States/UTs have set up Special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal

Spread the Message

Read Time:1 Minute, 36 Second

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.

There are laid down guidance and checklist for the conduct of inspections to assess the compliance of manufacturing facilities with the specified GMP and Good Laboratory Practice requirements.

CDSCO and the Ministry of Health and Family Welfare have taken regulatory measures to ensure the quality of medicines in the country as below:

The Drugs and Cosmetics Act, of 1940 was amended under the Drugs & Cosmetics (Amendment) Act of 2008 to provide stringent penalties for the manufacture of spurious and adulterated drugs. Certain offenses have also been made cognizable and non-bailable.
States/UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.
The number of sanctioned posts in CDSCO has significantly increased in the last 10 years.
To ensure the efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of the bioequivalence study along with the application for a grant of manufacturing license of oral dosage form of some drugs.
The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of a manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of the Central Government and State Government.
The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, the safety of excipients, etc. to the State Licensing Authority before granting of manufacturing license by the Authority.

The Union Minister of State for Health and Family Welfare, Dr. Bharati Pravin Pawar stated this in a written reply in the Rajya Sabha yesterday.