Usha Sharma – Mumbai
Pharmaceutical companies are now allowed to re-print / re-label medicine packs impacted by the recent price revisions ordered by the national drug pricing authority. A recently posted Central Drugs Standard Control Organization (CDSCO) circular clarifies that the Drugs Controller General of India (DCGI) has no objection to the re-labelling/re-printing of such packs and given the scale of the activity, has decided to ‘take the practical approach to expedite the printing of price so that the benefits of price reduction can be passed on to the consumers.’
This permission seems to be the result of a representation from the Organisation of Pharmaceutical Producers of India (OPPI) which requested CDSCO to issue clarifications on this issue after the National Pharmaceutical Pricing Authority (NPPA) released revised drug prices under the Drugs (Prices Control) Order (DPCO) 2013.
Tapan Ray, Director General, OPPI said, “There was an issue over section 104 A of Drugs and Cosmetic Acts, which does not allow any kind of re-labelling / re- printing on the products without an approval from the State Drug Controller of India. We requested the DCGI to issue an order so it becomes official and not violate the law. This solves the problem but there are still other major issues that the industry is facing.”
NPPA is in the process of fixing ceiling prices of scheduled formulations and manufacturers need to ensure that formulation packs of these drugs available in the market reflect the new prices, inclusive of local taxes as applicable, within 45 days from the date of the notification. The recent CDSCO circular brings transparency into the system and officially allows pharma companies to reprint/ re-label the concerned medicine packs without violating Rule 104 A of the Drugs and Cosmetic Act.