Efforts to come out with a new drug policy are once again on with government’s renewed initiative to prepare a revised National List of Essential Medicines in accordance with the recommendations of an expert committee. The new list contains a total of 348 medicines by categorising them as per therapeutic areas. The Department of Pharmaceuticals had come out with the idea of considering the NLEM as life-saving drugs on account of the inordinate delay in finalising and clearing the National Pharmaceutical Policy which sought to put a basket of 354 essential drugs under price control. The new NLEM which is revised one of the list prepared in 2003, has deleted 47 drugs and included 43 instead. In consideration of essentiality of drugs, they have been now categorized as primary, secondary and tertiary levels. In the NLEM 2011, 181 medicines fall under the category of primary,106 under the category of secondary and 61 under tertiary. Revision of NLEM was based on the two important national reference documents namely Indian Pharmacopoeia 2010 and National Formulary of India, 4th Edition, 2010. While the former deals with the standards of identity, purity and strength of medicines the latter provides the information on rational use of medicines particularly for healthcare professionals.
Currently, only 74 drugs are under price control as per the DPCO,1995 and more than half of them are not being manufactured by the pharma companies any more. At the same time more than 500 new drugs have been approved for marketing in the country by the DCGI after the notification of DPCO in 1995. All these drugs are outside price control and many of them are under patent. The patent protection and absence of price control on most drugs have been immensely helping the pharmaceutical companies, especially MNCs, to sell them at very high prices with support of medical practitioners. There has been no serious attempt by the chemicals ministry so far to include any of them under DPCO. The Group of Ministers, constituted to review and finalize the policy draft in 2007, held four meetings during 2007 and 2008 but no decision could be arrived at on the draft. The GoM was then reconstituted after UPA government assumed its second term. Nothing happened after that. Framing of the new drug policy has to be undertaken in the context of these hard realities. As GoM is not in a position to finalize the new policy, what the Department should do is to modify the 1995 DPCO on the basis of NLEM in discussions with medical experts and industry bodies.