Under the proposal, a suspended manufacturing licence can be restored only after the manufacturer completes which of the following?
- A.Payment of a penalty to the Licensing Authority
- B.Root Cause Analysis and Corrective and Preventive Action
- C.A fresh application for a new licence
- D.Re-testing by a private accredited laboratory
Correct answer
Explanation
The correct answer is Root Cause Analysis and Corrective and Preventive Action. The suspension is to continue until the manufacturer carries out an effective Root Cause Analysis to identify why the quality failure occurred and implements appropriate Corrective and Preventive Action, commonly abbreviated as CAPA, to the satisfaction of the Licensing Authority. Revocation of the suspension is permitted only after those measures are implemented and duly verified by that authority. Option A is wrong because no payment of a penalty is prescribed as the route to restoration. Option C is wrong because the licence is suspended rather than cancelled, so a fresh application is not the mechanism contemplated. Option D is wrong because verification rests with the Licensing Authority and the triggering report comes from a Government Analyst, not from a private laboratory. The purpose of the design is to ensure the underlying defect is genuinely corrected and safeguards are added to prevent it recurring.
Read the full article: Drugs Rules Amendment Proposes Instant Licence Suspension
Practice Questions
The Union Health Ministry's proposal for immediate suspension of manufacturing licences for substandard drugs amends which rules?
- A.Drugs Rules, 1945
- B.Drugs and Cosmetics Rules, 1955
- C.Drug Price Control Order, 1995
- D.Medical Devices Rules, 2017
Show answer
The Ministry of Health and Family Welfare proposed amendments to these rules so that the manufacturing licence of a drug declared Not of Standard Quality on specified critical parameters can be suspended immediately, without waiting for the full procedure that at present includes a show-cause notice.
Read the full explanation →Which of the following is NOT one of the critical parameters on which immediate suspension of a drug manufacturing licence has been proposed?
- A.Assay
- B.Dissolution
- C.Sterility
- D.Packaging weight
Show answer
The proposal names five parameters: Assay, Dissolution, Related Substances, Impurities and Sterility.
Read the full explanation →Under the proposed arrangement, the Government Analyst's test report in Form 13 would be endorsed to which of these, among others?
- A.Drugs Controller General of India
- B.Central Drugs Standard Control Organisation's Ethics Committee
- C.Pharmacy Council of India
- D.National Pharmaceutical Pricing Authority
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Consequential amendments have been proposed to Form 13, the test report of the Government Analyst, so that the report is endorsed to the Drugs Controller General of India, to the State or Union Territory Licensing Authority in whose jurisdiction the manufacturing site is located, and to the manufacturer as well…
Read the full explanation →How much office space was reclaimed by the Department of Health and Family Welfare under Special Campaign 6?
- A.1,25,114 square feet
- B.3,27,500 square feet
- C.5,82,449 square feet
- D.7,41,000 square feet
Show answer
The space was freed mainly through the records management exercise, in which 1,20,115 of the 1,25,114 physical files reviewed were weeded out and 32,542 of the 37,481 e-files reviewed were closed.
Read the full explanation →How many public grievances were disposed of by the Department of Health and Family Welfare under Special Campaign 6?
- A.6,026
- B.9,480
- C.12,840
- D.18,240
Show answer
The Department disposed of that many public grievances during the campaign, and alongside them it cleared 6,026 related appeals. It also addressed 119 references received from Members of Parliament and simplified 19 rules and processes.
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