Friday, December 19, 2014

#Generic drugs entering markets without proper testing

Some Pharmaceutical companies manufacturing generic drugs do not carry out proper tests. Drug controller general of India (DCGI) has failed to ensure the same.The Indian Council of Medical Research has taken up the matter with the Drug Controller General of India (DCGI) for action against such erring companies.

Action as permissible under the Drugs & Cosmetics Act, 1940 and the rules made there under will be taken by Drugs Controller General (India) after verification of facts.

The manufacture for sale of drugs is regulated through a system of inspection and licensing under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder. The manufacturer is required to comply with the conditions of license and follow the Good Manufacturing Practices (GMP) to ensure that the drugs manufactured by them are of standard quality. One of the conditions of the license is that the licensee shall either in his own laboratory, or in any other laboratory approved by the licensing authority, test each batch of the raw material used by him for manufacturing products as also each batch of the final product and shall maintain records showing the particulars of such tests.

The Health Minister, Shri J P Nadda stated this in a written reply in the Lok Sabha here today.