Regulator’s Guide: Mastering the Art of Effective Drug Sample Collection for Analysis

Before collecting a drug sample, DCOs must have a valid reason to believe that it is NSQ, adulterated, spurious, or counterfeit

N K Ahooja

February 25, 2024

370

FDA State Food and Drugs Administration — FDA

Table of Contents

Author
Recent Posts

N K Ahooja

Advocate |
Professor, MVN University Palwal, Haryana |
Former State Drugs Controller |
Food and Drugs Administration, (FDA) Haryana, India |
Email: narendervivek16@gmail.com

Drug Sample

Effective drug sample collection by Drugs Inspector / Drugs Control Officers (DCOs) is crucial in maintaining the integrity of drug quality and ensuring public safety.

Let’s delve into the essential requirements and precautions that DCOs must consider during the drug sample collection process.

In the realm of drug regulation, the role of DCOs is pivotal, especially when it comes to the collection of drug samples for analysis.

This process holds great significance in upholding the quality and authenticity of pharmaceuticals, safeguarding public health.

Follow us on WhtasApp Channel

Purpose of Sampling

The primary objective of sampling is the detection of not of standard quality (NSQ), adulterated, spurious, and counterfeit drugs.

This mission is not merely a bureaucratic duty but a vital responsibility to protect consumers from potentially harmful substances.

Precautions Before Collection

Avoiding Target-driven Collection: Collecting drug samples solely to meet monthly targets is discouraged. DCOs should focus on quality rather than quantity, preventing unnecessary waste of resources.
Financial Considerations: The exchequer’s resources are involved in the entire sampling process, from collection to analysis. DCOs must take precautions to minimize costs, considering drug sample, analysis, and transportation expenses.

Medicine Drugs Tablets Pills — Picture: Pixabay

Reasons for Sample Selection

Before collecting a drug sample, DCOs must have a valid reason to believe that it is NSQ, adulterated, spurious, or counterfeit.

Diligence in this stage helps in avoiding unwarranted expenditures and ensures the targeted drug samples are genuinely suspicious.

Efficiency and Reflection on DCOs

The efficiency of a Drugs Control Officer is reflected in the percentage of NSQ, adulterated, spurious, and counterfeit drugs detected.

Performance assessments by competent authorities rely heavily on this metric.

Click for Guidance documents for industry

Specific Steps in Drug Sample Collection

Every Drugs Control Officer designated as an Inspector under Section 21 of the Drugs and Cosmetics Act (Drugs Act) by the Competent State or Central Government must observe the following precautions while collecting drug samples on Form 17 for testing or analysis by the Government Analyst.

1. Avoid collecting drug samples solely to meet the monthly targets set by the controlling authority, as it leads to a wasteful use of time and energy, causing financial loss to the exchequer.

2. Given the significant expenditure incurred by the government in the collection, analysis, and transportation of drug samples, exercise due diligence before collecting drug samples, considering the costs involved.

3. The purpose of sampling is to identify NSQ, adulterated, spurious, and counterfeit drugs. Take all necessary precautions to detect such drugs.

4. Ensure there is a valid reason to believe that the collected drug sample is NSQ, adulterated, spurious, or counterfeit before selection.

5. Exercise due diligence before collecting drug samples, considering the substantial expenditure by the state and the time, money, and energy invested by the inspector.

6. The percentage of NSQ, adulterated, spurious, and counterfeit drugs reflects on the efficiency of the Drug Control Officer, impacting performance evaluations by competent authorities.

7. Collect drug samples of thermolabile drugs if not stored under proper conditions, as specified on the label and in accordance with Schedule P and Rule 96 of the rules.

8. Conduct a physical inspection of the drug before drug sample collection. If any discrepancies are found, collect the drug sample to protect the public from substandard or counterfeit drugs.

Click for more Articles on Pharmaceuticals

Click for more Legal Articles on Pharmaceuticals

9. Scrutinize the drug label thoroughly during sampling. If possible, compare it with the label of the original product. Any discrepancies should be noted for future comparison with the manufacturing firm’s control sample.

10. Check the QR code and other security features provided by the brand owner. If there is certainty that the product is not manufactured by the original brand owner, collect the drug sample.

11. Counterfeiters often target expensive and fast-moving drugs, making checking sale-purchase records crucial during sampling.

12. Develop informers who can act as eyes and ears for the department, providing valuable insider information.

13. Evaluate complaints on their merits and take appropriate action against NSQ, adulterated, spurious, and counterfeit drugs. Ensure complainants do not feel discouraged.

14. Protect the identity of complainants, as mandated by the Whistleblower Act, to encourage reporting of unlawful activities.

15. Utilize medical representatives, pharmacists, drug delivery personnel, and other para-medical staff as informers.

16. Develop insiders, such as manufacturing or analytical chemists, as informers in manufacturing units, ensuring their safety, security, and confidentiality.

Click for more on NSQ Drugs

17. Establish a whistleblower fund and recognize informers for providing useful information in detecting NSQ, adulterated, spurious, and counterfeit drugs.

18. Recognize that inspectors cannot be present at every shop or manufacturing unit but can gather essential information through informers.

19. Adhere to the inspector’s procedure outlined in Section 23 of the Drugs Act.

20. Ensure inspectors stay within their designated powers, as specified in Section 22 of the Drugs Act.

21. Follow circulars issued by the Drugs Controller General of India (DCGI) during drug sample collection, in addition to the mandatory provisions of Section 23 of the Drugs Act. DCGI circulars are advisory for enhanced duty performance.

22. Circulate DCGI circulars on drug sampling to all the Drugs Inspectors / Drugs Control Officer under their jurisdiction as the duties of an inspector are subject to the instruction of controlling authority as per rules 51 and 52 of Drug Rules.

23. Aim to collect the minimum drug sample quantity as prescribed in the DCGI circular, meeting the government analyst’s requirements for thorough drug analysis.

24. If the minimum drug sample quantity is unavailable and the drug control officer deems it necessary for detecting NSQ, adulterated, spurious, or counterfeit drugs, record the reason on Form 17 itself.

Click for more articles of the Author