Regulate quality of medicines, not prices, top Pharma Bureau official advises govt

Executive Director Pharma Bureau Ayesha Tammy Haque has advised the government to do away with price regulation, barring essential drugs, and focus on quality control instead to ensure smooth supply of medicines to the patients.

“The shortage of medicines has resulted in the growth of the gray market, as the vacuum is being filled by smuggled medicines without any warranty and genuine medicines are being replaced by spurious and counterfeit products,” said Ayesha, stressing that these markets have become bigger than white market.

She was speaking over a wide variety of issues in the pharma sector in Pakistan to a group of journalists at the Pharma Bureau office in Karachi on Wednesday.

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The Pharma Bureau, a representative body of 22 multinational pharmaceutical companies in Pakistan, has also urged the government to swiftly announce consumer price index (CPI)-adjusted prices for medicines, as the drug shortage is becoming a crucial issue for the patients.

Ayesha maintained that there are fake drugs in the market that are supposed to be life-saving, pointing towards the lack of enforcement from the government authorities.

“It’s not us or you who ought to control this menace of fake drugs. It’s the work of the government,” she said.

‘CPI adjusted price increase must for medicines’

Ayesha said the pharma industry has been urging the government to deal with the problem of drug shortages for over a year.

“This requires addressing the key issues of inflation and massive rupee devaluation, which have increased the costs of manufacturing.

“The industry filed for hardships, which have been reviewed and evaluated by the DRAP [Drug Regulatory Authority of Pakistan], and 262 hardship cases are pending approval of the federal government for over a year,” she said.

16pc-60pc hike in prices of various drugs witnessed

The industry official said lack of access to medicines was a growing concern as the availability of both locally produced and imported medicines was decreasing, forcing patients to purchase medicines at a higher price in the black market.

Along with hyperinflation, she added, the industry-specific challenges, including labour and energy-intensive processes, high energy costs, water purification challenges, and import tariffs increased the production costs significantly.

Ayesha said the pharmaceutical industry believes that unsustainable and unpredictable policies in addition to excessive controls, have led to drug shortages, counterfeiting, black-marketing, unavailability of essential drugs and medicines being imported at significantly higher prices in the market.

‘Retaining FDI is better than attracting FDI’

Ayesha pointed out that the multinational corporations (MNCs) in the pharma sector were leaving or trimming their operations and downsizing.

“Why is attracting FDI [foreign direct investment] more important than retaining those who have already invested here? What message is perceived when companies leave Pakistan?” she questioned.

Ayesha highlighted substantial losses faced by the pharmaceutical companies. With 262 hardship cases pending for the past eighteen months, she emphasised the necessity of creating a conducive environment and implementing long-term policies to revitalise investment in Pakistan’s declining pharmaceutical sector.

Moreover, Pakistan’s import dependency for active pharmaceutical ingredients and packaging materials, coupled with the continuous devaluation of the rupee, exacerbates the situation.

“The government should consider this plea as an SOS call from the industry to allow CPI adjusted price increase for the medicines,” she said, adding that the government acknowledges the issue, but is neither taking responsibility nor making any attempt to remedy the situation.

The pharmaceutical industry has been calling for sustainable policy making to ensure the availability of medicines.

“To support local manufacturing and enable export capabilities, long-term policies and comprehensive drug pricing strategies are crucial. By doing so, the industry can thrive, ensuring availability of affordable and high-quality medicines for patients,” Ayesha said.

Export potential

Pakistan exports only $300 million worth of medicines annually, Ayesha said. “It’s tiny when compared with India, who exports $25 billion of medicines.”

Despite around 700 companies operating in the country, she added that Pakistan’s pharma export is even overshadowed by a small country like Jordan, which has $3 billion exports from its pharmaceutical sector.

“Out of 700 companies, only three have certifications. Not a single company has FDA certification,” she said.