India, Aug. 12 -- The Government of India issued the following news release:

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.

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.

Table Omitted (The document can be viewed at https://www.pib.gov.in/PressReleasePage.aspx?PRID=2155448 )

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