FDA cancels licence of ayurvedic firm Inducare Pharma Pvt Ltd

There was a lack of cleanliness in the production department, suction filters were not cleaned and basic quality management systems such as pest control and packaging material records were absent.

Six drugs not of standard quality

Samples of medicines manufactured by the firm were declared not of standard quality and serious deficiencies were detected during the tests.

According to FDA officials in the drug Sinhanad Guggul, fungal growth and black spots were observed on the tablets and the product failed the prescribed Microbial Limit Test. Other medicines like Punarnavadi Mandur, Triphala Guggul, Knchanar Guggul,Hingvastak Churna and Triphala Churna did not comply with the prescribed norms and in some products there were insects and larvae and other foreign impurities.

Following these findings, the manufacturer was directed to immediately discontinue the production of the affected medicines and a show-cause notice was issued. Although the company submitted a written explanation and was subsequently granted a personal hearing, it failed to provide a satisfactory justification for the deficiencies that were identified by FDA.

After a detailed examination of the inspection reports, laboratory findings, show-cause proceedings, submissions made during the personal hearing, and other relevant records, the competent licensing authority ordered the permanent cancellation of the Ayurvedic drug manufacturing licence.

Tukaram Mundhe, Commissioner, Food and Drug Administration, Maharashtra State, in a statement issued here said that providing safe, and effective medicines to citizens is the highest responsibility of the Food and Drug Administration. “Drug manufacturers are required to strictly comply with the Drugs and Cosmetics Act, 1940 and Good Manufacturing Practice (GMP) standards. Strict regulatory action will be taken against any manufacturer found negligent in maintaining the quality of medicines,” he added.