3 weeks ago
FDA cancels licence of ayurvedic firm Inducare Pharma
The Food and Drug Administration is a group that makes sure medicines are safe.
There is a company called Inducare Pharma that makes ayurvedic medicine.
Ayurvedic medicine is made from natural plants and herbs.
The FDA sent inspectors to check the company's factory.
The inspectors found that the company was not keeping good records.
They could not prove which ingredients were used to make the medicines.
Keeping good records is very important so people know what they are taking.
Because of these problems, the FDA cancelled the company's license to make medicine.
The company can no longer make ayurvedic medicine until it fixes these problems.
The Food and Drug Administration cancelled the manufacturing license of ayurvedic firm Inducare Pharma Pvt Ltd in Jejuri, Pune.
Action was taken for violations of Good Manufacturing Practices (GMP) and the Drugs and Cosmetics Act, 1940 and Rules, 1945.
Inspectors found no record of the ingredients mentioned in the approved Ayurvedic text being used in actual production.
The firm's Batch Manufacturing Record (BMR) was found to be incomplete and inconsistent.
Essential records such as raw material batch numbers, analysis report numbers and manufacturing process steps were unavailable, FDA Commissioner Tukaram Mundhe said.
- Who
- The Food and Drug Administration, led by Commissioner Tukaram Mundhe, and ayurvedic manufacturer Inducare Pharma Pvt Ltd.
- What
- The FDA cancelled Inducare Pharma's manufacturing license after finding serious irregularities during an inspection.
- Where
- At Inducare Pharma Pvt Ltd in Jejuri, Pune.
- When
- Announced in an official statement issued Thursday (exact date not stated in the article).
- Why
- Because the firm violated Good Manufacturing Practices and the Drugs and Cosmetics Act, including missing records of ingredients used in production and incomplete Batch Manufacturing Records.
Key facts
- Company
- Inducare Pharma Pvt Ltd
- Location
- Jejuri, Pune
- Action Taken
- Manufacturing license cancelled
- Reason
- Violation of GMP and the Drugs and Cosmetics Act, 1940 and Rules, 1945
- Key Finding
- No record of approved Ayurvedic text ingredients used in actual production
- Batch Manufacturing Record
- Incomplete and inconsistent
- Announced By
- FDA Commissioner Tukaram Mundhe
Quotes
Tukaram Mundhe
FDA Commissioner
“There was no record available of the ingredients mentioned in the approved Ayurvedic text being used in actual production of the ayurvedic medicine. Batch Manufacturing Record (BMR) was found to be incomplete and inconsistent. Essential records like Batch Number of raw material, analysis report number, manufacturing process steps and other records were not available.”
indianexpress.com








