The clarification came from the National Pharmaceutical Pricing Authority (NPPA) that medical devices including orthopaedic implants will be in drugs category, which applies the provisions of DPCO 2013 to notified medical devices. NPPA said “Para 20 of DPCO, 2013 gives us the non-scheduled formulation monitoring. Under Drugs & Cosmetics Act & Rules, medical devices along with orthopaedic implants are classified as drugs. So the medical device manufacturers contention of saying that medical devices does not fall under the provisions of 2015 is totally incorrect.” By this statement NPPA has clearly refuted the contention of medical devices manufacturers especially orthopaedic implants manufacturers. READ ALSO: Register your medical devices in India, Documents required for medical device registration in India.
NPPA has asked for information on prices of orthopaedic implants earlier this year to initiate tough action against overpricing which violates Drugs & Cosmetics Act. Informations like product specifications, ex-factory price, landed cost, distributor cost, year to year maximum retail price (MRP) are also sought by NPPA. The NPPA mentioned, no manufacturer or importer or distributor can be allowed to increase their maximum retail price more than 10% within 12 months time. The manufacturers/importer/distributor shall be liable to deposit the overcharged amount along with interest thereon, from the date of increase in price in addition to the penalty.
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