GMP Certification

Yes. Most regulated markets (EU, US, and many developing countries) require WHO-GMP or a bilateral equivalent as a condition for pharmaceutical import. Indian exporters must obtain WHO-GMP certification from the Central Drugs Standard Control Organisation (CDSCO) or an accredited certifying body.

Schedule M sets the mandatory GMP requirements for drug manufacturing in India under the Drugs Rules, 1945. WHO-GMP certification is an additional external audit confirming that the facility meets the WHO's GMP standard, which is higher in some areas than Schedule M.

ISO 22716 is the international GMP standard for cosmetics. It is not mandatory in India but is required by many retailers and export buyers. It is enforced in the EU under the EU Cosmetics Regulation.

The GMP certificate covers a defined scope — typically the product categories manufactured at the audited facility. Adding new product categories may require a scope extension audit.

This varies by type. WHO-GMP certificates issued by CDSCO are typically valid for 3 years. ISO-based GMP certificates are valid for 3 years with annual surveillance.

CDSCO issues the government WHO-GMP certificate that is legally recognised under WHO's PICS framework. Accredited certification bodies issue certificates under ISO 22716, IS 15490, or their own GMP scheme — these are accepted by buyers but not always by all regulatory authorities.