New Delhi: India’s drug pricing regulator to be moved to health ministry
The PMO plans to transfer India’s apex drug pricing regulator from the ministry of chemicals and fertilizers to the health ministry because it has the technical expertise needed to take decisions on drug pricing.
Discussions in the PMO have begun to move the National Pharmaceutical Pricing Authority (NPPA) and department of pharmaceuticals to the health ministry.
This is a part of rationalizing drug safety and pricing as the Drug Controller General of India -- responsible for approving trials, licensing, drug safety, manufacturing standards, and sale, import and distribution of drugs --.is art of the health ministry.
While officials in the health ministry refused to confirm anything officially, a source, on condition of anonymity, said, “They do not possess the technical knowledge required for the job. There also have been some controversial decisions lately.”
The immediate trigger could have been the controversy surrounding fixing the cardiac stent pricing under National List of Essential Medicines (NLEM). There was criticism over stents having been divided just into two categories when there are several categories available, especially under the drug eluting stents category.
Confirming the development, a source in the health ministry said, “Yes. It is true. The PMO is thinking about the transfer and this is a step in the right direction.”
The health ministry had for long wanted to be given charge of these two drug regulatory bodies. There were even talks of dissolving NPPA in the past because of the too much control it wielded in deciding drug prices .
“You obviously can’t have two price categories when there are several varieties available in market. It required more thought but clearly there wasn’t enough technical expertise,” said the source.