Need for units to comply with WHO guidelines

THE pharmaceutical industry in India has become an important part of healthcare around the world, especially because it exports APIs.

- HARSHITA NEHRU

The country is a good supplier not only because it has great manufacturing skills and low costs, but also because the rules change quickly. Indian pharmaceutical companies must now meet international standards, the most important of which are the World Health Organisation (WHO) guidelines. This is because buyers from other countries want higher safety and quality standards. Following these rules isn't just about being able to sell in other countries; it's also about keeping patients safe, protecting India's reputation around the world, and making sure that its pharmaceutical exports are successful in the long run.

The rules and regulations in India

India's rules for exporting APIs have changed a lot in the last 10 years. The Central Drugs Standard Control Organisation (CDSCO) and state governments are in charge of issuing licenses, doing inspections, and making sure the rules are followed. Schedule M sets the rules for good manufacturing practices. To be relevant around the world, Indian pharmaceutical companies must follow the ICH Q7 and EU GMP standards. Documentation, processes, and standards for enforcing the law need to be regularly improved.

Setting up the centralised export NOC system in 2025 was a big step in the right direction. It got rid of the need for separate clearances at the state level. The CDSCO's choice to do this makes it easier to export goods, sets standards across India, and speeds up processing times by a lot with an online application gateway.

Why the WHO Guidelines Are Important