Sridhar Babu
| Photo Credit: The Hindu
Telangana Minister for Industries and IT D. Sridhar Babu has written to Union Minister for Chemicals and Fertilizers Jagat Prakash Nadda underscoring the need to streamline regulations, support innovation and enhance India’s global leadership in pharmaceutical services.
“Recent geopolitical developments have created immense opportunities in the pharmaceutical sector in general and pharmaceutical services sector — contract research organisations [CROs] and contract development and manufacturing organisations [CDMOs] — in particular,” he said.
The CRO and CDMO segment, which provides essential services across the entire drug development cycle from research, clinical trials to manufacturing and regulatory submissions, has been expanding at a compound annual growth rate of 10.75% and is poised to touch $2.5 billion by 2030, as per the Department of pharmaceuticals.
U.S. Act benefits India
The Biosecure Act in the U.S. is an interesting development for Indian pharma services segment and an opportunity that should not be ignored. India has the potential to emerge as a global leader and attract billions of dollars in investment if certain regulatory procedures are streamlined on a priority basis, he said, referring to his discussions with the industry.
Telangana is committed to the growth of pharmaceutical and life sciences sectors. Hyderabad is recognised globally as a leading pharmaceutical and life sciences hub with a thriving ecosystem that supports drug development, manufacturing and research, he said.
Suggestion to spur research
On key regulatory challenges hindering growth, Mr. Sridhar Babu in the letter, a copy of which was marked to Union Minister for Commerce and Industry Piyush Goyal, called for streamlining no objection certificate (NOC) and licensing for drug manufacturing. He said the need for counter signature of manufacturing licence from the Centre should be dispensed with as export NOCs are granted by Centre. NOCs or licences for new chemical entities in the early stages of research and development should be waived to accelerate research and innovation.
Since complex export processes and customs regulations come in way of CRDMOs expanding market reach, there is a need for easier access to star exporter status and streamlining customs processes through AEO certification. Besides helping expand market reach, the move will lead to increase in export volumes, reduce trade delays and costs as well as enhance the organisations’ global competitiveness, the letter shared by the Minister’s office on Wednesday showed.
Impact on drug development
While the rollback of customs duty on lab chemicals to 10% by the Centre recently is a positive step, the industry still faces issues on account of disruptions in research and development (R&D) and quality control. This could be addressed by amending the draft gazette notification No. 41/2024-Customs to include distributors and resellers for a seamless supply chain.
Other issues the Minister raised include measures to enhance protection of proprietary information by using specific codes instead of chemical names during initial screenings; providing flexibility in stability data requirements for licensing, particularly for export-focussed projects; and waiving licensing requirements for small lab-scale batches or implement a tiered licensing system to facilitate R&D activities.
