Last Updated on December 31, 2023 by The Health Master
With reference to the re-stickering of price controlled scheduled drugs and the National List of Essential Medicines (NLEM), the Drugs Controller General of India (DCGI) has issued a circular to the state drug controllers (SDCs) stating that it has no objection for relabeling and stickering of the drugs under Rule 104A of Drugs and Cosmetics (D&C) Rules and asking them not to intervene on the same.
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 pharma industry has welcomed this move as a timely gesture from the DCGI as the manufacturers can save a lot of time and energy involved in the value chain towards timely accessibility and affordability of medicines for patients and consumers.
“Since the activity involved is large, it is necessary to take the practical approach to expedite reprinting of price by the manufacturer at its premises so that benefits of price reduction can be passed on to the consumers in a timely manner.
The National Pharmaceutical Pricing Authority (NPPA) is not responsible for labeling or restickering formulations, according to this statement.
The DCGI had also issued a letter dated June 26, 2013 to the SDCs in this respect.
In pursuance to the NPPA order or notification no 1542 (E) to 1692 (E) dated June 14, 2013 and subsequent notifications in this regard which will follow for revising the ceiling price of the scheduled formulations, the NPPA is fixing the ceiling prices of scheduled formulations produced or available in the market.
Accordingly, the manufacturers are required to ensure within a period of 45 days of the date of the notification that the MRP of such scheduled formulation does not exceed the ceiling price (plus local taxes as applicable).
Consequent to the fixing of ceiling prices of the scheduled formulations by the NPPA, the manufacturers may be required to re-print/re-label the revised prices of scheduled formulations produced or available in the market.
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