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Shardul Nautiyal, Mumbai February 15 , 2023
The Indian Drug Manufacturers’ Association (IDMA) has urged the Department of Pharmaceuticals (DoP) to revisit their long pending recommendation of deleting Para 18 (i) of Drug Prices Control Order (DPCO-2013) as it leads to lower prices of pharma products and will also lead to increase in cases of overcharging.

According to the industry, the new National List of Essential Medicines (NLEM) will see further reduction in prices for the formulations which will be covered in the Scheduled category going forward. Para 18 (i) of DPCO-2013 averages the prices of scheduled formulations every 5 years.

As a part of the representation made by the IDMA, DoP has also suggested to make use of Integrated Pharmaceutical Database Management System (IPDMS 2.0) for the impact to be minimized for scheduled formulations.

IPDMS 2.0 envisages creating an authentic database of information on products, prices, production and sale of scheduled, non-scheduled formulations and active pharmaceutical ingredients (APIs). It also aims to optimize synergies in operations by providing a single window for submissions of various forms as mandated under the Drug Prices Control Order (DPCO) - 2013.

The NPPA on February 6 this year revised and fixed the ceiling price of 400 scheduled formulations with an average reduction of 15.39 per cent in ceiling prices, according to the ministry of chemicals and fertilisers.

The Ministry said that the Department of Pharmaceuticals (DoP) notified Revised Schedule-I of Drugs (Prices Control) Order (DPCO) on November 11, 2022 incorporating the National List of Essential Medicines (NLEM), 2022 notified by the ministry of health and family welfare on September 13, 2022.

There are 388 medicines (including 2 animal vaccines and 2 stents) consisting of approximately 954 formulations in the Revised Schedule-I of the DPCO, 2013.

Ceiling prices of total 890 scheduled formulations have been fixed under the NLEM- 2015, out of which ceiling prices of 174 formulations have been fixed during the last five years.

Retail prices of 2,262 new drugs have been fixed under DPCO, 2013 till February 3, 2023, out of which retail prices of 1,821 new drugs have been fixed in the last five years.

NPPA capped trade margin of non-scheduled formulations of 42 select Anti-cancer medicines under “Trade Margin Rationalization” approach in February, 2019, whereby the price of around 500 brands of anti-cancer medicines were reduced by up to 90%. This is in addition to 86 scheduled anti-cancer drugs whose ceiling prices have been fixed by NPPA.

A total of 5,178 cases alleging overcharging were received in NPPA during the period April, 2018 to January, 2023. NPPA examines such cases and if sufficient information indicating overcharging is found, overcharging proceedings are initiated as per the provisions under DPCO- 2013.

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