The National Institute of Pharmaceutical Education and Research (NIPER) has in principle agreed to set up a facility, along with the proposed pilot plant for formulations, to demonstrate various options of materials and techniques that could be used by small scale players to go for Schedule M norms.
NIPER agreed to set up the facility following an interaction with the industry in a bid to garner their views on problems faced in the SME pharma sector. The preliminary meeting, held on May 17 in this regard after continuous efforts by SME Pharma Industries Confederation (SPIC) vice-chairman and a member of NIPER board of governors Lalit Jain, was attended by NIPER director Prof P Rama Rao, SPIC secretary general Jagdeep Singh, A I S Bedi (Torque Pharma) and Sanjeev Singhal (Preet Remedie.).
The premier institute, which is planning to have wider consultations with the industry bodies, also asked the industry to compile and submit their problems to find possible ways to help the SME sector.
The industry cited their problems with regard to layout and options of materials and techniques for Schedule M compliance and product stability in formulations during shelf-life. They sought testing assistance from NIPER especially in the absence of reliable commercial test houses for export and wanted more regular workshops and training to the industry on practical aspects.
Prof Rama Rao informed that the Chemicals Ministry had already sanctioned the Schedule M compliant demonstration unit for SMEs at a cost of Rs 5.4 crore. NIPER director also considered the industry desire for a museum to demonstrate the materials and techniques used for flooring, walls, flushed windows, flushed doors etc. The model unit, as per WHO GMP guidelines, is expected to be ready by April 2009.
NIPER also agreed to look into the problems of product stability during shelf life as there were 3-4 members in the faculty who were capable of addressing these problems. Prof Rao also assured to look into the industry demand for testing especially in case of new molecules and exports.
On giving training to the industry, he asked the industry to provide the number of the interested units so that frequency of training programmes could be decided. He also sought specific problems of the industry so that guest faculty could be arranged.
In the wake of the meeting, SPIC leader said they had asked their State associations to compile the problems and send to the Confederation so that they could be forwarded to the NIPER.