Only 5.9% Spurious Drug Cases Resolved: Parliamentary Panel Slams Govt

The panel has expressed deep concerns about the low-resolution rate and inefficiencies in addressing cases related to spurious and adulterated drugs in the country.

The Committee’s findings and recommendations were outlined in its fifth report on the ‘Demands for Grants’ of the Department of Pharmaceuticals (DoP) for the fiscal year 2024-25, presented in the Lok Sabha.

Key Findings on Spurious and Adulterated Drugs

The Committee noted that Between 2015-16 and 2018-19, 2.3 lakh drug samples were tested by State Drugs Controllers. Out of these, 593 samples were declared spurious, and 9,266 were found to be of substandard quality. Shockingly, only 35 convictions were made, amounting to a mere 5.9% resolution rate. The Department of Pharmaceuticals clarified that this figure represents the percentage of cases decided and not the conviction rate, as conviction data is not maintained centrally. The Committee noted with concern that most of the 593 cases related to spurious or adulterated drugs remain unresolved and are still pending in various courts.

The DoP stated that State Drug Controllers conduct random drug sampling every month. Based on the analysis, actions such as issuing show-cause notices, stop-production orders, and suspending or cancelling licenses are taken under the Drugs Rules, 1945. Additionally, the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare have implemented several measures to improve drug quality and safety. These include risk-based inspections of over 400 drug manufacturing premises, resulting in more than 300 actions, such as suspension or cancellation of licenses.

Amendments to the Drugs Rules, 1945, have been introduced to enhance compliance with Good Manufacturing Practices (GMP). Larger manufacturers must implement these revised standards within six months, while smaller and medium-sized manufacturers have a 12-month timeline. Furthermore, regulations now require top drug brands and active pharmaceutical ingredients (APIs) to include bar codes or QR codes on their packaging for better traceability. Marketers of drugs are also held accountable for quality and regulatory compliance.

The Committee, however found the Department’s reply on the higher prevalence of Not of Standard Quality (NSQ) drugs from Government sources did not address the core reasons for the issue.

Also Read: Thane: Spurious drugs worth Rs 1.85 crore seized, 2 booked

Concerns About Delays and Lack of Centralized Data

The Committee expressed surprise at the absence of centralized data on conviction rates for spurious and adulterated drugs. The panel headed by Member of Parliament Kirti Jha Azad said;

"The Committee are surprised to find that the conviction rate data is not maintained centrally for penal action for spurious/adulterated drugs."

The report added;

"The Committee are concerned about the delays in disposal of cases as also the maintenance of centralized data pertaining to enforcement of penalties for spurious/adulterated drugs. The Committee, therefore recommend stringent action to be taken in a time bound manner for exemplary punishments for spurious/adulterated drugs."

Higher Prevalence of Substandard Drugs in Government Channels

The Panel further noted with serious concern that the National Survey of Drugs (2014–16) revealed that 10% of samples from government sources were substandard, compared to only 3% from private sources—a 3.17 times higher prevalence in government channels than in the retail market. The Committee observed that this discrepancy;

“undoubtedly pointing to loopholes in the procurement processes.”

Though various measures are taken by the Ministry of Health and Family Welfare to ensure that better quality and more effective, and safe drugs are made available to consumers. The Committee, however, found the Department’s reply on the higher prevalence of Not of Standard Quality (NSQ) drugs from Government sources did not address the core reasons for the issue.

Recommendations for Comprehensive Measures

The Committee demanded a detailed explanation of the challenges, flaws, and enabling factors contributing to the higher prevalence of NSQ drugs from government sources. The report read;

"The Committee, therefore, demands a detailed explanation of the challenges, flaws, and enabling factors contributing to the higher prevalence of NSQ drugs from Government sources."

Furthermore, the Committee found the Department’s response does not outline the measures in place to ensure the quality and integrity of pharmaceutical products throughout all stages of the distribution process, including procurement, purchasing, storage, distribution, transportation, 85 documentation, and record-keeping.

The Panel said;

"The Committee desires that the Government come out with more clarity on the previous legal authority and enforceability of the rules governing these distribution guidelines so that accountability be fixed accordingly."