Indian price regulator stirs debate on essential drugs
This article was originally published in Scrip
Despite attempting to make some seemingly well-intended efforts towards inclusive decision-making, India's National Pharmaceutical Pricing Authority (NPPA) may have stoked yet another debate with its latest notice on essential medicines.
Iin a notice dated 13 November, the pricing regulator referred to certain ''anomalies/discrepancies in specification/description'' in the National List of Essential Medicines (NLEM) 2011 that have been identified with reference to drugs specified in the Indian Pharmacopoeia, the National Formulary of India and market data and require rectification. Drugs on the NLEM 2011 are currently subject to price caps in India.
The regulator has now sought stakeholder comments within three weeks. The NPPA's notice proposes corrections/modifications pertaining to 86 medicines.
Industry appeared to have somewhat mixed views on the NPPA's latest notice. Senior officials told Scrip that while the regulator appeared to be fixing some typographical and in certain cases technical errors – for example specifying that the dosage includes tablets and capsules and not just capsules – it had also appears to have sneaked in words such as ''mass consumption'' as apparent criteria for inclusion in the NLEM, despite there being no such requirement.
"It is objectionable to bring in words such as mass consumption as a criterion for inclusion on NLEM," an industry official explained.
The NPPA notice mentions that the regulator had undertaken a detailed study of the drugs already included in NLEM 2011 with a view to ensuring that all life-saving and essential drugs of ''mass consumption'' were included in the list for safeguarding the public interest in line with the directions received from India's department of pharmaceuticals.
Industry officials also referred to draft guiding principles put forth by an eight-member expert panel mandated to review India's national list of essential medicines (NLEM) 2011 which endorsed, among others, the proposed exclusion of annual sale figures of drugs as a criterion while including a product in the revised NLEM given that a best-selling medicine may or may not be essential. The panel had proposed that the drug selection criteria should include the disease prevalence, safety and efficacy of the drugs and comparative cost-effectiveness of the alternative drugs (scripintelligence.com 31 October 2014).
expanded scope?
Some industry officials, though, were more critical of the NPPA's latest notice.
An Indian industry expert referred to how the NPPA had probably expanded, to a minor extent, the scope of price control, by adding certain drug strengths that are not currently in NLEM-2011. Misoprostol is one such example, with the 200mcg version being added, while NLEM-2011 includes only the 100mcg version, the expert told Scrip.
It's not clear if such instances could have a material impact on companies, but industry experts referred to a recent interim order from the Bombay High Court which prevents the NPPA from taking any coercive action against firms with respect to differentiated dosages not included in NLEM 2011. The court ruling was in response to a petition by the Indian Drugs Manufacturers' Association (IDMA). While details of the order could not immediately be ascertained a senior IDMA official confirmed to Scrip that such an order had been made and was effective till the next date of hearing.
Others suggested that the NPPA notice was ''pretty peculiar''. ''Why was the NLEM 2011 list incomplete; who spotted the issue and why is it being raised now?; If there was 'shoddy' work done in the past, then has its impact on consumers been assessed?'' an expert with a frontline firm told Scrip.
The expert claimed that the NPPA[which falls under India's ministry of chemicals and fertilizers] had neither explained why it was suggesting revisions to the NLEM [which is under the ministry of health and family welfare's authority] nor had it presented an assessment of whether any loophole was ''exploited'' to industry's advantage.
For its part, the expert believes, the domestic industry will need to engage closely with the NPPA to ensure that the latest exercise remains a ''remediation'' of a past oversight, and that the NPPA does not make'' unilateral'' changes to the NLEM as it may have attempted to do in the past.
''This is relevant since the NPPA recently made public its intention to include many non-essential medicines to the NLEM. The industry must ensure that its brief is not overstepped," the expert underscored.
Industry and the NPPA have been at loggerheads over the recent past, intensified by a previous controversial pricing order. In July, the NPPA had capped the prices of 108 formulation packs in the diabetes and cardiovascular segments exercising certain special powers in public interest – a move which pharmaceutical firms had slammed as unjustifiable (scripintelligence.com 14 July 2014). Industry has since challenged the move in court and a hearing is expected later this month in one such case. In September, though, the NPPA retracted internal guidelines concerning the capping of drug prices under the controversial "public interest" provision (scripintelligence.com 22 September 2014).