State-of-the Art Technologies Facilitate the Combating Sub-Standard Medicines
Amit Chopra
Managing Director & VPGM India and Middle East
Thermo Fisher Scientific

Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence and the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain.

The Indian pharmaceutical sector ranks 3rd in the world as far as volume is concerned, and is ranked 13th in terms of value. Being the largest provider of generic drugs globally, India's share in the global generic drug market is an impressive 20 percent. As per the World Health Organization, 35 percent of counterfeit drugs sold in various countries come from India. Also , approximately 25 percent of medicines sold in India are of substandard quality. The Indian pharmaceutical industry is strong in the field of manufacturing, but it is crucial to improve its ranking in producing approved and quality medicines.

Fraudulent drugs harm or kill millions around the world. Of these counterfeit drugs, the most common are those related to cardiovascular and cancer treatment. Further, there are various counterfeit antibiotics that are produced in large quantity. Additional common counterfeit drug categories include but are not limited to erectile dysfunction medicines, painkiller medicines, weight loss pills, psychiatric medications and medicines that are given during the treatment of various chronic ailments such as HIV, Diabetes, Alzheime's disease, etc.

Every stakeholder involved in the pharma business, including the policy makers, can play a pivotal role in putting a stop to this globally alarming issue. For example, the drug manufacturers need to strengthen their process around security of the manufactured drug -from raw material identification through production, supply to the end-user and destruction of unused /returned/rejected material including the packaging material. Players in the supply-chain process should closely monitor the movement of drugs from one point of sale/distribution to the other. Policy makers should frame stringent guidelines/regulations, increase the number of inspections on every stakeholder in the pharma business and drive campaigns that provide insight about counterfeiting and its implications to discourage such negligence.

For many years, pharmaceutical companies have relied on a combination of covert and overt security features in packaging and occasional forensic analysis to identify counterfeit drugs. However, counterfeiters have found ways to quickly and accurately replicate those features to deceive authorities and patients. While combating through traditional approaches like laboratory tests, random batch checks, routine screens etc., are being carried out, it can, only be used to verify a small fraction of all suspected samples. It becomes imperative for companies to create a robust mechanism to identify counterfeit drugs and loop-holes in the supply chain while making significant contributions to support research and innovation for the pharma industry through state-of-the-art technologies.

It becomes essential to make investments in high-end analytical instruments and consumables to support activities which will accelerate drug discovery, enhance productivity and enable regulatory compliance. By means of right technologies, manufacturers can achieve quality initiatives not just throughout the manufacturing process but also in the market place. There are products available in the market which examines chemical composition of all components of a pharmaceutical dosage and offers non-destructive, rapid and accurate raw material identification respectively. Handheld instruments are designed to detect a variety of applications, including incoming raw material identification, quality control and assurance, counterfeit product screening, process troubleshooting and quantitative analysis. Non -destructive, rapid and accurate raw material identification enabling immediate release of raw materials into production while also meeting the requirements of current good manufacturing practices(cGMP) and 21 CFR part 11 with minimal training required.

Raman spectroscopy examines the chemical composition of all components of a pharmaceutical dosage, including APIs, excipients, fillers, dyes and coatings to create a unique spectral fingerprint representing the authentic medicine. Such technological solutions enable leading pharmaceutical companies to quickly and effectively identify almost any pharmaceutical material from receipt to release.

Currently, major global pharmaceutical manufacturers and regulatory authorities use such analysers to verify the identity of either raw materials or finished products. Innovations are allowing brand owners and government agencies to develop new and powerful approaches towards anti -counterfeiting. These products have facilitated the seizure of thousands of counterfeit drugs that would otherwise have entered the supply chain with serious consequences.