Guest post_Excipients in drug formulations and nutritional supplements: The necessity of surveillance in Nepal

This guest-post is by Ishwor Poudel. 

Whenever a new drug moiety is discovered or prepared along with the successful set of preclinical and clinical trials  and is further intended to be marketed, it need to go through a series of preformulation studies,  compatibility tests and the  precise formulation strategy. Active medicinal component alone only can’t be adequate enough to design a dosage form.  It’s where the excipients or additives come to play the role. Excipients can be defined as a non reactive ingredient added in the formulation in order to achieve the stability and the robust aestheticism in a drug. While going through a medicine, we only glance at the active ingredient but there are lot more beyond that while a drug is designed. I just intend to give a brief bird eye view over what additives really mean in the formulation and about proper surveillance over the quality of such components as an essential requisite.

There is one normal misconception about additives in public mind that they are fully inert which can’t be considered true. Excipients are not inactive and have substantial impact on manufacture and quality, safety and efficacy of the drug substance in the dosage form. The basic function of the excipient being improvising functionality and processability, it provides a wider approach towards the drug delivery with lot of applications. There is no doubt regarding importance of additives in the formulation but there is always a question regarding if there is proper inspection of these components in the same manner as it is done for the active material. Nepalese medicines market is not that transparent as it appears to be and so are the surveillance criteria. The organoleptic additives used are of main concern as they seem to be derived from lot of sources and industries use a very flexible term to describe them.

Few months back, I was in a medicine and food supplement store and I went through the labels where I found such a conspicuous terms used. All permitted synthetic colours, natural flavours, permitted sweeteners were some of few which I remembered. As being a pharmaceutical aspirant, I was expecting a more specificity which any industrial person might find irrelevant but I think it’s essential.

A 500 mg paracetamol tablets weighs about almost a gram which is made up by using a diluent but are you sure that whether the lactose used as a bulking agent is of standard quality or not. Obviously certain criteria are clearly set by FDA and other regulatory bodies regarding the quality of the additives but can we assure that such things are being followed in the Nepalese pharmaceutical industry. I don’t have right to mock the poor control of the regulatory agencies here but these issue has to be properly resolved with time. This year only, 30 big companies of the pharmaceutical tycoon India is under screening by USFDA for possible malpractices and defective GMP. These should alarm the warning bell to the other Indian companies because they need to focus on maintaining the standards more than the profit oriented business. And it should be wake up call for the Regulatory authority of Nepal that proper regulatory guidelines should be improvised, implemented and monitored at regular basis.

The use of excipients is inevitable in the drug formulations and food products and it need to be synchronized with the proper alignment of the integration of regulations and quality control. And people also should develop a habit of not just looking at what they desire to see; it’s judicious to see what lies within and what lies beyond.