In a major effort to give a fillip to the Indian pharma exports, the Union government has now increased the validity of CoPP (Certificate of Pharmaceutical Product) from 2 to 3 years. The CoPP is issued after a manufacturing plant receives a WHO GMP approval for exporting products. The move according to the industry will provide a fresh impetus to up its overall growth.
 
The mandate for CoPP was to make doubly sure that all companies are able to consistently supply high quality drugs to the international market. Terming it as an excellent consideration by Central Drugs Standard Control Organisation (CDSCO) under the leadership of Dr. S Eswara Reddy in support of ease of doing business, Kaushik Desai, pharma consultant, said that the move will also help in reducing the workload on CDSCO and state regulators allowing them to focus on other demanding and equally important areas like drug safety monitoring to ensure total patient safety which is the agenda of the Indian healthcare sector.
 
In a phase where the regulatory departments are facing acute shortage of staff, the industry was hampered with delays in getting WHO GMP approval and issue of CoPP. Hence the extension of validity enables smooth transit for longer time frame, added Desai.
 
Karnataka pharma too chips in over 7 per cent of exports to the national pharma exchequer. Lauding the announcement as positive development, Sunil Attavar, president, Karnataka Pharmaceutical Manufacturers Association (KDPMA), said this is a great support to exporters.

Echoing the same view, Harish K Jain, secretary, KDPMA and director, Embiotic Labs who said, “We appreciate CDSCO led by DCGI Dr Reddy for fulfilling a long standing request of the industry to increase validity of CoPP from 2 years to 3 years. This move will go a long way in promoting 'Ease of doing business' as well as facilitate growth of exports from India. The very fact that WHO was consulted prior to this decision, reflects confidence of international community in India's drug regulatory authorities as well as quality systems adopted by Indian pharma industry.”

Sunil Mundra, managing director and member KDPMA said that extension of time line to 3 years for CoPP brings in a wave of efficiency for exporters with reduction in paper work encountered in the every two-year renewal of this certification. However, there is a need for more clarity on whether the WHO GMP certification validity is also increased to three years as CoPP is issued post this audit.