In March 2019, the Health Ministry of India released new guidelines for clinical research. What is the state of pre-market and post-market safety for patients and drugs in India, six months after these new guidelines were announced? Dr. Srikanth Krishnamurthy, a consulting pulmonologist at Sri Bala Medical Centre and Hospital, discusses the pre-market clinical research safety perspective; and Dr. J. Vijay Venkatraman, Managing Director and CEO at Oviya MedSafe, contributes the perspective of post-market drug safety in India.