Date: 05-Sep-2019

Karnataka DC department introduces new online service for industry, pharmacy trade to get manufacturing, sale licenses online

Karnataka drugs control department has strengthened its online service to facilitate industry and pharmacy trade to apply and get manufacturing and sales licenses online. The department has recently introduced its online services Seva Sindhu version 2 in a major breakthrough to go completely paperless. The department informed that while its Sakala services was also a first-of-its-kind move in the country, the Seva Sindhu is another pioneering effort. While the soft launch is complete, the formal launch of Seva Sindhu version will be in mid- September this year. While Sakala guarantees services to citizens with a stipulated time limit, the Seva Sindhu version 1 delivers services in a secure and easily accessible manner. The online submission and tracking of applications has enabled time bound approvals and eliminated physical touch points of documents that are submitted for approval. The Sakala services mandates designated officers in the drugs control department to carry out services within a stipulated time line of 7 working days. Seva Sindhu portal falls under the directorate of electronic delivery of citizens services of the department of personnel and administrative reforms which is the e-governance arm of the government. According to the state drugs control department both Sakaland Seva Sindhu bring in transparency, efficiency and speed to provide services to the pharma companies in the state. Version 2 offers a hassle free service delivery through reduced turnaround time, minimized visits to avail services and reduced opportunity cost. It also aids the department in simplifying processes of the department by removing cumbersome, time consuming and non-value added steps, thereby enhancing the service delivery mechanism. At a recent training workshop of pharma companies in Karnataka, the state drugs control department along with the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) organised a daylong seminar to highlight the data requirements for drug product approvals under the recent amendments to the Drugs and Cosmetics (D&C) Rules. In a presentation by P Ramesh, assistant drugs controller, Karnataka drugs control department, provided an insight into the requirements that industry need to adhere under the revised D&C Rules. The era of online submissions covers documentation which need to be scanned and uploaded in an appropriate format. This is because all the submissions are verified and processed by the manufacturing section. Now if the uploaded documents and information are not in order and requires further clarification, the drugs control department will send an online compliance letter to the applicant. Therefore, the companies should now upload the document of the stability studies, along with other relevant details besides flow sheet of fine chemicals and reactions involved in the synthesis of proposed bulk drugs, Ramesh explained.