WHO Prequalification Certification and the Price–Access Trade-Off in India's Pharmaceutical Market: An Empirical Framework for Evaluating the DPCO 2013 Policy Change
Vihaan Tannan
07/09/2026
India is a unique case in world healthcare because of its pharmaceutical industry. It supplies a large share of vaccines and generic medicines used across the world, but medicines are still a major expense for Indian families. This paper examines whether WHO Prequalification (PQ) certification is linked to a higher domestic price and whether the Drug Price Control Order of 2013 (DPCO 2013) changes this relationship.
We refer to this difference as the PQ price wedge. It is the difference in price between PQ-certified and non-PQ formulations of the same molecule, sold through the same market channel. To study it properly, the comparison has to be made at the brand and manufacturer level, and the price data must identify the channel in which the medicine was sold. The data must also cover a number of years before and after 2013.
The framework leads to three expectations. First, PQ certification can carry a premium because manufacturers bear additional compliance costs and because buyers may treat the certification as a sign of quality. Second, DPCO 2013 can reduce this premium only where the ceiling price actually applies and is enforced. Third, the size of the premium may not be the same for every therapeutic category, because donor demand, competition and the number of PQ-certified suppliers differ from one category to another.
The paper does not treat literature-derived benchmarks as original regression results. Instead, it identifies the data and validation steps needed to estimate the PQ price wedge credibly and explains the policy implications that would follow under alternative empirical outcomes.