(1995; 156 pages)
There are currently 200 large (including multinationals) and 8000 small (including contract manufacturers) manufacturers, of which 152 have a GMP Certificate.
The Drug and Cosmetics Act of 1940, the Drug and Cosmetics Rules of 1945 and the subsequent amendments are used for the control of import, manufacturing and export of pharmaceutical products.
Drug control is exercised at central and state level. The state regulatory authorities are responsible for regulation of manufacture, sale and distribution of drugs including the issuance of product certificates and GMP certificates. The central authorities are responsible for developing standards, control of the quality of imported drugs, coordinating state activities and concurrent control of the manufacture of vaccines and sera, I.V. fluids and blood products. Joint inspections are carried out by the central and state authorities for the licensing of new manufacturing premises and for the issuance of a Certificate of a Pharmaceutical Product.
In addition to various types of national certificates, the 1975 format of the WHO-type Certificate of a Pharmaceutical Product is issued when requested by importing countries.
Moreover, pharmaceuticals manufactured by contract manufacturers and not supported by a Certificate of a Pharmaceutical Product are exported to trading centres in Europe and Asia.