The pharmaceutical industry in Pakistan is strictly regulated by the Drug Regulatory Authority of Pakistan, which oversees drug approvals and pricing.^[1]

History

At the time of the independence of Pakistan in 1947, there were few production units in the country. Currently Pakistan has more than 800 large volume pharmaceutical formulation units, including those operated by 25 multinationals present in the country. Almost all the raw materials used in making of medicine are sourced from abroad.^[2] There are factors hindering growth such as the manufacturing of counterfeit drugs made from substandard active ingredients.^[3]

The Pakistan pharmaceutical industry meets around 90% of the country's demand of finished dosage forms and 4% of active ingredients. Specialized finished dosage forms such as soft gelatin capsules, parenteral fat emulsions and metered-dose inhalers continue to be imported. There are only a few bulk drug active ingredient producers and Pakistan mainly depends on imports of bulk drugs for its formulation needs resulting in frequent drug shortages.^[4] Political disturbances and allegations of under-invoicing add to the uncertainty of imports^[5] and clashes with the customs and tax authorities are common.

The national pharma industry has shown growth over the years, particularly over the last decade. The industry is trying to upgrade itself and today the majority industry is following local Good Manufacturing Practices (GMP) laws, with a few in accordance with international guidance. Currently the industry has the capacity to manufacture a variety of traditional products ranging from simple pills to capsules, ointments and syrups.

In 2017, the World Health Organization accredited the first Pakistani drug formulated by Getz Pharma.^[6]

Exodus of multinational companies (2000–present)

Over the past two decades, the presence of multinational pharmaceutical companies in Pakistan has significantly dwindled, decreasing to 22 from 48.^[7] The decline is attributed to the challenging business environment, where supplying quality medicines at rates lower than production costs has become unsustainable.^[7][1]

In April 2008, Merck Sharp & Dohme (Pakistan) Ltd, an American research-based company operating in Pakistan since 1960, divested its business, including its manufacturing unit and locally registered products to a Pakistani local company, Organon Bio Sciences.^[8][9] Similarly, Bristol Myers Squibb, another American company which was operational in Pakistan since 1984 and was manufacturing antibiotics, blood pressure control and cancer drugs in a local factory, transferred its business and product registrations to GlaxoSmithKline Pakistan in 2008.^[9][10]

From the UK, ICI also disinvested, selling its name and production licenses to a local entity, a move mirrored by Roche Pakistan in 2010.^[9][11] Johnson and Johnson, which entered Pakistan in 1966 upon President Ayub Khan's invitation, sold its pharmaceutical and surgical sutures manufacturing unit to a domestic company.^[9]

In November 2016, Merck Group divested its operations to a local company, Martin Dow.^[12][13]

In November 2022, Eli Lilly Pakistan, known for producing Humalog medical insulin for diabetes treatment, announced the closure of its operations in Pakistan.^[7]

Companies

Multi-national companies include:

• Herbion Pakistan^[14]
• Pakheim International Pharmaceuticals Pvt. Limited^[15]
• GlaxoSmithKline Pakistan
• Martin Dow
• Zafa Pharmaceutical Limited^[16]
• Searle Companies Limited
• Abbott Laboratories Pakistan

There are around 759 pharmaceutical units^[17] operated by upwards of 650 companies,^[18] some of which are listed below.

• Max Pharmaceuticals
• SAMI Pharmaceuticals^[19]
• Filix Pharmaceuticals is the first company to use USFDA registered ingredients and trial heat resistant packaging in Pakistan.^[20][21]
• CCL Pharmaceuticals^[22]
• Cosmo Pharma^[23]
• Pakistan Drugs Testing and Research Center (PDTRC) is the first WHO-PQ laboratory in Pakistan.