Last Updated on October 9, 2024 by The Health Master
Almost 42 % of the samples of medicines picked up by the National Pharmaceutical Pricing Authority (NPPA) and the supporting organisations during the first nine months of the financial year 2021-22 has shown prima facie violations of the Drug (Prices Control) Order, 2013.
The drug price controller has recovered an amount of Rs. 1,312.26 crore under the DPCO 1979, 1995 and 2013, as on September 30, 2021, according to the Department of Pharmaceuticals.
The NPPA works closely with the State Drug Controllers for enforcement activities and its own Price Monitoring and Resource Units (PMRUs) in various States helps the Authority to monitor the pricing activities.
It picks up samples of medicines from the open market regularly and analyses to monitor the price at which the medicines are sold to patients.
According to the data, during the period from April to December, 2021, there were 706 samples picked up, of which 295 were identified as prima facie violating the price control orders.
The full year numbers for the year 2020-21 indicates that the percentage of violation is higher at almost 50 per cent. Out of the total 1,073 samples collected in 2020-21, around 537 samples had prima facie violations detected.
These numbers include the cases of overcharging referred from State Drug Controllers and PMRUs.
While the percentage of violation has been fluctuating over a period, the violations in 2020-21 was more than double of the 225 violations (out of the total 553 samples) detected ten years back, on 2010-11, according to the Annual Report of DoP for the year 2021-22.
In 10 years from 2010-11, the year 2014-15 saw the highest number of samples being picked up, at 3,898 samples of which 1,020 samples were detected with prima facie violations.
The highest number of violations reported during the period was in the year 2017-18, when 1,032 samples out of the total 2,418 collected were detected with violations.
The year 2019-20, towards the end of which the country slipped into the grip of Covid-19 outbreak, saw 37.3 per cent of the drug samples violating the norms, which was 350 out of the total 938 samples, according to the data.
“NPPA has initiated about 2,209 cases of overcharging as on 30.09.2021. Amount of Rs. 1.312.26/- crore under DPCO 1979, DPCO 1995 & 2013 has been recovered as on 30.09.2021., from pharmaceutical companies.
Action for recovery of the overcharged amount along with interest thereon is a continuous process,” said the DoP in the Report.
Whenever companies are found selling scheduled formulations at prices higher than the price notified by NPPA, action is taken against such companies under the relevant provisions of DPCO 2013 and the overcharged amount, along with interest is levied on the company.
Similar action is taken whenever companies are found selling non-scheduled formulation at a price which is 10% higher than the MRP of the preceding twelve months and Wholesale Price Index (WPI) violation for scheduled formulations.
The overcharged amounts are recovered from the pharmaceutical company along with interest and penalty thereon from the date of overcharging.
Cases of companies not complying with the demand notices are referred to the District Collectors for recovery of overcharged amounts as arrears of land revenue and could also attract prosecution under the provisions of the Essential Commodities Act, 1955.
The DoP also said that the regulation of prices of medicines under the DPCO, 2013 by NPPA has resulted in net savings of around Rs. 12,447 crore per annum to the consumers.
The fixation of ceiling prices of scheduled formulations listed in NLEM 2015 (revised Schedule-I) has enabled savings of Rs. 2,643 crore to the consumers in addition to the saving of Rs. 4,547 crore to consumers on account of price fixation of coronary stents.
Fixation of ceiling prices of scheduled formulations under Schedule-I of NLEM 2011 enabled savings of Rs. 2,422.24 crore to the consumers. The para 19 price notifications resulted in savings of approximately Rs. 350 crore to the consumers.
NPPA has also fixed the ceiling price of the non scheduled orthopaedic knee implants, which has enabled savings of Rs. 1,500 crore to the consumers.
A savings of Rs. 984 crore to the consumers is estimated through the trade margin rationalization of anti-cancer drugs, it said.
It has also implemented trade margin rationalisation for medical devices and promoted voluntary price reduction of drugs which were essential to fight the Covid-19 pandemic, during the year 2021-22.
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