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WHO Assesses India's Drug Regulatory Authority and Vaccine Manufacturing

  • The World Health Organization (WHO) has assessed India's Central Drugs Standard Control Organization (CDSCO), the nation's top drug regulator.
  • The evaluation aimed to determine the status of India's National Regulatory Authority (NRA) concerning drug regulation.
  • The assessment also included an evaluation of vaccine manufacturing practices within India, a major global vaccine producer.
The World Health Organization (WHO) recently conducted an assessment of India's Central Drugs Standard Control Organization (CDSCO) and Drugs Controller General of India (DCGI). This evaluation aimed to determine the status of India's National Regulatory Authority (NRA) and its adherence to international standards. The assessment also included a review of vaccine manufacturing practices within the country.
The WHO's assessment is a crucial step in ensuring the quality and safety of pharmaceutical products manufactured in India. As a major exporter of drugs and vaccines, India's regulatory standards have a global impact. The evaluation covers various aspects of the regulatory system, including drug approval processes, manufacturing inspections, and post-market surveillance.
The findings of the WHO assessment are expected to provide valuable insights into the strengths and weaknesses of India's regulatory framework. These insights can then be used to implement necessary improvements and ensure that Indian-manufactured pharmaceutical products meet the highest international standards. The assessment is particularly important for vaccine manufacturing, given India's role as a major supplier of vaccines to global health initiatives.
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