‘8 Maharashtra firms found manufacturing ortho implants in unhygienic conditions’
An official from the Food and Drugs Administration (FDA), Maharashtra, said the eight firms from the state include three from Parel, Kurla and Mahalaxmi in the cityUpdated: Mar 22, 2019 13:43 IST
The safety and quality of orthopedic implants used in Maharashtra has come under the scanner again. Eight firms in the state were found manufacturing orthopedic implants in an unhygienic environment and violating quality control norms, on March 11. The raids at these firms, conducted by the Central Drugs Standard Control Organisation( CDSCO ), was part of a nationwide crackdown on 45 firms in Delhi, Maharashtra, Gujarat and Uttar Pradesh.
An official from the Food and Drugs Administration (FDA), Maharashtra, said the eight firms from the state include three from Parel, Kurla and Mahalaxmi in the city.
CDSCO officials said the units were found manufacturing implants in an unhygienic environment. The companies failed to maintain quality of the storage place, officials said. “We also found that the material used for the implants was of substandard quality. We are in the process of sending notices to the firms regarding these violations,” said a CDSCO official, who did not want to be named.
Despite several attempts, PBN Prasad, deputy drug controller, India, remained unavailable for a comment.
GR Rahane, assistant commissioner, FDA Maharashtra, said, “As we were not a part of the raids, we are not aware of the violations. However, we have written to the CDSCO officials if there is any further investigation to be carried out against the accused firms.” CDSCO is also investigating the hospitals or medical practitioners attached to the firms, who frequently bought the implants, which were cheaper as compared to branded ones.
Medical equipment industry members, however, said India does not have proper mechanism to check quality standards or laboratories to test orthopedic implants.
“In 2006, the orthopedic implants were added in schedule M of Drugs and Cosmetics Act before which it wasn’t even included in the drugs section. However, with the inclusion came large number of quality control measures which the smaller firms failed to follow. While we welcome the action against those violating the norms, the government also has to establish a set mechanism to check the quality of orthopedic implants,” said Abhay Pandey, president, All India Food and Drugs License Holders Association.
First Published: Mar 22, 2019 13:43 IST