The Katoch committee on Active Pharmaceuticals Ingredients (APIs), constituted by the department of pharmaceuticals (DoP) to formulate a long term policy and strategy for promoting domestic manufacture of APIs/bulk drugs in the country, has recommended revival of public sector units (PSUs) for starting the manufacture of selected and very essential critical drugs like penicillins, paracetamol etc.

In its recommendation, which has been submitted to the government recently, the panel said that revival of public sector units for starting the manufacture of selected and very essential critical drugs (e.g. penicillins, paracetamol etc.) /vaccines or lease the plants/assets possessed by these units is suggested as one of the options for consideration. Where feasible, it would be necessary to evolve ways and means of utilizing the resources available in public sector units such as IDPL for setting up API industry. Infusion of capital (about Rs. 500 crore each) is recommended to these units to start manufacturing important APIs in the very near future.

To facilitate ease of business in the API sector, the Katoch committee further recommended that in order to ensure single window clearance to manufacturers and provide common facilities and other support, the department of pharmaceuticals should have an institutional mechanism which could work in synergy with other important departments such as ministry of environment and forests, ministry of coal, department of financial services, department of revenue and others have units co-located at the site.

On the research and development (R&D) front, the committee recommended stronger industry-academia interaction by facilitating the to-fro movement of scientists between industry and academic institutions. It also stressed on institutional mechanism for ministry of human resources, and various science departments/agencies like DST, DBT, CSIR, ICMR etc to work together/in synergy on R&D relevant for best procedures of production.

Innovation should be measurable and awards should be given to the scientists and industry who contribute to the development of improved processes relevant to bulk drug industry. Technology development financing should be repaid. It also recommended import duty exemption on import of capital goods in respect of R&D and manufacturing of vaccines/APIs.