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

Source: The post is based on the article “Adopt WHO-standard good manufacturing practices: Govt sets deadline for pharmas”  published in Indian Express  on 3rd August 2023

What is the News?

Government of India has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) in India pharmaceutical industries.

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.

Why has the government made it mandatory for Indian pharmaceutical industries to follow GMP?

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.

What is the 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.