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INDIA BUSINESS WORLD - 1st FEBRUARY - TO - 15th FEBRUARY - 2009
PHARMA COS DON’T NEED WHO CERTIFICATE
DOMESTIC drugmakers will no longer need a certificate of good manufacturing practice (GMP) from the World Health Organisation (WHO) to sell their medicines within India.
The Drug Controller General of India (DCGI) has asked state drug controllers to let companies sell their brands in the country without the WHO's quality certificate, provided they comply with the quality norms set out in the Indian law. That is, if they produce the DCGI’s Certificate of Pharmaceutical Products (COPP), they can sell their brands in India. COPP and WHO certification are compulsory if the company wants to export, a government official, who asked not to be named, said. The DCGI would not issue WHO-GMP certificate to any company from now on.
"For marketing medicines within the country, only schedule M certification under the Drugs and Cosmetics Act (DCA) is required. State regulators have been directed that they no longer need to insist for a WHO-GMP certificate from manufacturers while giving them marketing permissions," the official said.
GMP is aimed at diminishing the risks inherent in pharmaceutical production. WHO GMP certificate is given based on certain guidelines laid down by WHO through which the regulator ensures that medicines and other medical products are consistently produced and controlled to the quality standards required for their best use.
The WHO-GMP certificate is a mandatory requirement in most global markets for companies to be able to sell their medicines. It is also required for specific drugs being supplied under the global disease control project to treat diseases like tuberculosis, malaria and AIDS.
However, the government claims that the Indian norms laid in the drug law are at par with the WHO-GMP guidelines and therefore there is no need to endorse the WHO norms.
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