CDSCO Committee Calls for Stronger Action Against Fake Medicines, Stricter Quality Checks
New Delhi: The growing threat of spurious drugs in India has prompted drug regulators to take a more aggressive stance. The Drugs Consultative Committee (DCC) functional under Central Drugs Standard Control Organization (CDSCO) has recommended enhanced deterrent actions to tackle the sale and storage of counterfeit medicines and proposed updating guidelines for handling Not of Standard Quality (NSQ) drug samples in light of stringent penalties under the Drugs and Cosmetics (Amendment) Act, 2008.
In its 65th meeting held on December 20, 2024, at CDSCO Headquarters, New Delhi, the DCC deliberated these issues and recommended measures to strengthen drug regulatory enforcement nationwide. As part of its recommendations, the committee suggested that State Licensing Authorities (SLAs) be consulted to make the deterrent actions more effective and proposed that an expert committee be empowered to co-opt additional specialists as needed. Additionally, the guidelines for handling NSQ samples will be revised to incorporate advanced testing parameters like impurity profiling, which are now included in updated pharmacopoeia standards.
Stronger Deterrents Against Spurious Drugs
The sale of counterfeit and substandard drugs remains a significant challenge for regulators, endangering patient safety and eroding trust in the healthcare system. DCC was apprised that to address this issue more effectively, many measures have been taken including amendment in the Drugs and Cosmetics Act, 1940 in the year 2008 by introducing enhanced penalties for those found guilty of manufacturing or selling spurious drugs.
DCC was also apprised that CDSCO has constituted a committee in this regard for appropriate advice. DCC noted the composition of the committee constituted on the issue pertaining to sale of spurious drugs in the market. The DCC deliberated the matter in detail and recommended that;
"Committee may also seek comments from the SLA’s so that the issue is addressed more effectively and recommended that the report of the Committee may be placed before DCC for further deliberation and consideration."
Further, DCC also recommended that;
"The committee shall also be empowered under the terms of reference to co-opt certain experts on need basis."
Updating NSQ Drug Sample Guidelines
The DCC also addressed the need to update the guidelines for handling Not of Standard Quality (NSQ) drug samples in accordance with advancements in testing standards and enhanced legal penalties.
The CDSCO Committee was apprised that the Guidelines for taking action on samples of drugs declared spurious or Not of Standard Quality (NSQ), in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008, were issued as per the recommendation of 40thDCC.
DCC was also apprised that the Pharmacopoeias are upgraded from time to time and several testing parameters such as Impurity Profiling etc. are included in various monographs which are not covered under the existing guidelines. Accordingly, it was proposed to update the guidelines w.r.t. samples of drugs declared spurious or NSQ.
After detailed deliberation, DCC agreed with the proposal for updation of guidelines and recommended that the existing guidelines may be circulated to all the members of the DCC for their comments/ suggestions for updation.
By tightening measures against spurious drugs and aligning NSQ testing with modern pharmacopoeia standards, the DCC look forward to fortifying public health protections and uphold the integrity of the pharmaceutical industry. The final recommendations from the expert committee and updated NSQ guidelines will be presented in upcoming DCC meetings for further consideration and implementation.
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