OUTLINING the current threats and opportunities of the pharmaceutical industry in a globally competitive environment, Dr C.L. Kaul
, Director, National Institute of Pharmaceutical Education & Research
, Chandigarh, has cautioned that with the advent of the patent regime by 2005, the pharma sector would no longer have the advantage of reverse engineering, which has been its strength and core business area. He
said the fast changing regulatory and intellectual property scenario would demand realignment of business activities of pharmaceutical companies.He
felt "our companies' inherent manufacturing strengths can be leveraged to acquire a substantial share of $10-15 billion of global manufacturing outsourcing market."Good manufacturing practices would increasingly come to reflect the policies of the organisations. Addressing a workshop on `Good manufacturing practices (GMP) of modern and herbal drugs: A tool for competitive advantage', organised by the Indian Chemical Manufacturers' Association (ICMA) here, Dr Kaul said in the changed economic scenario, "we need to strengthen our drive towards total quality management." He
said this would involve extension and awareness of quality into various operations of the organisation to foster an enduring quality culture.
Describing the above as an arduous task involving various elements, he
said a key factor was the involvement of the top management, who should believe that quality would lead to improved profits in the long run.Pointing out that there had been a paradigm shift in the last two decades in all aspects of production and marketing of pharmaceutical products, he
said outsourcing would emerge as a major challenge for the pharma sector in the new globally competitive environment.He
predicted that contract manufacturing opportunities for drug companies would emerge in a big way, as the number of global pharma majors may shrink to just 10 by 2010. Dr Kaul
said the key areas of GMP of companies which now needed attention were product design, stability testing (which was difficult and expensive, but could not be overlooked), manufacturing process, packaging controls, vendor relation and audit quality, personnel and training and complaints. He
said the same standards of manufacturing as applicable to modern medicines should also apply to herbal products, irrespective of the fact whether they were new entities, well established products or traditionally used products.