3 weeks ago
Maharashtra FDA Cancels 10 Ayurvedic Licences Over GMP Violations
In the Indian state of Maharashtra, special inspectors checked places that make Ayurvedic medicines.
Ayurvedic medicines are traditional herbal medicines.
The inspectors looked at 434 medicine-making factories.
They wanted to make sure the medicines were safe and made properly.
They found many factories were not following important rules.
Some factories had no trained workers, dirty rooms, or missing paperwork.
Because of this, 135 factories were told to explain their problems.
Ten factories were so unsafe that they lost their licences and can no longer make medicines.
The head inspector said all makers must follow the rules to keep people healthy.
This action helps make sure Ayurvedic medicines are high quality and safe.
The Maharashtra Food and Drug Administration (FDA) inspected 434 licensed Ayurvedic drug manufacturing establishments across the state.
10 manufacturers had their manufacturing licences permanently cancelled over serious quality, safety and efficacy violations.
135 manufacturers were issued show-cause notices and directed to explain the violations detected during inspections.
Violations included missing qualified technical staff, non-functional quality-control departments, unhygienic premises and missing or inaccurate records.
FDA Commissioner Tukaram Mundhe warned of strict action against manufacturers failing to comply with Schedule T Good Manufacturing Practices.
- Who
- The Maharashtra Food and Drug Administration (FDA) and its Ayurvedic Licensing Authority, led by Commissioner Tukaram Mundhe, and Ayurvedic drug manufacturers across Maharashtra
- What
- A statewide crackdown in which 434 Ayurvedic manufacturing establishments were inspected, 135 received show-cause notices, and 10 had their manufacturing licences permanently cancelled for serious GMP and quality violations
- Where
- Across the state of Maharashtra, India; the Maharashtra FDA is based in Mumbai
- When
- Not specified in the articles
- Why
- To enforce compliance with the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945 and Schedule T Good Manufacturing Practices, and to protect public health
Key facts
- Regulator
- Maharashtra Food and Drug Administration (FDA)
- Establishments inspected
- 434
- Show-cause notices issued
- 135
- Licences permanently cancelled
- 10
- FDA Commissioner
- Tukaram Mundhe
- Action ordered by
- Ayurvedic Licensing Authority, Maharashtra FDA
- Regulatory framework
- Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; Schedule T (GMP)
- Key violations
- Missing qualified technical staff, non-functional quality-control departments, unhygienic premises, missing records, incorrect manufacturing dates and inadequate cross-contamination safeguards
Quotes
Tukaram Mundhe
Commissioner of the Maharashtra Food and Drug Administration
“Manufacturers must strictly comply with prescribed GMP and quality‑control standards to ensure the safety, quality and efficacy of Ayurvedic medicines. Strict action will be taken against units violating the regulations.”
freepressjournal.in
Sources
Maharashtra FDA Cancels Licences Of 10 Ayurvedic Drug Makers Over GMP Violations, Issues Notices To 135 Units
Maharashtra FDA Launches Statewide Crackdown On Ayurvedic Drug Makers, Cancels 10 Licences Over Serious GMP & Quality Violations
Maharashtra FDA Cracks Down on Ayurvedic Drug Makers, Cancels 10 Licenses Over Major Violations
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