Drug price control rule hit Indian Pharma Companies

The National Pharmaceutical Pricing Authority (NPPA) has fixed prices of ten combination drugs under Drugs Prices Control Order (DPCO), 2013. This is a part of a recent move taken by the NPPA to fix or revise prices in respect of 56 formulation packs, both ceiling and retail price packs, under DPCO, 2013.

These combinations are referred to as “new drug” under paragraph 2(u) of the DPCO, 2013.

Of the ten combinations included by NPPA under DPCO, 2013, combination of paracetamol and mefenamic acid suspension was a part of earlier DPCO, 1995. The nine remaining combinations such as Dicyclomine HCl with combination, Atorvastatin with combination, Cyclosporine with combination, Pyrimethamine with Sulphamethoxypyridazine (MALARCE), Metformin Hydrochloride with Gliclazide and Pioglitazone, Tramadol and Diclofenac combination, Cetirizine HCl with Paracetamol and Phenylepherin HCl, Bisoprolol Fumarate with Amlodipine, and Glimepiride with Metformin Hydrochloride are included for the first time. All these mentioned formulations are based on bulk drugs.

Some of the manufacturers who are producing these combination drugs include Ipca Laboratories, Mankind Pharma, Cadila Healthcare, Lupin, Torrent Pharmaceuticals, Ajanta Pharma and Micro Labs.
Pharma analyst Ranjit Kapadia of Centrum Broking said, “While one of them was a part of DPCO 1995, the other combinations are new additions to the DPCO, 2013. However, what would be the impact of this is yet to be estimated, since these are relatively small products.”

The NPPA in its order said the retail price for a pack of the formulation would be arrived at by the concerned manufacturer in accordance with the retail price specified in the DPCO, 2013. “The manufacturer should issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013,” said the order, adding that the manufacturer may add local taxes only if they have paid actually or it is payable to the government on the retail price.

However, in case the retail price of the formulation is not complied as per instant price notification and notes specified in the above notification, then the concerned manufacturer/marketing company should be liable to deposit overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955, it added.

Prices of another eight formulations such as Neomycin with Bacitracin, Phenylephrine, Phenytoin Sodium, Polygeline, Pyridoxine, Sodium Meglumine Diatrizoate, Cefotaxime and Chlorpromazine have also been fixed by NPPA. They were a part of existing National List of Essential Medicines (NLEM) 2011 but the prices of these formulations were not available earlier.

The price regulator has also revised 36 notified ceiling prices based on increase in wholesale price index (WPI) as per provisions of DPCO, 2013, in effect from April 1, 2014