Panel’s suggestion on low cost drugs okayed

new delhi: the pharmaceutical policy, 2002, has accepted the drug price control review committee’s suggestion that low-cost drugs measured in terms of ‘cost per day per medicine’ may be taken out of price control. the policy statement released to the press today has said that any formulator can represent to the national pharmaceutical pricing authority with proof of per day cost to consumer or patient. nppa would be authorised to exempt such formulations from price control if it’s cost to consumer-patient does not exceed rs 2 per day, under intimation to the government. all orders passed by the nppa would be prospective in operation. if a formulator wishes to revise the price, he would be required to inform the nppa and seek fresh exemption. in case the revision results in an increase beyond the limit of rs 2 per day cost to consumer, the necessary price approval has to be obtained. the policy has otherwise stuck to the earlier method of identification of specific bulk drugs for price regulation on the basis of (a) mass consumption nature of the drug, and (b) absence of sufficient competition in such drugs. the dpcrc to consider mass consumption nature of a bulk drug on the basis of the top-selling brand has not been accepted by policy-makers as it would “give rise to anomalies�. the policy statement has noted that the sale value of any combination formulation is not directly relatable to a single particular bulk drug forming part of the combination formulation. combination formulations involve too many variables like strength of a particular bulk drug, its proportion with respect to other bulk drugs used in the combination formulation, price difference between bulk drugs used in combination formulation, pack sizes, dosage forms and so on. the policy has, however, taken into account the dpcrc’s recommendations to have effective monitoring and enforcement system and to move away from the controlled regime to a monitoring regime. it says a new system based solely on market prices data was required to be evolved and controls applied selectively only to cases where either profiteering or monopoly profit-seeking was noticed. in this context, the policy points out that although the prices of bulk drugs have been steadily decreasing, the same are not reflected in the retail price of non-scheduled formulations. there was a need to check high margins and commissions offered to trade, through high prices. the policy though has rejected the dpcrc recommendation to give powers to drug control authorities to dispose of small and petty offences as it would call for an amendment to the essential commodities act. it has, instead, proposed to strengthen the nppa by providing it powers under the dpco to make it mandatory for the manufacturer to furnish all the information as called for by the nppa, and also to regulate such prices where required. the policy which aims to reduce the price control from the present 74 drugs, has stipulated that bulk drugs would be kept under price regulation when the total mat value is more than rs 25 crore and the percentage share of any formulator is 50 per cent or more. also, when the total mat value is less than rs 25 crore but more than rs 10 crore, and the percentage share of any of the formulators is 90 per cent or more. the government will have an over-riding power to regulate prices if unusual movement of prices is seen.