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Consider the following statements regarding Good Manufacturing Practices (GMP) for pharmaceutical companies regulations:
  1. This system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945.
  2. 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?
Most Upvoted Answer
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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