The Central Drugs Standard Control Organization (CDSCO) has released updated regulatory guidelines for taking action against samples of drugs declared spurious or not of standard quality (NSQ), in light of the enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008.
The guidelines aim to provide a uniform framework for State Drug Control Organizations to implement the Act effectively and ensure public health safety.
The 2008 amendment significantly increased penalties for manufacturing spurious or adulterated drugs, with potential imprisonment for life and substantial fines. The CDSCO guidelines emphasize a firm hand in dealing with such offenses, while also ensuring fair treatment for licensed manufacturers with minor quality variations.
Categorization of NSQ Drugs
The guidelines categorize NSQ drugs into three groups:
Category A (Spurious and Adulterated Drugs)
Category A includes counterfeit drugs that misrepresent their identity or contain harmful adulterants.
These cases are to be treated with utmost urgency, involving cognizable and non-bailable offenses under Section 36AC of the Act.
Category B (Grossly Substandard Drugs)
Category B covers drugs from licensed manufacturers with serious quality defects due to negligence or non-compliance with Good Manufacturing Practices (GMPs).
Examples include significantly low active ingredient content, disintegration/dissolution failures, and contamination.
Category C (Minor Defects)
Category C includes drugs with minor quality variations due to factors like inadequate formulation studies or improper storage.
Examples include broken tablets, discoloration, and labeling errors.
Guidelines for Action
Spurious Drugs (Category A)
- Immediate investigation, invoking Section 36AC, and seeking police assistance.
- Expedited prosecutions to deter offenders.
Grossly Substandard Drugs (Category B)
- Prosecution if criminal intent or gross negligence is established.
- Judicious use of prosecution, with consideration of administrative measures like license suspension or cancellation.
Minor Defects (Category C):
- Administrative measures, including suspension/cancellation of licenses or compounding of offenses.
- Prosecution only when other measures are insufficient.
Key Provisions of the Guidelines
- Establishment of screening committees to review investigation reports.
- Clear procedures for testing patent and proprietary formulations.
- Emphasis on inter-state coordination and information sharing.
- Creation of a rapid alert system for spurious/adulterated drugs.
- Strengthening of State Drug Control Organizations with resources and manpower.
- The document also includes annexures that provide detailed lists of defects that fall under category A and B, and also guidelines from 1993 that are still applicable.
These guidelines aim to:
- Enhance the effectiveness of drug regulation.
- Protect public health by preventing the circulation of substandard and spurious drugs.
- Ensure fair and consistent enforcement of the Drugs and Cosmetics Act.
- Provide clear direction to state drug control organizations.
