The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licence of Inducare Pharma Pvt Ltd, an Ayurvedic drug manufacturer based in Jejuri MIDC in Pune district, after inspections found violations of Good Manufacturing Practices (GMP) and quality standards, officials said on Thursday.
The action followed violations of the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and GMP norms found in two inspections.
According to FDA, six medicines manufactured by the company were declared “Not of Standard Quality” (NSQ) by the government analyst based on laboratory test reports. These included Sinhanad Guggul, Punarnavadi Mandur, Triphala Guggul, Kanchanar Guggul, Hingvastak Churna and Triphala Churna.
The inspection report stated that some of the medicines showed fungal growth, excessive microbial contamination, insect infestation, larvae, lumps and other foreign impurities. Inspectors also found incomplete batch manufacturing records, absence of raw material testing, poor hygiene in the manufacturing facility, damaged equipment, missing cleaning records and inadequate quality control systems.
FDA officials said the company was issued a show-cause notice, its manufacturing activities were suspended and a personal hearing was conducted. However, the firm failed to provide a satisfactory explanation or submit evidence that the deficiencies had been rectified.
Tukaram Mundhe, commissioner, FDA, Maharashtra, said, “Any manufacturer found compromising the quality of medicines will face strict regulatory action.”
{{/usCountry}}Tukaram Mundhe, commissioner, FDA, Maharashtra, said, “Any manufacturer found compromising the quality of medicines will face strict regulatory action.”
{{/usCountry}}