On July 22, the Indian Department of Pharmaceuticals National Pharmaceutical Pricing Authority (NPPA) issued a Memorandum with respect to the maximum retail prices (MRP) for non-scheduled formulations for new drugs and medical devices. Essentially, it states that the NPPA monitors prices, and no manufacturer can increase prices by more than 10% from the previous 12 months. Also, the MRPs of products registered under different brands shall not exceed 10% either. This is India using price controls to reduce medical inflation.
In addition, the Indian CDSCO (medical device division) outlined a new, very long draft guidance document on medical device software. This guidance mimics the current device regulations under MDR-2017. However, more details are provided. In this guidance, medical device software is divided into two parts: Software in a Medical Device (SIMD) and Software as a Medical Device (SaMD). Examples of each software are included, along with information on software not covered under the MDR-2017. Software is divided into four classes (A-D), and this is determined by the risk classification and IFU. Additionally, the document outlines applicable standards, QMS requirements, and a document checklist for product registration, among other relevant details.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.