India must look at creating a world-class infrastructure to meet global standards in regulatory affairs, stated Drugs Controller General of India M Venkateswarlu.
In a presentation on the final day of the 58th Indian Congress, the DCGI said modern and state of the art production facilities supported by advanced research centres and an integrated marketing network were the primary requirements for meeting global regulatory approvals.
While the pharma industry is making efforts to achieve global standards, the regulator also should gear up to meet the challenges in the global scenario. The regulator needs multidimensional vision on how the industry will grow and address the consumers demands and update his information systems in the meeting areas of stem cell, cord blood banking and genomics.
A crucial requirement for a regulatory body is transparency. There is a need to maintain mutual trust between the industry and the regulatory body. Another requirement is the ability to take ideas from the industry and academia.
When India is being looked at by global pharma majors for outsourcing business in research and manufacture, the managerial skills of personnel need to be addressed carefully. The large technical work force in the country lacks the managerial skills. There is a need for knowledge enhancement across all segments: manufacture, marketing, legal, etc to keep pace with the global standards.
Some of the initiatives to be made for India to meet global regulatory requirements are the creation of an environment for an effective interaction with the regulatory authority and regular interaction between the industry and academia. There should be mutual bilateral agreements with countries. Participation in global networking and efforts support innovations would ensure fast track and fruitful approvals, he said.
Further to achieve global standards, upgrading pharmacy curriculum, creation of training programmes and a focus on consumer education are also necessary concluded the DCGI.