The ancillary sector that caters to the machinery requirement of Indian pharmaceutical industry may have a separate Good Ancillary Practices (GAP) to follow very soon. The GAP would elaborate on the good practices and systems ancillary industry should adopt and would supplement the norms specified in the Good Manufacturing Practices (GMP) notified by the Health Ministry.
The forthcoming Indian Pharmaceutical Congress (IPC), organized by five federating associations related to pharmaceutical sciences, is to take up automation and GAP in ancillary industry as a major area of discussion.
"The focus will be to prepare Indian ancillary industry through GAP. GAP is there today as a part of GMP. But we need full-fledged GAP. We will discuss the needs of Indian industry and the standards that should be set for ancillary industry. We will try to make the industry aware of this. ISP has a full-fledged guidance document for GAP. Industry has to absorb this automation and the system to validate automation. Any automation is important for the industry as it means less contamination," Dr M Venkateswarlu, Drugs Controller General of India and chairman - local organizing committee IPC informed Pharmabiz.
It should be noted that the large number of pharmaceutical companies in the country provides tremendous scope for the machinery manufacturers. According to machinery manufacturers association, there are more than 600 units of pharmaceutical machinery, comprising of small, medium and large scale with the estimated turnover of Rs 2,000 crore, out of which approx. 40 per cent is being exported across the world in more than 80 countries, including USA, Europe, UK.
The pharmaceutical machinery made by India are installed and are under operations at all the FDA approved manufacturing facilities in USA, Australia, Africa, etc. meeting the parameters of complete satisfactions.
Introduction of GAP can only enhance the capability of ancillary industry to meet the growing demand for sophisticated and validated machinery for pharmaceutical sector.