The expected improvement in availability and affordability of essential medicines as envisaged under the National Pharmaceutical Pricing Policy(NPPP 2012) has been badly vitiated to a large extent by the Drug Price Control Order (DPCO 2013), a study of the pharma industry by the leading business chamber Assocham.
Charging the National Pharmaceutical Pricing Authority (NPPA) of erroneous interpretation of the pricing control order and arbitrary and ultra vires exercise of power by it beyond the scope of both the national pharma pricing policy and the drug price control order, an Assocham study on the Pharmaceutical industry said this was causing chaos and unpredictability for the industry “in terms of implementation and adherence to the NPPP.
The study also found that the drug price fixation mechanism does not provide any distinction for formulations under NLEM that are sold as new drug delivery systems on development of which pharma industry had made considerable investments and had developed these for different set of patient groups. Included in this list were disposable tablets, gelatin coated tablets, bilayered tablets, sustained released tablets etc. Such specified drug formulations improved release pattern and stability of the drugs targeted to specific patient groups.
Pointing our several other anomalies and problems to industry posed by the wrong implementation of the price control order and pricing policy, Assocham study called for early formation of a robust regulatory framework for pricing of drugs so as to ensure availability of required medicines essential medicines- at reasonable prices. Such framework should also provide sufficient opportunity for innovation and competition, the chamber said.
Assocham Secretary-General DS Rawat said that it revealed the latent potential of the present 18 billion USD industry that is expected to grow to 45 billion USD by 2020.
Rawat said the study also showed how it could help access to healthcare, universal health coverage, expand and improve clinical trials, biosimilars, fixed dose drug combinations, active pharma ingredients, and improve proposed Drugs and Cosmetics Amendment Bill 2013.
"We believe that any pharmaceutical policy should benefit patients and support sustainable access to innovative products and availability of quality medicines while at the same time building a robust and competitive pharmaceutical environment which encourages and promotes manufacturing, R&D and innovations as well as continued investment," Assocham national council on drugs and pharmaceutical council chairman Bhaskar Iyer and co-chairman Umang Chaturvedi said.
The Assocham study expressed grave concern over the fact that 'India was behind China, Thailand, Brazil and other countries in public healthcare.
This had resulted in Indian poor having to spend as much as 75% of the healthcare costs from their pockets against 25% in Thailand and 44% in China. Health insurance coverage was only available 25% of the population. "There has been significant slowdown in Indian pharmaceutical industry," Rawat said.
