MCQ with answers

Drugs and Cosmetics Rules, 1945

10 explained questions below · 1,038 on this instrument in the practice banks · Rules as amended; Schedule M read in its revised form notified in December 2023.

The Drugs and Cosmetics Rules, 1945 are where the 1940 Act becomes operational: which form you apply on, what a licensee must do to keep the licence, what a label must carry, and — through the Schedules — which drugs are prescription-only, which need a special register, which need a special licence, and how a factory must be run. For a pharmacist or a drugs inspector, the Rules are the daily working text; for an examiner, they are the richest source of one-mark questions in the syllabus.

The heavily examined territory is the Schedules — H (prescription drugs), H1 (the 2014 tightening with its separate sale register), X (special licence, duplicate prescription), M (Good Manufacturing Practices, comprehensively revised in December 2023) and P (life period of drugs) — followed by the licence forms for sale and manufacture, the conditions of licence, and the labelling rules. Questions that look like memory tests are usually structure tests: the Rules tie each requirement to a specific rule and schedule, and the exam checks whether you know which.

The questions below are served from the reviewed bank; the D&C Rules are the single most-cited instrument in it, so most explanations quote the rule they rely on.

What the exams keep asking

  • ▸Schedules H, H1 and X — the prescription ladder and its register and licence requirements
  • ▸Schedule M — Good Manufacturing Practices (revised 2023) and Schedule P — life period of drugs
  • ▸Licence forms for retail and wholesale sale and for manufacture
  • ▸Conditions of licence for sale — what a licensee must record, display and preserve
  • ▸Labelling and packing of drugs — the mandatory particulars
  • ▸Sampling, sealing and dispatch of samples to the Government Analyst

10 practice questions, each explained

Attempt first, then open the answer. Every explanation says why the right option is right — and, where the bank holds it, quotes the provision.

  1. Question 1EASY

    Under the Good Manufacturing Practices for Ayurvedic, Siddha and Unani medicines set out in the chunk, what is the prescribed standard for water used in manufacture?

    • A)It shall be water for injection
    • B)It shall be pure and of potable quality
    • C)It shall be of any quality provided it is filtered before use
    • D)It shall be purified water conforming to a pharmacopoeial monograph
    Show answer & explanation

    Answer: B) It shall be pure and of potable quality

    The provision on water supply requires that water used in manufacture be pure and of potable quality, with adequate provision separately made for washing the premises.

    Why the others fail

    • A) A sterile-water standard is imported from elsewhere; the text does not state it.
    • C) Filtration is not the stated criterion; purity and potable quality are.
    • D) The text sets a potability standard, not a pharmacopoeial water specification.

    Source: Drugs and Cosmetics Rules, 1945, Rule 28 — The water used in manufacture shall be pure and of potable

    Source citedfrom the Drug Inspector bank
  2. Question 2EASY

    According to Schedule M para 21.1, what is the basis for Batch Processing Records in pharmaceutical manufacturing?

    • A)Developed based on the quality control laboratory standards and testing specifications
    • B)Based on historical batch records from previous successful manufacturing runs
    • C)Based on the relevant parts of the currently approved Master Formula and designed to avoid transcription errors
    • D)Created at the discretion of the production manager based on the batch size
    Show answer & explanation

    Answer: C) Based on the relevant parts of the currently approved Master Formula and designed to avoid transcription errors

    Para 21.1 states: 'There shall be Batch Processing Record for each product. It shall be based on the relevant parts of the currently approved Master Formula. The method of preparation of such records included in the Master Formula shall be designed to avoid transcription errors.'

    Why the others fail

    • A) Para 21.1 specifies the basis is the currently approved Master Formula, not QC laboratory standards.
    • B) Para 21.1 requires records to be based on 'currently approved Master Formula', not historical batches.
    • D) Para 21.1 specifies that records must be based on approved Master Formula, not discretionary.

    Source: Drugs and Cosmetics Rules, 1945, Schedule M, para 21 — There shall be Batch Processing Record for each product. It shall be based on the relevant parts of the currently approved Master Formula. The method of preparation of such records included in the Master Formula shall be designed to avoid transcription errors.

