Govt seeks feedback of industry on antibiotics in updated NLEM

The government-appointed committee tasked with preparing the new National List of Essential Medicines (NLEM) on Monday asked for industry feedback on which group of antibiotics should be excluded from the list.

The suggestions were sought during a stakeholders' meeting in Delhi, the focus of which was fighting the menace of antimicrobial resistance (AMR) in India. The expert committee, sources claimed, is considering the industry proposal to issue a draft NLEM list for public consultation in the interest of transparency and seek industry comments in a time-bound manner. 

AMR refers to the ability of a bacterium, virus or some other microbe to stop an antibiotic (or antimicrobial) from working against it. This results in treatments becoming in-effective and infections not only persist but also spread to others. 

Industry sources claimed that the Standing National Committee on Medicine (SNCM), which is working on drafting the new NLEM, has asked the industry to get back with their list of groups of antibiotics that need to be removed from the NLEM as Indian population has become resistant to these. Also, the SNCM wants to know which other groups of antibiotics be included on the list this time. The NLEM 2015 has roughly 376 medicines and medical devices. 

 The sources said industry representatives proposed that all non-effective drugs be deleted from the NLEM and drugs for which resistance is building up should not be considered. The industry feels inclusion in the NLEM may result in over-prescription and overuse, and increase the cases of resistance. 

 "Only the Access category of the WHO AMR list should be considered for inclusion in NLEM," the industry said. The expert committee, however, said that drugs from all three categories of WHO AMR list — i.e., Access, Watch and Reserve — are under consideration for preparing the new NLEM. 

 A recent study by the Indian Council of Medical Research (ICMR) has found that two of every three healthy Indians that it tested had antibiotic-resistant organisms in their digestive tracts. 

The government is also keeping the World Health Organisation (WHO) list of essential medicines in mind while drafting the new NLEM for India. It is comparing the WHO list with the 2015 NLEM and plans to make necessary amendments that suit the Indian context.  

Malini Aisola of  patient activist group All India Drug Action Network (AIDAN) said the WHO classification of antibiotics does not recommend certain antibiotic combinations. 

"AMR is a result of irrational combinations. We have suggested that the committee give a negative recommendation on the rampant use of irrational fixed-dose combinations (FDCs) in the domestic market," she added. AIDAN made a presentation before the committee on Monday. 

“The stakeholders meeting discussed many things - from the proposal of taking medicines priced under Rs 5 out of price control, to the possibility of invoking para 19 of the Drug Price Control Order (DPCO) to allow manufacturers raise drug prices when prices of bulk drugs went up significantly, to the issue of AMR and antibiotics," said a source who was present at the meeting. He added that the industry would soon prepare a list and get back to the SNCM.