New Delhi, Jul 22 (PTI) Since 2022, 905 firm units have been inspected, resulting in actions being taken against 694 of those firms based on risk criteria like the number of drugs declared as not of standard quality and other complaints, the government informed Parliament on Tuesday.
In a written reply to a question in the Rajya Sabha, Union Health Minister J P Nadda said isolated cases regarding spurious or adulterated or sub-standard drugs are received from time to time.
As part of quality monitoring and in order to assess the regulatory compliance of drug-manufacturing premises in the country, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022.
Firms have been identified on the basis of risk criteria like the number of drugs declared as not of standard quality, complaints, criticality of products etc.
“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), licence suspensions/cancellations, warning letters, and showcause notices, depending on the severity of non-compliance,” Nadda said.
The initiative has provided valuable insights into the manufacturing practices and led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework, he added.
All the drug manufacturers are required to comply with the conditions of their licence, including Good Manufacturing Practices (GMP) as prescribed under the Drugs Rules, 1945, to ensure the quality, safety and efficacy of drugs.
Further, the CDSCO uploads a list of drugs of various companies, which are declared not of standard quality or spurious or misbranded or adulterated by the central drug-testing laboratories, on its website (www.cdsco.gov.in) under the heading of “Drug Alert”, Nadda said. PTI PLB RC
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