NPPA extends price regulation on oxygen concentrators for six more months

New Delhi, November 26, 2021:

The National Pharmaceutical Pricing Authority (NPPA) has decided to extend the notification related to price regulation of oxygen concentrators based on the Trade Margin Rationalisation (TMR) approach applicable for six more months, till May 30, 2022.

Besides, the period to report stock details of four medical devices - bare metal stents, drug eluting stents, orthopaedic knee implants and oxygen concentrators has been relaxed from monthly to quarterly basis.

The Authority, in its meeting held on November 15, noted that the notification issued in June, 2021, related to price regulation of oxygen concentrators based on TMR approach is applicable to November 30, 2021.

Recommendations of the Standing Committee on Affordable Medicines and Health Products (SCAMHP) in its fourth and fifth meeting held on May 25 and 30, this year, was also taken into note by the authority, before deciding on the extension of the price regulation period.

“The Authority deliberated upon the matter in detail and was of the opinion that as Covid pandemic is still a risk to public health; availability of oxygen concentrators at affordable prices must be ensured,” said the minutes to the meeting.

Hence, it was decided that the notification be extended, before it expires, for another six months up to May 30, 2022. The Authority further decided that the matter be forwarded to SCAMHP for its recommendations.

According to the notification issued by the Authority in June, 2021, the Government has put a cap on the trade margin of oxygen concentrators at the first point of sale of the product, at 70 per cent.

In the same meeting, the Authority discussed the topic related to changing the reporting of stock related submissions quarterly instead of monthly for certain capped medical devices. The Authority deliberated upon the matter in detail and decided that the submission of information relating to stock details of medical devices namely, bare metal stents, drug eluding stent, orthopaedic knee implants and oxygen concentrators may be reported on quarterly basis instead of monthly.

The Authority also observed that a total of 82 applications were pending as on October 31, 2021, out of which 68 applications were presented for price approval in the meeting, while 14 applications are pending. It was further directed that action must be taken to process the applications as per the timelines.

During the meeting, a total of 51 applications for retail price fixation of 51 new drugs were considered and the Authority has approved the retail prices of 50 new drugs under the relevant norms of the Drug (Prices Control) Order, 2013. The formulations for which the retail prices were fixed include telmisartan + chlorthalidone tablet manufactured by Windlas Biotech Pvt Ltd and marketed by Mankind Pharma Ltd, cefixime tablets manufactured by Hema Laboratories and marketed by Softdeal Pharmaceuticals and tacrolimus ointment manufactured by Helios Pharma and marketed by Panacea Biotec, among others.

In connection with fixing the retail price of fixed dose combinations which has dapagliflozin drug, the Authority has noted its observations made in an earlier meeting that fixation of retail price of off-patented drugs based on market based data as per Pharma AWACS database, in respect of drugs whose retail price has been fixed based on Form V data for a considerable period, may be explored.

In continuation to this, the Authority has now observed that further analysis with respect to the price movement of drugs which became off-patent other than dapagliflozin needs to be done. The Authority has fixed retail price of fixed dose combinations of dapagliflozin and metformin hydrochloride IP as extended release tablets for various companies.

Dapagliflozin, the type II diabetes drug which was patented by pharma major AstraZeneca saw one of its patents in India expiring on October 2, 2020. Following this, several generic manufacturers have started manufacturing the drug and AstraZeneca, which claims it has one more patent for the drug which is valid through May 15, 2023, sued many of them in the Court. Dapagliflozin is an oral medicine, from a class of medicines named sodium-glucose co-transporter 2 (SGLT2) inhibitors. In February, this year, the company announced that it has received marketing authorisation for the drug for treatment of patients of chronic kidney disease up to State III. Pharmabiz