India’s government is proposing new regulations that could set significant caps on medical devices imported into the country, according to a new set of draft guidelines from the country’s Department of Pharmaceuticals.
The new regulation would require that 50% of all medical disposables and consumables and 40% of all implants be produced locally, according to the draft guidance.
Imported medical electronics, hospital equipment, surgical instruments, diagnostic reagents and in vitro diagnostic devices would be limited at 75%, with local producers supplying the other 25% of products in the country.
The Indian DoP said that it determined the percentage of supply that should be relegated to local producers based on its current understanding of the device market in India and discussions with various industry representatives.
The agency said that it will revisit and revise the rules “after one year or as soon as the relevant data in this regard becomes available, whichever is earlier,” according to its release.
Earlier this month, Indian regulators reportedly warned medical device companies that their “last opportunity” to submit data on pricing would end on March 15, eight months after issuing the original deadline.
India’s National Pharmaceutical Pricing Authority has already slapped price caps on stents and other devices and is auditing alleged hospital overpricing on stenting procedures; last month the NPPA flagged the country’s hospitals for “unethical profiteering” from “exorbitant” markups – some as much as 2,000% – for commonly used medical devices.