The National Pharmaceutical Pricing Authority has started an exercise to expand the National List of Essential Medicines (NLEM) 2011, to include all drugs of mass consumption, in addition to essential and life saving medicines. The pharmaceutical industry is up in arms against the plan The authority’s earlier attempt to regulate prices of mass consumption medicines was thwarted when the government summarily withdrew the related guidelines before the visit of Prime Minister Narendra Modi to the US. The move comes four years after the current list came into effect. The previous occasion such a list was formed was eight years ago. The revision of the NLEM is the prerogative of the health ministry, which had formed a core committee in May under VM Katoch, secretary, department of health research. The committee is yet to come out with its recommendations. In a letter to the industry ahead of the first stakeholder consultation on September 30, Injeti Srinivas, chairman of the Authority wrote that following a missive from the department of pharmaceuticals, the NPPA has started an exercise to identify more drugs for the NLEM “with a view to ensuring that all lifesaving and essential drugs of mass consumption are included in the revised NLEM for safeguarding public interest”. A detailed analysis of the top 300 molecules in terms of moving annual total (MAT) volume and MAT value and other studies are being carried out. The issues being looked at include strengths and dosage forms not covered under NLEM 2011. Some of these are “analogues of scheduled formulations; close substitutes in the same therapeutic class; paediatric dosages; high volume use fixed drug combinations, especially in certain therapeutic groups such as respiratory, anti-diabetic, derma, anti-malarial, anti TB/MDR TB; preparation of a separate list of lifesaving drugs based on existing lifesaving drugs list of government agencies like the CGHS; region-specific needs as reflected in states’ essential drugs lists; essential and lifesaving patented drugs; and inclusion of some medical devices which are already covered under the definition of drugs under the Drugs and Cosmetics Act 1940”. Only those drugs, which are included in the NLEM —348 currently — are subject to price control according to the National Pharmaceutical Pricing Policy 2012. NPPA has attempted to invoke a special provision under Drugs Prices Control Order 2013 empowering the government to impose price control of other drugs in “extraordinary circumstances” in fixing ceiling prices for 50 diabetic and cardiovascular medicines in July. While that order still remains effective — albeit under challenge in court — the government has made it clear to the regulator that this will not do in future. Hence the decision to expand health uses the word “revise” the NLEM. In a submission to NPPA following the consultation, the Indian Pharmaceutical Alliance (IPA) said that it is imperative that such exercises be undertaken regularly and through evidence-based decision making. The IPA has called for the inclusion of medical experts to decide on the revision to the NLEM, as earlier lists have been challenged “for want of evidence and lack of transparency..” “It is not the job of the NPPA to draw up the essential medicines list. There are fixed criteria for essentiality and the Supreme Court has already ruled that mass consumption is not a criteria for the inclusion of a drug in that list. This is at variance with the NPPP 2012,” said DG Shah, secretary general of the IPA.
