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DCGI in talks with stakeholders to come out with a unified online portal to ensure drug quality and patient safety
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Shardul Nautiyal, Mumbai
July 21 , 2023
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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.
The Government of India is currently engaged in upgrading the quality of regulatory practices in the country to bring in a high degree of uniformity in GMP practices across the states. According to experts, “A good regulatory system should help build a science based regulatory framework to support and promote research and development in the country. One of the mean interventions of the Central government to achieve its public health objectives is to ensure the drugs available in the country are safe, efficacious and conform to prescribed quality standards.”
The Maharashtra Food and Drug Administration (FDA) had in the month of May this year also sent a proposal to the state government to launch a quality assurance portal to ensure that safe and efficacious medicines are provided to the consumers and patients.
The quality assurance portal, according to Maharashtra FDA Commissioner Abhimanyu Kale, will help the manufacturers to keep a track on the production of medicine batches in a particular month and also the distribution data.
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).
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