Karnataka merges AYUSH drug authority with state FDA to streamline regulation

Aug 1, 2025

Karnataka AYUSH FDA merger, Unified drug regulation India, AYUSH licensing under FDA, AYUSH export compliance Drugs and Cosmetics Act AYUSH
Karnataka AYUSH FDA merger, Unified drug regulation India, AYUSH licensing under FDA, AYUSH export compliance Drugs and Cosmetics Act AYUSH

Source: Pharmabiz

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The Karnataka government has issued an official order to merge the AYUSH Drug Licensing Authority, Drug Enforcement Division, and Drug Testing Laboratories with the State Food and Drug Administration (FDA). This move brings traditional medicine regulation under the same authority as modern drugs, aiming for seamless coordination and stricter oversight. States like Maharashtra, Gujarat, Goa, and Kerala have already adopted this model. Karnataka’s integration is expected to improve quality control, eliminate regulatory overlap, and boost credibility in both domestic and export markets.

Key highlights

Unified regulatory structure announced

  • All AYUSH-related functions now fall under the State FDA’s drug administration wing.

  • Modern and traditional drug licensing, enforcement, and testing will be centrally managed.

  • This shift aims to streamline approvals, renewals, and enforcement actions.

Testing labs consolidated for higher efficiency

  • Testing will move from AYUSH’s single lab to NABL-accredited FDA labs in Bengaluru, Hubballi, and Belagavi.

  • Unified testing protocols will ensure consistent quality standards.

  • The merger reduces duplication and expands lab access statewide.

Improved compliance and consumer safety

  • Centralized governance enables better monitoring of production plants and medicine outlets.

  • Regulatory delays are expected to decrease with one authority overseeing all decisions.

  • Analysts must now meet stricter qualifications under Section 33F of the Drugs & Cosmetics Act.

Following national model of drug regulation

  • Gujarat, Maharashtra, Goa, and Kerala have already integrated AYUSH into their FDA systems.

  • Karnataka joins this trend to unify drug governance and enhance public trust.

  • Export potential of AYUSH medicines may increase due to improved oversight.

By merging AYUSH regulation with the State FDA, Karnataka is reinforcing its commitment to quality, safety, and regulatory efficiency. The move reflects a growing nationwide trend to simplify drug control and enhance transparency across India’s pharma ecosystem — from herbal to allopathic.

Karnataka AYUSH FDA merger
Unified drug regulation India
AYUSH licensing under FDA
AYUSH export compliance Drugs and Cosmetics Act AYUSH
Karnataka AYUSH FDA merger
Unified drug regulation India
AYUSH licensing under FDA
AYUSH export compliance Drugs and Cosmetics Act AYUSH

Karnataka merges AYUSH drug authority with state FDA to streamline regulation

Aug 1, 2025

Karnataka AYUSH FDA merger, Unified drug regulation India, AYUSH licensing under FDA, AYUSH export compliance Drugs and Cosmetics Act AYUSH
Karnataka AYUSH FDA merger, Unified drug regulation India, AYUSH licensing under FDA, AYUSH export compliance Drugs and Cosmetics Act AYUSH

Source: Pharmabiz

The Karnataka government has issued an official order to merge the AYUSH Drug Licensing Authority, Drug Enforcement Division, and Drug Testing Laboratories with the State Food and Drug Administration (FDA). This move brings traditional medicine regulation under the same authority as modern drugs, aiming for seamless coordination and stricter oversight. States like Maharashtra, Gujarat, Goa, and Kerala have already adopted this model. Karnataka’s integration is expected to improve quality control, eliminate regulatory overlap, and boost credibility in both domestic and export markets.

Key highlights

Unified regulatory structure announced

  • All AYUSH-related functions now fall under the State FDA’s drug administration wing.

  • Modern and traditional drug licensing, enforcement, and testing will be centrally managed.

  • This shift aims to streamline approvals, renewals, and enforcement actions.

Testing labs consolidated for higher efficiency

  • Testing will move from AYUSH’s single lab to NABL-accredited FDA labs in Bengaluru, Hubballi, and Belagavi.

  • Unified testing protocols will ensure consistent quality standards.

  • The merger reduces duplication and expands lab access statewide.

Improved compliance and consumer safety

  • Centralized governance enables better monitoring of production plants and medicine outlets.

  • Regulatory delays are expected to decrease with one authority overseeing all decisions.

  • Analysts must now meet stricter qualifications under Section 33F of the Drugs & Cosmetics Act.

Following national model of drug regulation

  • Gujarat, Maharashtra, Goa, and Kerala have already integrated AYUSH into their FDA systems.

  • Karnataka joins this trend to unify drug governance and enhance public trust.

  • Export potential of AYUSH medicines may increase due to improved oversight.

By merging AYUSH regulation with the State FDA, Karnataka is reinforcing its commitment to quality, safety, and regulatory efficiency. The move reflects a growing nationwide trend to simplify drug control and enhance transparency across India’s pharma ecosystem — from herbal to allopathic.

Share:

Karnataka AYUSH FDA merger
Unified drug regulation India
AYUSH licensing under FDA
AYUSH export compliance Drugs and Cosmetics Act AYUSH
Karnataka AYUSH FDA merger
Unified drug regulation India
AYUSH licensing under FDA
AYUSH export compliance Drugs and Cosmetics Act AYUSH