The National Pharmaceutical Pricing Authority has pulled up 67 pharma companies — including Lupin, Glenmark, GSK Pharma, Cadila, Biocon and Abbott — for 201 medicines that tried to violate the price control by taking advantage of loopholes.
Pharmaceutical companies appear to have found a way around the strict price control imposed on some medicines — by launching medicines with strengths other than those specified under the rules, or by combining them with drugs not under price control.
In a notice issued on Wednesday the NPPA said, “These companies have launched formulations (new drugs) by altering the scheduled formulation with strength/dosage other than as specified in DPCO 2013 (Drug Price Control Order) and/or in combination with other non-scheduled medicines without even applying for price approval from NPPA as required.”
It even raised questions over whether these formulations have approval from the drug regulator. “It is not clear whether these formulations have the approval of CDSCO (Central Drug Standard Control Organisation) and whether these are rational or irrational combination drugs, as many of these are fixed dose combinations,” the notice further added.
The medicines that have been pulled up include paracetamol (used for fever and pains), diclofenac (anti-inflammatory), azithromycin (used for treat certain bacterial infections), and glimepiride (used to treat type-2 diabetes).
The companies have been asked to furnish details of production and sales, besides the retail price of these formulations by June 15. The manufacturers would be liable to deposit the overcharged amount (over the fixed price), along with interest.