The problem restricting innovation and trials is not Indian Pharmas not wanting to put in money or the court freezing margins. It is the health ministry’s dysfunctional approval process for trials, and the peculiar market situation in India wrt pharma. 🧵 1. Ethics committee approval is mandatory for trials. But try forming an ethics committee if you’re a healthcare institution. It may take years to get permissions if you get it at all. Of course you can go to a committee that already exists. But the time taken, number of queries raised and conditions put are sufficient to deter the bravest of researchers even if it just a simple observational study with zero patient risk. Hospitals and pharma companies are still waiting for approvals of trials proposed over two years back. 2. The business model of Indian pharma is low cost production and high MRP to pass on maximum margins to sellers. To capture market space, Indian pharma companies keep printing higher and higher MRPs. No international pharma giant gives the kind of obscene margins Indian companies do, they focus on their brand image and pitch product quality instead. 3. For example: Before it’s MRP was restricted under DPCO, the same brand of a higher generation antibiotic (meropenem) made by a good Indian pharma company was sold with printed MRPs ranging from 600 to 3500 depending on what the buyer wanted, the supply price was the same: 300. The hospital pharmacy could then supply it to a rich delux class patient at 3500 and less affording general ward patient at 600. Something akin to bottled water being sold for MRP of 20 in stores and MRP of 60 to 100 at airports and cinema halls due to different captive audience at the point of sale. 4. The problem therefore is not Indian companies being restricted by price control hence not getting funds for research. They can very well readjust their pricing to make provision for research, this remains unrestricted. Their selling price to distributors matters to them, not the printed MRP decided by the buyer. 5. In fact, Indian pharma companies are putting in substantial efforts at research and have brought out some original research molecules that are doing well. It’s a late but good start. Even low cost drug giants like Mankind now have hundreds of scientists engaged in research. India also has not less than 128 startups doing dedicated research into new drugs. Over 1000 new drugs by Indian companies are currently in various stages of trials. So it is a myth that Indian companies are not doing research. The problem is not them. It’s the health ministry. 6. These trials will remain stuck if there is no one to give approvals in the first place. Look at the sad condition of the National Medical Commission. For over two years, all seats on NMC panels were lying vacant and the entire organisation was virtually defunct. Some but all vacancies have still not been filled after SC pulled them up for it. This is the body responsible for medical research and ethics in India and even today, most of the posts at the autonomous board for medical ethics and registration are lying vacant. UG and PG Medical education boards too are lying vacant. Is it not the responsibility of the health ministry to at least have the NMC functional at all times? The solution to the pharma research conundrum is lying in plain sight. Processes that work need functional govt departments. MoHFW Naddaji really needs to get his act together and pull up his socks and his subordinates to get things going.