Last Updated on January 9, 2024 by The Health Master
The Department of Pharmaceuticals (DoP) has been urged by the Indian Drug Manufacturers’ Association (IDMA) to reconsider its long-standing recommendation to delete Paragraph 18(i) of the Drug Prices Control Order (DPCO 2013), as doing so would result in lower prices for pharmaceutical products and a rise in overcharging.
In the future, formulations that will be covered in the Scheduled category under the new National List of Essential Medicines (NLEM) will see further price reductions.
Prices for scheduled formulations are averaged every five years, according to DPCO 2013’s paragraph 18(i).
Para 18(i) states as under:
18. Revision of ceiling price on the basis of moving annual turnover (MAT).– The revision of ceiling prices on the basis of moving annual turnover value shall be carried out,-
(i) as and when the National List of Essential Medicines is revised by the Ministry of Health and Family Welfare or five years from the date of fixing the ceiling price under this Order whichever is earlier;
DoP also recommended using Integrated Pharmaceutical Database Management System (IPDMS 2.0) as part of the IDMA’s representation in order to lessen the impact on scheduled formulations.
The creation of an authentic database of data on goods, costs, production, and sales of scheduled and non-scheduled formulations as well as active pharmaceutical ingredients (APIs) is one of the goals of IPDMS 2.0.
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.
According to the ministry of chemicals and fertilisers, on February 6 of this year, the NPPA revised and fixed the ceiling price of 400 scheduled formulations with an average reduction of 15.39% in ceiling prices.
According to the Ministry, the National List of Essential Medicines (NLEM), 2022, which was announced by the Ministry of Health and Family Welfare on September 13, 2022, was incorporated into the Revised Schedule-I of Drugs (Prices Control) Order (DPCO) on November 11, 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.
The ceiling prices of a total of 890 scheduled formulations have been fixed under the NLEM-2015, with the prices of 174 formulations fixed over 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.
The price of about 500 brands of anti-cancer medications was reduced by up to 90% in February 2019 as a result of the NPPA capping the trade margin of non-scheduled formulations of 42 select anti-cancer medicines.
This is in addition to 86 scheduled anti-cancer drugs whose ceiling prices have been fixed by NPPA.
During the period April 2018 to January 2023, the NPPA received a total of 5,178 cases alleging overcharging.
The 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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