Drugs Controller General of India (DCGI) is planning to set up special cell for supporting and regulating start-ups in the pharma sector, DCGI, Dr S Eswara Reddy, said at the BioAsia conference.
Many start-ups are also coming up in pharma and allied segments and are clueless about regulation. The aim of the cell is to give pharma start-ups proper guidance. Innovators need to know about the regulatory framework they have to comply with for market authorisation or commercialisation of their products. Big players or start-ups working on innovative products or solutions can approach the cell at any stage for any purpose. The new body, tentatively named Innovation Support and Regulatory Cell, will have trained staff to address the problems of innovators and start-ups. The proposed cell will be set up at the office of the Central Drugs Standard Control Organsiation at New Delhi within next two to three weeks.
Hyderabad Pharma City and country's largest Medical Devices Park
The Telangana government is gunning for doubling the size of the lifesciences ecosystem in Telangana to US$100 billion in the next 10 years to generate employment for 4 lakh people thanks to initiatives like the upcoming Hyderabad Pharma City and the country's largest Medical Devices Park, Telangana IT & industries minister K Taraka Rama Rao said.
Currently the entire lifesciences ecosystem, comprising the pharmaceutical and biotech sectors is pegged at $50 billion with over 800 companies present in the state, KTR said at the inaugural of the 15th edition of the BioAsia2018 summit that kicked off in the city on Thursday on the theme `Right Time, Right Now'. Over 1,500 delegates from 55 countries are participating in the three-day event.
He also told the gathering that even as the government is working on the Hyderabad Pharma City and the Medical Devices Park, the state government is also expanding the Genome Valley cluster, which is spread across 600 square kilometers (sqkm) and houses over 200 lifesciences players like Novartis, USP, DuPont, Ashland and Lonza with around 10,000 scientific and technical workforce, and will be immediately initiating formulation of an integrated masterplan for the cluster to mark the beginning of Genome Valley 2.0.
KTR said towards this end the state government has already accorded Genome Valley with the Industrial Area Local Authority (IALA) status, which will enable single point administration of the cluster by providing Genome Valley companies a single point contact for all government related approvals and further facilitating infrastructure development in the cluster. "IALA will be a game changer for the Genome Valley lifesciences cluster and herald a new era of development," he said.
According to him, the state government is also working very closely with government of India to accelerate the establishment of the country’s largest animal resources facility, which will amplify benefits to lifesciences companies, accelerate development and significantly reduce the time-to-market for new drugs.
As part of the state government's committment to ensure that at least one new vaccine is launched by companies based in the state every year, the government is mulling setting up first of its kind incubator focused on vaccine development in Genome Valley.
"We are also keen to establish an institute focused on emerging areas like immunotherapy, personalized medicine and nanomedicine. For this, we will work with our local institutes and industries, the government of India and other global organizations," he said. Pharma and Biotech are priority areas at the Telangana Academy for Skills and Knowledge (TASK) and will now focus on designing more courses tailormade for the lifesciences industry, he added.
Talking about the Lifesciences Infrastructure Fund that was announced last year, he said the fund will start making investments in 2018 and aims to create lifesciences assets worth at least Rs 3000 crore in the next two-three years.
The Telangana State Industrial Infrastructure Corporation (TSIIC) on Thursday inked an MoU with Central Spectrum Sdn Bhd, the master developer of Selangor Bio Bay, a mixed development project located in Pulau Indah in the Malaysian state of Selangor. As part of the MoU, TSIIC and CSSB will cooperate and collaborate with each other to support the promotion and facilitation of research in the field of life sciences, biotechnology, healthcare and medical devices.
Biocon will set up research and development (R&D) facility in Genome Valley
Biocon plans to grow its presence in Telangana, a decision that will see the Bengaluru-based bio-pharmaceutical firm expand the existing API unit in the city and through Syngene, its subsidiary, set up a research and development (R&D) facility in Genome Valley. Together, the two projects would create 1,500 jobs, a good chunk of them high-skilled ones.
The company’s expansion plan for the State was announced after a meeting of Biocon Managing Director Kiran Mazumdar Shaw and the State IT and Industries Minister K.T. Rama Rao on the sidelines of BioAsia 2018 here on Friday.
Biocon will expand its presence in Hyderabad on APIs/Intermediates and thereby add 500 new jobs, a release from the Minister’s office said. A senior official of the State Government institution said the API facility in Pashamylaram is on 10 acres and the company had sought 2.5 acres more for the expansion. The proposed investment would be around ₹150 crore, he added.
According to the release, the Minister, during the meeting, gave an overview of the infrastructure available in the State and being developed by the State Government, including the Hyderabad Pharma City, Medical Devices Park and Genome Valley Phase 2. A cluster of research operations of life sciences firm Genome Valley is located on the city outskirts.
He also briefed Ms. Shaw about the start-up ecosystem and a few interesting start-ups in the healthcare and pharma sectors.
Thai delegation
The release said a business delegation led by Chutima Bunyapraphasara, Deputy Minister of Commerce, Thailand, also met Mr. Rao on the sidelines of the event during which the latter highlighted the State’s proactive business environment and its top ranking in Ease of Doing Business index.
Another meeting, Mr. Rao had at the event was with the Italian Consul General, based in Mumbai, Stefania Costanza. The Consul General said a delegation of Italian Chamber of Commerce would soon be visiting Telangana to explore business opportunities.
Bio-pharmaceuticals firm Biocon will soon start an R&D lab of its subsidiary Syngene in Genome Valley in Telangana, which is expected to generate 1,000 high-tech jobs, the state government said. The company will also be expanding its current presence in Hyderabad on APIs (Active Pharmaceutical Ingredients/ Intermediates) to add 500 new jobs, it added.
Biocon MD Kiran Mazumdar-Shaw met Telangana IT and Industries Minister K T Rama Rao on the sidelines of BioAsia 2018 and informed the minister about Biocon's decision to expand their operations in Telangana, the statement said.
A business delegation headed by Chutima Bunyapraphasara, Deputy Minister of Commerce, Thailand, also met Rao on the sidelines of BioAsia 2018.
Further, Italian Consul General in Mumbai, Stefania Costanza, informed Rao that a delegation of the Italian Chamber of Commerce will soon visit Telangana to explore business opportunities, the statement added.
The minister also met Terri Bresenham, CEO & President, Sustainable Healthcare Division, GE. The GE team expressed interest in collaborating with the Telangana Academy of Skill & Knowledge (TASK) in healthcare skilling, the release added.
[With inputs from Newspapers & Telangana Govt. reports]