Orthopedic implant makers fight India price law scope, but NPPA says the law wins

Price checks by India's National Pharmaceutical Pricing Authority (NPPA) on certain orthopedic implants have once again raised hackles by companies concerned they are being swept up in a law that was not meant for their industry, Business Standard reports.

In June, NPPA reportedly asked Johnson & Johnson ($JNJ), Zimmer ($ZMH) and Stryker ($SYK) to submit details of production and pricing of their products, including those for knee and hip.

But, according to Business Standard, some of the companies--no names were available--contended that authority to ask for medical device prices like these is not covered by India's Drug Prices Control Order (DPCO), 2013.

But it turned out that last week the NPPA had an answer and wrote a sternly worded letter explaining exactly why it could ask for price details and went on to say the companies had a week to respond.

"This is with reference to clarification sought by some companies regarding applicability of the provisions of DPCO, 2013, in case of medical devices," NPPA said, according to Business Standard. "Orthopedic implants along with other medical devices are notified as 'Drug' under the Drugs and Cosmetics act 1940 and rules thereunder. Therefore, your contention that the provisions of DPCO, 2013 are not applicable to medical devices is totally incorrect."

Just to be sure the companies understood that NPPA had crossed the t and dotted the i, the letter added that "Para 29 of DPCO, 2013, empowers the government to call for any record and to inspect such report at the premise of manufacturers relating to sales of formulations, which includes 14 notified medical devices."

India's NPPA wants companies to plot prices over the past three years at the points of production, after import duties and costs, distributor markup and then sale to patients, Business Standard said.

- here's the story from Business Standard