29th April, 2003
Ministry of Chemicals & Fertilizers  


LIFE SAVING MEDICINES


LOK SABHA

Government announced the ‘Pharmaceutical Policy – 2002’ in February, 2002 with the objectives of ensuring abundant availability at reasonable prices within the country of good quality essential pharmaceuticals of mass consumption and strengthening the indigenous capability for cost effective quality production. The Policy provides, inter-alia, as follows:-

      "(i) The 279 items appearing in the alphabetical list of Essential Drugs in the National `Essential Drug List (1996) of the Ministry of Health & Family Welfare and the 173 items, which are considered important by that Ministry from the point of view of their use in various Health Programmes, in emergency care etc., with the exclusion, therefrom of sera & vaccines, blood products, combinations etc., should form the total basket out of which selection of bulk drugs be made for price regulation.

     

      ii.The Org-MARG data of March, 2001 would form the basis for determining the span of price control.

      iii. The moving Annual Total (MAT) value for any formulator in respect of any bulk drug will be arrived at by adding the MAT values of all his single-ingredient formulations of that bulk drug, its salts, esters, stereo-isomers and derivatives, covering all the strengths, dosage forms and pack sizes listed against that formulator in all groups/categories of the ORG-MARG (March, 2001).

    iv. The MAT value for all the formulators, as defined in sub-para (iii) above, in respect of a particular bulk drug will be added to arrive at the total MAT value in the retail trade.

    v. The MAT value for an individual formulator, in respect of any bulk drug, as arrived at in sub-para (iii) above, will be the basis for calculating the percentage share of that formulator in the total MAT value arrived at as in sub-para (iv) above, in respect of that bulk drug.

    vi. Bulk Drugs will be kept under price regulation if:-

    1. The total MAT value, arrived at as in sub-para (iv) above, in respect of any particular bulk drug is more than Rs. 2500 lakhs (Rs.25 crore) and the percentage share, as defined in sub-para (v) above, of any of the formulators is 50% or more.
    2. The total MAT value, arrived at as in sub para (iv) above, in respect of any particular bulk drug is less than Rs.2500 lakhs (Rs.25 crore) but more than Rs.1000 lakhs (Rs.10 crore) and the percentage share, as defined in sub-para (v) above, of any of the formulators is 90% or more.

    vii. All formulations containing a bulk drug as identified above, either individually or in combination with other bulk drugs including those not identified for price control as bulk drug, will be under price control."

A Public Interest Litigation in Karnataka High Court resulted in an order dated 12.11.2002 which stopped the Government from implementing the price control regime of the Pharmaceutical Policy- 2002. Government have filed a Special Leave Petition in the Supreme Court against the order of the Karnataka High Court.

This information was given by the Minister of Chemicals & Fertilizers, Shri Sukhdev Singh Dhindsa, in a written reply to a question in the Lok Sabha today.