Essential medicines should be perennially available

Only a small fraction of these is available in private pharmacies, says study

New Delhi, February 6, 2018: A recent research has revealed that India lacks access to essential medicines, despite the approval of thousands in an attempt to generate wider availability. It has found that the policy to open up the market has generated a large number of brands of medicines, but there are still not enough available in the pharmacies.

Although multiple brands of selected medicines are listed in professional and commercial databases — running into thousands — only a small fraction is available in private pharmacies. Apart from this, the medicines are also available in fixed dose combinations (FDCs), where two or more drugs are combined in a set ratio in a single dose form, usually a tablet or capsule. There are concerns in India over the safety and effectiveness of these products.

Speaking about this, Padma Shri Awardee Dr K K Aggarwal, President Heart Care Foundation of India (HCFI) and Immediate Past National President Indian Medical Association (IMA), said, “Essential medicines are those that satisfy the priority health care needs of the population. These should be available at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. Essential drugs satisfy the priority healthcare needs of a majority of the community. The NLEM assumes importance in India where out-of-pocket expenditure on health care is quite high and only a few have health insurance.”

The Alma Ata Declaration adopted by the World Health Assembly in 1978 was the first international declaration, a milestone, which brought primary health care to the forefront. It outlined provision of essential drugs as one of the essential components of primary health care. In the same year, the World Health Assembly passed a Resolution urging Member States to establish national lists of essential medicines and adequate procurement systems.

Adding further, Dr Aggarwal, who is also the Vice President of CMAAO, said, “Of the thousands of drugs in the market, as many as 70% are duplicative or ‘me-too’ drugs and hence nonessential. Therefore, it is important to derive a system to facilitate selection of fewer drugs from the numerous that are available. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.”

Many criteria are considered to include a drug in the NLEM.

• The medicine should be approved/licensed in India.
• The medicine should be useful in disease which is a public health problem in India.
• The medicine should have proven efficacy and safety profile based on valid scientific evidence.
• The medicine should be cost effective.
• The medicine should be aligned with the current treatment guidelines for the disease.
• The medicine should be stable under the storage conditions in India.
• When more than one medicine is available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness.
• Price of total treatment to be considered and not the unit price of a medicine.
• Fixed Dose Combinations (FDCs) are generally not included unless the combination has unequivocally proven advantage over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance