The All India Organisation of Chemists & Druggists (AIOCD), an apex body of 8 lakh chemists and druggists across the country, has demanded amendment to certain provisions of Drug (Prices Control) Order, 2013 to make drug pricing policy more robust and transparent thereby improving availability, affordability and accessibility of drugs for patients.

The trade body in a letter to Department of Pharmaceuticals (DoP) on May 1, 2017 stated that definition of distributor and manufacturer in para 2(f) and (n) of DPCO, 2013 respectively need to be amended and replaced with definition of distributor mentioned in DPCO 1995. As per DPCO 1995, a distributor was appointed by the drug manufacturer. It helped those involved in drug trade return, replace pharmaceutical products in case of breakage, leakage, said Suresh Gupta, general secretary, AIOCD.

The AIOCD sought the amendment in the light of recommendations of Dr. R. A. Mashelkar Committee. The panel set up to examine the extent and problem of spurious/sub-standard drugs in the country submitted recommendations to the government in 2003.

The Committee suggested that the drug manufacturers should have limited number of main stockists and only these main stockists should sell pharma products to retailers or hospitals. With an aim to discourage proliferation of drug distribution outlets, it recommended creation of better surveillance system by the trade association on defaulting members and to take strict action against them, play a proactive and visible role to contain the menace of spurious/counterfeit drugs.

It further emphasised role of chemists/pharmacists acting as a watchdog to prevent entry of any spurious/substandard drugs or those purchase from unauthorized sources or without proper bills in the supply chain. It called on pharma industry to use their well- developed marketing network to identify the distribution channel and persons involved in spurious drug trade.

It further stressed on AIOCD role in educating their members about spurious drugs menace and co-operating with the regulatory authorities to eliminate sale of spurious and sub-standard drugs by their members.

Gupta said that considering all above recommendations we urged the government to amend the definition of distributor and amend that supplementing as a stockist appointed by a manufacturer for stocking drugs or sale to a dealer.

The AIOCD further demanded amendment to para 4 of DPCO providing formula for the calculation of ceiling price of a scheduled formulation; para 13 of DPCO governing implementation of revised ceiling prices notified by NPPA; para 24 carrying into effect the price fixed or revised by government, its display & proof thereof.

He said “In addition to our demand for amendment to para 4 of DPCO, we have suggested formula for calculation of ceiling price of a scheduled formulation which is as follows: 1) retail price (RP) minus percentage (DPCO 1995 formula) then the retailers margin is equal to RP minus 20 per cent; 2) if the margin is to be calculated on PTS then the formula should be as follows: Price to stockiest (PTS) plus 39 per cent so as to maintain 20% margin to retailer and 10 per cent margin to distributor.”

The AIOCD submitted suggestions to DoP. The suggestions were sought by a six-member committee consisting 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). The committee was set up by the government to strengthen regulatory provisions of DPCO, make pricing policy more in favour of poor patient's affordable medicare and health security, bring improvements in NPPA to ensure better and quicker implementation of DPCO and usher in greater transparency helping reduce litigations and review petitions.