UPSC Prelims Practice Questions — Union Health Ministry Brings Pregabalin Under Schedule H1 to Strengthen Regulation and Prevent Misuse

Question 1

The regulation and enforcement of the Schedule H1 category of drugs under the Drugs Rules, 1945 is primarily carried out by which one of the following bodies?

Accepted Answer

Central Drugs Standard Control Organisation (CDSCO)

Answer

Narcotics Control Bureau

Answer

National Pharmaceutical Pricing Authority

Answer

Food Safety and Standards Authority of India

Question 2

Under the Drugs and Cosmetics Rules, 1945, which one of the following best describes the distinctive regulatory requirement for drugs listed in Schedule X?

Accepted Answer

The prescription must be retained by the pharmacist for two years and the drugs stored under lock and key with a special licence

Answer

The drugs may be sold over the counter without any prescription

Answer

The drugs need only a separate register maintained for three years, with no special licence

Answer

The drugs are governed solely by the NDPS Act, 1985 and lie outside the Drugs and Cosmetics Rules

Question 3

Pregabalin was brought under Schedule H1 in 2026 through a Gazette notification issued under the provisions of which one of the following?

Accepted Answer

The Drugs and Cosmetics Act, 1940 read with the Drugs Rules, 1945

Answer

The Narcotic Drugs and Psychotropic Substances Act, 1985 exclusively

Answer

The Pharmacy Act, 1948 alone

Answer

The Food Safety and Standards Act, 2006

Question 4

The 2026 Gazette notification G.S.R. 377(E) amending the Drugs Rules, 1945 added how many new drug(s) to the Schedule H1 list?

Accepted Answer

One

Answer

Three

Answer

Ten

Answer

Forty-six

Question 5

Schedule H1 was created in 2013 by amending the Drugs and Cosmetics Rules, 1945 through a notification issued by which Union Ministry?

Accepted Answer

Ministry of Health and Family Welfare

Answer

Ministry of Chemicals and Fertilizers

Answer

Ministry of Home Affairs

Answer

Ministry of Consumer Affairs, Food and Public Distribution

Question 6

In India, approval for marketing a new drug such as pregabalin is granted by which one of the following authorities?

Accepted Answer

Drugs Controller General of India (DCGI)

Answer

Indian Council of Medical Research

Answer

National Medical Commission

Answer

Central Drugs Laboratory

Question 7

With reference to pregabalin in comparison with gabapentin, consider the following statements:
1. Both drugs act by binding to the α2δ subunit of voltage-gated calcium channels.
2. Pregabalin, unlike gabapentin, exhibits linear pharmacokinetics across its therapeutic dose range.
3. Pregabalin is a structural analog of dopamine, whereas gabapentin is an analog of GABA.
Which of the statements given above is/are correct?

Accepted Answer

1 and 2 only

Answer

1 only

Answer

2 and 3 only

Answer

1, 2 and 3

Question 8

The highest statutory technical body that advises the Central and State Governments on technical matters arising out of the Drugs and Cosmetics Act, 1940 — including amendments to its Schedules — is:

Accepted Answer

Drugs Technical Advisory Board (DTAB)

Answer

Drugs Consultative Committee

Answer

Central Drugs Laboratory

Answer

National Pharmaceutical Pricing Authority

Question 9

Under the Drugs and Cosmetics Act, 1940, the power to add to or amend the Schedules by notification in the Official Gazette is vested in which one of the following?

Accepted Answer

The Central Government, after consultation with the Drugs Technical Advisory Board

Answer

The Drugs Controller General of India, on his own authority

Answer

The State Drug Licensing Authorities acting collectively

Answer

The Central Drugs Standard Control Organisation, by executive order

Question 10

Which one of the following is the apex/nodal agency for coordinating drug law enforcement and combating illicit trafficking under the Narcotic Drugs and Psychotropic Substances Act, 1985?

Accepted Answer

Narcotics Control Bureau

Answer

Central Bureau of Narcotics

Answer

Directorate of Revenue Intelligence

Answer

Central Drugs Standard Control Organisation

Question 11

The separate register recording the supply of a Schedule H1 drug must be maintained and kept open for inspection for a minimum period of how many years?

Accepted Answer

Three years

Answer

Two years

Answer

Five years

Answer

Ten years

UPSC Prelims Practice Questions — Union Health Ministry Brings Pregabalin Under Schedule H1 to Strengthen Regulation and Prevent Misuse

Q1. The regulation and enforcement of the Schedule H1 category of drugs under the Drugs Rules, 1945 is primarily carried out by which one of the following bodies?

Q2. Under the Drugs and Cosmetics Rules, 1945, which one of the following best describes the distinctive regulatory requirement for drugs listed in Schedule X?

Q3. Pregabalin was brought under Schedule H1 in 2026 through a Gazette notification issued under the provisions of which one of the following?

Q4. The 2026 Gazette notification G.S.R. 377(E) amending the Drugs Rules, 1945 added how many new drug(s) to the Schedule H1 list?

Q5. Schedule H1 was created in 2013 by amending the Drugs and Cosmetics Rules, 1945 through a notification issued by which Union Ministry?

Q6. In India, approval for marketing a new drug such as pregabalin is granted by which one of the following authorities?

Q8. The highest statutory technical body that advises the Central and State Governments on technical matters arising out of the Drugs and Cosmetics Act, 1940 — including amendments to its Schedules — is:

Q9. Under the Drugs and Cosmetics Act, 1940, the power to add to or amend the Schedules by notification in the Official Gazette is vested in which one of the following?

Q10. Which one of the following is the apex/nodal agency for coordinating drug law enforcement and combating illicit trafficking under the Narcotic Drugs and Psychotropic Substances Act, 1985?

Q11. The separate register recording the supply of a Schedule H1 drug must be maintained and kept open for inspection for a minimum period of how many years?