Counterfeit drugs: A growing menace
According to FDA, Counterfeit or sub-standard drugs are medicines that may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit medicines are illegal and can be harmful to one’s health.
As one can imagine, counterfeit or fake drugs are considered as a curse in a regulated industry, where the prescription or right medicine at the right dose would determine the difference between life and death.
The national regulatory body CDSCO identifies three kinds of counterfeit or sub-standard drugs:
• Misbranded: drugs that claim higher than actual therapeutic value or are labeled in misleading ways
• Adulterated: drugs that in whole or in part, consist of toxic and harmful substances or substances that reduce the quality or strength of the drug
• Spurious: drugs that are sold in the names of other drugs/companies, or have been wholly or partially substituted by other drugs, or claim to be a product of a fictitious company
The estimates on the share of counterfeit drugs in the Indian market vary. For example, CDCSO claims that 4.5% of drugs in India are counterfeit or sub-standard. However, a recent ASSOCHAM study claims that close to 25% of India’s drugs are counterfeit or substandard.
As per a recent study, the drug categories that are most commonly counterfeited include common used medications like fever and pain relievers, antibiotics, vitamins etc. Whichever way we look at it, counterfeit drugs are a true menace. They not only adversely impact the health consequences of the patient, but also call into question the reliability of the key participants like doctors, pharmaceutical companies and drug stores with strong quality standards and practices.
Some of the contributing factors that need to be considered:
1. Low patient awareness: Self-medication combined with pharmacy switching of physician prescriptions, lead to consumption of counterfeit and sub-standard drugs. However, aware patients will likely insist on consuming only prescription or recognized brand name drugs.
2. Enforcement of regulations: We need strict enforcement, regulations, increased penalties and duration of imprisonment for a person who imports, manufactures or sells adulterated or spurious drugs in cases proving guilty.
3. Limited inspections and quality controls: Coupled with limited national testing labs, and drug inspectors which limits the government’s ability to proactively identify and limit the production and sale of counterfeit drugs.
Strategies to counter the growth of counterfeit drugs:
We need a combination of strong regulatory enforcement and product traceability to fight counterfeiting. Both the government and the industry must take some initiatives in this regard. However, the real fight against counterfeiting begins at home. Consumers need to check the label of the medicine and the drug prescribed when they buy the product at the pharmacy.
We need to ensure that as patients we are more aware of the risks of counterfeit drugs. We also should name and shame pharmacists who try and resort to product switching.