Telangana: Sridhar Babu Urges Reform in India's Pharma Sector

 Hyderabad: Telangana IT and industries minister D. Sridhar Babu has recently written to union minister for chemicals and fertilizers Jagat Prakash Nadda highlighting crucial issues impacting India’s pharmaceutical services sector.

India’s pharmaceutical industry, recognised globally for its significant contributions, is poised for further growth, particularly within the contract research organisations (CROs) and contract development and manufacturing organisations (CDMOs) sectors. The sector is projected to grow at a rate of 10.75% CAGR and reach $2.5 billion by 2030, he said

To foster this growth, Sridhar Babu recommended streamlining licencing processes. He said there is a need to simplify the issuance of no objection certificates (NOCs) and manufacturing licences by removing the need for central countersignatures and waiving early-stage research NOCs.

Improving access to star exporter status and streamlining customs processes will boost export capabilities and reduce trade delays. The recent Budget's rollback of customs duty on lab chemicals to 10 per cent was a positive step but still leaves industry issues unresolved. To address ongoing disruptions in research and development and quality control, amending the draft gazette notification (41/2024-Customs) to include distributors and resellers is essential for a seamless supply chain, the minister said.

Enhancing measures to protect proprietary information by using specific codes instead of chemical names during initial screenings will strengthen confidentiality protections. He also suggested providing flexibility in stability data requirements for licensing, particularly for export-focused projects, and waiving licensing requirements for small lab-scale batches or implementing a tiered-licensing system to facilitate research and development activities.

Sridhar Babu said these recommendations aim to streamline regulatory processes, support innovation, and enhance India's global leadership in pharmaceutical services. He said India is regarded as the pharmacy of the world and Hyderabad is globally recognised as a leading pharmaceutical and life sciences hub, with a thriving ecosystem that supports drug development, manufacturing and research.

Among others, the US Government's Biosecure Act is an interesting development for the Indian pharma services industry and is an opportunity that should not be ignored. India has immense potential to emerge as a global leader in this segment and could attract billions of dollars in investment if certain regulatory procedures are streamlined, he said in the letter, a copy of which was also sent to commerce and industries minister Piyush Goyal.