India provides the world with many drug products and drug substances. To ensure high quality, the Union Health Ministry now requires that all state drug authorities gather data on all Indian pharmaceutical companies. The Indian central government wants to collect information on drug formulations and imported and exported drugs, so there is more transparency in their oversight. Information on drug manufacturing sites, sales, drugs that are being manufactured, etc. will now need to be shared with the government authorities. The Department of Pharmaceuticals will do further research on API production too.
In addition, on September 15, India’s CDSCO announced that going forward, all raw material and packaging material manufacturers will now need to be audited by their drug manufacturers. This requirement is a result of final drug manufacturers purchasing raw materials from drug ingredient suppliers who were not licensed to put up for sale pharmaceutical quality ingredients. Finally, Indian drug manufacturers would now be under stricter supervision to provide more data and be more forthcoming with drug recalls.
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.