Gujarat FDCA’s online WHO-GMP certificate verification to boost exports: Dr H G Koshia

With the effective implementation of its flagship e-governance programme, Gujarat Food and Drug Control Administration (FDCA)’s online WHO-GMP certificate verification is all poised to boost pharma exports, informs Gujarat FDCA commissioner Dr H G Koshia.

Good Manufacturing Practice (GMP) is a critical concept in the pharmaceutical industry. According to the World Health Organization (WHO), WHO-GMP certification ensures that products are consistently produced and controlled, according to quality standards by the manufacturers.

He further added that now with a QR Code, regulatory agencies of any country to which India exports can now verify the WHO- GMP certificate in a timely, instant, seamless and transparent manner.

This comes close on the heels of the recent notification for implementation of the new version of Schedule-M aimed to ensure compliance to standards of drugs, promotion of exports, and also to build trust on the quality of drugs manufactured and sold.

Under the revised norms, the words ‘Good Manufacturing Practices’ (GMP) have been replaced with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’.

On August 2, 2023, the Union health ministry had given 12 months’ time for small manufacturers and 6 months’ time to large units to get their WHO-GMP certification. Larger companies with a turnover of over Rs. 250 crore have been asked to implement the changes within 6-months, while medium and small-scale enterprises with turnover of less than Rs. 250 crore have been asked to do so within one year.

Gujarat FDCA has also made Non-Conviction Certificates (NCC) and Performance Certificates (PC) for pharma companies online to make the procurement process of medicines seamless and less time consuming.

Issuance of certificates online is also a part of strengthening of the drug regulatory system in Gujarat.

Gujarat FDCA has rolled out the online mechanism for granting NCC and PC to pharma companies towards Ease of Doing Business (EoDB). The rolling out of NCC and PC online will also complement the Gujarat FDCA’s flagship m-governance programme.

Source : 1