RECENT RULES AND REGULATIONS RELATED TO MANUFACTURING DRUG PRODUCT IN QUALITY CONTROL AS PER CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO) IN INDIA COMPARISON WITH UGANDA

Ashok Kumar P.*, Roshni T.N., Thanushree Y.N., Jyothi R. and Jothsna A.M.

ABSTRACT

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. Its headquarters is located in Delhi and it has 6 zonal offices, 4 sub zonal offices, 13 port offices and 7 laboratories spread across the country. Good manufacturing practices (GMP) are complex and thorough. Wide array of regulatory requirements needs to be followed. Following GMP results in high quality products. GMP is mandatory in countries with a regulated pharmaceutical market and in the WHO prequalification programme too. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. Comparing the manufacturing regulatory requirements of India and Uganda helps to recognize the pharmaceutical manufacturing market size.

Keywords: CDSCO (central Drugs Standard Control Organisation); GMP (good manufacturing practices); Pharmaceutical marketing; regulatory requirements; quality of product.