The pharmaceutical industry in the country has 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.
According to experts, 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.
Driving home the point that it involves a huge investment in manufacturing differentiated/modified dosage forms, sources said that dosage forms like SR/CR; gelatin coated tablets, gelatin enrobed tablets; effervescent, dispersible, soluble tablets; soft gelatin capsules (soft gels); etc, formulations developed by companies investing large sum in R&D, plant, specialised equipments, intellectual property and development of processes and technologies.
Differentiated/modified dosage forms are patient-friendly and 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.
The DPCO 1995 recognised different formulations and prices were fixed according to the technical category. However, since DPCO 2013 does not recognise cost, the ceiling price fixed under DPCO 1995 for a certain formulation on actual cost basis, has got reduced substantially due to averaging out the prices.
Even though the differentiated/modified dosage forms should have been outside the ambit of the price control, the industry sources said that in a number of cases, the differentiated dosage forms have been included in the list of products while calculating the average prices for setting ceiling prices for molecules in the basic dosage forms. Even if it is the department's thought that the differentiated dosage forms should have been under price control, these products are different to the conventional dosage forms and even if averaging was to be done, it should have been done separately for each molecule in each specific dosage forms separately, sources said.
Cautioning the government about the need to resolve the issue immediately, the industry said that otherwise it will result in non-availability of products to patients who are already on the product thereby impacting their lives, lay-offs of workers and will kill the innovation dependent upon such differentiated/modified technologies and will also lead to closure of operations.