The Indian drug business is a huge business estimated at about $67 billion per year. Many Western drug companies rely on Indian APIs, excipients, and final drug products. Last December, the Health Ministry required all Indian drug companies to meet Indian GMP requirements. In India’s Drug and Cosmetics Rules 1945, GMP requirements are outlined in Schedule M. Indian drug makers with over 2.5 billion rupees (about $30 million) were given 6 months to meet GMP standards while companies with sales below this threshold were given 12 months to comply.
Despite this new requirement, the adoption of GMP standards in India has been very slow. Given this, the Indian DCGI is now considering issuing GMP certificates (and renewal licenses) only for companies that actually demonstrate they follow GMP requirements. The central drug regulator and state drug regulators will now be cracking down on GMP certificates. During the last 8 months, about 420 drug facilities have been inspected and samples tested. As a result, over 320 disciplinary actions have been issued to suspend licenses, cancel licenses, etc. Hopefully, increased GMP supervision will bring India’s drug factories more in line with global requirements.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.