Mint Explainer: The rationale behind bringing 44 drugs under price control

Aug 24, 2023

New Delhi: India's National Pharmaceutical Pricing Authority (NPPA) has extended price controls to an additional 44 drugs, commonly prescribed for conditions ranging from pain management and mental health issues like depression and anxiety, to gastrointestinal disorders, hypertension, and various autoimmune diseases. This regulatory move falls under the ambit of the Drugs (Prices Control) Order of 2013, and aims to establish a structured pricing environment to ensure the accessibility of essential medications at reasonable costs. Mint explains.

Prices of drugs in India are regulated as per provisions of Drugs (Prices Control) Order, 2013, by NPPA, under the aegis of Department of Pharmaceuticals (DoP), that fixes the ceiling price of scheduled medicines. It also fixes retail price of ‘new drugs’ for existing manufacturers of scheduled formulations. For non-scheduled formulations, a manufacturer is at liberty to fix its maximum retail Ppice (MRP) but cannot increase the same by more than 10% of what was prevalent during the preceding 12 months.

As per DPCO 2013 provisions, drug prices have been cut to ensure availability of medicines at affordable prices.

# What measures do drug manufacturers & retailers have to take now?

A drug manufacturer will have to issue a price list to NPPA through Integrated Pharmaceutical Database Management System (IPDMS) and submit a copy to State Drug Controller and dealers. Every retailer and dealer shall display the price list as furnished by the manufacturer at his business premises in a manner easily accessible to any person wishing to consult the same.

Manufacturers not complying with regulations are liable to deposit overcharged amount as per the provisions of the DPCO, 2013 and Essential Commodities Act 1955.

So far, retail prices of around 2,450 new drugs have been fixed. In July, ceiling price of 915 scheduled formulations were notified. During the covid-19 pandemic, NPPA regulated the price of oxygen concentrators, pulse oximeter, blood pressure monitoring machine, nebulizer, digital thermometer and glucometer under “Trade Margin Rationalization". The government has also regulated prices of cardiac stents and orthopedic knee implants and 42 select anti-cancer medicines.