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Drugs

Karnataka Considers Voluntary Inspections for Manufactured Drugs Amid Quality Concerns

Strategic Insights

— 1 min read

The Karnataka state government is exploring a new approach to ensuring the quality of manufactured drugs, after initial plans to establish an independent agency for quality checks faced challenges. In response to appeals from city pharmacists, the government is considering introducing voluntary inspections, operating under the Quality Council of India (QCI), a public-private body. This move aims to address quality concerns and follows a recent tragedy involving contaminated cough syrups that led to the deaths of 23 children.

Key Takeaways:

  • The Karnataka state government is considering introducing voluntary inspections for manufactured drugs under the Quality Council of India (QCI).
  • The move follows appeals from city pharmacists and a recent tragedy involving contaminated cough syrups that led to the deaths of 23 children.
  • The proposed model operates like existing bodies in construction, jewellery, and financial sectors where mandatory quality systems are in place.
  • The plan requires amendments to the Drugs and Cosmetics Rules, 1945, by the central government before becoming mandatory.
  • The Bangalore District Chemists and Druggists Association has demanded a nationwide mechanism for testing drugs.
  • The state government plans to start voluntary inspections while waiting for the central government's consent to amend the rules.
  • Once amended, the rules will require drug manufacturers to undergo assessments by the agency at least once a year or every three years.

Statistics:

  • 23 children died due to contaminated cough syrups
  • The Karnataka state government is considering a new approach to ensure the quality of manufactured drugs
  • The Quality Council of India (QCI) is a public-private body that could operate under the proposed model
  • The proposed model operates like existing bodies in construction, jewellery, and financial sectors
  • The plan requires amendments to the Drugs and Cosmetics Rules, 1945, by the central government
  • 1,000+ pharmacists have visited the department to express concerns about drug quality

Sources:

  • TOI
  • Letter from Bangalore District Chemists and Druggists Association to central and state health departments

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