WHO - GMP Certification withdrawn

DCGI withdraws WHO-GMP certification, COPP made mandatory

The Drugs Control General of India (DCGI) has taken a decision to discontinue issuance of WHO GMP certificate for both pharma products and plant audits. The decision comes in the wake of objection raised by the World Health Organization on handing over these certificates at random.

The WHO-GMP had been a mandatory requirement for global markets entry and specifically for countries which had no dedicated regulatory authority. It was also required for specific drugs which were being used for supplies under the global disease control initiatives such as TB, HIV/AIDS, malaria control project funded by Word Health Organization and other international agencies. These certificates were issued for products and later to plants where these products were manufactured and audited by WHO.

The Indian pharma regulator has been issuing the Certificate of Pharmaceutical Products (COPP) which is on par with the WHO-GMP certificates. For the marketing of drugs within the country only Schedule M certification is required.

The COPP certificates have a validity period of two years and there will be a joint inspection carried out by both Central Drugs Standard Control Organization (CDSCO) and the State drugs control departments, Dr. BR Jagashetty, Karnataka drugs controller, told Pharmabiz.

The drug inspectors will no longer need to insist on the WHO-GMP certification. The companies which already have WHO -GMP compliance can apply for COPP when the former needs to be renewed.

According to the Jagashetty, the withdrawal of WHO-GMP certification allows Indian certification, COPP, to gain recognition.

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