The Small and Medium Pharmaceutical Industry Centre (SMPIC) at the NIPER, Mohali, is considering the option of outsourcing process validation and stability studies as the NIPER still has not enough staff strength to entertain all such requests coming from the SME units.
The consultative committee of the SMPIC has constituted a sub-committee to look into the options on stability studies as the SMPIC had been requested by many SMEs to get the stability studies done by the NIPER as part of product development. The sub-committee has Prof Saranjit Singh, Prof Arvind Bansal, Rajesh Madan and Bhavin Mehta as its members.
The meeting of the Consultative Committee, held recently, discussed the options and assessed that the NIPER cannot take up the stability studies for the product. The suggestion of outsourcing the same came up in the meeting and was supported by most of the members, sources said.
Though the SME members also sought assistance from the NIPER on the green chemistry technologies for off patent APIs, the institute disclosed that it did not have enough manpower in the process chemistry section under the department of Pharmaceutical Technology.
The NIPER officials also briefed the SMPIC committee that the accreditation of the laboratory at the centre will be completed in next six months, in three stages. In the beginning, the scope of accreditation of the lab will be tested and later it may be extended to include calibration as required by the SME pharma. Besides, construction work of the formulation plant was in progress, the meeting was told.
The meeting also discussed the development of biotech products by NIPER faculties. It was also suggested that a series of biotech products like anti-cancer and anti-cardiovascular enzymes, amino acids, other secondary metabolic and antibiotics could be thought of for development.