GMP Standards

NEWS: Adopt WHO-standard good manufacturing practices: Govt sets deadline for pharmas

What is in the News?

• Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organisation (WHO) standards.

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.

 The 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.

 Importance of this Move

• GMP certification holds great importance as it reduces the likelihood of product contamination, labelling errors, and inconsistent ingredient levels.
• For India, a major medicine exporter to low- and middle-income countries, WHO-GMP certification is crucial.
• It’s also necessary for the procurement of products under the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) from suppliers with this certification.

Practice Questions for Prelims

Consider the following statements about Good Manufacturing Practices (GMP)
1. GMP system was first incorporated in India in 1988 in Schedule M of Drugs and Cosmetics Rules, 1945
2. 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 eight months,

Which of the above given statements is/are correct?
a) 1 only
b) 2 only
c) Both 1 and 2
d) Neither 1 nor 2

Ans. a)

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