Changes In Indian Regulatory Affairs

Go CDA ! Get Global !!
Big Wait!! - But better late than never. The crux of centralizing drug authority to meet the global standards seems to get resolved in the months to come. A major issue that was resurfaced time and again since independence in Pharmaceutical Industry since its evolution is ready to gain the benefits in the global market.
CDA or Central Drug Authority, in real terms will be a major breakthrough for pharmaceutical industry in India, as it will open Global opportunities for India. Under CDA , a chairman will be appointed with three to five members with comprehensive powers at national level to control and regulate the pharmaceutical affairs as per the drugs and Cosmetics(amendment) Bill 2007. The bill to be brought up in upcoming winter session of parliament will empower and strengthen the Drug regulatory Authority by centralizing the licensing authority in the hands of chairman in parallel with global standards.
With the proposed Structure of Drug Regulatory Authority, a plethora of Global opportunities will prop up. These opportunities will cover, contractual manufacture (agreement for global manufacture of pharmaceutical products in compliance to the international standards), contractual research and development including formulation development, clinical research, collaborative clinical trials and customized synthesis, services like analytical method development and validation, clinical data management, ancillary equipment and material production, and manufacture of packaging material. India is a hub for contractual manufacturing process of pharmaceutical products due to its cheapest manufacturing cost across the globe. Thus, the licensing being centralized, Vaccine manufacturing units in India will gain the most. Only 15 countries around the globe producing vaccines hold Licensing of Vaccines on Global Standards. India will get the cutting edge over others once CDA get formulated as India holds 14 units who manufactures vaccines. While figure for other countries producing vaccines merely reaches to a high of maximum 5 units.
The CDA will now have a chairman with not more than five members but at least three members , to be appointed by Central govt. with the defined criteria for the qualification and procedure of appointment. The CDA office will be maintained at Delhi and all the existing power of CDSCO to be shifted to CDA itself. DCGI (Drug Controller General India) will then work under Chairman with additional DC(I) appointed separately both in AYUSH and Drugs. Under this will come ten departments to be controlled by DCGI and they will include Regulatory affairs, Imports, New drugs, Biotechnological Products, Pharmacovigilance, Medical Devices and Diagnostics, Organizational Services, Training, Quality Control affairs and legal and Consumer affairs.

Source:http://fermish.com