THE ongoing delay in making new, approved lifesaving medicines available to patients is a serious lapse in Pakistan’s drug regulatory system. It is difficult to justify why medicines that have already met with the standards set by the Drug Regulatory Authority of Pakistan should remain out of public reach simply because the government has yet to approve their prices. For patients, this is not merely inconvenient; it is a question of health and, in many cases, survival. Nearly 40 registered medicines are reportedly awaiting price notifications months after the relevant process was completed and recommendations forwarded to the federal government. They include advanced therapies for cancer, diabetes, Parkinson’s, autoimmune disorders and critical care. These are treatments that can extend lives, improve the quality of life and prevent irreversible complications in patients with few or no alternatives. The official explanation that cabinet approval is still pending shows how cumbersome the system has become. Pricing should not be an open-ended approval process after a medicine has already cleared Drap’s scrutiny.

A regulatory framework that takes years to register a medicine and then delays its market entry for months makes no sense. The cost of these delays is borne entirely by patients. Illness does not wait for files to move through government offices. When legitimate supplies are delayed or blocked, desperate patients turn to smuggled or unregistered medicines. These products are priced exorbitantly, and their authenticity, storage conditions and supply chains cannot be guaranteed. Counterfeit and substandard medicines find space in such an environment. Ironically, excessive regulation ends up weakening effective oversight. The uncertainty also discourages pharmaceutical investment. Companies cannot indefinitely absorb unpredictable delays after completing an already lengthy approval process. Many simply conclude that introducing medicines is commercially unviable. The steady exit of several multinational pharmaceutical companies reflects, among other factors, the uncertainty surrounding pricing and market access. The government and drug regulator must recognise that regulation is not an end in itself. Its purpose is to protect public health while ensuring timely access to essential medicines. Once approval has been granted, price determination should be completed within a transparent, predictable and binding time frame. Patients should not have to pay for bureaucratic inertia.

Published in Dawn, July 22nd, 2026