16 Questions
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?
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 [email protected]
Who will consider the objections and suggestions received regarding the draft rules?
The Central Government
What is the designation of the authority to whom objections and suggestions regarding the draft rules can be addressed?
Under Secretary (Drugs), Ministry of Health and Family Welfare
What date do the rules come into force?
The date specified in the final notification
Who are exempted from the rules?
Manufacturers presently licensed to manufacture drugs before 31st October, 2020
What is substituted for the words 'Good Manufacturing Practices' in rule 74?
Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products
What is substituted for the words 'Good Manufacturing Practices' in rule 76?
Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products
What is substituted for the words 'Good Manufacturing Practices' in rule 78?
Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products
What is the new schedule that replaces Schedule M?
Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products
Who is responsible for the quality of pharmaceutical products?
The manufacturer
What is the responsibility of senior management in ensuring pharmaceutical quality?
To ensure that an effective pharmaceutical quality system is in place
What must the manufacturing premises be used exclusively for?
Production of drugs
What must the licensee evolve for inspection and reference?
Appropriate methodology, systems, and procedures
Test your knowledge on the draft rules proposed to amend the Drugs and Cosmetics Rule, 1945 by the Central Government in consultation with the Drugs Technical Advisory Board.
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