Saturday, February 14, 2009

WHO GMP Certification is no more a reqirement for Domestic Manufacturers !

The Economic Times reports that domestic drug makers may not require GMP certificate from WHO. As popularly known within Pharma fraternity, the COPP (Certificate of Pharmaceutical Products) is issued by DCGI on behalf of WHO after a GMP inspection of a firm which intends to export its products. This could be a way forward by DCGI and CDSCO which intents to bring Indian GMPs or Schedule M at par with other international GMP and Quality regulations.
"For marketing medicines within the country, only schedule M certification under the Drugs and Cosmetics Act (DCA) is required. State regulators have been directed that they no longer need to insist for a WHO-GMP certificate from manufacturers while giving them marketing permissions," the official said. GMP is aimed at diminishing the risks inherent in pharmaceutical production. WHO GMP certificate is given based on certain guidelines laid down by WHO through which the regulator ensures that medicines and other medical
products are consistently produced and controlled to the quality standards required for their best use.
For complete News, click here

5 comments:

  1. Thanks, I’ve seen your blog before during my, all of the ex-pats are linked together, which is really cool. Thanks for the mention and I put your link up here too. FDA rules and regulations. gmp training

    ReplyDelete
  2. Nice post, I bookmark your blog because I found very good information on your blog, Thanks for sharing more informationQuality Services & Training Pvt.Ltd.

    ReplyDelete
  3. nice blog !! thanks for sharing the information about who-gmp certification india . this blog is really nice and interested to read.

    ReplyDelete
  4. nice blog, i was looking for blog related of who-gmp certification india . then i found this blog this is really nice and interested to read.

    ReplyDelete