Last Updated on October 9, 2024 by The Health Master
The drug regulator has reiterated its stand on the relabeling or sticking an updated maximum retail price (MRP) on the drug packages in tune with the revised prices of the National List of Essential Medicine (NLEM) products in the market.
The Drugs Controller General (India), Dr Rajeev Singh Raghuvanshi in a letter to all State and Union Territory drug controllers said that his office has already communicated in January 27 that it has no objection for re-labelling or stickering of the drugs under the Rule 104A of the Drugs Rules, 1945.
Rule 104A is reproduced as under:
[104A. Prohibition against altering inscriptions on containers, labels or wrappers of drug. –No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug:
Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the Licensing Authority.]
The clarification comes after the DCGI received representation from the stakeholders and communication from the Department of Pharmaceuticals regarding the regulatory stand on the relabeling of drugs in the wake of the price changes affected in the recent past.
It may be noted that the National Pharmaceutical Pricing Authority (NPPA) has been in the process of revising the prices of essential medicines listed in the NLEM after the Schedule I of the Drugs (Prices Control) Order, 2013 was revised replacing the NLEM, 2015 with the NLEM, 2022.
The prices of these drugs again underwent a change with the NPPA allowing a price hike in tune with the Wholesale Price Index (WPI) increase of 12.12 per cent, effective from April 1, 2023.
It is in this context the DCGI has clarified that it reiterates its stand on the matter, communicated to the drug regulators in the States and Union Territories on January 27, 2023.
Must read: DCGI allows relabeling & re-stickering of drugs: Rule 104A
In the letter in January, the then DCGI VG Somani observed that consequent to the fixing of the ceiling prices of the scheduled formulations by NPPA as per the above, the manufacturers may be required to re—print/re-label the revised prices of scheduled formulations produced or available in the market.
“Accordingly, the office of DCGI does not have any objection for re-labelling/stickering of the drugs concerned under Rule 104A of the Drugs Rules, 1945 for this purpose,” said the DCGI.
“Since the activity involved is large, it is necessary to take the practical approach to expedite re-printing of price, so that the benefits of price reduction can be passed on to the consumers,” added the regulator in January.
The Department of Pharmaceuticals has recently said that the NPPA has fixed the ceiling price of 651 formulations till the end of March 31, 2023.
The price reduction following the inclusion of NLEM 2022 into the DPCO, 2013 has resulted in a price cut of around 6.73 per cent on around 651 formulations, even after the prices were allowed to increase in tune with the Wholesale Price Index (WPI) increase.
As per the WPI increase, the prices of scheduled formulations were allowed to be increased by 12.12 per cent from April 1, 2023.
However, based on the revised Schedule I of the DPCO, 2023, prices of 870 formulations are being revised or fixed based on NLEM, 2022. So far prices of 651 scheduled formulations have been reduced by around 16.62 per cent.
Even after considering the 12.12 per cent price increase based on the WPI, the price of these 651 essential medicines are still down by 6.73 per cent for the consumer.
The Department said, “There has been an average reduction of 6.73 per cent in the ceiling price of scheduled drugs under NLEM, 2022.“
“The estimated annual savings in moving annual turnover (MAT) for 651 formulations fixed under NLEM 2022 till March 31, 2023 is Rs. 3,532.24 crore approximately”.
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