Drug Controller General of India (DCGI) Dr Surinder Singh has said that the centralisation of issuing of Certificate of Pharmaceutical Products (CoPP) was introduced in the country by his office recently to uphold the image of the country on the regulatory frameworks, especially in the wake of steady increase in export of pharma products from the country.
Dr Singh said that his decision to centralize the CoPP was based on a letter from the World Health Organisation (WHO) on April 29 this year in which the world health body had taken objection to the use of its name or logo in the title of such certificate. In the letter, the WHO had also found fault with the way the CoPP was issued in India. WHO said that the CoPP is issued by the National Regulatory Authority (NRA) of the producing country based on certain guidelines and formats as laid down by WHO. Referring to some cases, the WHO complained that such guidelines or formats are not followed in India while issuing CoPP by some state authorities.
Dr Singh said that his decision to centralize the CoPP was based on a letter from the World Health Organisation (WHO) on April 29 this year in which the world health body had taken objection to the use of its name or logo in the title of such certificate. In the letter, the WHO had also found fault with the way the CoPP was issued in India. WHO said that the CoPP is issued by the National Regulatory Authority (NRA) of the producing country based on certain guidelines and formats as laid down by WHO. Referring to some cases, the WHO complained that such guidelines or formats are not followed in India while issuing CoPP by some state authorities.
Source: Pharmabiz
