200 pharma companies will be facing action, for launching new formulations or drugs without the approval of prices by The National Pharmaceutical Pricing Authority (NPPA).
"We have decided to take action against those (200) pharmaceutical companies which launched formulations or new drugs without even applying for our price approval as required under Para 15 (2) of the Drug Price Control Order (DPCO) 2013," said the watchdog in a statement here.
‘Pharma industry is to obtain prior approval from The National Pharmaceutical Pricing Authority before launching new formulations that may be categorised as new drug.’
The companies have launched formulations by altering a schedule formation with dosage other than as specified in the DPCO, 2013 and combining with other non-schedule medicines.
Though the central government had issued the DPCO in 2013, the regulator found that the drug manufacturers have not complied with the provisions related to new drugs in the Essential Commodities Act, 1955.
The authority also directed the pharma industry association to obtain prior approval from it before launching any formulation that may be categorised as new drug.
The offending companies have to furnish production and sales details along with the corresponding MRP certified by a competent auditor for the formulations in the list along with the reasons for non-compliance of provisions related to new drugs.
As a state-run regulator, the NPPA controls the prices of pharmaceutical drugs across the country.
"With the number of cases being high (200), the Authority is not in a position to issue individual, 'show cause notice' due to manpower shortage," added the statement.