Indian Regulators Seek Details on Orthopedic Implant Pricing

India’s National Pharmaceutical Pricing Authority is asking several orthopedic implant manufacturers to provide details on cost increases that potentially may violate drug pricing laws.

In a letter addressed to executives at pharmaceutical associations and device manufacturers, NPPA asks for a brief description of the products, the maximum retail price and the percent increase in the MRP for each of the last three years. The regulator is looking into possible violations of the Drug Pricing Control Order of 2013, which states that no manufacturer, importer or distributor may raise the MRP of a nonscheduled drug more than 10 percent during the preceding 12 months.

According to the letter, the companies had sought clarification on whether DPCO 2013 provisions apply to medical devices, something NPPA confirms. “Orthopedic implants along with other medical devices are notified as ‘Drug’ under the Drugs & Cosmetic Act 1940 and rules thereunder,” the letter states.

The rules authorize the government to inspect price list records, including those of 14 notified medical devices. NPPA asks the associations to encourage their member companies to provide the information within seven days of receipt of the letter.

The authority previously asked for this information in a May 15 notice that highlighted media reports alleging orthopedic implants have been sold at exorbitant prices with high profit/trade margins.

The letter comes as industry continues its ongoing push for a distinct definition of medical devices and a pricing and reimbursement system separate from that of drugs. The government took a step in that direction last month by announcing the creation of a dedicated authority to oversee the regulation and production of medical devices. Industry groups may comment on the government proposal through July 15 (IDDM, June 12).

The latest NPPA letter is available here: www.fdanews.com/071315-NPPA-request.pdf. — Elizabeth Hollis