The pharma companies include Lupin Pharmaceuticals, Aurobindo Pharma, Zydus Cadila, Orchid Chemicals and Pharmaceuticals, Ranbaxy Laboratories and Dr Reddys Laboratories in the alliance LAZORR which aims to improve productivity using the best practices and counter the soaring input costs in the industry.
The alliance will help to bring assured quality by the domestic manufacturers using the current good manufacturing practices (cGMP) thus giving a green quality signal to the global pharmaceutical industry.
The alliance aims to address operational challenges with the rising inputs costs both power and raw materials to improve the production efficiency. Though the above said pharma companies are a competition amongst themselves, it would help in branding Indian APIs and formulations as the est quality products to the global markets, say industry experts.
A Lupin spokesperson told FE, LAZORR is a collaborative platform that was created to help member companies six of lndias largest pharma companies share best practices, in a bid to improve efficiency; bring down rising operating costs as also help each other compete better and more effectively in the global market place. This initiative becomes more significant in the current scenario given the fact that India has emerged as the best quality manufacturer of generic drugs in the world.
LAZORR is a pioneering effort in the Indian pharma industry and will benefit all players, Orchid spokesperson says. Aurobindo officials say power is a major issue apart from water usage and material costs which the alliance would collectively focus on and reduce operational challenges that are affecting the industry.
Incidentally, the FDA has also started talking about early adoption of new technological advances by the industry for modern quality management techniques, including implementation of quality systems approaches and enhance the consistency and coordination of FDAs drug quality regulatory programs, in part, by integrating enhanced quality systems approaches into the Agencys business processes and regulatory policies concerning review and inspection activities.
The alliance would foster cGMP among Indian pharma players thereby adhering to a set of codes, and guidelines for the manufacture of drugs, medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs).
cGMP would ensure a drug with zero defects. As a manufacture of pharmaceutical dosage forms is technology driven, the cGMPs have always got to be current, says Ajaykumar Sharma, practice head-pharma, healthcare, South Asia and Middle East, Frost & Sullivan
According to Frost & Sullivan statistics, the total approved sites in India (2010) says that there are 149 are approved by US Food and Drug Administration; 84 are approved by Medicines and Healthcare products Regulatory Agency; 153 are approved by European Directorate for the Quality of Medicines; 814 are approved by World Health Organization for Current Good Manufacturing Practices; 49 sites are approved by Certificate of Suitabillty.