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Good Manufacturing Practices (GMP) Standards

Good Manufacturing Practices (GMP) Standards:

The government has set a deadline for pharmaceutical companies to implement the revised Good Manufacturing Practices (GMP) standards, aligned with World Health Organisation (WHO) standards.

New regulations:

  • Companies with over Rs 250 crore turnover must adopt the revised GMP within six months, while smaller enterprises having a turnover of less than 250 crore have a year.
  • Non-compliance could lead to license suspension or penalties.
  • The move aims to enhance drug quality and safety, addressing deficiencies found in inspections
  • The changes will include a pharmaceutical quality system, quality risk management, and product quality review.

Good Manufacturing Practices (GMP)

  • Good Manufacturing Practices (GMP)standards are guidelines and regulations that ensure the quality, safety, and consistency of pharmaceutical products.
  • GMP system was first incorporated in India in 1988 in Schedule M of Drugs and Cosmetics Rules, 1945.
  • It was revised in 2018, bringing them on par with WHO standards.
  • Presently, only 2,000 of 10,500 manufacturing units in the country were found to be compliant with WHO-GMP standards.