Union Minister for Chemicals and Fertilizers Ram Vilas Paswan has sought the views of the Parliamentary Consultative Committee on Chemicals on the proposed 'National Pharmaceutical Policy 2006' here (on July 1, 2006) today.

Presenting the highlights of the draft policy before the committee, Paswan wanted the members to come forward with their suggestions on various issues proposed in the draft. The draft policy along with Cabinet Note is presently under circulation among all concerned department for their comments. The policy would be finalized by the Cabinet on receipt of these comments and subsequent changes.

The draft National Pharmaceutical Policy, 2006 seeks to strengthen the Drug Regulatory System and the patent office. It focuses on research and drug development with clinical trials. The policy lays emphasis on developing human resources in pharmaceutical sciences by opening more institutions on the pattern of the National Institute of Pharmaceutical Education and Research (NIPER). The policy aims at providing a better access to anti-cancer and anti-HIV/AIDS drugs to the patients.

The draft has proposed rationalization of excise duty on pharmaceuticals. It also seeks to streamline the system of bulk procurement of drugs by the Government besides promoting the generic medicines. Drugs would be made available to the poor, especially the families living below the poverty line. The proposed policy encourages production of critical bulk drugs in India with emphasis on good manufacturing practices.
A Settlement Commission for settling old dues under the Drugs (Prices Control) Order, 1979 and a Drug Price Monitoring Awareness and Accessibility Fund (DPMAA Fund) are among the proposals.

The Minister informed the MPs that in addition to the existing 74 drugs and their formulations, the 354 drugs with specified strength as mentioned in the National List of Essential Medicines (NLEM), 2003 have also been included in the draft Pharmaceutical Policy. Apart from the cost plus method, other systems of price control like negotiated prices, differential prices, reference prices and bulk purchase price have also been proposed. He said the raw material cost would be obtained from the manufacturers, central public enterprises in the pharmaceutical sector, import data and market sources.

Paswan disclosed that the Maximum Allowable Post-manufacturing Expenses (MAPE), presently 100 per cent over the manufacturing cost, is proposed to be made 150% in general and an additional 50% MAPE for R&D intensive companies which fulfill the laid down standards.

"For existing 74 drugs under price control MAPE would continue to remain at 100% for one year in order to avoid a sudden increase in prices. It would be increased thereafter on the above pattern. Based on the given percentage of MAPE, prices would be fixed for all drugs in the cost-plus price control system. Wherever possible ceiling prices would be fixed. Maximum Retail Price (MRP) would be inclusive of all taxes as in the case of all other packaged commodities" The minister explained.

The highlights of the proposed policy include the announcement of a new Drugs (Prices Control) Order would be issued under the Essential Commodities Act 1955 to replace the existing DPCO, 1995, re-structuring and strengthening of the National Pharmaceutical Pricing Authority (NPPA) - greater computerization and better monitoring, price monitoring cells in the State Drug Controller Offices with funding from Government of India, enacting Drugs (Price Management and Distribution) Act for effective regulation of drug prices and for handling health emergencies - it will also provide compounding of minor offences, fixation of trade Margins on generic-generic drugs, would be fixed (15% - wholesalers and 35%-retailers) and change in the name of Department of Chemicals and Petrochemicals to reflect Pharmaceuticals also (Name proposed is - Department of Chemicals, Petrochemicals and Pharmaceuticals).