New Delhi: The government on Tuesday made it mandatory for knee implant manufacturers and importers to maintain production and supply of knee implants by invoking an emergency clause under the drug price control law.
The department of pharmaceuticals (DoP) under the ministry of chemicals and fertilizers invoked powers under the Drugs (Prices Control) Order, 2013, to mandate firms to continue the sale of knee implants without interruption, following the recent price cap on knee implants. DoP, in its order posted on its website on Tuesday, directed firms to submit a weekly report on “distribution" and “production" of knee implant systems.
The National Pharmaceutical Pricing Authority (NPPA) had in August reduced the average price for knee implants by as much as 69%. According to notification issued by the price regulator, the most widely used complete knee implant (Cobalt Chromium) now costs Rs54,720 plus GST, against Rs1.58 lakh earlier. NPPA also capped the price of a second surgery to Rs1.13 lakh against Rs2.76 lakh earlier. Prices of special metals such as Titanium and Oxidised Zirconium were also capped at Rs76,600 (prices of these were not capped earlier; they used to cost Rs2.49 lakh). The government has asked manufacturers to maintain production, import and supply of orthopaedic knee implant systems that existed before August when the price caps were announced. Under Section 3 (i) of DPCO, 2013, the government can regulate distribution and direct any manufacturer to raise production and sell products to institutions, hospitals or any agency as the case may be in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest.
“With the view to achieve adequate availability and regulate distribution of drugs, in case of emergency or in circumstances of urgency or in case of non commercial use in public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase production and to direct formulators to sell the formulations to institutions, hospitals or any agency," DoP said in its order.
Additionally, the companies are also directed to furnish the production figures from 2015 to 2017-18. “The move will ensure uninterrupted supply of knee implants by the manufacturers and importers. NPPA can take action against the company in case it receives any complaint of shortage or the company is charging a higher price," said an official, requesting anonymity.