Pharma Insights on Spurious Drugs and Not Standard Quality Medications

Understanding Spurious Drugs vs Not Standard Quality Medications

The Central Drugs Standards Control Organisation has recently identified 53 drugs categorized as Not Standard Quality (NSQ), prompting major concerns within the pharma industry. These medications include essential items from recognized manufacturers like Alchem and Sun Pharma. The implications surrounding these classifications highlight critical challenges to drug quality in India.

Defining the Differences

According to Gangadi Madhukar Reddy, MD and CEO of MedPlus Health Services, NSQ refers to drugs failing to meet quality standards set by regulatory bodies due to factors such as labeling errors, ingredient concentration discrepancies, or dissolution profile variations. For instance, a medication labeled to contain 100 mg of an active pharmaceutical ingredient could register between 95 mg and 105 mg, resulting in NSQ classification.

Conversely, spurious drugs represent counterfeit products that consist of harmful or ineffective substances, either lacking active ingredients or containing entirely different compounds. As articulated by Rajeshwari Hariharan, Counsel at Delhi High Court, spurious drugs are those that are adulterated or where the active ingredient is entirely disparate.

Legal Implications and Market Challenges

• Severe penalties are imposed on manufacturers of spurious drugs, including criminal charges and potential jail time for directors.
• The Indian Pharma Alliance highlights the importance of distinguishing NSQ from spurious drugs to protect the reputations of legitimate manufacturers.
• Many small retailers increase risks by sourcing from wholesalers, inadvertently contributing to the spurious drug issue.

Consumer Protection Strategies

Both Reddy and Hariharan stress the necessity for stringent regulations coupled with effective consumer education. Integrating technology, such as QR codes on packaging, could empower consumers to verify the authenticity of their medications, ensuring they receive genuine products.

Key Takeaways for Consumers and Manufacturers

In conclusion, as the debate around NSQ and spurious drugs escalates, the pharmaceutical industry must take urgent action to safeguard both consumer health and credibility in the market. Enhanced transparency and consumer awareness are essential for combating the challenge of drug safety.