Investigating the Illicit Manufacture of Pharmaceutical Drugs in Sri Lanka-A Case Study on the Underworld of Counterfeit Drugs

Introduction

The pharmaceutical industry allocates substantial number of resources to discover new cures and treatment options, aiming to combat various illnesses and diseases that impact the global community [1]. It stands out as one of the industries with substantial demand and significant financial investments [1].

Pharmaceutical drug manufacturers bear the responsibility of prioritizing patient well-being by upholding high standards in laboratory practices, clinical trials, manufacturing processes, distribution and storage facilities. However, the industry faces challenges such as increased demand, profit potential, weak regulatory oversight and a tendency to exploit legal market gaps contributing to the simultaneous rise of the illicit pharmaceutical industry.

The illicit manufacturing of pharmaceutical drugs has emerged as a pressing global concern, casting a shadow over the integrity of the pharmaceutical industry and posing threats towards the public health and safety [2]. In recent years, number of clandestine laboratories worldwide, which are engaged in the production of counterfeit and substandard medications has reached alarming levels. The illicit manufacture of pharmaceutical drugs not only undermines the principles of patient well-being but also erodes trust in the health care system. As the demand for pharmaceutical drugs increase worldwide driven by factors such as the population growth, higher incidence of diseases and improved access to healthcare, the illicit manufacture of drugs has found a suitable ground for its growth.

The widespread and intricate issue of drug addicts misusing pharmaceutical drugs contributes significantly to the substance abuse crisis. The illicit pharmaceutical drug market has experienced exponential growth in recent years, fueled by the escalating demand from individuals struggling with substance abuse disorders [3]. Originally designed to alleviate pain and treat medical conditions, prescription drugs transform into tools of dependency in the hands of drug addicts, resulting in numerous social, health and economic consequences [4].

Case Study

In April 2023, a six storied building, situated in a densely populated area in Colombo, Sri Lanka was apprehended by officers of the Police Narcotic Bureau, suspecting it’s involvement in the clandestine manufacture of illegal drugs. The individual in custody has rented out four floors of the building (ground to third floor) for the manufacturing process of drugs. Following a report to the courts, the magistrate of the area instructed the Government Analyst of Sri Lanka to conduct a thorough investigation of the apprehended building. A team of Forensic analysts from GAD visited the site and observed a range of materials including chemicals, machinery, machinery components, plastic containers, chemical glassware, balances, various coloured powders and differently coloured empty capsules stored within the premises. The forensic analysts inspected the equipment and chemicals, carried out preliminary and screening tests on- site and collected samples for further analysis in the laboratory.

The screening test conducted with the hand-held Raman analyser revealed the presence of tramadol in the samples collected from the site. Further analysis was performed utilizing the Gas Chromatography – Mass Spectroscopy (GCMS) technique (Figure 1).

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Results and Discussion

Raman Spectroscopy results revealed the presence of tramadol in the white powder in the green-coloured capsules and powder spilled over a machine in first floor, menthol in a white crystalline substance stored in a plastic bag and nicotinamide in an off-white powder stored in a plastic container (Figure 2).

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Presence of Tramadol, Lidocaine, Chlorphenamine, Nicotinamide and Menthol in the samples collected from the site was confirmed by the GCMS analysis.

The retention time for tramadol in the Total Ion Chromatogram (TIC) was 12.354 minutes. Characteristic mass peaks with m/z values of 58, 263, 135 and 188 were identified in both the mass spectrum of the sample and the library search result, confirming the presence of tramadol (Figure 3a).

The retention time for lidocaine in the TIC was 13.300 minutes. The mass peaks m/z at 86, 58, 120, 217 and 234, characteristic for lidocaine were observed in the sample (Figure 3b).

The retention time for Chlorphenamine in TIC was 14.258 minutes. Characteristic mass peaks with m/z values of 58, 72, 167, 203 and 216 were identified in both the mass spectrum of the sample and the library search result, confirming the presence of chlorphenamine (Figure 3c).

Nicotinamide has a retention time at 11.550 minutes and mass peaks m/z at 51, 78, 94, 106 and 122. The library search results matched with that of the sample, confirming the presence of Nicotinamide (Figure 3d).

Menthol has a retention time at 6.333 minutes with characteristic mass peaks m/z at 55,71,81,95,109,123 and 138. The library search results aligned with that of the sample, confirming the presence of menthol (Figure 3e).

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Tramadol is a synthetic opioid analgesic used to manage moderate to moderately severe pain [5].

However, non-medical use of tramadol has become a global problem. The incidence of tramadol related deaths and tramadol overdosing has notably risen over the past 10-15 years [6]. In the last decade, Sri Lanka has witnessed the abuse of tramadol, prompting its classification as a controlled drug under the “Poison, Opium and Dangerous Drugs “Ordinance, starting from November 2022.

Lidocaine is a local anesthetic which is commonly used for various medical procedures, including dental work, minor surgeries and certain diagnostic tests [7, 8]. Limited records are available regarding lidocaine misuse or overdoses, but existing data suggests that lidocaine can lead to toxicity when used frequently or inappropriately [9, 10].

Chlorphenamine is a first-generation antihistamine that is commonly used to relieve symptoms associated with allergic conditions, such as hay fever, allergic rhinitis and hives [11]. Adverse effects of the drug include sedation, nausea and vomiting, and diarrhea or constipation [12]. Acute chlorphenamine poisoning case has also been reported due to higher oral dose of the drug [13].

Natural menthol is isolated from the plant Mentha canadensis and is also synthesized on a large scale [14]. This compound is generally considered safe, and toxic effects and overdoses are rarely reported [14]. However, a case study has documented fatal menthol toxicity following acute exposure to menthol vapor [15]. In Sri Lanka, menthol has been found to be abused to adulterate methamphetamine, primarily due to its similar physical appearance to ice-like structures.

Nicotinamide is a form of Vitamin B3 and primarily used to treat the nutritional niacin deficiency [16]. However, abuse or overdose may lead to side effects, including skin irritation, flushing, nausea, itching, headache, vomiting and epigastric pain [17]. While cases of niacin toxicity have been reported, they are typically non-fatal [17, 18, 19, 20].

Conclusion

Forensic analysts have offered effective support to the law enforcement officials during this investigation of illicit manufacture of pharmaceutical drugs. Portable Raman Analyser proved to be an effective instrument for identifying drugs in the field. GCMS analysis confirmed the types of pharmaceutical drugs present in the samples collected from the site.

This discovery of illicit drug manufacturing laboratory raises concerns about potential public health risks associated with the production of counterfeit drugs or the misuse of legitimate pharmaceutical ingredients. The relevant authorities are expected to take further actions, including potential arrests, prosecutions and regulatory measures to enhance oversight and prevent such illicit activities in the future.