Domestic drug makers will not need GMP certificate

NEW DELHI: Domestic drug makers 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 is at par with the WHO-GMP guidelines and therefore there is no need to endorse the WHO norms. "We are also in talks with several international agencies in order to ensure that companies holding the COPP do not face problems in exports. It is important for the government as well to ensure that our own regulations find enough recognition in the international markets," the official said.

The drug regulator gives a COPP after conducting an inspection of the manufacturing plant. The certificate is valid for a period of two years. The Indian pharmaceutical market is estimated to be at around Rs 65,000 crore. Out of this, export accounts for around Rs 30,000 crore.