Self-sufficiency in drugs?

Wednesday, 7 June 2017 00:00 -     - {{hitsCtrl.values.hits}}

The Government plans to scale up its drug production to meet 90% of the requirement by next year, according to Health Minister Dr. Rajitha Senaratne. The claim is so ambitious as to be outlandish but the logic, as explained by the Minister, is to save precious foreign exchange amounting to about Rs. 45 billion annually. Two dozen investors have already joined with the Health Ministry and the Government is keeping its eyes open for more. So what would Sri Lanka have to do to make this a reality? What are the risks?

The global pharmaceutical industry is an important aspect of the world economy today, providing about $ 1 trillion in revenues annually. The American pharmaceutical industry accounts for about 40% of these revenues. However, China is fast catching up as having the fastest growth in the industry. European pharmaceuticals have also shown high revenues in prescription sales. In this industry individual companies are also massive players with Pfizer in the US having sales revenues of about $ 52.8 billion in 2016 while Johnson & Johnson realised revenue of $ 71.8 billion, making the latter the biggest pharmaceutical company in the world. 

So emerging markets such as Sri Lanka can, theoretically, manufacture their own drugs if they focus on generic types of medicine. But Sri Lanka would need to put in place a solid regulatory and legal framework to maintain standards. Monitoring of the pharmaceutical industry involves several aspects such as environmental monitoring in drug production; decontamination; microbiological testing; storage; and waste water management. These processes involve meeting regulatory rules for product safety and marketing. The issue of adverse drug effects has been the initiative behind strict regulations of the pharmaceutical industry worldwide. These complaints have reached 1,000 or more cases a year for every key marketed drug product sold in the market in recent decades. 

On one hand if Sri Lanka will mass produce drugs, then it also needs a process by which to evaluate complaints of substandard production, but on the other still needs to keep the market open for new experimental drugs to be imported for patient needs. Sri Lanka already has a system for this but it would need to be enhanced if the industry has the capacity to manufacture new types of drugs.  

Pharmacovigilance has become important in the industry as well in monitoring unrecognised drug risks, recognition of pre-disposing factors, and refuting spurious safety claims of drugs. In recent decades, pharmaceutical companies themselves have established their monitoring units to further the safety of their products. Pharmacovigilance has its origins in clinical medicine, clinical and pre-clinical pharmacology, immunology, toxicology, and epidemiology. Physicians and other closely-related sources are the usual information gatherers regarding Adverse Drug Reactions (ADRs).

Different methods of reporting of ADRs are practiced in different nations which account for the actions taken by the pharmaceutical companies. Policymakers also have to consider whether they would like to allow multinational pharmaceutical companies to invest in Sri Lanka as they would bring technology and other resources to the industry but also carry regulatory and legal risks. Larger companies acting as international investors would also have to tailor their business structures to be able to operate in an emerging market such as Sri Lanka. All these issues deserve far more attention than mere target setting.

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