Hyderabad, India – Telangana DCA makes headway in regulatory expertise Inspector Ch. Karthik Siva Chaitanya of Telangana’s Drugs Control Administration (DCA) recently completed advanced training on Good Manufacturing Practices for Biopharmaceuticals in the Netherlands. The training is imparted at the Biotech Training Facility in Leiden Bioscience Park and showcases India-Netherlands cooperation in medical product regulation.
A Step Towards Global GMP Standards
Pharmaceuticals looks promising for India, and Telangana is an important drugs manufacturing as well as regulatory hub. The DCA in Telangana ensures the quality, safety and efficacy of pharmaceutical products for the consumers. The biopharmaceutical products involve complex biological procedures, so there is an increased need for trained regulators.
The Ministry of Health, Welfare and Sport (VWS) of the Netherlands and the Central Drugs Standard Control Organization (CDSCO) of India have signed a Memorandum of Intent (MoI) to improve bilateral cooperation in medical product regulation.
Training Programme: What to Expect
The training was held from 27 to 31 January 2025 at the Biotech Training Facility in Leiden Bioscience Park, Europe’s largest life sciences and biotechnology research park. Eleven officers from India attended the course, including presenters from regulatory bodies such as CDSCO and state drug control administrations.
Participants attended a five-day GMP training course on up-to-date GMP standards applicable to biopharmaceutical manufacturing. Key topics include:
Root Cause Analysis and Risk Assessment
Root cause analysis and risk assessment was a major part of the training provided to inspectors for pharmaceutical production. The training included identifying, analyzing, and mitigating risks that could have a negative impact on drug quality and patient safety.
Advanced Biopharmaceutical Production Techniques
Since biopharmaceuticals deal with living cells and intricacies of biological systems, the training covered
- Upstream and downstream processing
- Fermentation and cell culture technology
- Sterilization assurance and control for contamination
Adherence to International Regulatory Norms
With India fast growing its share of pharmaceutical exports around the globe, the inspectorates must be conversant with the international norms on GMP guidelines, particularly as outlined by –
- The World Health Organization
- US Food and Drug Administration
- European Medicines Agency
Case Studies and Practical Exposure
Hands-on case studies, real-world inspection scenarios, and interactive sessions with European regulators and experts kept the participants busy.
The Importance of This Training for Telangana
Telangana is the ‘Pharma Capital of India’. Hyderabad has more than 800 pharmaceutical and biotechnology companies. The state also has India’s first Hyderabad Pharma City to make India a global pharmaceutical powerhouse.
Training of DCA inspectors on international GMP standards would help in better regulatory oversight, better industry compliance and enhanced credibility of Indian pharmaceutical exports on global platform.
“Welcoming the initiative, Telangana DCA Director General Dr V B Kamalasan Reddy said, “Telangana continues to play a significant role in India’s pharmaceutical industry and having globally trained inspectors ensures world-class regulatory standards. This training will strengthen our inspection and enforcement capabilities. .
Impact on Indian Biopharmaceutical Regulations
Biopharmaceuticals—vaccines, monoclonal antibodies, and gene therapies—are becoming a key focus area for India’s healthcare and pharmaceutical sectors. Ensuring the safety, efficacy, and quality of these complex products calls for well-trained regulators.
This international training could enable the Telangana DCA inspectors to be more adequately equipped and function for the following: []
- Biopharmaceutical manufacturing facilities
- Conduct GMP Compliance inspections
- Quality control measures for biologics
- Audits of pharmaceutical exports for regulated markets
Strengthen India-Netherlands Cooperation
It represents the growing partnership between India and the Netherlands in the pharmaceutical sector. India is a key partner for the European biotech sector. By involving India, it enables knowledge sharing, regulatory convergence and innovation in drug development. As the Netherlands Embassy in India said, it is just the first step of many to strengthen bilateral regulatory cooperation in the future.
With this training completed, Telangana’s DCA will have a much stronger methodology to inspect biopharmaceutical facilities across the state. This will trickle down to other inspectors and regulatory officials resulting in much more skilled, globally competent regulation workforce.
The Government of India and CDSCO are also working together to further strengthen and expand these collaborations, to ensure that Indian pharmaceutical regulations are globally compliant.
