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.
The Karnataka drugs controller has issued orders about the discontinuation of the WHO-GMP certification to the Karnataka Drugs and Pharmaceutical Manufacturers Association and the North Karnataka Drugs &Pharmaceuticals Manufactures Welfare Association via order No. DCD/CR-767/SPLCELL1/08-09.
India has over 750 WHO-GMP compliant facilities. In Karnataka, the WHO-GMP units include AstraZeneca, Anglo French and Group Pharmaceuticals to name a few. Strides has 13 world class plants in India (Bangalore), Singapore, Brazil, Mexico, Poland and Italy and all of them conform to WHO's cGMP guidelines.
According to Sunil Attavar, joint secretary, Karnataka Drugs and Pharmaceutical Manufacturers association and managing director, Group Pharmaceuticals Limited, there were certain countries which insisted on WHO-GMP certificates to confirm the product stability analysis among other parameters, but now the COPP is being issued based on WHO format. Now with the official order, pharma units will no longer need to seek WHO-GMP certificates.
In 2004, Pharmabiz had reported that DCGI had directed pharma manufactures not to seek WHO-GMP certificates for domestic marketing of products giving all the importance and compulsory requirement of Schedule M.