    Source citedfrom the Drug Inspector bank
  3. Question 3EASY

    Under Rule 150K(2), if an approved institution's approval has been suspended or withdrawn, within what period may the institution appeal to the State Government?

    • A)There is no appeal period; the approving authority's order is final.
    • B)Within six months of the withdrawal or suspension order.
    • C)Within three months of the date of the withdrawal or suspension order.
    • D)Within one month of the withdrawal or suspension order.
    Show answer & explanation

    Answer: C) Within three months of the date of the withdrawal or suspension order.

    Rule 150K(2) clearly specifies that an approved institution may appeal to the State Government within three months of the withdrawal or suspension order.

    Why the others fail

    • A) Rule 150K(2) explicitly provides for appeal to the State Government within three months.
    • B) The statutory period is three months, not six months.
    • D) Rule 150K(2) prescribes a three-month appeal period, not one month.

    Source: Drugs and Cosmetics Rules, 1945, Rule 150K — Any approved institution whose approval has been suspended or withdrawn may within three months of the date of the order, appeal to the State Government

    Source citedfrom the Drug Inspector bank
  4. Question 4EASY

    Approval for carrying out tests of identity, purity, quality and strength of drugs or cosmetics on behalf of a licensee for manufacture shall be granted in:

    • A)Form 37
    • B)Form 34
    • C)Form 36
    • D)Form 39
    Show answer & explanation

    Answer: A) Form 37

    The rule provides that approval to carry out such tests on behalf of a licensee for manufacture of drugs or cosmetics is granted in Form 37.

    Why the others fail

    • B) Form 34 is the report of test or analysis of cosmetics.
    • C) Form 36 is the application form, not the instrument of approval.
    • D) Form 39 is used to furnish reports of results of test or analysis.

    Source: Drugs and Cosmetics Rules, 1945, Rule 150-C — these rules, on behalf of licensee for manufacture of drugs or cosmetics shall be granted in

    Source citedfrom the Drug Inspector bank
  5. Question 5EASY

    Under the chunk, the memorandum that must accompany the portion of sample or container sent by an Inspector to the Government Analyst is in which Form?

    • A)Form 35
    • B)Form 18
    • C)Form 19
    • D)Form 20
    Show answer & explanation

    Answer: B) Form 18

    The chunk requires the sample or container to be sent in a sealed packet enclosed together with a memorandum in Form 18, addressed to the Government Analyst.

    Why the others fail

    • A) Form 35 is the Inspection Book, a licensee record, not a despatch memorandum.
    • C) Form 19 is the sale-licence application form, not the analyst despatch memorandum.
    • D) Form 20 is a form of licence to sell drugs, not a sample despatch memorandum.

    Source: Drugs and Cosmetics Rules, 1945, Rule 57 — together with a memorandum in Form 18

    Source citedfrom the Drug Inspector bank
  6. Question 6EASY

    Schedule M requires production areas to be well lit particularly where:

    • A)Records are retained after batch release
    • B)Visual on-line controls are carried out
    • C)Personnel change into uniforms
    • D)Raw materials are quarantined on receipt
    Show answer & explanation

    Answer: B) Visual on-line controls are carried out

    Production areas must be well lit, and the text singles out places where visual on-line controls are carried out, since inspection accuracy depends on illumination.

    Why the others fail

    • A) Record retention is unrelated to the lighting requirement.
    • C) Change rooms carry facility requirements, but the lighting emphasis is on visual on-line control.
    • D) Quarantine of incoming materials is dealt with separately and no lighting condition is attached to it.

    Source: Drugs and Cosmetics Rules, 1945, Schedule M, para 9 — Production areas shall be well lit, particularly where visual on-line controls

    Source citedfrom the Drug Inspector bank
  7. Question 7EASY

    Where the Licensing Authority is satisfied with the clinical trials, in which forms may permission be granted?

    • A)Form 44 or Form 44-A only
    • B)Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be
    • C)Form 45 only, in every case
    • D)Form 46 or Form 46-A only
    Show answer & explanation

    Answer: B) Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be

    The rule states that the Licensing Authority, after being satisfied with the clinical trials, shall grant permission in Form 45 or Form 45-A or Form 46 or Form 46-A, subject to the conditions stated therein.

