The Indian Pharmaceutical Association (IPA), Karnataka branch has highlighted regulatory roadblocks faced by pharmaceutical manufacturers in terms of compliance.  The recent global regulatory charges against a few Indian companies have further pressed the need to relook at the manufacturing processes and devise mechanisms to put in place systems.

In order to place impending issues in perspective, IPA-Karnataka branch organised a seminar on ‘Current Regulatory challenges in pharmaceutical manufacturing’ which is the first in the series after its parent body Indian Pharmaceutical Association commemorates its Platinum Jubilee in December 2013.
 
The half day event with 175 participants was held in Bengaluru at the Atria Hotel on May 31,2014 which set the tone to highlight the issues and paved a roadmap for the future. The event was inaugurated by Karnataka Health and Family Welfare principal secretary,  Sivasailam N who recommended scheduled inspections of pharma production facilities by the state drug control department inspectorate team for which total support would be extended.  

In his opening remarks, Dr. BR Jagashetty, president, IPA Karnataka branch and the former drugs controller, government of Karnataka pointed out that the state pharma industry was known for its high standards of quality as was known for its total compliant Schedule M certified companies after Gujarat and Maharashtra, besides being second in electronic issuances of licenses after   Gujarat. The state was the first to  announce  Karnataka  pharmaceutical  a policy focusing on industry development among others.  

Further, the meets ensured industry, trade and academia an opportunity to review and interact with experts. It provided a comprehensive overview and insights into the regulatory challenges faced by Indian companies including those from Karnataka in the global pharmaceutical market.

The panel of experts were represented by Dr. Vadlamudi Rao, president, Indian Pharmaceutical Association who highlighted on the need to develop capabilities to meet the current regulatory challenges faced by the Indian pharmaceutical companies.

Karnataka drugs controller Raghurama Bhandary who is also the vice president , IPA, said that keeping pace with the changing global transformation Indian pharma particularly the small and medium manufacturers need to redefine quality standards on par with the international inspectorate needs.

Sharing experiences with various case studies and insights into regulatory challenges with the delegates, Sridhar S Rao, Quality Head of Injectables, Agila a Mylan company spoke on Quality Risk Management. This was followed by Dr. HV Raghunandan, associate professor, JSS College of Pharmacy, Mysore who made a presentation on Design for Manufacture of Pharmaceutical and AG Raghu, Technical Director, Gland Chemicals addressed on the topic ‘Operational excellence as the ultimate strategy for regulatory compliance’.