The national drug price regulator National Pharmaceutical Pricing Authority (NPPA) has rejected the industry's demand to  keep the differentiated/modified dosage forms out of the ambit of DPCO 2013, on the plea that 'there is no provision in the DPCO 2013 to keep scheduled formulations of specified dosage, route of administration and strength out of the ambit of price control on the  basis of new or innovation drug delivery system except as provided  for under paragraph 32 of DPCO 2013'.

Earlier in July this year, the industry had  urged the NPPA to keep the differentiated/modified dosage forms out of the ambit of DPCO 2013, as these dosage forms are patient-friendly and involve huge investments in R&D to develop them.

The NPPA has fixed a separate ceiling price in case an innovative drug delivery system of a scheduled formulation where there is a separate mention of it in addition to the traditional form, for example, sublingual tablets for 'Glyceryl Trinitrate', sustained release tablet or capsule for 'Nifedipine'.

But, where there is no such distinction made in the First Schedule on the basis of the drug delivery system, the ceiling price fixed is applicable for all type of dosage forms, including drugs delivery system of that essential medicines/scheduled formulation as per the provisions of the DPCO 2013 for that specified category of API, route of administration, strength and dosage forms i.e. tablet, capsule, injection, etc as the case may be, the NPPA while rejecting the industry's plea in this regard said.

To support its demand for keeping the differentiated/modified dosage forms out of the ambit of DPCO 2013, the industry pleaded with the NPPA that the pharmaceutical industry is a differentiated/modified technology driven industry, wherein new technology is introduced for administration of drugs to the patient, with an objective of providing patient-friendly dosages along with therapeutic dosage compliance, anti-counterfeiting measures to provide patients with a genuine product, better therapeutic value, superior quality dosage forms combined with benefit of better safety profile.
 
The industry further pleaded that differentiated/modified dosage forms involve huge investment in R&D. The manufacturing process is also different compared to normal dosage forms. The materials used in manufacture of such dosage forms are also often distinct. Thus considering the superiority of the differentiated/modified dosage forms, same should not be clubbed with normal dosage forms for arriving at the ceiling price, the industry pleaded with the government.