Maharashtra FDA starts online WHO-GMP certification system for manufacturers

As part of its plan to introduce e-governance, the Maharashtra Food and Drugs Administration (FDA) has launched online WHO-GMP certification system for all the manufacturers across the state. The aim of this online system is to issue WHO-GMP certificates faster to all the manufacturers including loan licensees.

The main features of online WHO-GMP certification system for manufacturers will help in saving their time as they will be able to apply online for all the products they manufacture. They can receive certificates faster and has user friendly features.

Maharashtra FDA commisioner Mahesh Zagade said, "Since August 16, 2012 we have stopped taking any applications manually and we have asked all the applicants to submit their applications only through online system." Zagade further added that it is required for all the manufacturers to add the details of the products approved, under the respective licence granted (Form 25 or Form 28, etc). This is necessary while making an application for WHO GMP Certificate or COPP.

Zagade informed that if the applicant wants to apply for new WHO GMP Certificate he should apply within 60 days prior to expiry of already granted WHO GMP Certificate or he can make an application for WHO GMP Certificate for the first time. But he must provide license, approved product details correctly and completely. All the WHO-GMP certificate holders (including loan licensees) should register online and upload all data regarding their products.

FDA has assigned O Sadhwani, Joint Commissioner (Law), FDA, Mumbai to issue certificates: WHO-GMP certificates and Certificate of Pharmaceutical Product(s) to the manufacturers on their request. The validity of COPPs certificates shall be two years from the date of grant of the certificate.

According to the current data, Maharashtra FDA has registered 69 manufacturers (own licensee) and 35 loan licensee holders. Sources from the FDA said, "The manufacturers across Maharashtra are applying online and number is increasing tremendously."

For issuing WHO-GMP certificates, the FDA is charging a fixed sum of money. For fresh WHO-GMP Certificate – Inspection fee (Own) Rs.5000 will be charged for each section, for fresh WHO-GMP Certificate - Inspection fee (Loan) Rs.2000 for each section, for unit WHO-GMP Certificate Rs.1000 for every 10 products, for new COPP with Annexure (with Validation & Stability) Rs.1500, for new COPP without annexure (with Validation & Stability)Rs.1000, for COPP with any type of Annexure Rs.1000, and for COPP without annexure Rs.500.