To bring in better quality management that will help Indian pharmaceutical manufacturers grow their business nationally and internationally, the Health Ministry has given six months for small manufacturers and 12 months to large units, to get their World Health Organisation-Good Manufacturing Practices (WHO-GMP) certification.
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GMP comprises mandatory standards that build and bring quality to products by way of control on materials, methods, machines, processes, personnel, and facility or environment, etc. The GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was done in June 2005. WHO-GMP standards are now part of the revised Schedule M.
