Hence the 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 document, 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. Few SMEs are engaging external consultants on retainer basis or few are engaging some of GMP personnel of large organization on informal basis.

Organizations that have complied with the local GMP norms and wish to enter into outside markets, they need to upgrade their GMP norms to meet such regulations, for ex., organization to enter into US market need to meet USFDA GMP norms, to European market it is EDQM norms etc.  In general there is no serious difference in any of these regulations, expect how the regulatory bodies evaluate.

Some of the SMEs whom we interacted have shown interested in availing any intervention for implementation of basic Schedule ‘M’ (i.e. regulatory norms of Govt.of India) quality certification and few for upgrading to next level to enable them to enter export markets.

Currently available service providers are well experienced to meet the requirement of the industry. As industry base is growing, and the regulatory requirements are revised on a regular basis, more and more such service providers are entering field. The cost of facility up gradation to meet any of these regulations depends on their present status. GMP consultants can provide inputs by way of plan as per regulatory requirements and to meet the same. 

Pharmaceutical manufacturers have to upgrade their quality testing facilities on a regular basis based on current regulatory requirements. To meet the basic criteria of safety, quality and efficacy, quality testing for raw materials, in-process materials and final products besides packing materials is part of any regulatory requirements. 

With increased consciousness of patients and availability of technology, current regulatory challenge of a cluster firm is not to estimate the purity of the active material, but to assess the content of impurities. To estimate this level of concentrations, the cost of analytical equipment will be very high and in many cases it is not in the reach of pharma SMEs. As per Schedule ‘M’ regulations it is expected that entrepreneur has to create all such facilities to test the quality of incoming, in-process and final product besides packing materials. Outside testing labs are catering to local pharma industry in a big way but at time these service are not affordable by Cluster SMEs.