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No proposal to end medicine deregulation, health authorities say

Islamabad: There is currently no proposal under consideration to reverse the deregulation of non-essential medicines, federal health authorities said after pharmaceutical manufacturers warned that any rollback of the policy could trigger medicine shortages, factory shutdowns, unemployment and serious setbacks for Pakistan’s pharmaceutical exports and healthcare system.

Senior officials at the Ministry of National Health Services, Regulations and Coordination said despite reports circulating within the industry about a possible policy reversal, the government was not considering withdrawal of deregulation introduced for non-essential medicines in 2024.

“There is no proposal under active consideration to reverse deregulation of non-essential medicines,” a senior health ministry official said, adding that the government remained committed to strengthening local pharmaceutical manufacturing, improving medicine availability and promoting exports.

Another ministry official said the government was trying to maintain a balance between affordability for patients and sustainability of the pharmaceutical industry to ensure uninterrupted supplies of medicines across the country.

The clarification comes amid growing concern within Pakistan’s pharmaceutical industry, where manufacturers fear that reversal of deregulation could undo recent gains achieved in exports, investment, medicine availability and manufacturing capacity.

Industry officials claim deregulation helped pharmaceutical exports rise by around 34 percent, from nearly $336 million before the policy change to approximately $450 million in 2025.

Manufacturers also expanded investment in WHO, PIC/S and EU GMP compliant production facilities aimed at accessing regulated international markets, including Europe, the United States, Canada and Australia.

Pharmaceutical industry representatives maintain that deregulation allowed manufacturers to improve quality assurance systems, maintain international certifications, strengthen pharmacovigilance and ensure better availability of medicines in the local market.

A senior pharmaceutical industry official warned that reimposition of strict price controls on non-essential medicines could have “disastrous consequences” for both patients and the industry.

“If deregulation is reversed, Pakistan could again face medicine shortages, closure of manufacturing lines, decline in exports, layoffs and reduced investment. Ultimately, patients suffer the most when medicines disappear from the market,” the official said.

Industry representatives argue that for years Pakistan’s pharmaceutical sector operated under rigid pricing controls that discouraged investment and made business operations commercially unsustainable for several multinational companies.

According to industry officials, global pharmaceutical companies including Pfizer, Novartis, Sanofi, Bayer and Johnson & Johnson either exited Pakistan or significantly reduced operations over the past decade due to pricing and business challenges.

Industry leaders also argue that pharmaceuticals remain one of the few major sectors subjected to strict administrative pricing despite rising inflation, currency depreciation and increasing operational costs.

“No other major industry faces this level of pricing restriction despite pharmaceuticals being directly linked with public health,” an industry representative said.

The pharmaceutical sector also rejected the perception that medicines in Pakistan are expensive, maintaining that DRAP’s regional reference pricing system consistently shows medicine prices in Pakistan remain among the lowest in the region.

Manufacturers further warned that policy uncertainty could undermine Pakistan’s efforts to achieve higher international regulatory standards, including DRAP’s target of attaining WHO Maturity Level 3 status.

They also fear that reversal of deregulation could negatively affect ongoing plans for local manufacturing of Active Pharmaceutical Ingredients (APIs) and vaccines, both considered essential for reducing dependence on imported raw materials and easing pressure on foreign exchange reserves.

The Pakistan Pharmaceutical Manufacturers Association has urged the government to maintain long term policy continuity, arguing that repeated policy reversals damage investor confidence and discourage industrial expansion.

Industry estimates suggest Pakistan’s pharmaceutical exports could potentially reach nearly $10 billion by 2032 if export oriented reforms, investment confidence and policy continuity continue.

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