Drugs and Cosmetics Rule 1945 Amendment Draft
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Questions and Answers

What is the purpose of the draft rules mentioned in the text?

To further amend the Drugs and Cosmetics Rule, 1945

Who has the power to make the proposed amendments to the Drugs and Cosmetics Rule?

The Central Government

What is the timeline for consideration of the draft rules?

Thirty days from the date of availability of the Official Gazette of India containing the draft rules

Where can objections and suggestions regarding the draft rules be addressed?

<p>Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi.— 110011 or e-mailed at <a href="mailto:[email protected]">[email protected]</a></p> Signup and view all the answers

Who will consider the objections and suggestions received regarding the draft rules?

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

What is the designation of the authority to whom objections and suggestions regarding the draft rules can be addressed?

<p>Under Secretary (Drugs), Ministry of Health and Family Welfare</p> Signup and view all the answers

What date do the rules come into force?

<p>The date specified in the final notification</p> Signup and view all the answers

Who are exempted from the rules?

<p>Manufacturers presently licensed to manufacture drugs before 31st October, 2020</p> Signup and view all the answers

What is substituted for the words 'Good Manufacturing Practices' in rule 74?

<p>Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products</p> Signup and view all the answers

What is substituted for the words 'Good Manufacturing Practices' in rule 76?

<p>Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products</p> Signup and view all the answers

What is substituted for the words 'Good Manufacturing Practices' in rule 78?

<p>Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products</p> Signup and view all the answers

What is the new schedule that replaces Schedule M?

<p>Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products</p> Signup and view all the answers

Who is responsible for the quality of pharmaceutical products?

<p>The manufacturer</p> Signup and view all the answers

What is the responsibility of senior management in ensuring pharmaceutical quality?

<p>To ensure that an effective pharmaceutical quality system is in place</p> Signup and view all the answers

What must the manufacturing premises be used exclusively for?

<p>Production of drugs</p> Signup and view all the answers

What must the licensee evolve for inspection and reference?

<p>Appropriate methodology, systems, and procedures</p> Signup and view all the answers

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