Karnataka drugs control department has unearthed an unlicensed manufacturing unit of Sangam Health Care Products Ltd at Gulbarga in the northern part of the state engaged in the production of Intravenous (IV) infusion sets. The total value of the infusion sets sold under the brand ‘Safti’ is estimated to be valued at Rs.2 crore. This is the largest haul in the state by the State drugs control department. The Hyderabad-based company has violated the Drugs and Cosmetics Act & Rules to indulge in unlicensed manufacturing.
Sangam Health Care is a joint venture company of the Patil Group Of Industries and Boin Medica Co. Ltd., South Korea which is one of the largest manufacturers of medical disposables and surgical products. The products manufactured at the facility have to undergo extensive physical, chemical, biological, pyrogen, sterility and toxicity tests. The products are not just made available in India but are recognized in many parts of West Asia, Middle East, Africa, Europe & Latin America. The company’s range of products are IV sets, needles and syringes. Its advanced production unit in Hyderabad has a 40,000 sq.ft.of clean room area. The company is ISO 9002 compliant having a WHO GMP product certification and registered with the Directorate General of Supplies & Disposables (DGS & D).
The company went on to set up a full-fledged manufacturing unit at Gulbarga and did not apply for a license to produce the infusion sets which is a gross violation of the D&C Act & Rules, said Dr BR Jagashetty, Karnataka Drugs Controller.
The department’s enforcement team led by Nazir Ahmed, deputy drugs controller (in-charge) of the Gulbarga region carried out a massive 24 hour search and swooped down at the production plant to confiscate the entire manufactured range along with the raw materials, machinery and incriminating articles.
The drug inspectorate team have been alert and this portrayed their aggressiveness to nab the violators, said Dr Jagashetty.
While the quality of the sets also matter, there is need to ensure that the required clearances are sought to manufacture the product because it comes under the category of drug, stated medical experts. It is also learnt that further investigation would be carried out. |
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