The Confederation of Indian Industry (CII) is taking the lead to help establish a model cGMP facility having the approval of major drug regulatory agencies to facilitate easy entry for Indian drugs to the developed world markets. The proposal is to involve Quality Council of India (QCI) in developing a common facility to be used by the domestic drug industry for getting quicker approvals from agencies like US FDA and UK MHRA. The CII may approach the government seeking sufficient funds for establishing the facility.
According to sources, CII is looking at the creation of a nodal body to control and regulate policies in GMP for all pharmaceutical manufacturers with emphasis on SMEs. Creation of appropriate cGMP infrastructure for various dosage forms, establishment of pre-clinical research facility for SMEs and establishment of cGMP accredited process development facility for API are among the major objectives of the initiative. As per the initial estimates, an initial investment of about Rs 100 crore would be required to materialize the project.
The CII had recently organized an industry-government interaction to obtain necessary feedback on its proposal. The organization feels that the response from the office of the Drugs Controller General of India, Council for Scientific and Industrial Research (CSIR), QCI, industry associations and individual pharma companies was encouraging.
The CII has stated that the proposed facility would serve as a one-stop shop for testing of product to establish processes for drugs and pharmaceuticals. The agency thus created would aim at global partnerships with US FDA, WHO etc to assist Indian drug companies create cGMP infrastructure of world standards. The testing lab, part of the proposed facility, would include analytical, bio-chemical, micro-biological and chemical testing facility for laboratory analysis. The production facility would be of global standards and would facilitate small scale trial for feasibility testing, process evaluation and determination and establishment of parameters for commercial production. The facility could be used by the pharmaceutical companies to carry out small scale production for test marketing to establish market potential and credentials. Accreditation of GMP consultants is another objective of the programme.
QCI, an autonomous body promoted by the Ministry of Commerce & Industry, is mandated to establish and operate National Accreditation Structure for conformity assessment bodies. QCI is also assigned the task of monitoring and administering the National Board for Quality promotion and oversee effective functioning of the National Information and enquiry services. Indian Industry is represented on QCI by three premier industry associations ASSOCHAM, CII and FICCI.