Even after almost one year of its proposal, the Department of Pharmaceuticals (DoP)'s ambitious Rs.100-crore Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), meant to assist the medium pharma units to comply with WHO-GMP, US FDA and other international norms, is still stuck with the planning commission. As per initial plans of the DoP, the scheme was to come into effect from July 1, 2010 and the date was postponed to January 1, 2011.


The files regarding the scheme is still pending with the planning commission. The commission has been asking for several details regarding the scheme from the DoP which the department has been providing and we are waiting for the planning commission's nod to begin the scheme, senior officials said. The DoP had submitted the detailed proposal regarding the PTUAS to the planning commission in May last year.


The DoP had proposed Rs.100-crore outlay to support at least 200 medium pharma units to comply with the international norms during remaining period of the current Five Year Plan in the initial phase.


Once the planning commission accords its permission, the scheme will be launched which will be a boon to the medium pharma units who are looking to upgrade their units to comply with WHO-GMP, US FDA and other international norms but are unable to do so due to financial constraints. Under the proposed PTUAS scheme, the DoP will provide an interest subsidy of five per cent on loans availed for such purposes, amounting upto a project cost or loan amount of Rs.10 crore, senior DoP officials said.


In fact, the PTUAS scheme was to come into effect from July 1 last year. But, the DoP could not launch the scheme as per the plan due to the delay in getting the permission from the planning commission. The total financial outlay for the scheme will be decided by the planning commission, the official said.


The PTUAS is to be made operational for the pharma Medium Enterprises (ME) initially for a period of two years and to be extended for a further period of two years at the discretion of the government.


Under the scheme, technology up-gradation would primarily aim at complying with the Good Manufacturing Practices (GMP) 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 MEs so as to comply with WHO GMP/other international norms.


The list of eligible machinery will be upgraded by the ministry on a periodic basis by a Technical Committee which will be set up by the ministry.


Under the scheme, only new machinery will be permitted. Benchmarking of the cost of machinery will be done by a committee. This committee shall also look into all possible disagreements between lending institutions, units and SIDBI regarding eligibility and the cost of equipments/machinery.


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 activities. 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 will be 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, 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.