Non-bailable Prosecution Added Under the Drugs & Cosmetics (Amendment) Act of 2008

In a written response to the Rajya Sabha, Union Minister of State for Health and Family Welfare Dr. Bharati Pravin Pawar stated: In accordance with a risk-based approach, the Central Drugs Standard Control Organization (CDSCO) and a number of State Licensing Authorities (SLAs) inspect pharmaceutical manufacturing facilities to determine whether or not they are meeting the requirements of Good Manufacturing Practices (GMP) outlined in the Drug Rules of 1945. Read More Business News on our website.

There are set down directions and agendas for the lead of reviews to survey the consistency of assembling offices with the predetermined GMP and Great Research facility Practice prerequisites.

The following are the regulatory measures that the country’s CDSCO and Ministry of Health and Family Welfare have taken to guarantee the quality of medicines:

1. Under the Drugs & Cosmetics (Amendment) Act of 2008, the Drugs and Cosmetics Act of 1940 was amended to impose severe penalties for the production of counterfeit and adulterated drugs. Additionally, cognizable and non-bailable offenses have been added to the list.
2. In order to speed up the process of getting rid of violations of the Drugs and Cosmetics Act, states and UTs have established special courts.
3. In the past ten years, there has been a significant increase in the number of sanctioned CDSCO posts.
4. The Drugs and Cosmetics Rules of 1945 have been amended to require applicants to submit the results of a bioequivalence study with their application for a manufacturing license for an oral dosage form of some drugs in order to guarantee their efficacy.
5. The Drugs and Cosmetics Rules of 1945 have been amended to require that the manufacturing facility be jointly inspected by the Drugs Inspectors of the State Government and the Central Government prior to the issuance of a manufacturing license.
6. The Drugs and Cosmetics Rules of 1945 have been amended to require applicants to provide evidence of stability, excipient safety, and other factors to the State Licensing Authority before the Authority issues a manufacturing license.