Indian drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has issued notices to several pharmaceutical companies that have marketed combination drugs without complying Drug Price Control Order (DPCO) 2013.
The pricing regulator found that these companies have launched the drugs by either altering the scheduled formulations as specified in the DPCO 2013, or in combination with non-scheduled medicines without pricing approval.
DPCO 2013 has been issued by the union government of India under the Section 3 of Essential Commodities Act 1955 and violation of any of these provisions is punishable with the deposit of overcharged amount with interest and penalty.
NPPA identified a total of 201 new brands introduced by nearly 66 companies that violate DPCO 2013.
With the issuance of notices by NPPA, all companies concerned are required to provide batch wise production and sale details along with their respective prices to the regulatory authority.
The details should mention the reasons of non-compliance and be certified by a chartered or cost accountant.
NPPA can decide to take suitable action if the companies fail to provide their replies by 15 June.
If the companies provide satisfactory reasons for this non-compliance, the names of the respective companies will be removed from the list.