Overview of Laws and Enforcement Hurdles

Bangladesh introduced the Drugs and Cosmetics Act, 2023, replacing laws dating back to 1940 and 1982. The new act consolidates oversight under the Directorate General of Drug Administration (DGDA), covering licensing, manufacturing, import, distribution, sale, storage, and advertising of drugs and cosmetics. It also requires strict compliance with Good Manufacturing Practices (GMP) and World Health Organization standards for production and distribution.

Despite the modernized framework, enforcement remains a challenge. Bangladesh has around 86 local pharmaceutical manufacturers that produce almost 98 percent of domestic demand, and more than 200,000 pharmacies nationwide. Regulating such a vast and fragmented supply chain requires more inspectors and stronger oversight.

The rise of online and social media drug sales adds complexity. While e-pharmacies must be licensed, many unregistered vendors operate through Facebook, WhatsApp, and similar platforms. Reports suggest over 1,500 illegal online drug sellers are active, compared to only a handful of licensed e-pharmacies.

Judicial delays and weak enforcement further erode deterrence. Even when counterfeiters are caught, lengthy legal processes and modest penalties limit the impact. As a result, counterfeit and substandard medicines continue to penetrate the market. Estimates suggest that fake medicines may account for up to 20 percent of sales, worth hundreds of crores of taka annually. Globally, the World Health Organization estimates that about 10 percent of medicines in low- and middle-income countries are falsified or substandard, showing the scale of the challenge.

Recent Incidents and Reports (2024-2025)

Recent years have seen several high-profile seizures and alarming reports. In Dhaka, raids on Midford Market and other hubs have uncovered stockpiles of counterfeit antibiotics, painkillers, and cosmetic products. These operations revealed how widespread the problem is, especially in informal retail chains.

A 2024 study on antibiotic use highlighted that more than two-thirds of antibiotics purchased online were misused, with patients often failing to complete prescribed courses. This not only reduces treatment effectiveness but also accelerates antimicrobial resistance. In rural areas, limited access to licensed pharmacies drives many people to buy drugs from unlicensed vendors or online sellers, where the risks of counterfeit products are highest.

Law enforcement has occasionally partnered with international organizations such as INTERPOL in regional crackdowns, but the challenge remains systemic: counterfeiters exploit weak oversight, fragmented supply chains, and consumer desperation.

Risks to Industry and Nation

The counterfeit drug trade poses risks that extend far beyond the immediate health dangers to patients.

Health risks are the most severe. Counterfeit medicines can cause treatment failure, prolonged illness, and in the worst cases, death. The misuse of substandard antibiotics contributes significantly to antimicrobial resistance, which is emerging as one of the greatest public health threats of this century.

Economic losses are also significant. The pharmaceutical industry—one of Bangladesh’s most important export sectors—faces revenue hits of 10 to 20 percent due to counterfeit competition. Fake products erode legitimate sales, reduce profit margins, and undermine export credibility.

Reputational damage is another consequence. International buyers and regulators may become hesitant to source from Bangladesh if counterfeit or substandard products are linked to its supply chains. This could jeopardize the country’s growing pharmaceutical exports, which are a source of national pride and economic growth.

Finally, public trust is undermined. If people believe that medicines are unsafe or unreliable, they may avoid seeking formal treatment or rely on unverified remedies, deepening health crises and increasing social costs.

Legal Provisions and Punishments

Domestic Laws

The Drugs and Cosmetics Act, 2023 provides a strong legal foundation. It criminalizes the manufacture, sale, and distribution of counterfeit medicines. Licensing and registration requirements apply to manufacturers, importers, distributors, and retailers. Advertising and e-pharmacy sales are also regulated.

Punishments

Severe penalties are available under the law. Counterfeiting can lead to cancellation of licenses, heavy fines, and imprisonment, with life sentences possible in extreme cases. However, enforcement and prosecution remain inconsistent, limiting the deterrent effect.

Intellectual Property Laws

Trademark laws also provide a legal avenue to combat counterfeit branding, labels, and packaging. Remedies include fines, imprisonment, and civil damages. However, IP enforcement tends to be slower, with limited coordination between drug regulators, customs, and IP authorities.

International Standards

Bangladesh can look to international models for inspiration. The Medicrime Convention sets clear standards for prosecuting medical product counterfeiting. The TRIPS Agreement provides minimum IP protection standards. The EU’s Falsified Medicines Directive mandates tamper-evident packaging and track-and-trace systems, while the U.S. Drug Supply Chain Security Act enforces serialization and end-to-end supply chain visibility. These approaches show the importance of combining regulation, technology, and enforcement.

Conclusion and Advisory

Counterfeit medicines remain a critical threat to health, industry, and trust in Bangladesh. While the 2023 Drugs and Cosmetics Act has laid the legal groundwork, stronger enforcement, technological integration, and international collaboration are urgently required.

Key steps forward include expanding the number of DGDA inspectors, adopting digital track-and-trace systems for drug packaging, cracking down on unlicensed e-pharmacies, and educating consumers about safe medicine use. Ratifying international conventions and aligning with global best practices would also strengthen Bangladesh’s credibility.

For pharmaceutical companies and distributors, compliance is no longer optional—it is essential for survival. Legal experts such as Ahammad Jonaed & Partners can provide crucial support in navigating licensing, intellectual property protection, supply chain compliance, and enforcement actions. By aligning legal and operational strategies, firms can protect their brands, secure consumer trust, and remain competitive in export markets.

Bangladesh’s fight against counterfeit medicines is not only about enforcing laws—it is about safeguarding public health and protecting one of the country’s most promising industries. With consistent reforms and active industry collaboration, Bangladesh can move toward a safer, stronger, and more credible pharmaceutical future.