11/04/2026
Generic Prescribing in Nepal: Good, Bad or Ugly ?
Generic prescribing in principle aims to improve access to quality medicines at affordable prices.
In Nepal, however, the reality is more complex and demands a careful, system-level evaluation before its widespread implementation.
A significant proportion of Nepalese pharmaceutical companies DO NOT manufacture active pharmaceutical ingredients (molecules). Instead, they rely on imports from India and other countries. Most pharmaceutical companies here just do local processing, packaging or branding.
At present, the Department of Drug Administration (DDA) faces critical limitations. It remains understaffed and under-resourced to ensure:
1. Comprehensive drug quality testing across the full range of marketed medicines
2. Mandatory and periodic bioequivalence surveillance for all formulations
3. Real-time pharmacovigilance and quality monitoring
In such a scenario, shifting to generic prescribing introduces a practical dilemma. When a physician prescribes to patient by molecule (generic), the final choice of product (Brand) often rests with the retail pharmacist.
In a market where commercial incentives exist, there is a risk that selection may be influenced by margins or availability rather than by robust evidence of quality and bioequivalence.
This creates an imbalance: control over drug selection shifts away from the prescribing doctor, yet clinical responsibility and accountability remain with them. Understandably, this may lead to hesitation, as the physician’s primary obligation is to ensure patient safety and therapeutic efficacy.
It is also important to recognize that generic prescribing can be driven by both legitimate and questionable motives.
On one hand, it can:
1. Promote equitable access to essential medicines
2. Reduce financial burden on patients
3. Encourage rational prescribing practices
On the other hand, if poorly regulated, it may:
1. Displace established, quality-assured brands without ensuring equivalent standards
2. Flood the market with lower-cost alternatives of uncertain bioequivalence
3. Undermine trust in the healthcare system and the doctors
However, there is also a parallel concern. While affordability is crucial, unjustified price inflation in the name of “quality” must NOT be ignored.
One pragmatic solution for the government is to implement rational price caps at the molecule level. This can help balance affordability with fair market practices.
For Nepal, the transition to generic prescribing should NOT be rushed. It should follow the establishment of minimum and non-negotiable following safeguards:
1. The capacity to test the quality of all drugs available in the market
2. Early adoption of advanced drug-testing technologies, including pre-market evaluation where feasible
3. Routine and enforced bioequivalence studies across different brands
4. A functional system for real-time quality surveillance and pharmacovigilance
5. Adequate staffing, funding and technical strengthening of the DDA
Without these foundational elements, enforcing generic prescribing risks creating confusion, eroding trust and potentially compromising patient safety.
Generic prescribing is not inherently flawed. But in the absence of strong regulatory systems, it can shift from a well-intentioned policy to a source of clinical uncertainty.
Nepal must first build the infrastructure that guarantees quality. Only then can generic prescribing truly serve its intended purpose: safe, effective and affordable care for all.
Dr Bishow Shrestha
MBBS, MD, FICM, FIMV, FPCCM, FCCP
