Good Manufacturing Practices for Pharma Companies

Why in news?

• The government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes at par with WHO standards.

What are Good Manufacturing Practices (GMP)?

• Good Manufacturing Practices (GMP) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
• In India, GMP was revised in 2018, bringing them on par with World Health Organisation (WHO) standards.
• The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world.

Why the government made it mandatory now?

• The Indian pharma industry is facing a credibility crisis. In 2022, the WHO had said that the deaths of dozens of children in Gambia and Uzbekistan were due to contaminated cough syrups manufactured by Indian drugmakers.
• In February 2023, blindness, severe eye infections and a death in the US were linked to India-made eye drops.
• In this context, making GMP mandatory would help restore India’s image as the pharmacy of the world.

Which Pharma companies need to follow GMP?

• Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months.
• However, medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year.
• The companies will also have to introduce a GMP-related computerized system. These computer programmes will be designed to automatically record all the steps followed and checks done, which will ensure all the processes are followed.
• Those who do not comply with these directions will face suspension of license and/ or penalty.

Significance of these directions:

• Currently, only 2,000 of the 10,500 manufacturing units in the country have been found to be compliant with the global WHO-GMP standards.
• Now, all will have to implement the revised GMP, ensuring quality medicines for the domestic market and abroad.

PRACTICE QUESTION

Consider the following statements:

1. The World Health Organisation (WHO) has established detailed guidelines for Good Manufacturing Practices (GMP) to minimize the risks involved in any pharmaceutical production

2. Many countries have formulated their own requirements for Good Manufacturing Practices (GMP) based on WHO Good Manufacturing Practices (GMP).

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

Answer