In its ongoing crackdown for non-compliance of rules, Maharashtra Food and Drug Administration (FDA) has seized orthopaedic implants worth Rs.2.31 crore from a Mumbai based manufacturer who was manufacturing, stocking and supplying the products in a clandestine manner without a license.
Led by Maharashtra FDA Commissioner Dr Harshadeep Kamble, the operation was based on a tip-off which revealed that the implants were illegally manufactured, stocked and supplied in Bhiwandi in violation of Drugs and Cosmetic Rules.
Further to this, orthopaedic implants were also seized from Akola worth Rs.4.40 lakhs.
Against the backdrop of rampant practices of overcharging of coronary stents at the point of care, drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has recently fixed prices of coronary stents after bringing it under National List of Essential Medicines (NLEM) following adverse market reports of unethical markups at every stage of the supply chain.
Meanwhile NPPA chairman has said, “Considering the current situation, the drug pricing regulator is also planning to collect data on pricing and availability of orthopaedic implants and other medical devices from different sources to help notify their ceiling prices also soon.”
Orthopaedic implants is one such product which is subject to unethical markups in the supply chain and it has been given to understand and patients are fleeced at the point of care through the hospital - dealer nexus. Government is keen on collecting data on these devices to get an idea about the volume of consumption, cost of manufacturing and price at which they are supplied to a patient. Following a review, these devices could soon follow cardiac stents as new additions under the NLEM. Devices must be placed on the NELM before their prices could be capped, as per the Rules.
Stocks of various orthopaedic implants, including Intramedulary Nails and Interlocking Bolts worth Rs.4 lakhs were also seized from the premises of GT Hospital following a raid led by Maharashtra FDA Commissioner Dr Harshadeep Kamble recently.
Section 18(c) prohibits stock, distribute and sale of the medical devices, except under Licence issued under Drugs and Cosmetics Rules, 1945. This is an offence attracting penalty of imprisonment of 3 to 5 years and fine of minimum Rs.one lakh, as prescribed under Section 27(b)(ii) of the said Rules.
Investigations revealed that this firm was selling these implants to about 22 various stockists in Maharashtra. Based on interrogation of the accused and other leads, a team of assistant commissioners and drug inspectors of FDA, Nanded raided the premises of Asclepious Enterprises, Ganesh Nagar, Nanded and seized stocks worth Rs.1.07 crore of various orthopaedic implants, from the said premises.
The medical devices seized were Acetabular Cups, Shoulder Prosthesis rods, Muller Stem, Biopolar Hip Cross, Cancellous, Angle Radius, Poesteriomedial Tibia, Distal Tibia Nails, Cortex, Platonic Stem, Syrus Femur Nails, etc. These devices include some sterile implants to be used in orthopaedic operations. The said implants are used in Hip Replacement surgeries, Hip Joints procedures, fractures, etc.
It was also revealed that despite having no licence, Asclepious Enterprises, Nanded, was appointed as an authorized dealer for Maharashtra by the manufacturers namely Sharma Surgical and Engineering Pvt. Ltd, Vadodara, Gujarat and Orthotech Implants, Valsad, Gujarat. Since the devices are manufactured in Gujarat, a team of FDA, Maharashtra is likely to go to Gujarat for further investigations.