Facelift of CDSCO

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Mohammad Shahbaz Alam

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

DCG (I) should be independent like USFDA and you can name it Indian Drug Authority (IDA). It should not be controlled by ministry of health. Currently DCG (I) is like a sandwich in between Ministry of Health and Industry. They take care more of MOH and less of industry. Actually, DCG (I) is an ethical facilitator for pharmaceutical and healthcare industry and in real sense DCG (I) is like a mother of industry and his prime responsibility is to nurture industry and bring Indian healthcare on fast forward track to meet their commitment without bribe and approach.DCG (I) should act like revenue generator for MOH and profit generator for industry people. No one can disturb or ignore industry for long period of time because industry has to grow by hook or crook. All healthcare related industries gone down badly because of the poor leadership and unbiased controlling. Huge firing is there in clinical research organization because market is full of uncertainty and there is no work to do. If there is a gut in regulators then they should stop production of unethical production of fixed dose combination of big Pharma giants who are manufacturing since more than a decade without the approval CDSCO. Rather than doing these regulators targeting small growing companies who are financially weak and can shut down. Yes every day small companies are shutting down every day and there is no botheration to the regulators. CDSCO should try to groom small companies by guiding them and assisting them because it is need of the hour. Till now sub regulators have not been fired or transferred by the DCG (I) even after multiple complain by the stake holders. There is no fear of losing job or punishment with the regulators or sub-regulators. For good wishes from the industry people, they become committed for action, otherwise no botheration of whether approval is urgent or very urgent. There should be 360 degree appraisal system in practice for promotion and demotion so that they start caring for all stake holders. Regulators should stop monopolistic approach as there was same attitude earlier of government banks and telecom departments.

Biography :

He has completed his Ph.D at the age of 32 years from IGNOU and postdoctoral studies from Bhartya Vidya Bhawan, New Delhi, India. He is the managing director & Ceo of Meher Pharma International, a Premier Global Pharma Regulatory Service Organization. His two books have been published by Atalantic publisher New Delhi, India and these books are available for global students in reputed journals. He is serving as an editorial board member of repute jurnal of drug today group. Name of his book is human resource management and contemporary human resource management.