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All new medicines to come under price control -Sushmi Dey

-The Times of India

NEW DELHI: The drug price regulator has mandated companies to seek its approval for every new medicine, including combinations of existing ones, to ensure that consumers are not overcharged. According to the National Pharmaceutical Pricing Authority (NPPA) all innovative launches like new combinations of price-controlled medicines as well as those with changed strengths and dosages will be treated as 'new medicines'.

The move is aimed at spanning the price regulation of essential medicines, while also keeping a check on innovative branding and marketing strategies of pharmaceutical companies to circumvent price control, an official, in the know of developments, told TOI.

Currently, prices of 374 medicines are directly capped by the government at the average price of those being sold with at least 1 per cent market share. This roughly accounts for 10-13% of the total domestic pharmaceutical market pegged at around Rs 79,000 crore.

In order to escape price regulation, companies often launch newer combinations by making minor changes to existing price-controlled medicines. Sometimes, firms also tweak the strengths and dosages to bypass the price ceiling.

While such products are launched as newer brands, companies benefit from such strategies because under the existing law, firms are free to fix the launch price of all medicines, other than the 374 that are directly under government control. Even for such medicines, companies are free to raise prices by up to 10% annually.

"Market launch and/or sale of a 'new drug', as defined under paragraph 2 (u) of the DPCO (Drugs Price Control Order) 2013 without prior approval of retail price by the NPPA or where such approval stands withdrawn shall not only attract recovery of overcharged amount along with interest and penalty but also prosecution under Section 7 of the Essential Commodities Act, 1955," NPPA said in a recent notice.

The regulator has also asked companies to submit a compliance certificate from Drug Controller General of India (DCGI), which monitors quality of medicines and gives approval to new products.

The move is the latest among various stringent measures adopted by the government and the regulator in recent past to keep prices of medicines under check. The regulator has already proposed to revise the list of essential medicines to include medicine formulations that are commonly sold