<span style="color: #222222;">Minister of State for Health Dr Bharati Pravin Pawar has said that Central Drugs Standard Control Organisation CDSCO in coordination with various State Licensing Authorities SLAs conducts inspections of pharmaceutical manufacturing units in order to assess the status of compliance, to the requirements of Good Manufacturing Practices GMP under the Drug Rules 1945, as per risk based approach. <br />''<br />''In a written reply in the Rajya Sabha on Tuesday, Ms Pawar said, there are laid down guidance and checklist for conduct of inspections to assess the compliance of manufacturing facilities with the specified GMP and Good Laboratory Practice requirements. She said, CDSCO and Ministry of Health and Family Welfare have taken regulatory measures to ensure the quality of medicines in the country. <br />''<br />''The Minister said, the Drugs and Cosmetics Act, 1940 was amended under Drugs and Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. She said, certain offences have also been made cognizable and non-bailable. Dr Pawar said, States and UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. <br />''<br />''She said, the number of sanctioned posts in CDSCO has been significantly increased in last 10 years. The Minister said, to ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs. <br />''<br />''She said, the Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government. She added that the Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.</span><br />
News On AIR | March 21, 2023 7:12 PM
CDSCO in coordination with various SLAs conduct inspections of pharmaceutical manufacturing units: MoS for Health Dr Bharati Pravin Pawar