Even as confusion prevailed on the definition of the word manufacturer as far as implementation of the NPPA's Order S.O. 412(E) dated 13th February, 2017 related to ceiling price fixation of coronary stents under paragraph 19 of the DPCO 2013, the drug price regulator has issued an Addendum on its Order to redefine the word 'manufacturer'.

As per the Addendum, “(p) Under paragraph 2(n) of the DPCO, 2013, the manufacturer means any person who manufactures or imports or market drugs for distribution or sale in the country. Accordingly, any person who imports stents directly without having registration certificate (RC) in Form 41 issued under Drugs and Cosmetics Act, 1945 and Rules, thereunder in its own name and does it under Form 10 license issued on the undertaking given in Form 9 by another person having RC in Form 41, issued under Drugs and Cosmetics Act, 1945 and Rules, thereunder, shall be construed as ‘distributor’ for the purpose of this order under the Drug (Price Control) Order, 2013.

“(q) Trade margin in excess of 8% specified hereinabove, in whatsoever form, if any involved in the transactions between such distributors, as stated in aforesaid para (p) of this order with any other ‘person/institution/hospitals’ upto consumer/patient, shall be liable to be deposited, jointly or severally, by the concerned along with interest payable from the date of transaction under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.”

Earlier, vide its Gazette Notification S.O. No. 412 (E), dated 13.02.2017, the NPPA had notified the ceiling prices of coronary stents. As per the notification, the NPPA had put a cap on the prices of bare metal stents - the basic category – at Rs. 7,260 and that of more advanced drug-eluting and bioresorbable stents at Rs. 29,600. Besides, the NPPA had also issued subsequent clarifications issued through Office Memoranda (OM). As per the notification and clarificatory OM, the hospitals are required to comply with the notified ceiling price of stents and to adhere to instructions in letter and spirit.

As per the notification, hospitals are also required to issue detailed bills to the patients clearly mentioning the brand name, name of the manufacturer/importer/batch no., category of the stent (BMS/DES) and other details of stent, if any.