The Andhra Pradesh Drug Control Authority (APDCA) has recently unearthed Sangam Healthcare Pvt. Ltd’s illegal activity and found that the firm which was issued stop orders earlier for manufacturing IntraVenous Infusion Sets (IV sets) in the State has stealthily shifted its activity to Karnataka and is carrying out its manufacturing activity there without having the permission of the state DCA there.
Last week after cracking its whip on M S Healthcare Pvt. Ltd. for illegally manufacturing cough syrup without having any licence, the Andhra Pradesh DCA is continuing its inspection and vigil on fraudulent manufacturers and had trapped the firm Sangam Health Care, for stealthy shifting its illegal activities from Andhra Pradesh to Karnataka. The same information is shared with DCA Karnataka and the authorities there have seized IV sets and machinery worth Rs.50-60 lakhs.
According to sources, Sangam Health Care was issued stop manufacturing orders earlier for unsafe manufacturing practices. On 18.02.2012 and 22.02.2012, Sangam Health Care, located in Yellampet Village of Medchal Ranga in Reddy District was inspected and the firm was found manufacturing Intra Venous Infusion Sets (IV sets) and disposable syringes under the brand name ‘SAFTI’ in gross violation of the provisions of the Drugs and Cosmetics Act, 1940 by not conducting the critical tests like sterility test on 514 batches, abnormal toxicity test on 414 batches and LAL test (fever causing protein component - endotoxin test) on 601 batches of the above IV sets. The components required for assembling the above IV sets and syringes are being assembled without any proper washing, cleaning and drying.
The production activities of the company were stopped by issuing an order on 19.05.2012 and even today the stop production orders are in force.
“After the stop production orders were issued on 19-05-2012, we grew suspicious about the firm’s activities and a strict vigil was kept on the firm. Information was gathered and the officers of the drugs control administration from Hyderabad carried out searches in Hyderabad and other places for possible manufacturing site of IV sets and came to know about a specific hide out at Nehrugunj, Gulburga in Karnataka where they were assembling and sterilizing these IV sets with old batch numbers and without obtaining any permissions from the State of Karnataka,” said R P Thakur, IPS, director general, APDCA.
“We have shared the same information with the Drugs Control Authorities of Karnataka. As per our information huge quantities of materials worth approximately above Rs.50-60 lakhs have been seized by the authorities there. The investigation is still in progress on suspected places of illegal manufacturing in Andhra Pradesh and Karnataka,” added the DG.
Continuing its inspections and vigil on fraudulent drug and medical equipment manufacturers in the state, the APDCA is working tirelessly to expose the undercover activities of the drug manufacturing firms in the state and is aiming to contain spurious drugs and their manufacturers.