In an effort to stop the increasing incidence of substandard or poor quality drugs in India, the government has proposed to offer financial assistance to drug firms for upgrading manufacturing facilities according to the current quality standards.
A considerable proportion of the medicines being circulated and sold across India are not of standard quality because a large number of drug making factories are not complying with the standard manufacturing practices as most of them find to costly to afford.
Reports also indicate India, one of the biggest medicines manufacturing hubs in the world, could well be a source for fake or poor quality drugs spreading in several regions of the world where the Indian companies export to.
In view of this, the Department of Pharmaceuticals (DoP), government of India has reportedly sent the proposal to launch a scheme to assist the medium pharma enterprises in the country for the technological upgradation of their manufacturing units to comply with the current good manufacturing practices (GMP) set out by world’s leading agencies and regulatory bodies such as WHO, US FDA etc.
The proposed scheme called the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) 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, reports said.
The interest-subsidised loans can be used for upgrading factory premises, plant and equipment for manufacturing pharmaceutical products for this purpose.
The funds can also be used to select list of well-established and improved technologies and components of equipment that are relevant and essential for upgradation of the factories so as to comply with WHO GMP/ other international norms.
The technologies and equipment list for upgradation of facilities will be periodically revised by the ministry with the help a Technical Committee to be set up.
Pharma companies can undertake multiple activities for technology upgradation such as laboratory, pollution treatment devices, controls, training, documentation, information technology, energy generation, energy saving equipments and automation in production activities, provided they are meant for forward or backward integration.
The subsidised interest will be reimbursed by the department of pharmaceuticals through its nodal agencies.
The medicine companies, however, can avail the use of only new machinery.
But they are permitted to avail of benefits of other schemes, in addition to PTUAS.
The scheme offers a lending period upto five years with a moratorium of one year. The interest subsidy would be available during the currency of loan subject to a maximum period of six years.
If the factory closes midway, and not in operation during the period of availment of incentives the company will lose its eligibility for the interest incentive.
The scheme is expected to boost the production drugs under good quality manufacturing practices and bring down low-quality products being circulated in India currently.
A lot pharmaceutical producers 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, reports said.