With the global regulatory environment evolving, there is an increasing level of awareness being generated in terms of compliance with reference to clinical trials and Good Manufacturing Practices in India. Besides this, there is a greater focus by the government on making healthcare accessible through schemes like Jan Aushadhi, said Aradhana Johri, secretary, Department of Pharmaceuticals. She was speaking during the 52nd Annual Celebrations of Indian Drug Manufacturers Association (IDMA) in Mumbai on January 4.
She suggested that capacity building needs to be done through upgrading Research and Development and enforcing compliance at the local level through a robust and reliable regulatory mechanism.
In order to give boost to the Indian pharma industry, Glenn Saldanha, chairman, Glenmark Pharmaceuticals Ltd said, "There is a need to develop complex generics by Small and Medium Enterprises (SMEs) through partnering with front end players and large companies. Contract Research and Manufacturing Services (CRAMS) remains a big opportunity in the global market scenario. The API market opportunity will also remain large as more Indian companies file generic applications in the US and European Union (EU).”
Other trends which are followed in the pharma sector globally are that regulatory requirement is being upgraded to match developed markets is becoming the norm across emerging markets. Investment per molecule has gone up. However pricing power is being diminished. Besides this, India, Germany and Japan have implemented some level of pricing control.
Speaking on the occasion Manish Doshi, out-going president, IDMA said, "Pharma industry has been facing challenges on all fronts - be it the contentious Fixed Dose Combinations (FDCs), the formation of Central Drug Authority (CDA), the banning of PET bottles and the retrospective price implementation issues but IDMA has been taking up these issues with all stake holders concerned to arrive at an amicable solution."
Sharing his views on the occasion, incoming IDMA president S V Veerramani said, "In order to showcase India's potential in Pharma industry globally, IDMA is committed to resolve the challenges confronting Indian pharma industry to become the preferred supplier of safe, efficacious and quality generics globally."