Context

An expert committee set up in 2018 to update India’s latest list of essential medicines has called on industry and civil society bodies for discussions before it finalises drugs to be included in it.

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• The Standing National Committee on Medicines (SNCM) has called pharmaceutical associations, companies and patient groups to conduct its “first” stakeholder’s consultation on the existing National List of Essential Medicines (NLEM).

Issues of discussion

• Issues of AMR (Antimicrobial resistance) and inclusion and deletion of drugs in the latest NLEM.
• Inputs on cancer and cardiology medicines that should be a part of the new list.
• Discussion on the addition of penicillin preparations, which some stakeholders say may be a point of contention as Indian drug makers are highly dependent on Chinese firms for the raw ingredients of such formulations and that the costs of these ingredients have been on the rise.

Background of the consultations

• They follow changes to the format of the World Health Organisation’s (WHO) global model list of essential medicines.
• WHO has recently revised its guidance on essential medicines adding 12 ground-breaking medicines for five cancer therapies to treat melanoma, lung, blood and prostate cancers.
• It has also added new oral anticoagulants to prevent stroke.
• Besides, the UN agency has strengthened its advice on antibiotics to use for the most common and serious infections to achieve better treatment outcomes and reduce the risk of antimicrobial resistance.
• It has recommended three new antibiotics for the treatment of multi-drug resistant infections is added as essential.

Significance

• Evaluation: The idea behind the stakeholder consultation is to evaluate the WHO list in the Indian context by determining the “essentiality” and “affordability” factors of these medicines.
• Inclusion: This includes inclusions of expensive new cancer and cardiovascular drugs as well as categorizing antibiotics—those with wide application and low potential to add to AMR (Access), those with higher resistance potential requiring limited access (Watch) and those to be used as a last resort option against multi-drug resistant bacteria (Reserve).

Way Ahead

• India would have no choice but to also look into the issue (of the highly priced cancer drugs in WHO’s list) to see which ones would be needed here.
• The list also needs to look at including more medical devices to ensure their affordability.
• Following this, the National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing watchdog, caps the ceiling prices of these medicines.
• Once a drug is included in India’s NLEM, the Department of Pharmaceuticals will notify it under Schedule I of the Drug (Prices Control) Order, 2013, for price control.

What is an Essential Medicine?

• According to WHO, Essential medicines are the medicines that "satisfy the priority health care needs of the population".
• People should have access to these medicines at all times in sufficient amounts. The prices should be at generally affordable levels.

NLEM

• It is a list of medicines prepared by the Ministry of Health and Family Welfare based on essentiality and made part of the Drugs Price Control Orders (DPCO), 2013 (DPCO 2013) in the form of first Schedule of the DPCO 2013.
• It is one of the key instruments in healthcare delivery system of a country which inter alia includes accessible, affordable quality medicine at all the primary, secondary, tertiary levels of healthcare.
• The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e. cost, safety and efficacy.
• Furthermore it promotes prescription by generic names. The list serves as a reference document for correct dosage form and strength for prescribing.
• NLEM of India was prepared and released in 1996. This list was subsequently revised in 2003, 2011 and 2015.