APIs of drugs may soon get track and trace for authentication

According to recent news reports, the Health Ministry may soon introduce codes to track and trace key ingredients that are used to make medicines in India. The move will be the first step by the government to determine the origin and movement of drugs manufactured here and ensure their authenticity.

A senior official from the Health Ministry said, “A draft amendment mandating quick response (QR) codes at each level of the packaging of active pharmaceutical ingredients (APIs) used to give medicines their therapeutic effect is ready and will be notified soon.”

“For a medicine to be effective, the API has to be effective. As a first step, every API manufactured or imported in India will bear a QR code on its label at each level of packaging.” the official said.

India currently imports APIs of the value of Rs 12,255 crore from China to make essential medicines, as per government data. Drugs Technical Advisory Board (DTAB) India’s main drug advisory body during a meeting this year discussed necessary provisions for India’s drugs and cosmetics rules mandating QR coding on API labels.

Earlier this year, issues with qualities of APIs were raised during a Drugs Consultative Committee (DCC) meeting when Punjab sought provisions to make API manufacturers accountable and responsible for the quality of products.

“APIs by various vendors have been found without specifications with respect to their quality and in certain cases, desired effects are not obtained,” revealed the DCC minutes of the meeting. A track and trace system for pharma products has been under discussion for several years but implementation has bee stalled after the intervention by sections of the industry in the past.

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