ESSENTIAL MEDICINE LIST

CONTEXT

IN

• It also includes four drugs that are still under patent –bedaquiline and delamanid, used in the treatment of multiple drug-resistant tuberculosis, dolutegravir used to treat human immunodeficiency virus (HIV) infection, and daclatasvir used in treating viral infections such as Hepatitis C.
• Endocrine medicines and contraceptives like fludrocortisone, ormeloxifene, insulin glargine, and teneligliptin (for diabetes control) have also been added to the list.
• Montelukast, acting on the respiratory tract, the ophthalmological drug latanoprost, and cardiovascular medicines dabigatran and tenecteplase are on the list too.

OMISSION

• NLEM includes four patented medicines for which companies have had robust access mechanisms in place for India.
• The Organization of pharmaceutical Producers of India (OPPI) is concerned with this inclusion of the four patented drugs and the implication it has on value for innovation.

GROUNDS OF DRUG INCLUSION

• For inclusion in NLEM, the drugs have to be useful in treating diseases that are a public health problem in India.
• They have to be licensed /approved by the Drugs Controller General (DCGI), have proven efficacy and have a safety profile based on scientific evidence that is comparatively cost-effective and aligned with the current treatment guidelines.
• They have to be recommended under the National Health Programs of India (for instance, ivermectin is part of the Accelerated Plan for Elimination of Lymphatic Filariasis,2018).
• When more than one medicine is available from the same therapeutic class, a prototype that is the best-suited medicine of that class is included.
• Besides this, the price of the total treatment is considered and not the unit price of a medicine.
• Fixed dose combinations are usually not included.

 GROUNDS OF DRUG ELIMINATION

• A medicine is deleted from the list if it is banned in India.
• If there are reports of concerns on the safety profile and if a medicine with better and is cheaper available.
• If the disease, for which a particular medicine is recommended, is no longer a national health concern the drug is taken off the list.
• In the case of antimicrobials –if the resistance pattern has rendered an antimicrobial ineffective, it is removed from the NLEM.

 PURPOSE OF LIST

• To promote rational use of medicines considering three important aspects which are cost, safety, and efficacy.

NATIONAL LIST OF ESSENTIAL MEDICINE (NLEM)

• It is a dynamic document and is revised regularly considering the changing public health priorities as well as advancements in pharmaceutical Knowledge.
• It was first formulated in 1996 and was revised thrice in 2003, 2011and 2015 before 2022.
• In NLEM medicine is categorized based on the level of the healthcare system as primary, secondary, and tertiary.
• The NLEM independent standing National Committee on Medicines (SNCM) was constituted by the Union Health Ministry in 2018.
• After a detailed consultation with experts and stakeholders, the committee revised the NLEM, 2015 and submitted its report on NLEM, 2022 to the Health Ministry.
• The government accepted the recommendations of the committee and adopted the list.

National Pharmaceutical Pricing Authority (NPPA)

• NPPA is an organization of the Government of India which was established, inter alia, to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995.
• The organization is also entrusted with the task of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers.
• It also monitors the prices of decontrolled drugs to keep them at reasonable levels.

Functions of NPPA 

• To implement and enforce the provisions of the Drugs (Prices Control) Order following the powers delegated to it.
• To deal with all legal matters arising out of the decisions of the Authority;
• To monitor the availability of drugs, identify shortages, if any, and take remedial steps;
• To collect/ maintain data on production, exports, and imports, market share of individual companies, the profitability of companies, etc, for bulk drugs and formulations;
• To undertake and/ or sponsor relevant studies in respect of the pricing of drugs/ pharmaceuticals;
• To recruit/ appoint the officers and other staff members of the Authority, as per rules and procedures laid down by the Government;
• To render advice to the Central Government on changes/ revisions in the drug policy;
• To assist the Central Government in parliamentary matters relating to drug pricing.

Organization of Pharmaceutical Producers of India (OPPI)

 It was established in 1965 and represents the research-based pharmaceutical companies in India.

For Prelims & Mains