FDANews
The QMN Weekly Bulletin

India Responds to Drug Quality Concerns with Electronic Monitoring Plan

March 31, 2017

In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply.

Under the proposal by the Ministry of Health and Family Welfare, drugmakers would be required to register with the portal and provide data on drug sales, including details of wholesalers, batch numbers, quantities supplied, and batch expiration dates.

Once the platform is in place, only registered drugs would be allowed to sell in the country. Details for each step of the product supply chain will be required — from manufacturer sales to distributors to distributor sales to pharmacies and any products pharmacies sell or return to drugmakers.

India requires bar codes for exported pharmaceuticals, but not for domestic sales. The ministry hopes the new portal for supply chain quality assurance will avoid the need for bar coding of domestic products.

In late February, the ministry proposed risk-based pre-inspections to monitor the quality of drugs.

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