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Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations :
- This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945.
- Under new GMP regulations, companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months.
Which of the statements given above is/are correct?
- a)1 only
- b)2 only
- c)Both 1 and 2
- d)Neither 1 nor 2
Correct answer is option 'C'. Can you explain this answer?
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Most Upvoted Answer
Consider the following statements regarding Good Manufacturing Practic...
< b="" />Explanation:< />
Good Manufacturing Practices (GMP) are a set of regulations and guidelines that are followed by pharmaceutical companies to ensure the production of safe, effective, and high-quality drugs. These practices cover various aspects of manufacturing, including facility design, equipment maintenance, personnel training, quality control, and record-keeping.
< b="" />Statement 1:< /> This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945.
< b="" />Statement 2:< /> Under new GMP regulations, companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months.
< b="" />Correct Answer:< /> c) Both 1 and 2
< b="" />Explanation:< />
< b="" />Statement 1:< /> This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945.
- The statement is correct. Good Manufacturing Practices (GMP) were first incorporated in India in 1988 through an amendment to the Drugs and Cosmetics Rules, 1945. These rules are applicable to pharmaceutical companies and provide guidelines for the manufacturing, storage, and distribution of drugs.
- Schedule M of the Drugs and Cosmetics Rules, 1945 specifically outlines the requirements for GMP compliance, including aspects like premises and equipment, personnel, sanitation, documentation, quality control, and more.
< b="" />Statement 2:< /> Under new GMP regulations, companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months.
- The statement is correct. In recent years, the Indian regulatory authorities have revised the GMP regulations to ensure the quality and safety of pharmaceutical products. As per the revised regulations, companies with a turnover of over Rs 250 crore are required to implement the revised GMP within six months from the date of notification.
- The purpose of this requirement is to ensure that larger pharmaceutical companies comply with the updated standards and practices, thereby improving the overall quality of the drugs manufactured in India.
In conclusion, both statements are correct. Good Manufacturing Practices (GMP) were first incorporated in India in 1988 through Schedule M of the Drugs and Cosmetics Rules, 1945. Under the new GMP regulations, companies with a turnover of over Rs 250 crore have to implement the revised GMP within six months.
Good Manufacturing Practices (GMP) are a set of regulations and guidelines that are followed by pharmaceutical companies to ensure the production of safe, effective, and high-quality drugs. These practices cover various aspects of manufacturing, including facility design, equipment maintenance, personnel training, quality control, and record-keeping.
< b="" />Statement 1:< /> This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945.
< b="" />Statement 2:< /> Under new GMP regulations, companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months.
< b="" />Correct Answer:< /> c) Both 1 and 2
< b="" />Explanation:< />
< b="" />Statement 1:< /> This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945.
- The statement is correct. Good Manufacturing Practices (GMP) were first incorporated in India in 1988 through an amendment to the Drugs and Cosmetics Rules, 1945. These rules are applicable to pharmaceutical companies and provide guidelines for the manufacturing, storage, and distribution of drugs.
- Schedule M of the Drugs and Cosmetics Rules, 1945 specifically outlines the requirements for GMP compliance, including aspects like premises and equipment, personnel, sanitation, documentation, quality control, and more.
< b="" />Statement 2:< /> Under new GMP regulations, companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months.
- The statement is correct. In recent years, the Indian regulatory authorities have revised the GMP regulations to ensure the quality and safety of pharmaceutical products. As per the revised regulations, companies with a turnover of over Rs 250 crore are required to implement the revised GMP within six months from the date of notification.
- The purpose of this requirement is to ensure that larger pharmaceutical companies comply with the updated standards and practices, thereby improving the overall quality of the drugs manufactured in India.
In conclusion, both statements are correct. Good Manufacturing Practices (GMP) were first incorporated in India in 1988 through Schedule M of the Drugs and Cosmetics Rules, 1945. Under the new GMP regulations, companies with a turnover of over Rs 250 crore have to implement the revised GMP within six months.
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Consider the following statements regarding Good Manufacturing Practic...
Recently, the government of India has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) for pharmaceutical companies which were revised in 2018, bringing them on par with World Health Organisation standards.
- Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
- It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
- It covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.
- The GMP system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was done in June 2005. WHO-GMP standards are now part of the revised Schedule M.
- There are around 10,500 manufacturing units in India out of which around 8,500 fall under Micro, Small and Medium Enterprises (MSME) category.
- The country has about 2,000 units in MSME category in the country having WHO-GMP certification.
What are the new regulations?
- Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months,
- Medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year.
Hence both statements are correct.
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Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations : This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945. Under new GMP regulations, companies with a turnover of over Rs 250crore will have to implement the revised GMP within six months.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer?
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Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations : This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945. Under new GMP regulations, companies with a turnover of over Rs 250crore will have to implement the revised GMP within six months.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer? for UPSC 2024 is part of UPSC preparation. The Question and answers have been prepared according to the UPSC exam syllabus. Information about Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations : This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945. Under new GMP regulations, companies with a turnover of over Rs 250crore will have to implement the revised GMP within six months.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer? covers all topics & solutions for UPSC 2024 Exam. Find important definitions, questions, meanings, examples, exercises and tests below for Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations : This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945. Under new GMP regulations, companies with a turnover of over Rs 250crore will have to implement the revised GMP within six months.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer?.
Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations : This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945. Under new GMP regulations, companies with a turnover of over Rs 250crore will have to implement the revised GMP within six months.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer? for UPSC 2024 is part of UPSC preparation. The Question and answers have been prepared according to the UPSC exam syllabus. Information about Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations : This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945. Under new GMP regulations, companies with a turnover of over Rs 250crore will have to implement the revised GMP within six months.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer? covers all topics & solutions for UPSC 2024 Exam. Find important definitions, questions, meanings, examples, exercises and tests below for Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations : This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945. Under new GMP regulations, companies with a turnover of over Rs 250crore will have to implement the revised GMP within six months.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer?.
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