The new Drug Price Control Order (DPCO), being prepared by the high-level panel as part of the recently-notified pharmaceutical pricing policy, may make sterner provisions on the manufacturers to submit requisite date required for fixing and revising prices by the National Pharmaceutical Pricing Authority (NPPA).
One of the major difficulties in price fixation of scheduled drugs and derivative formulations faced by the NPPA was the non-submission of the requisite data and information by the manufacturing units. In most cases where the reduction in the input cost (including raw materials) takes place, the concerned manufacturing units do not come forward with the pricing applications as required under the DPCO.
It is learnt that the high-level inter-ministerial panel, currently on the task of preparing the new DPCO, was apprised of this practical problem and some remedial steps in this regard could come in the new order.
The existing provisions do not give enough teeth to the NPPA in this regard and the agency usually depends on the State drug controllers to impress upon the manufacturing units to submit the required information. But, it is not very successful in many cases, thus affecting the pricing mechanism.
The State Governments are authorized to take action under Essential Commodities (EC) Act, 1995 for violation of the provisions of the DPCO, 1995. However, prosecution under EC Act, 1995 sometimes does not lead to stringent action against defaulters. There are no provisions of fines or penalties for the violation of the DPCO,95 for non submission of requisite data, price list and for not allowing officers of NPPA to visit and inspect the manufacturing premises.
Recently the Parliamentary panel attached to the Chemicals Ministry had also suggested pro-active steps in this regard. “The Committee is of the view that there is an urgent need for taking definite steps to encourage the manufacturing units to submit the data in time and desire that NPPA should chalk out mechanism for co-ordination with State Enforcement Agencies in this regard,” it said.
A seven-member panel, comprising representatives from the concerned ministries, are finalizing the draft of the new DPCO that would bring the 348 essential drugs under the price control, as per the new drug pricing policy.
It is also reported that the panel is also considering provisions to make it mandatory for the drug manufacturers to share the production records of essential drugs with the government so that the NPPA can better monitor the availability of these drugs in the market.