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Government to increase validity of WHO’s GMP certificate to boost pharma trade

The WHO GMP certificate is mandatory in most global markets for pharmaceutical companies to be able to sell medicines as the manufacturer of an exporting country must be licensed by the regulatory authority of that country and comply with the WHO GMP guidelines. The government of India has decided to increase its validity from 2 years to 3 years.

According to S. Eswara Reddy, Drug Controller General of India (DCGI), "The move is aimed at reducing delay in the registration process and promoting exports" as according to the Pharmaceuticals Export Promotion Council of India, "The international pharmaceutical industry is expected to grow at a compound annual growth rate (CAGR) of 22.4% to touch $55 billion by 2020".

The certificate of a pharmaceutical product (COPP) is issued under WHO GMP guidelines by the health agency to take care of the risks inherent in pharmaceutical production. The certificate helps the regulator to ensure that drugs exported from the country are quality controlled. Currently in India, the time period of validity of COPP is not specified under GMP guidelines and hence the COPP is issued with the validity of two years which can be extended twice for six months each. According to S Eswara Reddy, Drug Controller General of India (DCGI)," Granting COPP for a period of three years with the condition to monitor the WHO GMP by inspection on a periodic interval would reduce the delay in grant of COPP by reducing the burden on state licensing authorities and would also facilitate exports from the country".

The government is also taking other steps to boost exports such as increasing R&D investments so that the pipeline (for new medicines) does not get dry and seeking greater market access for India's products in countries like China.