(28 July 2018) Report of R-Clinic at Pune

Report on R Clinic  (R-Clinic-FY1819-02)

BIG Conclave 2018, Venture Center, Pune

RIFC’s second R Clinic was organized on 27th July 2018 at the BIG Conclave 2018, Venture Center, Pune. It was an interactive session between participants who are BIG grantees and “experts in the regulatory field”.

R Clinic, themed on the “Awareness on the current Regulatory requirements for Medical Devices in India” and “Overview of the regulatory requirements for Clinical Trials for Medical Devices in India”

Ms. Syamni Sasidharan, Quality Assurance Executive from MolBio Diagnostics Pvt. Ltd., Goa. She spoke on the salient features of medical devices, including classification, working of licensing clearance system (Authorities, officers, and bodies) and product recalls on knowledge of risk to safety. Regulatory requirements for GMP manufacturing site, and post-approval regulatory mandates.

Dr. Prasad Kulkarni, Medical Director, Serum Institute of India Ltd., Pune. He highlighted the current Indian Drug Regulatory System, Apex/Committee, and their functions. He described the prior requirements for the clinical trials in India. Clinical trial phases, costs, and process flow as per the Schedule Y of D&C Act and its rules. He has pointed at the global position of India in the clinical trials market.

The overall feedback received was positive, though there are certain areas where the entrepreneurs would like more information like IVD devices, clinical performance requirements and willing to have a one to one talk with the regulators to clear specific queries apart from the acts and rules. Also, few participants are keen to undergo/ join a workshop on the specific processes of regulatory needs.

RIFC will be communicating with the entrepreneurs further to resolve their queries and work on the suggestions in the upcoming R Clinic.

Some of the pointers for our next R Clinic would be:

  1. One to one talks with regulators.
  2. Case studies group discussion on documentation requirements for clinical investigation, manufacturing for sale and risk management.

Navnath Kadam
RIFC, Venture Center, Pune