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Mumbai co forges WHO GMP certificate to register products in Korea
Our Bureau, Mumbai | Friday, September 3, 2004, 08:00 Hrs  [IST]

The Maharashtra state Food and Drug Administration has confiscated forged documents supposedly showing WHO GMP compliance for the manufacturing facility of a bulk drug manufacturing company based in Mumbai.

The company, which is alleged to be Techno Drugs & Intermediates (P) Limited, had submitted these fake WHO GMP certificates to register its products in Korea. The company has already bagged export orders from some Korean companies, it is learnt.

The company forged the GMP compliance certificate for the company's bulk drug facility, by duplicating the signature of Commissioner, Gujarat Food and Drug Control Administration (FDCA). The copies of the certificate are found notarized by the Notary in Mumbai.

The forgery came to light when the Korean drug authority crosschecked the certification with the Gujarat FDCA. According to S P Adeshara, commissioner, Gujarat FDCA, since his office has not issued WHO GMP certificate to any bulk drug units in this name, he asked the Maharashtra FDA to investigate the case following the enquiry from Korea.

The WHO GMP certificate, which is normally issued by the state drug administration after a joint inspection of the facility by the central and state drug control officials, implies that the drug manufacturing facility is in compliance with the quality standards specified by the WHO.

Techno Pharma, which has its registered office in Mumbai, has valid manufacturing license from Gujarat since it has been manufacturing bulk drugs and intermediates in the Panoli facility since long.

S W Deshpande, Joint Commissioner (Vigilance), FDA, Maharashtra, when asked about the investigation, said "since the documents have been confiscated from the office of company, we will hand over the case file to Gujarat FDCA and further action will be initiated by them." However, as the charge against the company falls under 'cheating' the responsible people will be immediately arrested, he added.

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