With the aim of ensuring assured quality and limiting the flow of fake drugs into the market, the Drugs Technical Advisory Board (DTAB) has recommended “making it mandatory to have QR coding on labels of Active Pharmaceutical Ingredient (API) — the most important constituent of any drug formulation — for tracing the origin and movement of APIs from manufacturers to formulators through a system of networking.’’
India’s top drug advisory body DTAB in a recent meeting noted that in the supply chain for APIs, the “security and integrity in proper storage condition” played a very important role to enhance quality supply.
It added that in various fora, stake holders had suggested incorporating a system of QR coding on the packing of APIs for tracing the origin and movement of the drug ingredients.
“DTAB after detailed deliberation has now recommended to include necessary provisions under the Drugs and Cosmetics Rules, 1945, for this,’’ confirmed a senior Health ministry official, who spoke on condition of anonymity.
According to Health ministry officials, the QR coding for API will provide key benefits including better price control and more effective quality control.
APIs are the active raw materials used in medicines to give them their therapeutic effect. Currently, India relies on other nations for 60%-80% of its API supplies and the Health ministry has been working to reduce the dependence on China.
“India continues to rely on imports of key starting materials, intermediates and APIs from China, with the share of dependence increasing over time,” the Federation of Indian Chambers of Commerce and Industry (FICCI) said in a study last year. “This potentially exposes us to raw material supply disruptions and pricing volatility,’’ FICCI noted.
Recently, the Supreme Court had directed the central government to devise a mechanism that would help ensure consumers could benefit from price control of drugs. The ministry says it has been working on introducing QR coding for medicine packaging, which can then be linked to software supervised by the National Pharmaceutical Pricing Authority (NPPA).