Steps taken to Prevent Sale of Adulterated Drugs
Steps taken to Prevent Sale of Adulterated Drugs
The Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare have taken following regulatory and enforcement measures to prevent the entry of Not of Standard Quality (NSQ)/adulterated/spurious drugs in the market.
The CDSCO has made the said requirements regarding QR Codes available to the general public by publishing the notification in this regard on its website (https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications) and has also advised industry stakeholders for public awareness campaigns in this regard.
Further, the guidance for identification and verification of spurious drugs have also been provided on the website of CDSCO describing the process flow for verifying the authenticity of the drugs by reading the bar code or quick response code.
In case of drug samples declared as NSQ by the Drugs Testing laboratories under CDSCO, the respective manufacturing firms are asked for immediate recall and stop further distribution of the not of standard quality drugs in the market. Further, based on investigation outcome, actions are taken by the licensing authorities concerned under the provisions of Drugs & Cosmetics Act & Rules made thereunder such as stop production orders, stop testing orders, license suspensions/cancellations, warning letters and show cause notices.
The Union Minister of State for Health and Family Welfare, Smt. Anupriya Patel stated this in a written reply in the Rajya Sabha today.
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- In order to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO, in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022. As of now, 905 units have been inspected, resulting in 694 actions being taken. These actions include Stop Production Orders (SPO), Stop Testing Orders (STO), license suspensions/cancellations, warning letters, and show cause notices, depending on the severity of non-compliance. This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework.
- On 17.11.2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E) which has come into force from 1st of August, 2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule H2, shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.
- On 18.01.2022, the Drugs Rules, 1945 were amended vide G.S.R. 20 (E) providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label at each level of packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the minimum particulars including unique product identification code, Batch Number, Manufacturing date, Expiry Date etc.