The small-scale drug units expressed mixed response, on the proposal of Confederation of Indian Industry (CII) to join their project for setting up a common cGMP facility for the development of the pharmaceutical industry in the country upto global standards.

While the CII has approached the Confederation of Indian Pharmaceutical Industry (CIPI) seeking support for the program, many of the executive committee members of the organization are not fully supportive of the proposal.

The representatives from CII presented their proposal with the structure of the program, meant to support Indian pharma industry to develop globally, in the two-day executive meeting of CIPI held at Chennai. The CII has also asked for a commitment from the CIPI to utilize the facility, once if the organization is interested in participation.

The members of CIPI feel that the CII plan may be useful to API sector rather than formulation industry, particularly the SSIs. The members asked for a foolproof roadmap of the program.

"CIPI is open to the proposal from CII. But if the program is focusing on multinationals and large scale companies, we cannot co-operate with them. We have asked for the proposal from the CII for further discussion," TS Jaishankar, Chairman, CIPI told Pharmabiz.

In the meeting, some of the members have made suggestions to modifying the program, for the welfare of SSI units. They suggested that the program should provide help for the SSI to set up Standard Operating Procedure (SOP) documentation and it would be better if the CII could also identify the vendor. They opined that a basic plan and construction for aiding SSI manufacturers should be formed prior to the program. The members also welcomed the idea of a pre-audit training facility, offered in the program.

The CII representatives explained that the facility is to provide support and services for the Small and Medium Scale Entrepreneurs in the pharma sector. The program is to facilitate infrastructure for pre-clinical trial, pre production and post production quality control, in-house training programs, pre-audit training, SOP preparation and documentation and filling up formats.



"The program is totally for the development of the pharmaceutical industry in India to grow globally with Good Manufacturing Practices. We have already conducted talks with the Ministry of Health, Council for Scientific and Industrial Research (CSIR), various associations in the industry and many of the major companies in the country, for their response. We have got a response that such a facility can provide better service to the pharma industry," Dr. R N Choudhury, Senior Counsellor (Total Quality Management), CII told Pharmabiz.

He said that the program, under the Quality Management division, is on evolution stage, prior to develop feasibility reports. Both the organizations concluded the discussion with pointing out the need of further discussion after a thorough study of the proposed program.