Drug Regulatory Index

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Drug Regulatory Index

Context:

The Union government is developing a Drug Regulatory Index to assess states and UTs on their ability to enforce central regulations on drugs, medical devices, and cosmetics.

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  • The Drug Controller General of India (DCGI) is finalising the parameters for this index.
  • Currently, states and UTs follow different regulations, leading to inconsistent enforcement.

Need for the Index

  • Inconsistent drug enforcement across states and UTs.
  • Some states allow fixed-dose combinations that are not permitted by the Centre.
  • Lack of awareness among states regarding the number of manufacturing and sales units in their jurisdiction.
  • Weak information dissemination in northeastern states.
  • The index aims to bring uniformity, transparency, and better coordination between the Centre and state governments.

Parameters of the Drug Regulatory Index

  • Number of raids conducted.
  • Availability of enforcement staff.
  • Samples tested & failure rates.
  • Vacant and filled regulatory posts.
  • Resources allocated.
  • Number of manufacturing & sales units.
  • Additional parameters are being added for comprehensive assessment.

Implementation & Approval

  • The decision was taken in a Drugs Consultative Committee (DCC) meeting under the Central Drugs Standard Control Organisation (CDSCO).
  • The meeting was chaired by Rajeev Raghuvanshi, DCGI, in January 2024.
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