Manufacture of Drugs and Cosmetics
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Questions and Answers

For how long must records or registers be retained after repacking?

  • 5 years (correct)
  • 2 years
  • Indefinitely
  • 3 years

    • What is the minimum quantity of reference samples that must be maintained from each batch of drugs manufactured?

  • Half the quantity required for testing
  • None, if expiry date is not specified
  • Equal to the quantity needed for testing
  • Twice the quantity required for testing (correct)

    • What is the stipulated retention period for reference samples of drugs that bear an expiry date?

  • 6 months after expiry
  • 1 month after the expiry date
  • 3 months beyond the date of expiry (correct)
  • 1 year after manufacture

    • Who must approve advertisements for drugs listed in Schedule H, H1, or X?

    <p>Central Government</p> Signup and view all the answers

    What does a loan licence allow an applicant to do?

    <p>Use manufacturing facilities of another licensee</p> Signup and view all the answers

    What process does the term 'manufacture' exclude when related to drugs or cosmetics?

    <p>Dispensing of any drug</p> Signup and view all the answers

    Which of the following is NOT prohibited for manufacture and sale under the stated guidelines?

    <p>A drug properly labeled with ingredients</p> Signup and view all the answers

    What must be displayed on patent or proprietary medicine according to the prohibition?

    <p>The true formula or list of active ingredients</p> Signup and view all the answers

    Under what condition can small quantities of drugs be manufactured according to the guidelines?

    <p>For examination, test, or analysis</p> Signup and view all the answers

    What is the consequence of manufacturing or distributing a drug that is not of standard quality?

    <p>It is strictly prohibited.</p> Signup and view all the answers

    Which statement is accurate regarding the claims made about drugs?

    <p>Claims must not suggest preventing or curing diseases.</p> Signup and view all the answers

    What regulation applies to the sale of cosmetics containing harmful ingredients?

    <p>They must not contain any unsafe ingredients.</p> Signup and view all the answers

    What is required for a person to manufacture drugs or cosmetics legally?

    <p>A license issued according to the Chapter</p> Signup and view all the answers

    What must the Inspector provide after completing the inspection?

    <p>A detailed descriptive report with recommendations</p> Signup and view all the answers

    What happens if the LA or Central Licence Approving Authority is not satisfied with the application?

    <p>The application is rejected with reasons provided</p> Signup and view all the answers

    How long is a valid licence valid unless suspended or canceled?

    <p>5 years</p> Signup and view all the answers

    What must a licensee maintain according to the conditions of the licence?

    <p>Staff, premises, and equipment</p> Signup and view all the answers

    What is required from the licensee for each batch of raw material used?

    <p>Testing in a laboratory approved by the LA</p> Signup and view all the answers

    When will further requirements specified in the Rules come into effect?

    <p>4 months after publication</p> Signup and view all the answers

    What occurs if the application for renewal of a licence is not made within 6 months of its expiry?

    <p>The licence is considered expired</p> Signup and view all the answers

    What type of records must a licensee maintain regarding the testing of products?

    <p>Records or registers showing particulars of tests</p> Signup and view all the answers

    What form is issued for a loan license to manufacture drugs specified in Schedules C and C1?

    <p>Form 28</p> Signup and view all the answers

    Which one of the following is NOT required to be justified in the application for patent or proprietary medicines?

    <p>Cost-effectiveness of the drug</p> Signup and view all the answers

    Which types of drugs are excluded from being manufactured under a loan license in Form 28A?

    <p>Drugs specified in Schedule X</p> Signup and view all the answers

    What happens to a loan license in Form 28A if the license it is based on is cancelled?

    <p>It automatically becomes invalid.</p> Signup and view all the answers

    Which of the following is a condition for maintaining a license in Form 28A?

    <p>Testing each batch of raw material used.</p> Signup and view all the answers

    What is required if the licensee wants to manufacture a drug formulation containing a single active ingredient?

    <p>Application must be made in the proper name.</p> Signup and view all the answers

    When do new requirements specified in rules come into effect in relation to the licensing provisions?

    <p>After 4 months of publication.</p> Signup and view all the answers

    What must be maintained in relation to the testing of products under Form 28A or Form 28DA?

    <p>Records of tests for raw materials and final products.</p> Signup and view all the answers

    What is the minimum imprisonment term for someone convicted of a similar offense related to cosmetics?

    <p>2 years</p> Signup and view all the answers

    What is the penalty for manufacturing or selling spurious cosmetics?

    <p>Imprisonment for up to 3 years and a fine of Rs. 50,000</p> Signup and view all the answers

    What is the consequence of not disclosing the name of the manufacturer?

    <p>Imprisonment for up to 1 year or a fine of Rs. 20,000</p> Signup and view all the answers

    What is the penalty for manufacturing drugs that are prohibited in public interest?

    <p>Imprisonment for up to 3 years and a fine up to Rs. 5,000</p> Signup and view all the answers

    What is the maximum fine for using a GA report for advertising a drug or cosmetic?

    <p>Rs. 5,000</p> Signup and view all the answers

    For a second conviction related to cosmetic offenses, what is the maximum imprisonment term?

    <p>2 years</p> Signup and view all the answers

    What fines can be imposed for the sale of cosmetics that are in contravention of specific provisions?

    <p>Up to Rs. 20,000</p> Signup and view all the answers

    In the event of a violation concerning document maintenance, what is the maximum penalty?

    <p>Imprisonment for up to 1 year</p> Signup and view all the answers

    Study Notes

    Manufacture Definitions and Exclusions

    • Manufacture of drugs and cosmetics encompasses all processes involved in creating, altering, finishing, packing, labeling, or treating a product for sale or distribution.
    • Compounding, dispensing, and ordinary retail packing of drugs are not included as manufacturing activities.

    Prohibition of Certain Activities

    • Prohibited actions include manufacturing or selling any drug or cosmetic that is:
      • Not of standard quality, misbranded, adulterated, or spurious.
      • A patent or proprietary medicine without proper labeling of active ingredients.
      • Claimed to cure or mitigate diseases without substantiation.
      • Unsafe due to harmful ingredients.
      • Manufactured or imported contrary to regulations.
    • License is mandatory for all manufacturing and distribution activities.

    Inspection and Licensing Process

    • Inspectors must provide a detailed report after inspections, including findings and recommendations.
    • Licenses are issued by the Licensing Authority (LA) after ensuring compliance with regulations.
    • If requirements are unmet, the applicant is informed of reasons for rejection and necessary conditions for future approval.

    License Duration

    • Licenses are valid for five years unless suspended or canceled.
    • Renewal applications must be submitted before or within six months after expiration to maintain validity.

    License Conditions

    • Licensees must maintain adequate staffing, facilities, equipment, and adhere to the Act and its rules.
    • Testing of raw materials and final products is required, with records retained for five years, allowing inspector access.
    • Reference samples of manufactured drugs must be kept for specified durations.

    Loan Licenses

    • A loan license allows an applicant without manufacturing capabilities to use another licensed manufacturer’s facilities.
    • Specific forms (Form 28A for general drugs, Form 28DA for specific parenterals, vaccines, and recombinant DNA drugs) are required.

    Penalties for Non-compliance

    • Manufacturing or selling spurious or adulterated cosmetics may lead to imprisonment of up to three years and fines of at least Rs. 50,000.
    • Other non-compliance penalties can include one year of imprisonment or fines up to Rs. 20,000.
    • Failure to disclose manufacturer information can result in imprisonment and fines.

    Additional Regulations

    • Continued monitoring for compliance with testing, documentation, and advertisement regulations is essential.
    • Violations of safe manufacturing practices can have severe legal consequences, including imprisonment and fines.

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    Description

    This quiz covers the definition and processes involved in the manufacture of drugs and cosmetics. It explores procedures such as labeling, packing, and altering products intended for sale or distribution. Understand key terms and regulatory considerations related to pharmaceutical and cosmetic manufacturing.

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