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CMOs take note: DCGI sole issuer of GMP certs from October

07-Sep-2009

Related topics: Globalisation, Contract Manufacturing, Bulk ingredients, Drug delivery, formulation, Fill & finish, packaging, Regulatory affairs

Soon CMOs seeking GMP accreditation in India will need to contact the Drug Controller General of India (DCGI), which will be the only body issuing certificates from next month onwards.

At present good manufacturing practice (GMP) certificates are issued by authorities on a state by state basis. However, following recent World Health Organisation (WHO) comments about the lack of uniformity, the country has decided to centralise the accreditation process.

The DCGI said that under the new scheme the Central Drugs Standard Control Organisation (CDSCO) will be responsible for issuing all GMP certificates, following appropriate facility inspections.

The body will also be the sole issuer of export approvals for drugs made in the country, which is also likely to affect the country’s contract manufacturing sector.

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