The Gujarat Food and Drugs Control Administration (FDCA) recently raided two medical device manufacturing units in the state for making and selling medical devices without requisite license. These Ahmadabad based companies, SCM Orthocare and Zedac Orthocare, were found to be flouting the provisions under Section 18(c) of the Drugs and Cosmetics (D&C) Act.
It is understood that following a tip off, the Gujarat drug regulator raided and seized products worth Rs.2.80 lakh from the manufacturing site of the companies. Following the raid, they have already sent six samples of different products from both the companies to the drug and food-testing laboratory in Baroda for checking the quality of the products.
Dr H G Koshia, commissioner of Gujarat FDCA informed that these manufacturers where found to be making high-end devices and selling it across the country. They were found to be manufacturing orthopedic implants like plates, nails, screws and other end products that were intended to be implanted in the body of unsuspecting patients. He stressed that this is a case of gross violation of the law of the land and will be seriously dealt with under the requisite law.
“As of now, we have sealed their manufacturing units, stopped the sale of their products and sent show cause notices to the respective owners. Once we get corroborative report on the samples collected on the quality of the raw materials like steal that were used to manufacture these products, we will go ahead with charging criminal cases against these culprits for endangering and putting the lives of patients at risk for manufacturing not of standard quality devices. Gujarat FDCA is taking all the possible measures to crack down on such illegal cases so that the life of the patients are not put at risk, especially since implanting low quality or defective device can endanger the life of the patient. We have already alerted and strengthened our workforce for finding similar cases and would like to caution any wrongdoers that strong action will be taken against them,” warned Dr Koshia.
He further added that at present there are around 150 plus licensed medical device manufacturers in the state. These manufacturers are categorized into plastic disposable manufacturers; medical disposable manufacturers; orthopedic implants manufacturers and cardiac stents manufacturers. It is important to note that as of now, the ministry of health and family welfare has notified and considered only 14 devices as drugs under Section 3, clause (b) Sub clause (iv) of the Drugs and Cosmetics Act (D&C Act). They are disposable hypodermic syringes; disposable hypodermic needles; disposable perfusion sets; in vitro diagnostic devices for HIV, HBsAg and HCV; cardiac stents; drug eluting stents; catheters; intra ocular lenses; I.V. cannulae; bone cements; heart valves; scalp vein set; orthopaedic implants and internal prosthetic replacements. Further it has also regulated eight new products like blood grouping sera; ligatures, sutures and staplers; intra uterine devices (Cu-T); condoms; tubal rings; surgical dressings; umbilical tapes and blood and blood related component bags as 'drugs' under the Act.