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Ramesh Shankar, Mumbai September 29 , 2017
The Department of Pharmaceuticals (DoP) has invoked paragraph 3 of Drugs (Prices Control) Order, 2013 (DPCO, 2013) to ensure compliance of the price capping of the primary knee and revision knee along with maintaining its uninterrupted supply in the country.

As per paragraph 3 of DPCO, 2013, the government may, with a view to achieve adequate availability and to regulate the 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 the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacture(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be.

Under the provision, for the purpose of giving any direction under sub-paragraph (i),call for such information from manufacturers of active pharmaceutical ingredients or bulk drugs or formulations, as it may consider necessary and such manufacturer shall furnish the required information within such time the government may fix.

The DoP decided to invoke the powers under paragraph 3 of DPCO, 2013 to ensure uninterrupted supply of knee implant system in the country, as after fixing the ceiling price of knee implants, in the larger public interest, uninterrupted supply of knee implant system will have to be ensured by the government.

Now, the DoP has directed the companies to furnish the production figures for 2015-16; 2016-17 and 2017-18; to maintain production/import/supply of the orthopedic knee implant systems at the same levels before August, 2017; and to submit a weekly report on orthopedic knee implant system produced and distributed. This DoP order will be valid initially for six months period.

Earlier on August 16 this year, the government had brought orthopedic knee implant system under price control, slashing the prices of knee implants ranging from 59 to 69 per cent.

According to the August 16 notification issued by the NPPA, the standard, widely used cobalt chromium in knee replacement surgery will now cost Rs.54,720 as against an earlier MRP of Rs.1,58,324. Similarly, the price of special metals like titanium and oxidised zirconium have been slashed by almost 70 per cent, to Rs.76,600 from Rs.2.49 lakh. In case of revision knee replacement, which is usually done if the primary replacement fails, prices of implants have been cut by 59 per cent. Primary knee replacement system has been fixed in the price range of Rs.38,740, Rs.24,280, Rs.16,990, Rs.9,550 and Rs.4,090 respectively based on the patient’s condition and requirement.

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