The National Pharmaceutical Pricing Authority (NPPA) has decided to bring in subject experts to consider requests by the industry regarding separate prices for cementless knee implants.

The Multidisciplinary Committee (MDC) of Experts, which advises the Authority regarding matters related to pricing of drugs and medical devices, has decided to co-opt subject experts from hospitals like All India Institute of Medical Sciences (AIIMS), Maulana Azad Medical College (MAMC), Sports Injury Centre (SIC), Safdarjung, and prominent charitable hospital to look into the matter.

Subject Experts from the National Institutes of Pharmaceutical Education and Research (NIPERs), the institutes of national importance under the Government of India, may also be co-opted for deliberation on the matter, it added.

The ceiling prices of knee implants have been notified by the NPPA under the Drugs Prices Control Order (DPCO), 2013, on August 16, 2017, stating that all manufacturers shall comply and implement the ceiling prices mentioned by the authority for knee implants irrespective of it being cementable, uncementable, gender specific or unisex.

As per the notification, the manufacturer of uncemented implants, however, may approach the NPPA with supporting documents, for fixation of separate ceiling price or retail price.

The MDC observed that now the companies are seeking separate price for cementless knee implants and the Committee noted that the Authority, in its meeting held on August 14, 2017, decided that in case some innovative product by an overseas or Indian manufacturers is to be launched, which does not fall in any of the prescribed category or has some superiority over the existing implants, the companies will have option to explore the window provided under the DPCO, 2013 for fixing separate ceiling price or retail price.

According to the Paragraph 11(3) of the DPCO, related fixing of ceiling price or retail price of a pack, in case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price for such formulations with specified therapeutic rationale, considering various factors.

Paragraph 11(4) provides powers to the Government to form a Committee of Experts, as it may deem fit, within a period of fifteen days from the date of issue of the DPCO, to recommend fixing of separate ceiling price of scheduled formulations or retail price of a new drug as per the parameter mentioned in the previous paragraph.

It may be noted that in September, last year, the Authority has notified extension of ceiling prices of orthopaedic knee implants for knee replacement system for one more year till September 15, 2025, observing that the existing ceiling prices have contributed to increased access to affordable healthcare to the general public.

On the ceiling price of orthopaedic knee implants, the Authority received requests from various industry associations for a price revision, highlighting the factors such as fluctuations in foreign exchange, increase in manpower costs, freight costs, and supply chain issues.

However, the Authority observed that the exchange rate of US Dollar to Indian Rupee was more or less at the same level during the period under consideration. The sales data submitted by the manufacturers and importers of these implants to the NPPA shows an increase of 22.71 per cent over the previous period indicating that the existing ceiling prices have contributed to increased access to affordable healthcare to the general public, it added.

"Accordingly, the Authority decided that the ceiling prices of knee implant systems as applicable on September 15, 2024 may be further extended for one year up to September 15, 2025," said the Authority.

Considering the allowable increase in 2019, 2022 and 2023 as per provisions of the DPCO, 2013, over the ceiling prices notified initially in August, 2017, the authority also published the worked out ceiling prices to be continued with effect from September 16, 2024. The prices of 11 primary knee replacement systems and four secondary knee replacement systems were notified by the Authority during the time.