NPPA said relabelling of stents is not mandatory, and called upon manufacturers and importers to issue revised price lists as quickly as possible in line with its price cap order - a move seen as an attempt to simplify the process ensure continuation of cardiac services to patients.
Indian drug price regulator National Pharmaceutical Pricing Authority (NPPA) in a notification on Friday said relabelling of stents is not mandatory, and called upon manufacturers and importers to issue revised price lists as quickly as possible in line with cap order. The move is being percieved as an attempt to simplify the procedure to ensure continuation of cardiac services to patients.
NPPA's announcement comes amidst media reports of manufacturers and importers are withdrawing stents from the market holding up cardiac service delivery to patients.
“It is suggested that such price lists may be issued by e-mail, so as to reach dealers and retailers quickly,” said AK Khurana, director (pricing) of NPPA in the latest memo.
Khurana asked the manufacturers to follow electronic submission of such price list through integrated pharmaceutical database management system (IPDMS) of the NPPA a proof thereof.
NPPA on Thursday wrote to all chief secretaries to ensure compliance of stents price capping, its availability and uninterrupted cardiac care services, and directed the states and Centre to urge manufacturers to maintain production, import and supplies of stents at the precap level.
NPPA also opened up new helpline – 1800111255 for citizens to register complaints regarding prices and supply and availability of coronary stents. The regulator also asked citizens to file complaints of price non-compliance or shortage on its website through Pharma Jan Samadhan.
NPPA has capped the prices of bare metal stent at Rs 7,260 and drug-eluting stent (DES) and biodegradable stents at Rs 29,600. Both the prices are exclusive of value added tax. DES constitutes 95 percent of the market.
The steep price-cuts and immediate implementation of the notification by NPPA has caused quite a heartburn to stent manufacturers who sought at least 45 days time from the drug price regulator to comply with the order that involves relabeling MRP prices of stents with distributors and retailers. Some manufacturers even issued veiled threat that this could lead to supply disruption.
Stent manufacturers have condemned the reports and said that none of their member have withdrawn any products from the market.
Medical Technology Association of India (MTaI), as an industry association representing research based medical technology organizations said the claims made by certain sections of the media that medical device companies are trying to create an artificial shortage of stents (is) absolutely unacceptable and a deliberate attempt to tarnish the image of the companies.
“All MTaI companies are complying with the laws and recent orders from NPPA and we would like to state that all MTaI member companies are working hard to make products available while simultaneously conducting the complex and mammoth task of relabeling entire stocks,” the industry body said.
“We appeal everybody to demonstrate patience as we are in the process of re-handling lifesaving products. In the interest of patient safety, the process of relabeling needs to maintain sterility and proper handling of products,” MTaI added.
AdvaMed and its member companies that include big MNCs like Abbot, Medtronics and Boston Scientifc refuted the claims that medical device companies are trying to create an artificial shortage of stents.
All the AdvaMed member companies remain compliant to the laws of the land, no member companies have withdrawn any stents from the market, the medical devices lobby group said.
“We would like to state that all AdvaMed member companies have been diligently following the re-labelling norms and specifications laid out in the rules of the government, pursuant to the notification. It is important to note that the execution of relabeling exercise is a huge and first-ever for the stent sector and needs to be performed carefully to ensure product quality or packaging integrity; due to which we had sought additional time for transition,” Advamed added.