HYDERABAD, FEBRUARY 04, 2025: Ch Karthik Siva Chaitanya, Drugs Inspector of the Drugs Control Administration, Telangana, has successfully undergone advanced training in Good Manufacturing Practices of Biopharmaceuticals in the Netherlands. The program was offered by the Ministry of Health, Welfare, and Sport (VWS), Government of the Netherlands, for Indian Regulators at the Biotech Training Facility, located in the prestigious Leiden Bioscience Park, the Netherlands.
The Ministry of Health, Welfare, and Sport (VWS), the Netherlands, and the Central Drugs Standard Control Organization (CDSCO), Government of India, have a Memorandum of Intent (MoI) on cooperation in the field of medical products regulation. Under the aegis of this MoI, the Ministry of Health, Welfare, and Sport (VWS), the Netherlands, in collaboration with the Biotech Training Facility (BTF), Leiden, the Netherlands, has offered training to the Drugs Regulatory Authorities of India. A total of eleven officers from India have been trained in the Netherlands from 27th January to 31st January, 2025.
Mr Ch. Karthik Siva Chaitanya, Drugs Inspector, Drugs Control Administration, Telangana, attended the advanced training program at the reputed Biotech Training Facility, Leiden, the Netherlands, along with ten other officers from the Central Government and the states of Madhya Pradesh and Gujarat. Biotech Training Facility, Leiden, the Netherlands, is a hands-on training institute well-known both within and outside Europe for its practical Good Manufacturing Practices (GMP) and operational training in a real-life environment. It is situated in the Leiden Bio Science Park (LBSP), the largest life sciences cluster in the Netherlands, which ranks among the top five science parks in Europe.
The training covered advanced Good Manufacturing Practices (GMP) topics, including root cause analysis, critical aspects of production, upstream and downstream processing, conceptual design to a qualified facility, scientific problem-solving, contamination control, technology transfer, aseptic processes, and single-use technologies in biopharmaceutical production, blending theoretical concepts with practical demonstrations for enhanced understanding.
The regulators from India had the opportunity to interact with the regulatory bodies of the Netherlands—CCMO: Central Committee on Research Involving Human Subjects, CBG: Medicines Evaluation Board, and IGJ: Health and Youth Care Inspectorate—during their official visit to the Netherlands.
The Drugs Control Administration, Telangana, expresses its gratitude to the Drugs Controller General (India), CDSCO, New Delhi, the Ministry of Health, Welfare, and Sport (VWS), the Netherlands, and the Embassy of the Kingdom of the Netherlands, New Delhi, for including the Drugs Control Administration, Telangana, in this exceptional program.
The training provided deep insights into global Good Manufacturing Practices (GMP) standards and their application in the biopharmaceutical sector, which will be instrumental in strengthening regulatory oversight in Telangana, a key state in the manufacturing of biopharmaceuticals in India.
Such advanced global training programs will greatly support the Drugs Control Administration, Government of Telangana, India, in ensuring the compliance of biopharmaceuticals with global quality standards and safeguarding public health. Karthik Siva Chaitanya, Drugs Inspector, Drugs Control Administration, Telangana, has been appreciated for the successful completion of his training in the Netherlands.
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