Even as the Department of Pharmaceuticals (DoP) is gearing up to launch the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) for the medium scale pharma units to upgrade their units as per WHO-GMP, US FDA norms, the industry has urged the government to extend the scheme to the small scale pharma units also.



Urging the DoP to extend the scheme to the SSIs, the industry has apprised the DoP that since several medium scale units have already upgraded their units as per the WHO-GMP and other international standards, the scheme will be a huge success if it is extended to the SSIs.



The industry has informed the government that more manufacturers will avail of the same if it is also extended to SSIs, since many of the medium scale units are already complying with WHO GMP and it is only the SSIs who are not Schedule M complaint but interested to upgrade to WHO GMP if it is financially viable. By virtue of extending this scheme to SSIs, the scheme is likely to become more popular with them, it has informed the DoP.



The DoP is launching the PTUAS scheme from early next year to assist the medium pharma enterprises in the country for the technological upgradation of their units to comply with WHO-GMP, US FDA and other international norms. At present, the scheme is awaiting the planning commission's nod to implement it. Under the 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.

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 scheme is to be made operational for the pharma medium enterprises initially for a period of two years, which can be extended for a further period of two years at the discretion of the government. The interest will be reimbursed by the DoP through its nodal agency, SIDBI or IDBI. For this part of the interest, the ME units will have to approach the nodal agency and an MoU/tripartite agreement has to be signed by them with the nodal agency and the lending banker.