New Delhi, Aug 2 The Central Drugs Standard Control Organisation (CDSCO) along with State Drugs Controllers (SDCs) have conducted risk-based inspections of 400 premises including MSMEs to assess the regulatory compliance of drug manufacturing premises in the country, Union Minister for Chemicals and Fertilizers J.P. Nadda told the Lok Sabha on Friday.
The firms have been identified based on risk criteria such as the number of drugs declared as 'Not of Standard Quality', complaints, criticality of the products, etc.
During the inspection, drug samples were drawn and tested. Certain samples were found to be 'Not of Standard Quality'. Based on the findings of inspectors, more than 300 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules, the minister stated.
Under the Drug and Cosmetics Act 1940 and the rules framed thereunder, the regulatory control over the manufacture and sale of drugs is exercised through a system of licensing and inspection by the State Licensing Authorities appointed by the state governments.
The licensee is required to comply with all the conditions of a license including Good manufacturing practices (GMP) as prescribed under Drugs Rules, 1945. State Licensing Authorities are empowered to take action on violation of any conditions of such licenses including prosecution in the court.
The CDSCO and the Ministry of Health and Family Welfare have also taken regulatory measures to ensure the quality of medicines in the country.
These include amending the Drugs and Cosmetics Act to provide stringent penalties for the manufacture of spurious and adulterated drugs. Certain offences have also been made cognisable and non-bailable.
Besides, states and union territories have set up special courts for speedy trial of offences under the Drugs and Cosmetics Act, the Union Minister added.
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