The 2026 modification of Bangladesh’s National Essential Medicines List expands to 295 essential medicines and applies price-control regulations to them. It is an important addition to the country’s pharmaceutical policy regime. In Bangladesh, where out-of-pocket medical expenses remain high, it is important to reanalyse the changes alongside relevant national and international drug pricing regulations for essential medicines to navigate gaps and future impacts. This article analyses the international standards and development of national policies relevant to essential medicine regulations in Bangladesh.
Before delving into our main discussion, it is first important to understand what ‘Essential Medicine’ means. The World Health Organisation (WHO) described ‘Essential Medicine (EM)’ first in 1977, as medicines that are basic, indispensable and of utmost importance. Later in 2002, it was defined as medicines that safely and effectively address the population’s healthcare needs on a priority basis. These medicines are selected based on evidential benefits, public health significance, costs, affordability, and other pertinent criteria. EMs should always be accessible within functional health systems at an affordable price and in sufficient quantities to meet patient demand. To guide countries, the WHO updates its Model Lists of Essential Medicines every two years through an open application process. The WHO Expert Committee on Selection and Use of Essential Medicines reviews the request and enlists the medicines based on equitable geographical and gender considerations. The 2025 WHO Model List of Essential Medicines includes 520 medicines, of which 374 are for children. More than 150 countries have adopted their national essential medicine list based on this list. The lists of EMs are linked to improve prescribing and service quality, achieve cost savings, expand access, and increase the availability of EMs compared to non-essential medicines. The national model can be modified to fit different healthcare environments, budgets and their systems.
Bangladesh established its first-ever comprehensive framework to ensure quality, access and rational use of medicines (RUM) through the National Drug Policy (NDP) in 1982. Later, the 2005 and 2016 National Drug Policies were enacted, introducing several changes. The Department of Drug Administration (DGDA) is entrusted with the duty of controlling the prices of all domestically produced medicines and supervising the market.
Before the NDP of 1982, the medicine market of Bangladesh was flooded with unauthorised and unsafe drugs. This regulation was widely praised for fostering a positive atmosphere in the drug market. It encompassed 16 principles formulated by the expert committee to evaluate all pharmaceutical, medicinal, therapeutic, and medical items existing on the market, as well as newly approved or catalogued medications. It formulated a list of 150 EMs and a supplementary list of 100 specialised medicines. Some notable outcomes of the NDP 1982 are: the revision of the Drugs Act 1940, the use of generic names for manufacturing, the creation of the National Formulary by 1983, the regulations for pricing, labelling, and promotional activities, the elimination and restriction on use of product patents, the establishment of special drug courts, the establishment of a National Drug Control Laboratory by 1985, prohibiting the multinational pharmaceutical industry from producing simple drugs such as common analgesics, vitamins, antacids, etc. It implemented a strict prohibition on analgesics, antibiotics and other combination drugs if there are alternatives.
Under these regulations, Bangladesh witnessed a significant growth in its medicine market. Accessibility of EMs increased, the medicine prices became more stable, and the quality improved. The number of imported drugs reduced, and Bangladesh became a drug-exporting country. Furthermore, the government instructed manufacturers to produce 60% of total production as EMs and fixed the market price.
In contrast, the NDP 2005 eased the price control rules and permitted the pharmaceutical companies to raise the prices of medications, including EMs. Patients who pay primarily out of pocket faced a greater financial burden. It is believed that the pharmaceutical industry influenced the policy-making process for the NDP 2005. As a result, the 2005 Policy does not adequately prioritise ensuring the safety, effectiveness, affordability, and availability of necessary medications. Previous public health safeguards established by the NDP 1982 were weakened by the absence of explicit limitations on combination medications and local production priority in the NDP 2005.
In the NDP 2016, the government increased the number of EMs to 285,which includes antibiotics, hypertension, pain relief, asthma, fever treatments, and vitamins. However, the government fixed the prices of 117 drugs only, and the prices of other medicines were set based on proposals from manufacturers. Moreover, this list included Ayurvedic, herbal, and homoeopathic medications, which have been criticised for being scientifically unsound. Combination drug registration was discouraged by NDP-2016, but it did not provide any precise restriction on combination drugs.
In recent times, the interim government led by Muhammad Yunus has made several attempts to stabilise the medicine market. On 8 January 2026, the government expanded the EM list by 295-296 items by adding another 135 drugs. This list includes oxygen, hypertension and diabetes medicines but excludes cancer medications. The vendors are instructed to sell these drugs at the prices fixed by the government. The prices shall be adjusted gradually over a four-year time frame. This regulation also sets a defined price range for 1100 non-essential drugs. The Drug Administration-1 wing under the Ministry of Health and Family Welfare has also issued the Drug Pricing Method 2026 (Allopathic) to manage the drug prices. The prices shall be set using a cost-plus benchmarking formula, considering primary packaging expenses, raw materials costs, and a reasonable category-based profit margin. This Gazette is formulated in the essence of section 30 of the Drugs and Cosmetics Act, 2023. Under this provision, the government can set the retail prices of relevant drugs and the maximum prices of the local raw materials.
These long-awaited drug policy modifications can play a vital role to ensure availability and affordability of essential and non-essential medicines in Bangladesh. Generally, the WHO updates its EM list every two years, but in Bangladesh, it remained unobserved for a long time after 2016. As a consequence, the prices of medicines increased, and quality control became difficult. Indeed, the general mass has been facing difficulties accessing medicines and health services. The operational healthcare structure of Bangladesh is not supported by any health insurance. Many people and families pay medical expenses out of their pocket, often resorting to their own savings and loans. Low-income families are most adversely affected by this financial hardship. Although the pharmaceutical sector in Bangladesh has escalated rapidly over the years, its own citizens have been facing hardships accessing medicines because of structural disparity and weak law enforcement. Bangladesh, as an LDC country, enjoys the WTO TRIPS waiver extended to 2033, which benefits the local manufacturers. Presently, it is exporting medicines to more than 150 countries after meeting 98% of its national demand. Bangladesh has the potential to meet the necessary medicine demand of its citizens at a very affordable price, and these recent drug regulations can help to achieve that goal.
The 2026 drug regulation reforms could be seen as a rare silver lining amidst persistent structural issues in the pharmaceutical industry. This new commitment to affordability and equitable access to healthcare comes after decades of partial price control and regulatory dispersion. However, the successful implementation of these policies depends on how well national drug policies align with WHO universal guidelines, evolving public health requirements, and the evolving intellectual property regime. Future policies should give utmost priority to necessary budget allocations, an independent regulatory body and minimal influence from industrialists. The government needs to adopt a rights-based approach to ensure access to healthcare services with special attention to low-income and vulnerable groups. Lastly, it is very important to monitor the impact of these modifications and adapt up-to-date initiatives that align with evolving scientific research, disease patterns, and international legal obligations.
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