Podcast
Questions and Answers
For how long must records or registers be retained after repacking?
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?
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?
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?
Who must approve advertisements for drugs listed in Schedule H, H1, or X?
What does a loan licence allow an applicant to do?
What does a loan licence allow an applicant to do?
What process does the term 'manufacture' exclude when related to drugs or cosmetics?
What process does the term 'manufacture' exclude when related to drugs or cosmetics?
Which of the following is NOT prohibited for manufacture and sale under the stated guidelines?
Which of the following is NOT prohibited for manufacture and sale under the stated guidelines?
What must be displayed on patent or proprietary medicine according to the prohibition?
What must be displayed on patent or proprietary medicine according to the prohibition?
Under what condition can small quantities of drugs be manufactured according to the guidelines?
Under what condition can small quantities of drugs be manufactured according to the guidelines?
What is the consequence of manufacturing or distributing a drug that is not of standard quality?
What is the consequence of manufacturing or distributing a drug that is not of standard quality?
Which statement is accurate regarding the claims made about drugs?
Which statement is accurate regarding the claims made about drugs?
What regulation applies to the sale of cosmetics containing harmful ingredients?
What regulation applies to the sale of cosmetics containing harmful ingredients?
What is required for a person to manufacture drugs or cosmetics legally?
What is required for a person to manufacture drugs or cosmetics legally?
What must the Inspector provide after completing the inspection?
What must the Inspector provide after completing the inspection?
What happens if the LA or Central Licence Approving Authority is not satisfied with the application?
What happens if the LA or Central Licence Approving Authority is not satisfied with the application?
How long is a valid licence valid unless suspended or canceled?
How long is a valid licence valid unless suspended or canceled?
What must a licensee maintain according to the conditions of the licence?
What must a licensee maintain according to the conditions of the licence?
What is required from the licensee for each batch of raw material used?
What is required from the licensee for each batch of raw material used?
When will further requirements specified in the Rules come into effect?
When will further requirements specified in the Rules come into effect?
What occurs if the application for renewal of a licence is not made within 6 months of its expiry?
What occurs if the application for renewal of a licence is not made within 6 months of its expiry?
What type of records must a licensee maintain regarding the testing of products?
What type of records must a licensee maintain regarding the testing of products?
What form is issued for a loan license to manufacture drugs specified in Schedules C and C1?
What form is issued for a loan license to manufacture drugs specified in Schedules C and C1?
Which one of the following is NOT required to be justified in the application for patent or proprietary medicines?
Which one of the following is NOT required to be justified in the application for patent or proprietary medicines?
Which types of drugs are excluded from being manufactured under a loan license in Form 28A?
Which types of drugs are excluded from being manufactured under a loan license in Form 28A?
What happens to a loan license in Form 28A if the license it is based on is cancelled?
What happens to a loan license in Form 28A if the license it is based on is cancelled?
Which of the following is a condition for maintaining a license in Form 28A?
Which of the following is a condition for maintaining a license in Form 28A?
What is required if the licensee wants to manufacture a drug formulation containing a single active ingredient?
What is required if the licensee wants to manufacture a drug formulation containing a single active ingredient?
When do new requirements specified in rules come into effect in relation to the licensing provisions?
When do new requirements specified in rules come into effect in relation to the licensing provisions?
What must be maintained in relation to the testing of products under Form 28A or Form 28DA?
What must be maintained in relation to the testing of products under Form 28A or Form 28DA?
What is the minimum imprisonment term for someone convicted of a similar offense related to cosmetics?
What is the minimum imprisonment term for someone convicted of a similar offense related to cosmetics?
What is the penalty for manufacturing or selling spurious cosmetics?
What is the penalty for manufacturing or selling spurious cosmetics?
What is the consequence of not disclosing the name of the manufacturer?
What is the consequence of not disclosing the name of the manufacturer?
What is the penalty for manufacturing drugs that are prohibited in public interest?
What is the penalty for manufacturing drugs that are prohibited in public interest?
What is the maximum fine for using a GA report for advertising a drug or cosmetic?
What is the maximum fine for using a GA report for advertising a drug or cosmetic?
For a second conviction related to cosmetic offenses, what is the maximum imprisonment term?
For a second conviction related to cosmetic offenses, what is the maximum imprisonment term?
What fines can be imposed for the sale of cosmetics that are in contravention of specific provisions?
What fines can be imposed for the sale of cosmetics that are in contravention of specific provisions?
In the event of a violation concerning document maintenance, what is the maximum penalty?
In the event of a violation concerning document maintenance, what is the maximum penalty?
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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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