Drug Inspector practice: Drugs and Cosmetics Act and Rules
20 original questions on the Drugs and Cosmetics Act 1940 and Rules 1945 for Drug Inspector and GPAT preparation, with answers, explanations and section references. Tap an option to check your answer, or open "Show answer".
1. Under the Drugs and Cosmetics Act 1940, a drug that is coloured, coated, powdered or polished so that damage is concealed, or made to appear of better therapeutic value than it really is, is deemed to be:
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Answer: B — This is one of the situations listed for misbranded drugs. Spurious and adulterated drugs are separate categories with their own lists of conditions.
2. A drug is deemed to be adulterated if:
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Answer: D — Mixing in a substance that reduces quality or strength is an adulteration condition. Improper labelling is a misbranding condition, while a name belonging to another drug or a fictitious manufacturer are spurious-drug conditions.
3. A drug whose label bears the name of a company purporting to be its manufacturer, where that company is fictitious or does not exist, is deemed to be:
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Answer: A — A fictitious or non-existent manufacturer on the label is one of the conditions that make a drug spurious. Note that misbranding covers false claims and wrong labelling, not a fictitious manufacturer.
4. Which of the following makes a drug "adulterated" under the Act?
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Answer: C — Preparation, packing or storage under insanitary conditions is an adulteration condition. A false claim is misbranding, and imitation or a false manufacturer origin are spurious-drug conditions.
5. For the purposes of the manufacture, sale and distribution chapter of the Act, a drug is of "standard quality" if it complies with the standards set out in:
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Answer: B — Section 16 defines standard quality for drugs by reference to the Second Schedule of the Act, which lists the pharmacopoeial and other standards. Schedules M and H are in the Rules and deal with GMP and prescription status.
6. The Drugs Technical Advisory Board is constituted by the Central Government to:
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Answer: A — The Board is an advisory body for technical matters. Licences are granted by licensing authorities, samples are tested by Government Analysts, and prosecution is carried out in court.
7. Who is the ex officio Chairman of the Drugs Technical Advisory Board?
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Answer: D — Section 5(2) lists the Director General of Health Services, ex officio, as Chairman. The Drugs Controller, India is also an ex officio member but not the Chairman.
8. The main purpose of the Drugs Consultative Committee is to:
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Answer: C — The Committee consists of two Central Government representatives and one representative of each State Government, and exists to promote uniform administration of the Act across States.
9. Which of the following persons cannot be appointed as a Drug Inspector under the Act?
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Answer: C — Section 21(3) bars anyone with a financial interest in import, manufacture or sale of drugs or cosmetics from appointment as an Inspector, to avoid conflict of interest. The same bar applies to Government Analysts under section 20(4).
10. An Inspector who finds a drug in respect of which an offence is suspected may order the person in possession in writing not to dispose of the stock for a specified period not exceeding:
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Answer: B — Under section 22(1)(c) the order not to dispose of stock may be for a specified period not exceeding twenty days, unless the Inspector seizes the stock because the defect cannot be removed by the possessor.
11. When an Inspector takes a sample of a drug for test or analysis from a retail shop, the sample is divided into how many portions, and one portion goes to the Government Analyst?
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Answer: D — The sample is divided into four portions, sealed and marked in the presence of the person from whom it is taken. One portion is restored to that person, one is sent to the Government Analyst, one is produced in court and the fourth goes to any person whose particulars were disclosed under section 18A. Where the sample is taken from premises on which the drug is being manufactured, it is divided into three portions only.
12. After receiving a copy of the Government Analyst's report, the person from whom the sample was taken must notify in writing his intention to adduce evidence in controversion of the report within:
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Answer: C — The report is conclusive evidence of the facts stated in it unless the person notifies, within twenty-eight days of receiving the copy, that he intends to challenge it. The court may then send the retained sample to the Central Drugs Laboratory.
13. Section 18A requires a person who is not the manufacturer (or his agent for distribution) to disclose to the Inspector, when required:
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Answer: A — This traces the source of suspect products back along the supply chain, so that the next person in the chain can also be given a copy of the Analyst's report.
14. Under section 18 of the Act, no person may manufacture for sale, or sell, stock, exhibit or distribute any drug except:
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Answer: B — Section 18(c) makes a licence compulsory for manufacture for sale or distribution, with limited exceptions such as small quantities made for examination, test or analysis. The licensing authorities that issue the licences are defined in the Rules.
15. The Ayurvedic, Siddha and Unani Drugs Technical Advisory Board is constituted under which section of the Act?
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Answer: C — Section 33C constitutes the ASU Drugs Technical Advisory Board for Chapter IVA. Section 5 is the Drugs Technical Advisory Board for other drugs and cosmetics, and section 33F deals with Government Analysts for ASU drugs.
16. Which of the following is included in the definition of "drug" in the Act?
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Answer: A — The definition includes all substances intended for use as components of a drug, including empty gelatine capsules. Cosmetics are defined separately in section 3(aaa), and tobacco products are not drugs under this definition.
17. Schedule M of the Drugs Rules 1945 deals with:
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Answer: B — Schedule M lays down GMP and premises, plant and equipment requirements. It was revised by notification G.S.R. 922(E) dated 28 December 2023. Schedule H covers prescription drugs, Schedule N pharmacy requirements, and Schedule P life period of drugs.
18. Drugs in Schedule H of the Drugs Rules 1945 are:
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Answer: A — Rule 97 requires a medicine containing a Schedule H substance to carry the Rx symbol and the boxed warning that it is not to be sold by retail without the prescription of a Registered Medical Practitioner. Lock-and-key storage in retail premises is required for Schedule X substances (rule 65), and Schedule J lists diseases for which no drug may claim a cure.
19. Which statement about Schedule H1 and Schedule X of the Drugs Rules 1945 is correct?
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Answer: B — Schedule H1 (inserted by G.S.R. 588(E) of 30 August 2013) lists certain antibiotics, antituberculosis drugs and psychotropic substances; rule 65 requires each supply to be recorded in a separate register (prescriber, patient, drug, quantity) kept for three years. Schedule X lists substances such as amphetamines, barbiturates and ketamine, which need separate licences, the XRx label and lock-and-key storage.
20. Schedule J of the Drugs Rules 1945 contains:
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Answer: A — Schedule J lists diseases and ailments for which no drug may claim to prevent or cure, supporting the misleading-claim provisions of the Act. Pharmacy premises are dealt with in Schedule N.