As a preliminary step to operationalize the proposed Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) for the medium pharma industries in the country, the department of pharmaceuticals (DoP) has asked the pharma industry to provide a list of the machineries and equipments required by a medium enterprise for technology upgradation to WHO GMP and other international GMP norms.
The DoP has also asked the industry associations to send their comments to the department on the proposed scheme which is being launched by the government to address the special needs of the medium pharma enterprises (as per the definition given in the MSME Development Act, 2006) with some financial assistance for making their manufacturing facilities WHO GMP complaint through an interest subsidy on loan availed for such proposals. The industry's comments and suggestions and the list of machineries and equipments will be discussed at a meeting being convened by the DoP on March 11. The first meeting with regard to the PTUAS was held on February 26.
Besides, the ministry has also asked the industry associations to provide project reports of a few units who wish to upgrade their units as per WHO-GMP norms.
The salient feature of the PTUAS scheme is to provide financial assistance by way of reimbursement of 5 per cent point of the interest charged by the banks on the sanctioned loan on project technology upgradation amounting up to project cost/loan amount of Rs 10 crore. The scheme will be initially for a period of two years from July 1 this year to June 30, 2012 and to be extended for a further period of 2 years at the discretion of the DoP.
The interest will be reimbursed by the government through the nodal agency namely, SIDBI/IDBI.
Technology up-gradation under the scheme would primarily aim at complying with the Good Manufacturing Practices as per WHO GMP/other international GMP norms and requirements of premises, plant and equipment for pharmaceutical products for this purpose. The list of well established and improved technologies include quite a few important components of equipments that are relevant and essential for upgradation of medium industries so as to comply with WHO GMP/other international norms.
Under the scheme, only new machinery will be permitted. A medium enterprise can undertake one or more activities under technology upgradation. However, multiple activities can be undertaken only in an integral manner, i.e., by way of forward or backward integration. For formulation activities packing in various forms shall be considered as integral activity.
The upgradation includes laboratory (both instrumentation and microbiological), pollution treatment devices, controls, training, documentation, information technology, energy generation (DG), energy saving equipments and automation in production activities.
PTUAS is totally independent of other similar schemes. ME units are permitted to avail of benefits of other schemes, in addition to PTUAS unless specifically provided otherwise. The lending period is restricted to five years with a moratorium of one year i.e; the interest incentive would be available during the currency of loan subject to a maximum period of six years. The unit should be in operation during the period of availment of incentives and if the unit closes down/becomes NPA, the unit would not be eligible for interest incentive.