Question 1

All Fixed Dose Combinations (FDCs) are unscientific and banned in India.

Accepted Answer

Many FDCs (like certain anti-TB or HIV drug combinations) are highly useful and legal. Bans or restrictions apply specifically to irrational combinations lacking therapeutic justification or posing severe age-specific safety risks.

Question 2

Chlorpheniramine and Phenylephrine are entirely banned because they are highly toxic chemicals.

Accepted Answer

They are only restricted for children under 4 years of age as a combination; they remain approved, safe, and effective for adults.

Question 3

Consider the following statements regarding the regulation of medicines in India:
1. Chlorpheniramine Maleate primarily acts as a nasal decongestant, whereas Phenylephrine Hydrochloride is an antihistamine.
2. Section 26A of the Drugs and Cosmetics Act, 1940 empowers the Central Government to restrict or prohibit the manufacture of a drug in the public interest.
3. The Drugs Technical Advisory Board (DTAB) is a statutory body constituted to advise the government on technical matters related to drugs.
How many of the above statements are correct?

Accepted Answer

(b) Only two — Statement 1 is incorrect because it swaps the roles: Chlorpheniramine is an antihistamine, and Phenylephrine is a decongestant. Statements 2 and 3 are correct. Under Section 26A, the government can regulate or restrict drugs, and DTAB is indeed the statutory advisory body.

Question 4

Match List I (Terms/Bodies related to drug regulation) with List II (Their primary role or description):
List I:
A. Section 26A of Drugs and Cosmetics Act
B. Chlorpheniramine
C. Phenylephrine
D. Prof. Kokate Committee
List II:
1. Power of Central Government to prohibit manufacture of drugs in public interest
2. Antihistamine
3. Nasal Decongestant
4. Rationalization of Fixed Dose Combinations (FDCs)
Select the correct answer code:

Accepted Answer

(a) A-1, B-2, C-3, D-4 — A matches with 1 (Section 26A allows the government to ban/restrict drugs). B matches with 2 (Chlorpheniramine is an antihistamine). C matches with 3 (Phenylephrine is a decongestant). D matches with 4 (the Kokate Committee was formed to examine the safety and efficacy of unapproved FDCs).

Question 5

Assertion (A): The Ministry of Health and Family Welfare mandated warning labels rather than a complete nationwide ban on the Chlorpheniramine and Phenylephrine Fixed Dose Combination (FDC).
Reason (R): The FDC poses severe life-threatening risks to adults and lacks any therapeutic justification across all age demographics.

Accepted Answer

(c) A is true but R is false — Assertion (A) is true as the government restricted the drug for under-4s and mandated warning labels instead of banning it entirely. Reason (R) is false because the drug is effective and safe for older children and adults; the severe risks (like elevated heart rate) are specific to the under-4 demographic.

Ban on Chlorpheniramine and Phenylephrine FDC for Under-4s

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