The Gujarat Food and Drug Control Administration (FDCA) recently froze the activities of Bangalore based Vascular Concept Ltd. as the company failed to produce the Central Licensing Approval Authority (CLAA) approval to the drug authorities.

During the investigation, the officials found 942 cardiac stents worth Rs. 70,000 lakh belonging to five different brands like Provova, Projecta, Projecta PS, Pro-Star Plus and Pronova from the company's C&F agent in Ahemadabad.

Dr H G Koshia, commissioner, Gujarat FDCA informed that all the seized cardiac stents in the price range of Rs. 45,000 to Rs. 75,000 each were found to be manufactured and distributed in Gujarat without licenses.

Under the law, all companies engaged in business connected with blood banks and manufacturing or marketing of vaccines or medical devices in India are required to get approval from the CLAA. After which it goes to the Drug Controller General of India's (DCGI's) office for marketing and manufacturing license.

“In spite of having such a huge order with them, the company's representatives were unable to provide us with license which prompted us to take preventive action against them. As of now, we could not seize the products from the facility as the company had the license for distribution, but to ensure public safety we have frozen all their products until further notice,” said Dr Koshia.

He further informed that he has already referred the matter to the DCGI's office and is hopeful that DCGI will look into this issue at the earliest and take appropriate action against the company.

Dr Koshia stressed, “We believe that this company has operation in other parts of the country as well and so we want to ensure that corrective steps are taken to stop their activities in other states, in the absence of proper approvals, for ensuring public safety.”

Not all the medical device manufacturers are required to comply with the CLAA approval. Under the current law, manufacturer's who are involved in the manufacturing, marketing or distribution of 10 medial devices notified under the D&C Act   are required to have this certification.