Revised essential drugs list on Indian agenda amid tensions
This article was originally published in Scrip
The pharmaceutical industry's virtual no-show at a recent key consultative session called by India's apex drug pricing authority has highlighted the heightened ongoing tensions in the sector.
Sources in the know told Scrip that India's National Pharmaceutical Pricing Authority (NPPA) called a consultative meet with industry and trade on 17 September but bulk of industry excused itself.
On the agenda were key issues including discussions around the revision of India's National List of Essential Medicines (NLEM) 2011 - an exercise that is expected to expand the list of price capped drugs that are mass-consumed in the country; timely implementation of pricing orders and; the implementation of an Integrated Pharmaceutical Database Management System in the country.
Sources said that industry had sought time from the regulator to study the agenda – a request which is believed to have been declined by the NPPA. ''Industry is not willing to walk in without adequate preparation,'' one official said. Others said that the NPPA's high-handed approach in issuing pricing notifications, including the controversial ones in July which allegedly failed to keep even the department of pharmaceuticals in the loop (scripintelligence.com, 1 August 2014), has been a source of significant concern across industry. The NPPA could not be immediately reached for a comment.
In July the NPPA capped the prices of 108 "formulation packs" in the diabetes and cardiovascular segments, including products such as Merck & Co's Januvia (sitagliptin) and GSK's Volibris (ambrisentan), exercising certain special powers under para 19 of the Drugs Prices Control Order (DPCO) 2013 – a move which pharmaceutical firms have since slammed as unjustifiable (scripintelligence.com, 14 July 2014). The caps are expected to lower prices of these formulations in the range of less than 1% at the lower end to more than 79% at the upper end.
Industry has since challenged the move in court (scripintelligence.com 1August 2014).
agenda
The 17 September meeting called by the NPPA had some critical issues on the agenda, including the revision of the NLEM 2011.
The pricing regulator is said to have referred to a detailed analysis of the top 300 molecules in terms of moving annual total (MAT) volume and MAT value and other studies already underway as part of the review exercise.
Issues under consideration in the proposed review include the strengths and dosage forms not covered under the NLEM 2011; analogues of scheduled formulations; close substitutes in the same therapeutic class; pediatric dosages and high-volume use fixed drug combinations, especially in segments such as respiratory, diabetes, dermatology, malaria and TB/ MDR-TB.
Also under consideration is the preparation of a separate list of life-saving drugs based on existing life-saving drugs lists of certain government agencies; region-specific needs as reflected in states’ essential drugs lists; essential and lifesaving ''patented'' drugs; and the inclusion of some medical devices which are already covered under the definition of drugs under the Drugs and Cosmetics Act 1940.
The NPPA has already held interactions with some other stakeholders including public health experts and state drug controllers on the issue and the 17 September meet was aimed at getting industry's feedback. India's Ministry of Health and Family Welfare has already set up a core committee chaired by Dr V M Katoch, secretary, department of health research, and director general, Indian Council of Medical Research to review the NLEM.
The NPPA agenda details also referred to how the present span of price control for scheduled drugs (in NLEM 2011) is around 15-17% of industry's moving annual turnover for June 2013-May 2014 estimated at around INR820bn ($13.4bn) as per IMS Health data. This, the regulator believes, is not high ''by any standards''. It also notes that currently only 40 of the top 100 molecules by volume sales are covered by the NLEM and even within that, coverage of formulations is inadequate in some.
Scrip earlier reported that India was evaluating the possibility of expanding its list of essential medicines. Industry then said that the government appeared to be acting in haste without giving adequate time for the current pricing policy to play out and that further price controls will impact negatively the workings of an already ''beleaguered'' industry (scripintelligence.com, 26 June 2014).
Last year India notified the Drug Prices Control Order 2013 capping the prices of around 652 formulations across 27 therapeutic segments specified in its NLEM 2011, in line with a previously announced national pharmaceutical pricing policy.