Key Points
- Manufacturers say regulated prices no longer cover production costs
- Industry seeks greater pricing powers for drug regulator
KARACHI: Pakistan is facing a shortage of more than 100 life-saving medicines, with pharmaceutical manufacturers blaming prolonged delays in price approvals and revisions for drugs that have become financially unviable to produce.
The medicines include treatments for serious conditions such as cancer, hypertension and diabetes, according to drug manufacturers and suppliers. They say products have gradually gone out of production over the past two years as production costs rose above their regulated retail prices.
Former Pakistan Pharmaceutical Manufacturers Association (PPMA) chairman Tauqeer Ul Haq told Business Recorder that applications seeking price increases for financially unviable medicines had remained pending for more than two years.
He said the total number of medicines in question reached close to 105. However, the actual number of hardship cases could be higher because manufacturers had stopped filing new applications after earlier cases remained unresolved.
Under Pakistan’s Drug Pricing Policy 2018, manufacturers can apply for price revisions in hardship cases when medicines become commercially unviable at existing prices. Haq said the prolonged delay has contributed to the discontinuation of some medicines’ availability.
Haq said manufacturers were not seeking a general increase in medicine prices but an upward revision for products whose production costs had made their existing prices unsustainable.
He also warned that shortages could expose patients to counterfeit or smuggled medicines in case genuine products were no longer available through the formal supply chain.
PPMA Senior Vice Chairman Kamran Nasir told the newspaper that the Drug Regulatory Authority of Pakistan (DRAP) and its Drug Pricing Committee had already reviewed hardship applications and recommended revised prices.
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The recommendations were sent to the federal cabinet for final approval, but Nasir said the summary had been submitted several times over the past two years without a decision.
Nasir argued that DRAP should have the authority to make final decisions on hardship cases because it has the technical expertise to assess medicine prices and production costs.
He said the current system requires DRAP’s technical assessment to go to the cabinet, which he described as an unnecessary additional step for individual medicine-pricing cases.
According to Nasir, pharmaceutical manufacturers recently met Federal Minister for National Health Services, Regulation and Coordination Mustafa Kamal, Planning Minister and Deputy Chairman of the Planning Commission Ahsan Iqbal, and Adviser to the Prime Minister on Industries and Production Haroon Akhtar.
He said the ministers agreed to raise the issue with the prime minister and recommend that DRAP be empowered to regulate medicine prices immediately.
Nasir said DRAP did not simply accept manufacturers’ requested prices when reviewing hardship cases. Instead, it compared prices of similar medicines in regional markets, including India, Bangladesh and Sri Lanka, before recommending prices for Pakistan.
Pakistan’s price-cost balance
He said manufacturers needed sufficient margins to cover production and distribution costs, maintain their workforce and reinvest in manufacturing capacity.
The shortage highlights the need to balance affordable regulated medicine prices with the manufacturing cost of essential drugs.
The manufacturers contend that medicines priced below their production costs will eventually disappear from the market unless hardship cases are resolved.
It is not only the price that concerns the patients, but also the availability.
Under Pakistan’s drug-pricing system, a “hardship case” refers to a medicine whose approved price has become commercially unviable because production and other costs have risen significantly.
Manufacturers can apply to the Drug Regulatory Authority of Pakistan (DRAP) for a price revision when they can no longer produce the medicine at the existing regulated price.
DRAP reviews the application, including production costs and comparable prices in regional markets, before recommending any adjustment.
The mechanism is intended to prevent essential medicines from being discontinued while keeping any price increase subject to regulatory scrutiny.
DRAP’s Drug Pricing Committee assesses hardship applications and recommends revised prices, but the federal cabinet has approval authority.
