Government Inspections of Pharmaceutical Manufacturing Units

Since 2022, government authorities have conducted risk-based inspections on over 500 pharmaceutical manufacturing units. This initiative is aligned with India's objective to enhance the quality of locally produced medicines and curb the distribution of spurious drugs.

Actions Taken

• More than 400 actions have been implemented, including: 
  • Issuance of show cause notices
  • Stop production orders
  • Suspension or cancellation of licenses

Current Status of Pharmaceutical Units

• India hosts approximately 10,500 manufacturing units producing various dosage forms and active pharmaceutical ingredients.

Quality Concerns with Exported Drugs

There have been instances where exported Indian drugs did not meet international quality standards. A notable incident involved the World Health Organization linking the deaths of dozens of children in Gambia to contaminated cough and cold syrups produced by Indian manufacturers in 2023.

Regulatory Measures and Inspections

Government raids have been carried out across various pharmaceutical companies in different states. Companies found in violation of regulations received show cause notices. Multiple drug manufacturers are currently under scrutiny as inspections continue.

Implementation of Good Manufacturing Practices

• The Health Ministry has notified Schedule M rules to enforce good manufacturing practices, which include: 
  • Prompt recall of products known or suspected to be defective
• India’s drug regulator has emphasized the urgent need to review good manufacturing practice regulations and quality management systems in pharmaceutical companies.