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
Correct answer
Explanation
The correct answer is the Drugs Rules, 1945. 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. The remaining options name other instruments that were not amended by this proposal, and none of them is the parent rulebook referred to in the announcement. Aspirants should be careful here, because questions on pharmaceutical regulation often mix up the parent Act, the rules framed under it, and price control orders. In this story the only instrument being changed is the set of rules of 1945, along with a consequential change to Form 13, which is the test report of the Government Analyst. Remembering the year attached to the rules is the quickest way to eliminate the wrong options.
Read the full article: Drugs Rules Amendment Proposes Instant Licence Suspension
Practice Questions
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 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
Show answer
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.
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
Show answer
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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