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.
Talking to Pharmabiz, in the backdrop of the Madras High Court orders staying his order in this regard, Dr Singh said that the country's reputation was at stake due to the multiple authorities in issuing the CoPP which is an important document as far as international commerce is concerned. He said his order has nothing to do with Drugs & Cosmetics Act as export is not mentioned in the Act.
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.
"We shall prefer that issue of such important documents should be controlled at central level then at state level," the WHO said.
Dr Singh clarified that his action in this regard was aimed to strengthen the regulatory framework in India to instil confidence among the world trading community to give a boost to the offshore commerce. He said being the drug regulator of the country, he is responsible to provide the latest data on CoPP to the visiting international regulators. In the present system, it is very difficult to compile the data of CoPP products in India. "If CoPP is issued by my office only, I will be able to collect the data at a very short notice, say in some hours," DCGI said.
Talking about his plans to ease the system of issuing CoPP, Dr Singh said he is strengthening the manpower of his department to meet the deadlines in issuing the CoPP by his offices spread across the country. There will be one uniform format and all the CoPP products will be displayed on the website with expiry dates. There will be a turnaround time for issuing the CoPP and the companies will be alerted by the CDSCO about the expiry of the license three months in advance, Dr Singh said.