Pharma industry world over is heavily controlled by regulatory bodies. In India the pharma industry is covered by Drug & Cosmetic act 1945. One of the chapters of the said act – Schedule ‘M’ governs the manufacturing and quality control practices of the industry. The schedule stipulates the requirements of facilities so that quality is inbuilt in to the systems. Any pharmaceutical manufacturers in any sector – micro, small or large are covered under this act, and any manufacturer without this certification cannot function.

Good Manufacturing Practices (GMP) implementation has two fold – system and facilities. System implementation involves identification of all activities, writing down them in sequential manner, practicing them rigorously and documenting besides other activities. GMP implementation requires experienced personnel; small and medium enterprises are unable to afford such personnel to employ on a full time basis.

Some of the cluster firms have indicated that some soft loans by way of concessional interest and higher moratorium can help the industry. Also they have indicated that any special products / packages from financial institutions for GMP implementation and up gradation will help the industry in a big way. BDS providers in the area of equipments, for facility up gradation to meet requirements are not available in the cluster.