National List of Essential Medicines, 2015: Endocrinology perspective.

Sir,

The Indian National List of Essential Medicines (NLEMs) has recently been revised (2015).[1] The 2015 version of NLEMs is a comprehensive, updated, and rational listing of drugs, which fits the requirements of an essential medicine. The endocrinology-related sections of NLEMs, in particular, have been improved significantly as compared to the 2011 NLEMs.[23] The endocrinology section has expanded from 23 to 24 drugs, with 4 additions and 3 deletions. The vitamins and minerals section, which contains Vitamin D has seen 2 deletions.

Glibenclamide has been deleted from the NLEMs, marking a major shift toward consideration of safety and tolerability of chronic care, as opposed to short-term efficacy and economy. Glimepiride 1 mg and 2 mg tablets have been added to metformin, ensuring that a modern, safe, and well-tolerated sulfonylurea[4] is now available for use.

Metformin is listed as an essential medicine in 500, 750, and 1000 mg strengths. Care has been taken by the authors to include both immediate release and extended release formulations. It must be noted, however, that 250 and 850 mg strengths are not listed, and that 750 mg metformin tablet is not widely available in India.

While the recommendations that accompany the NLEMs 2015 are quite clear, the inclusion of fixed dose combinations of metformin and glimepiride as essential medicines is doubtful. At the same time, fixed ratio combinations of insulin (30:70 combination of soluble and Neutral Protamine Hagedorn (NPH) insulin are included as essential drugs. The semantics of the insulin preparations have been optimized, mentioning 40 U/ml preparations of soluble, premixed, and NPH insulin. This choice reflects an understanding of Indian prescription and management trends. No insulin trade name is listed in the current NLEM; this is worthy of appreciation.

It is praise worthy that all anti-diabetic drugs are recommended for availability at primary as well as secondary and tertiary levels. This implies that diabetes management can be and should be, provided at primary health care level as well. The concise, yet comprehensive listing of drugs in the diabetes section of the NLEMs 2015 provides an opportunity to strengthen primary diabetes care delivery, within available resources.[56]

While some endocrine drugs which are “essential” for management are not listed, for example, desmopressin, the NLEMs explain this by alluding to the rarity of the medical condition (diabetes insipidus, in this case).[1] Similar justification can be used to explain the omission of growth hormone. However, for life-threatening conditions such as adrenal insufficiency, hormone replacement therapy must be categorized as essential. This is an endocrine right, and is part of the human right to life.

In this regard, hydrocortisone is rightly included as an essential medicine, in both oral and injectable forms, at all levels of care. Addition of fludrocortisone and glucagon, both of which are life-saving drugs in adrenal insufficiency and hypoglycemia, will add strength to the NLEMs.

Addition of cholecalciferol to the NLEMs and deletion of ergocalciferol have helped rationalize the NLEMs and make it concordant with the modern pharmacotherapeutic landscape. The specification of all strengths of thyroxine as being essential is a step in the right direction. Another step which is congruent with modern endocrinology practice is the inclusion of carbimazole as the only anti-thyroid drug.

Human chorionic gonadotropin (hCG) and levonorgestrel have been added to the 2015 NLEMs, keeping in view their unique indications and advantages. While the NLEMs has included a fair representation of estrogens, progestogens, ovulation inducers, and oral contraceptives, testosterone preparations are notable by their omission. The need for testosterone replacement in androgen-deficient men is unambiguous, and an injectable testosterone ester preparation should have been made available at secondary and tertiary levels.

In summary, the NLEMs 2015 is a comprehensive coverage of endocrine and metabolic pharmacotherapy. This will help strengthen endocrine care, at affordable process, across the country. We welcome the editions to the NLEMs 2015, especially addition of glimepiride, hCG and cholecalciferol, and correction of insulin-related taxonomy. We hope to see fludrocortisone, testosterone, and glucagon in the future editions of NLEMs.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.