DCGI in Talks with Stakeholders to Develop a Standardised Web Platform to Assure Drug Quality and Patient Safety

The Drugs Controller General of India (DCGI) is in talks with the state drug controllers (SDCs) and all other stakeholders including drug manufacturers, agencies like the Indian Pharmacopoeia Commission (IPC), Bureau of Indian Standards (BIS), Indian Council of Medical Research (ICMR) and National Institute of Biologicals (NIB) among others to come out with a unified online portal for effective regulatory oversight to ensure quality of drugs and patient safety. The unified online portal will ensure that safe and efficacious medicines are provided to the consumers and patients in a transparent manner through a mechanism of traceability from the producer to the consumer.

The portal will hold accountable all the concerned stakeholders including manufacturers, retailers and wholesalers towards quality and effective traceability of the medicines. The idea of coming out with a unified online portal was also discussed recently along with the concerned stakeholders with the Union minister of health and chemicals and fertilizers Dr Mansukh Mandaviya. “The drug regulatory system is responsible for protecting the public health by assuring the safety, efficacy and quality of human and veterinary drugs, biological products, medical devices, diagnostics and cosmetics.

The drug regulatory system is also responsible for advancing public health by keeping its systems contemporary and by helping to speed innovations that make pharmacotherapy more effective. The regulatory system also helps in getting accurate and adequate information concerning the appropriate use of medicines and related products,” according to the DCGI Dr Rajeev Singh Raghuvanshi. This regulatory step comes at a time when the pharma industry is gearing up towards the implementation of the QR code August 1, 2023. The implementation is a part of the Drugs (Eighth Amendment) Rules, 2022 which mandates barcodes on the label of top 300 brands of formulations. This QR code will help identify misbranded or counterfeit medicines as well as recall the products if its quality gets compromised during manufacturing. Counterfeiting in pharma constitutes almost 25% to 30% of the products (State of Counterfeiting in India 2022 report).