture, sale and distribution of a drug in the public interest is conferred by which one of the following provisions?

  • A. Section 10A of the Drugs and Cosmetics Act, 1940
  • B. Section 18 of the Drugs and Cosmetics Act, 1940
  • C. Section 26A of the Drugs and Cosmetics Act, 1940
  • D. Section 33P of the Drugs and Cosmetics Act, 1940

Q2. Which one of the following statements best describes the scope of Section 26A of the Drugs and Cosmetics Act, under which the recent prohibition of 16 Fixed Dose Combinations was notified?

  • A. It empowers the Central Government, by notification in the Official Gazette, to prohibit the manufacture, sale or distribution of a drug or cosmetic in the public interest under the Act of 1940
  • B. It empowers the Central Government to prohibit the import of any drug into India in the public interest under the Drugs and Cosmetics Act, 1945
  • C. It empowers State Drug Controllers to cancel manufacturing licences of irrational drug combinations under the Drugs and Cosmetics Act, 1948
  • D. It empowers the Drugs Controller General of India to recall any patented drug from the market under the Drugs and Cosmetics Act, 1955

Q3. Under the Drugs and Cosmetics Act, 1940, who chairs the Drugs Technical Advisory Board (DTAB), the highest statutory body advising the Central and State Governments on technical matters of drug regulation?

  • A. Union Secretary, Ministry of Health and Family Welfare
  • B. Director General of Health Services (DGHS)
  • C. Drugs Controller General of India (DCGI)
  • D. Director General, Indian Council of Medical Research (ICMR)

Q4. In the context of India's drug regulatory architecture, the 'Drugs Consultative Committee (DCC)' is best described as which one of the following?

  • A. A statutory body chaired by the Drugs Controller General of India that advises the Central Government, State Governments and the DTAB primarily to secure uniformity throughout India in the administration of the Drugs and Cosmetics Act, 1940
  • B. A non-statutory expert committee under NITI Aayog that recommends inclusion or deletion of medicines in the National List of Essential Medicines
  • C. A statutory body chaired by the Director General of Health Services that recommends prohibition of irrational fixed dose combinations under Section 26A of the Drugs and Cosmetics Act, 1940
  • D. An inter-ministerial committee under the Department of Pharmaceuticals that fixes the ceiling prices of scheduled formulations under the Drugs (Price Control) Order

Q5. Which one of the following is the principal World Health Organization (WHO) technical document that lays down guidelines for the registration of Fixed Dose Combination (FDC) medicinal products?

  • A. WHO Technical Report Series 929, Annex 5
  • B. WHO Model List of Essential Medicines (latest revision)
  • C. WHO AWaRe Classification of Antibiotics
  • D. WHO Good Manufacturing Practices (TRS 986, Annex 2)

Q6. With reference to Fixed Dose Combinations (FDCs), consider the following statements: 1. An FDC contains two or more active pharmaceutical ingredients combined in a fixed ratio within a single dosage form. 2. WHO endorses an FDC only when the combination is therapeutically rational, i.e., the combination is more efficacious and/or safer than its individual components used alone. 3. In India, an FDC is defined under Rule 122-E of the Drugs and Cosmetics Rules, 1945. 4. The WHO AWaRe classification categorises all Fixed Dose Combinations into Access, Watch and Reserve groups based on their rationality. Which of the statements given above is/are correct?

  1. An FDC contains two or more active pharmaceutical ingredients combined in a fixed ratio within a single dosage form.
  2. WHO endorses an FDC only when the combination is therapeutically rational, i.e., the combination is more efficacious and/or safer than its individual components used alone.
  3. In India, an FDC is defined under Rule 122-E of the Drugs and Cosmetics Rules, 1945.
  4. The WHO AWaRe classification categorises all Fixed Dose Combinations into Access, Watch and Reserve groups based on their rationality.
  • A. 1, 2 and 3 only
  • B. 2 and 4 only
  • C. 1, 3 and 4 only
  • D. 1, 2, 3 and 4

Q7. In June 2026, the Union Ministry of Health and Family Welfare issued gazette notifications prohibiting the manufacture, sale and distribution of how many Fixed Dose Combinations (FDCs) for human use, with immediate effect?

  • A. 14
  • B. 16
  • C. 156
  • D. 328

Q8. The June 2026 prohibition by the Union Ministry of Health and Family Welfare on the manufacture, sale and distribution of 16 Fixed Dose Combinations was issued by invoking which one of the following statutory provisions?

  • A. Section 5 of the Drugs and Cosmetics Act, 1940
  • B. Section 18 of the Drugs and Cosmetics Act, 1940
  • C. Section 26A of the Drugs and Cosmetics Act, 1940
  • D. Section 33P of the Drugs and Cosmetics Act, 1940

Q9. In the gazette notifications issued on 10 March 2016 under Section 26A of the Drugs and Cosmetics Act, 1940 — based on the recommendations following the Kokate Committee's review — how many Fixed Dose Combinations (FDCs) did the Union Government prohibit for human use?

  • A. 156
  • B. 328
  • C. 344
  • D. 418

Q10. In its judgment dated 15 December 2017, the Supreme Court of India referred how many Fixed Dose Combination (FDC) medicines to the Drugs Technical Advisory Board (DTAB) for fresh re-examination?

  • A. 156
  • B. 328
  • C. 344
  • D. 349

Q11. With reference to the Supreme Court of India's judgment dated 15 December 2017 on Fixed Dose Combinations (FDCs), consider the following statements: 1. The Court referred the FDCs to the Drugs Technical Advisory Board (DTAB) constituted under Section 5 of the Drugs and Cosmetics Act, 1940. 2. The DTAB/sub-committee was directed to submit a consolidated report within six months of receipt of the judgment. 3. The DTAB was directed to examine the FDCs on the parameters of Section 26A of the Drugs and Cosmetics Act, 1940, including risk to human beings. 4. The Supreme Court itself, by the said judgment, prohibited the manufacture and sale of 344 FDCs in public interest. Which of the statements given above is/are correct?

  1. The Court referred the FDCs to the Drugs Technical Advisory Board (DTAB) constituted under Section 5 of the Drugs and Cosmetics Act, 1940.
  2. The DTAB/sub-committee was directed to submit a consolidated report within six months of receipt of the judgment.
  3. The DTAB was directed to examine the FDCs on the parameters of Section 26A of the Drugs and Cosmetics Act, 1940, including risk to human beings.
  4. The Supreme Court itself, by the said judgment, prohibited the manufacture and sale of 344 FDCs in public interest.
  • A. 1 and 3 only
  • B. 2 and 4 only
  • C. 1, 2 and 3 only
  • D. 3 and 4 only

Q12. Entry 19 of the Concurrent List in the Seventh Schedule of the Constitution of India deals with which one of the following subjects?

  • A. Drugs and poisons, subject to the provisions of Entry 59 of the Union List with respect to opium
  • B. Public health and sanitation; hospitals and dispensaries
  • C. Adulteration of foodstuffs and other goods
  • D. Economic and social planning