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The government has expanded the ambit of the QR code-based track-and-trace mechanism to cover all antimicrobials, vaccines, anti-cancer medicines, and narcotic and psychotropic drugs, a move aimed at strengthening safeguards against counterfeit and substandard medicines. The Union Health Ministry has notified amendments to the Drugs Rules, 1945, bringing these categories of medicines under Schedule H2, which mandates the use of bar codes or Quick Response (QR) codes for product identification and verification. Under the amended provisions, manufacturers will be required to print or affix a barcode or QR code on the primary packaging label of the drug formulation, or on the secondary packaging where space constraints exist, the ministry said. The code will enable authentication and verification of medicines through software applications across the supply chain. According to the ministry, the QR code will contain key product information such as a unique product identification code, .
Alembic Pharmaceuticals Ltd on Friday said it has received approval from the US health regulator for its generic version of Carbidopa, Levodopa and Entacapone tablets used in treatment of Parkinson's disease. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Carbidopa, Levodopa and Entacapone tablets of strengths 12.5 mg/50 mg/200 mg; 18.75 mg/75 mg/200 mg; 25 mg/100 mg/200 mg; 31.25 mg/125 mg/200 mg; 37.5 mg/150 mg/200 mg; and 50 mg/200 mg/200 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo tablets of similar strengths of Orion Corporation, it added. Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease, the company said.
Zydus Lifesciences on Friday said the US health regulator has granted Orphan Drug Designation to Desidustat, a novel oral product medication for the treatment of Sickle Cell Disease. The US Food and Drugs Administration's (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease. We believe that Desidustat can address this unmet need," Zydus Lifesciences MD Sharvil Patel said in a statement. Therapeutic options for management of Sickle Cell Disease are currently limited. A Phase II, double blind, randomised, placebo controlled, parallel, multi-centre, proof-of-concept study to evaluate the efficacy and safety of Desidustat oral tablet for treatment of SCD has been completed, and data will be published in a medical journal, the drug firm said. Orphan drug designation by
The Ayush Ministry on Wednesday signed an MoU between its export promotion council and Zepto Limited to facilitate online access to Ayush medicines and wellness products across the country. The memorandum of understanding (MoU) aims to strengthen digital discovery while ensuring quality compliance and consumer trust in traditional healthcare products. Zepto is an Indian quick-commerce platform offering delivery of groceries and essentials in a short amount of time. Addressing the occasion through a video message, Union Ayush Minister Prataprao Jadhav said innovation-driven Indian startups are playing a critical role in improving last-mile access to trusted wellness products. He emphasised that partnerships with credible digital platforms such as Zepto demonstrate how technology can be responsibly leveraged at scale to connect India's rich AYUSH heritage with modern, transparent and convenient distribution channels nationwide. The minister further noted that the collaboration align