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With an aim to regulate the quality of active pharmaceutical ingredients (APIs), the government will soon make it mandatory to incorporate QR code on labels of bulk drug substance for tracing its origin and movement from manufacturers to formulators through a system of networking.
API of good quality is core to the manufacturing of effective and safe drugs. The supply chain with respect to its security and integrity in proper storage condition plays a very important role to enhance quality supply of APIs.
At a meeting held on April 2, 2019, the Drugs Technical Advisory Board (DTAB) of the Union health ministry deliberated the proposal for incorporation of QR coding on packing of APIs for tracking and tracing in the supply chain.
The DTAB after detailed deliberation recommended to include necessary provisions under the Drugs and Cosmetics Rules, 1945 for making it compulsory to have QR coding on packs of APIs for tracing its origin and distribution from manufacturers to formulators through a system of networking.
The Board’s recommendation will be sent to Union health and family welfare ministry for consideration.
In various fora, stakeholders suggested to have a system of QR code on packaging of APIs to monitor supply of APIs from manufacturers to formulators.
The proposal to implement QR code on packs of API was also discussed at Indian Pharmaceutical Association Forum meet held at Central Drugs Standard Control Organization headquarters in New Delhi on March 25, 2019.
The meet was attended by the Drugs Controller General of India (DCGI) and representatives from several pharmaceutical associations including Bulk Drug Manufacturing Association (BDMA), Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Alliance (IPA), Federation of Pharma Entrepreneurs (FOPE), Laghu Udayog Bharati (pharma wing), etc.
At the meet, industry representatives raised concern over malicious activities in API and excipients business like refilling, relabeling, converting food grade or other similar grade materials to pharma grade by changing labels. To address the issue, the representatives suggested to implement track and trace system for APIs/excipients used in pharmaceutical industry on high priority.
The DCGI had shown positive attitude towards implementation of barcode on packs of API to monitor its quality supply and asked BDMA to clarify its stand over the issue. The central drug regulator further directed stakeholders to come out with guidelines for API traders and manufacturers.
Welcoming the initiative to make mandatory usage of barcodes on packs of APIs, BR Sikri, vice president of BDMA said, “BDMA has always supported the initiative. It will help the government track and authenticate APIs at every stage of their movement from manufacturing plant to formulation facility. It will ensure that genuine APIs reach drug makers.”
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