    Why the others fail

    • A) Form 44 is the application form for Phase-I trials, not a permission form.
    • C) The rule names four alternative permission forms, to be used as the case may be.
    • D) This drops Form 45 and Form 45-A, which the rule equally lists.

    Source: Drugs and Cosmetics Rules, 1945, Rule 122DA — permission in Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be, subject to

    Source citedfrom the Drug Inspector bank
  8. Question 8EASY

    According to Schedule M para 20.1, what is the basis for preparing a batch packaging record?

    • A)Based on the relevant parts of the packaging instructions, designed to avoid transcription errors
    • B)The batch packaging record may be prepared from any recent packing operation of the same dosage form
    • C)Based on the master formula record and approved by quality control personnel
    • D)At the discretion of the production supervisor based on the batch size and product type
    Show answer & explanation

    Answer: A) Based on the relevant parts of the packaging instructions, designed to avoid transcription errors

    Para 20.1 states: 'A batch packaging record shall be kept for each batch or part batch processed. It shall be based on the relevant parts of the packaging instructions, and the method of preparation of such records shall be designed to avoid transcription errors.'

    Why the others fail

    • B) Para 20.1 requires the record to be 'based on the relevant parts of the packaging instructions', not generalized from other batches.
    • C) Para 20.1 specifies that BPR is based on packaging instructions, not master formula records.
    • D) Para 20.1 specifies that BPR must be based on packaging instructions and designed to avoid transcription errors, not left to discretion.

    Source: Drugs and Cosmetics Rules, 1945, Schedule M, para 20 — A batch packaging record shall be kept for each batch or part batch processed. It shall be based on the relevant parts of the packaging instructions, and the method of preparation of such records shall be designed to avoid transcription errors.

    Source citedfrom the Drug Inspector bank
  9. Question 9EASY

    According to Schedule L-I, para 2(d), what material specification is required for laboratory tabletops?

    • A)Acid, alkali and solvent resistant material that is smooth and free from crevices as far as possible.
    • B)Steel surfaces that can withstand mechanical impact from heavy equipment.
    • C)Any smooth surface, provided it is regularly cleaned and disinfected.
    • D)Wood treated with waterproof sealant to prevent water absorption.
    Show answer & explanation

    Answer: A) Acid, alkali and solvent resistant material that is smooth and free from crevices as far as possible.

    Schedule L-I, para 2(d) specifies: 'Tabletops shall be constructed with acid, alkali and solvent resistant material and shall be smooth and free from crevices as far as possible.'

    Why the others fail

    • B) While steel may have some resistance, the clause specifically requires resistance to chemical agents (acid, alkali, solvents).
    • C) Smoothness alone is insufficient; chemical resistance is a material property requirement.
    • D) Treated wood does not meet the chemical resistance requirement; acid, alkali and solvent resistant material is specified.

    Source: Drugs and Cosmetics Rules, 1945, Schedule L-I, para 2 — Tabletops shall be constructed with acid, alkali and solvent resistant material and shall be smooth and free from crevices as far as possible.

    Source citedfrom the Drug Inspector bank
  10. Question 10EASY

    As per para 27.1 of Schedule M, the product recall system must be devised for timely information of which parties, up to the retail level?

    • A)Only the State Licensing Authority
    • B)Only hospitals that purchased the batch
    • C)All concerned stockists, wholesalers and suppliers
    • D)Only the original manufacturer's board of directors
    Show answer & explanation

    Answer: C) All concerned stockists, wholesalers and suppliers

    Para 27.1 requires the recall system to be devised for timely information of all concerned stockists, wholesalers, suppliers, upto the retail level within the shortest period.

    Why the others fail

    • A) The chunk names stockists, wholesalers and suppliers up to retail level, not solely the licensing authority.
    • B) The recall system covers the whole distribution chain to retail level, not hospitals exclusively.
    • D) The board of directors is not the party named for recall information; the trade chain down to retail is.

    Source: Drugs and Cosmetics Rules, 1945, Schedule M, para 27 — devised for timely information of all concerned stockists, wholesalers, suppliers,

    Source citedfrom the Drug Inspector bank

Practise the full set with real marking

These 10 are a fixed sample. The practice engines serve the whole bank — shuffled, scored the way the exam scores, explanation after every answer.

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