There was a time when only generic players abroad used to turn to India as a sourcing base for their bulk drug requirement. It is a thing of the past today. All the top multinationals operating in the pharmaceutical industries are increasingly setting their sight to India for their key APIs and generics needs.
A clutch of Indian companies like Dishman Pharma, Shasun Chemicals, Suven Pharma, Innovasynth Technologies, Hikal, Matrix Labs, Divis Labs, Orchid Pharmaceuticals, Strides Arcolabs, and Jubilant Organosys are actively engaged in making quality bulk drugs and APIs for MNCs like GSK, Bayer, Merck & Co, Merck KGaA, Pfizer, Aventis, Solvay Labs and Novartis. These companies are also involved in providing contract research and synthesis services to their clients.
"Today, the trend is that major MNCs especially from US have started looking towards Indian manufacturers for key bulk drugs and intermediates. The quality of Indian products, their cost competitiveness, plants complied to FDA standards and above all the well anticipated, yet to be implemented product patent regime are the key factors responsible for this growing trend," said Dr. J.R. Vyas, chairman and managing director, Dishman Pharmaceuticals and Chemicals Ltd.
Dishman serves eight foreign clients out of which about four are pharma MNCs. The company supplies eprosartan mesylate, a key API in the area of cardiovascular products.
Indian companies have been serving major global generic companies like Teva, Alpharma, Sandoz, Merck Generics, Ivax, Apotex, Bexel, Hexal, Stada, and Par Pharma. Some of the key bulk drugs and intermediates sourced by foreign clients from India include gabapentin, pantaprazole, ondansetron, omeprazole, lanzaprazole, loratidine, glibipizide, cipro, citalopram, gatifloxacin, norfloxacin, olanzapine, alprazolam, flucanozole, terbinafine, and others.
In the meanwhile, citing major market for bulk drugs and APIs due to boom in generics, many Indian traditional pharma companies are taking special interest in bulk drugs business. Companies like Cipla, Nicholas Piramal, Ranbaxy, Dr. Reddy's Labs, Glenmark Labs, Themis Medicare, Unichem Labs and Sun Pharmaceuticals have set up dedicated facilities for making bulk drugs for exports.
Moreover, Indian companies have gone a step further and are helping their foreign clients in not only manufacturing the API/formulation, but also filing for overseas marketing approval like DMF/ANDA, and marketing of these products. "The Traditional role of an Indian company was restricted to just manufacturing. However, today Indian companies with its excellent global distribution infrastructure, also helps its foreign client in distributing the products manufactured by it (Indian company) for him. Moreover, the Indian partner helps the client in joint filing of DMFs/ANDAs, and shares the risks associated with it," said Jaideep Iyer, vice president, Life Sciences and Biotechnology at Yes Bank. Companies like Cipla, Ranbaxy, Dr. Reddy's, and Strides follow this model.