The ongoing issue of counterfeit medicines in India is driving the government to introduce mandatory barcoding on all locally sold medicines. This initiative comes amidst rising concerns about India’s reputation as a burgeoning source of counterfeit medications.
The Problem of Counterfeit Medicines
The severity of India’s counterfeit medicine problem was recently highlighted by the Office of the United States Trade Representative (USTR) in its annual ‘Special 301 Report’ on Intellectual Property Protection and review of ‘notorious markets’ for piracy and counterfeiting released in April. The report revealed that nearly 20% of all pharmaceutical goods marketed in the Indian market, amounting to $4.3 billion in 2013-14, are counterfeit.
Pharmaceutical Sector in India
India is a global leader in the production of inexpensive generic medicines, courtesy of its high domestic demand and low manufacturing costs. Despite being the thirteenth largest in terms of value, India’s pharmaceutical market ranks third worldwide in volume. Counterfeiting, however, is significantly more common in lower and middle-income countries, with an estimated 10-30% of medicines in these regions being counterfeit – a stark contrast to just 1% in high-income countries.
Factors Fuelling Counterfeit Medicines Market in India
A multitude of factors contribute to the proliferation of counterfeit medicines in India. These include limited medical care access, particularly in rural areas, a fragmented supply chain, a lack of consumer awareness, a widespread culture of self-medication, the high cost of genuine medicines, weak legislation enforcement and corruption, the growing prevalence of online pharmacies and advanced technology aiding counterfeiting.
Classification of Poor Quality Drugs in India
As per the Drug and Cosmetic (D and C) Act, 1940, poor quality drugs fall under three categories: misbranded, spurious and adulterated drugs. The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare’s Directorate General of Health Services, has segmented not-of-standard-quality (NSQ) products into three categories – A, B and C – to facilitate their quality evaluation.
Before moving on, let’s take a look at some important facts:
| Category | Description |
|---|---|
| A | Spurious and adulterated drug products that hide the true identity of the product or formulation. These may or may not contain active ingredients and are typically produced by unlicensed individuals or even licensed manufacturers. |
| B | Grossly substandard drugs where products fail the disintegration or dissolution test, and the active ingredient assay is below 70% and 5% of the permitted limit. |
| C | Products with minor defects such as changes in formulation colour, small variations in net content, and sedimentation in clear liquid preparations, failing weight variation tests and the presence of foreign matter and labelling errors. |
Role of Barcoding in Counteracting Counterfeit Medicines
Barcoding for domestic drug sales will help verify the authenticity of medicines and facilitate their monitoring, ensuring availability, tracking expiration and enabling efficient recalls when required.
Further Steps to Tackle Counterfeit Medicines
In addition to barcoding, several other measures can also be employed in the fight against counterfeit medicines. Raising public awareness could be a crucial step, given that about 78% of India’s 650 million mobile phone users have internet access. Online education about counterfeit and spurious medicine could be a rapid and effective way to address the issue.
Implementation of innovative anti-counterfeiting technologies can also make a significant difference. New generation anti-counterfeiting technologies such as forensic markers (chemical, biological and DNA taggants), cloud-based supply chain data repositories, and blockchain technology in supply chains can all be leveraged to combat counterfeit drugs.
