National Institute for Pharmaceutical Education and Research (NIPER) has decided to construct a GMP Compliant Pilot Formulation Plant at an estimated cost of Rs 5 crore. The project will come in handy for the pharma units, especially for the small and medium units, as the pilot project will provide comprehensive information regarding setting up of a GMP complied plant.

According to sources, the pilot project will be ready in another 8-9 months and tender has already been floated for the project. Out of the estimated cost of Rs 5 crore for the project, the ministry of chemicals will provide Rs 3.4 crore as grant and the rest will be met by NIPER itself.

The new project is part of NIPER's initiative to provide better information to the industries on quality compliance. The premier pharma educational institution has been doing a yeoman's service in this regard ever since its inception. The institution has been conducting workshops both for the industry and the regulators on quality under the capacity building programme. It has already completed 52 such workshops involving more than 2550 people.

The new project, which will not be a manufacturing unit, will be mostly useful to the small and medium industries as they will get useful information on how to build a GMP complied unit. Once completed, the units can visit the plant for understanding about the GMP norms in building such plants. The NIPER will also conduct training in this regard.

The construction of a pilot GMP complied plant is significant given the kind of thrust the government is putting on quality of medicines. To enhance the standard of drug manufacturing and also to ensure maximum efficacy and safety of medicines, the government had already implemented GMP for the pharma sector.

Ever since, the central government's decision to implement GMP by amending the Schedule-M of the Drugs & Cosmetics Act in 2005, the SSIs and medium industries have been struggling to comply with the new quality standards, largely due to the ignorance about setting up such units. The new project is expected to work as a guide in this regard.