In its ongoing crackdown for non-compliance, Maharashtra Food and Drug Administration (FDA) based on 427 raids across the state seized illegal products worth Rs. 17.17 crore in 305 seizures done over a period of one year.
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. 1 lakh, as prescribed under Section 27(b)(ii) of the said Rules.
Around 55 FIRs have been lodged related to such cases out of which 37 cases are related to drugs and remedies act violation.
Latest in the series of such cases was seizure of 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. FDA investigation revealed that the implants were illegally manufactured, stocked and supplied violation of Drugs and Cosmetic Rules.
Orthopaedic implants is one such product which is subject to unethical markups in the supply chain much the same way as was done in cases of overcharging of coronary stents. It has also been given to understand and patients are fleeced at the point of care through the hospital - dealer nexus.
Investigations revealed that a 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.
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.
The drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) is also planning to collect data on pricing and availability of other medical devices from different sources to help notify their ceiling prices also soon. Government is also 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.
Against the backdrop of rampant practices of overcharging of coronary stents at the point of care, drug pricing regulator NPPA had 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.