The Central government has formed a new committee to suggest major improvements in the Drug (Prices Control) Order, 2013, also known as DPCO, 2013, so that it is “more in favour of poor patient’s affordable medicare and health security”.
The Central government also wants this committee to “review the scope of DPCO, 2013, and to suggest ways to strengthen the regulatory provisions of the order”. The National Pharmaceutical Pricing Authority (NPPA), which works under the Department of Pharmaceuticals (DoP), has the powers to cap the prices of drugs that are listed in DPCO, 2013. Moreover, the DPCO also lists the rules and regulations that the NPPA has to follow while deciding the price cap.
The six member committee consists of two joint secretaries from DoP, member secretary of NPPA, a joint secretary from health ministry, the Drug Controller General of India (DCGI) and executive director of National Health System Resource Centre (NHSRC).
According to government notice dated April 6, 2017, this committee will “suggest ways to make DPCO, 2013, more comprehensive in light of past experience of implementing” it. This committee will also be free to consult other government agencies, representatives of industry or civil society “in the interest of more effective DPCO”.
In the terms of reference that has been set for committee, it is stated that this committee will “suggest ways for making existing mechanism for collection of market-based data on prices of medicines more robust and streamlined and for strengthening the existing pharmaceutical database management system”.
Moreover, the committee will look at this issue as well: “Procedural improvement and process re-engineering in NPPA to ensure better and quicker implementation of government policy (DPCO) and bring greater transparency so as to reduce litigation and review petitions. Draft detailed Standard Operating Protocol (SOPs) may be recommended for identified regulatory functions such as pricing of medicines, monitoring and enforcement activities, action against pharmaceutical in overpricing cases etc.”
The pharmaceutical industry has been raising various issues related to implementation of the DPCO, 2013. Expressing concern over unpredictability in drug pricing control regime, FICCI president Pankaj R Patel, also the chairman and managing director of Zydus Cadila, had said on February 11 that there is need for a clear demarcation of roles between the pricing regulator and the central government.
“There is a need to consider by the government the widening of scope of power to reduce (prices). I think there is a need to be clearly understood differentiation between a regulator and the government. Regulator is not a government. Government is a government. And, I think that clear definition and clear demarcation has to happen and that is what we need to ensure so that going forward, we have smooth working environment,” Patel said while addressing the ‘India Pharma 2017’ exhibition in Bengaluru on February 11.
Para 31 of the DPCO 2013 gives the Centre the power to review decisions of the National Pharmaceutical Pricing Authority (NPPA). Generally, the reviewing authority under this is an under secretary of the Department of Pharmaceuticals (DoP).