DoP tweaks composition of scheme steering committee to implement scheme for development of APIs

Shardul Nautiyal, MumbaiThursday, October 17, 2019, 08:00 Hrs  [IST]

As a way forward to develop bulk drugs industry in the country, the Department of Pharmaceuticals (DoP) has tweaked the composition of Scheme Steering Committee (SSC) aimed at implementing Assistance to Bulk Drug Industry for Common Facility Centre sub-scheme under the scheme for development of pharmaceuticals industry.

Under this scheme, financial assistance would be provided for creation of common facilities in any bulk drug park set up by state governments or state corporations.

The sub-scheme would be implemented through a one-time grant-in-aid to be released to State Implementing Agency (SIA) set up for the purpose. The proposals under the sub-scheme will be considered for approval by the SSC.

The new SSC has on its board Secretary, DoP as the Chairman of the committee with Financial Adviser, DoP, Joint Secretary, Ministry of Environment, Forest and Climate Change, Joint Secretary, Department for Promotion of Industry and Internal Trade, Joint Secretary, Ministry of Health and Family Welfare, Drugs Controller General of India (DCGI), Representative of SIA as Members and Joint Secretary (Policy), DoP as the Convenor of the committee.

The SSC may co-opt representatives of industry associations, R&D institutions and invite other government officials as well as private sector experts as special invitees as may be necessary from time to time.

As per the terms of reference of SSC, it shall approve the projects and also monitor their implementation. There would also be two stage process for approval of the projects - in-principle approval and final approval.

In-principle approval for a project will be accorded by the SSC based on preliminary proposal submitted by the SIA or state government. Major feature of the proposed project is availability of land.

Such in principle approval will be valid for a period of 6 months from the date of approval. Before that, it is expected that the project would be ready for final approval.

In case, final approval is not accorded to the project within 6 months, in-principle approval will automatically lapse, unless it is specifically extended by the SSC.

A project will be accorded final approval by the SSC, if conditions are fulfilled like establishment of project specific SIA, procurement of requisite land by the SIA, preparation of detailed project report (DPR) by SIA and its appraisal by SSC, opening of separate bank account for the purpose by the SIA with any scheduled commercial bank.

The funds to be released by DoP under this sub-scheme shall be transferred to the said account of SIA.

With reference to tying up of sources of funds for the balance amount, the SSC shall approve the project components and funding thereof depending upon the merits of the proposal.

Besides this, the various aspects and outcomes of the sub-scheme shall be reviewed by the SSC after two years from the date of its initiation.