The Central Ministry of Health has proposed an amendment to the Drugs Rules 1945 to make it mandatory to authorize qualified personnel for issuing batches of medicine.

The Central Ministry of Health has recently proposed amendments to the Drugs Rules, 1945, whose main objective is to officially recognize the qualifications of employees who distribute drug batches. This step has been taken to reduce public health risks arising from increasing counterfeit drugs and irregular distribution networks. Under the proposed amendment, all drug distribution centres, wholesalers and pharmaceutical companies will be required to have their employees obtain training and certificates approved by the regulatory authority. In this process, the Central Drugs Standard Control Organization (CDSCO) will be empowered to act as an authorized inspector, thereby strengthening quality control at every stage of distribution.

The Drugs Rules, 1945 had established the basic framework for regulating the drug industry in India, but in recent decades the expansion of digital trade, online pharmacies and international supply chains has added new complexity to regulatory challenges. In recent years, reports of increasing incidents of counterfeit drugs and unsafe distribution practices have exposed patients to serious health risks. In this context, the ministry's proposal will not only enforce regulatory compliance strictly, but also encourage pharmaceutical companies to invest in their human resources and promote continuous training of employees, thereby improving the overall reliability of the health system.

Reactions to the amendment proposal from various industry organisations and consumer groups are mixed. While many experts consider it a necessary step towards strengthening drug safety, some industry representatives...