Can the biotech and pharma make money in space? That was the question Congress posed at a hearing on the International Space Station’s, Florida held recently.
“I think I can,” Tom Pickens, CEO of a space flight services company-turned biotech called SPACEHAB, told Congress. SPACEHAB has been sending up science payloads for the past 23 years. The company has mostly worked with government scientists, but when Pickens joined in 2003 as a member of the board of directors, he had a team of engineers assess what kinds of research would be most commercially viable. To fit the bill, experiments had to be cheap to transport and provide an advantage – in efficiency, quality or capability – over what could be done on Earth. Two methods stood out: growing crystals for X-ray crystallography, and vaccine production. So SPACEHAB is going from space transport to drug discovery. The company’s “first product will be a vaccine,” said Pickens.
But will investors bite? So far, said Bruce Pittman, a founding member of the Alliance of Commercial Enterprises and Education for Space, a group pro-commercial space advocates, he hasn’t seen any venture capital investment in this area, a fact that Pickens concedes. However, Pittman told The Scientist, “The stars are beginning to align.”
On April 18th, Space Florida, the state’s aerospace development organization, announced that it would partner with SPACEHAB to help spur biotech in space, and awarded the company $90,000 in seed funding. The money will retroactively support infectious disease experiments SPACEHAB sent up in March 2008, and the follow-up experiment to be launched in May, to validate those experiments.
Deb Spicer, spokeswoman for Space Florida, said that if the experiments are deemed successful, the agency plans to approve a larger contract, which is likely to be upwards of $100,000. (The exact amount has yet to be released.)
Congress wants verification “from someone that’s not the science community” that conducting life science research in space can be lucrative, Pickens said. “The American people want a return on investment”.
At the same time, there are others who see the value in making India one of their global hubs.
Drug Regulatory Authority not being an autonomous body vary immensely in their rules and law making in state and Center. The overall objective to ensure that medicinal products quality, Safety and efficacy remains the same but implementing the policy and measures taken tends to differ a lot in the states.
Whereas the manufacturing / sale and quality monitoring of drugs in the country is looked after by state government respectively, on the other hand the making of legislation, laying down standards, monitoring imports and exports and Clearance of New drugs comes under the scrutiny of Central government. Besides this there stands some responsibilities that are performed by both State and Center in collaboration jointly. The duties to be performed jointly are mainly approval of license for the manufacture of the various drugs and Medical Devices.
The amalgamated responsibilities held differently have left the global companies between major haves and haves not. Juxtaposition of Central and state government distinct statutory functions under the act in India, other countries such as USA, Canada, China, South Africa, Malaysia, Australia, Thailand holds Centralized Drug Regulatory Authority.’
With upcoming law on centralizing the drug Authority in India on the recommendation of health committee under the leadership of Hon’ble Dr. Anbumani Ramadoss (Minister of Health and Family Welfare), India will see yet another scintillating face of scope of Pharmaceutical and Healthcare Industry. The idea behind the Central Drug Authority (CDA) authority in India is making it as an autonomous body with all the comprehensive powers as per the Drug and Cosmetics
(amendment) Bill, 2007.
The Central Drug Authority (CDA) will have a chairman with not more than five members but at least 3 members, to be appointed by Central govt. with the defined criteria for the qualification and procedure of appointment. The CDA office will be maintained at Delhi and all the existing power of CDSCO to be shifted to CDA itself. DCGI (Drug Controller General India) will then work under Chairman with additional DC (I) appointed separately both in AYUSH and Drugs.
With the proposed Structure of Drug Regulatory Authority, a plethora of Global opportunities will prop up. These opportunities will cover, contractual manufacture (agreement for global manufacture of pharmaceutical products in compliance to the international standards), contractual research and development including formulation development, clinical research, collaborative clinical trials and customized synthesis, services like analytical method development and validation, clinical data management, ancillary equipment and material production, and manufacture of packaging material. India is a hub for contractual manufacturing process of pharmaceutical products due to its cheapest manufacturing cost across the globe.
Central Drug Authority (CDA) will raise the expectations of global pharmaceutical companies to join hands in India for setting up their units or tie-ups with contract Research organizations (CRO). The fact is that the pharmaceutical market in India has a huge potential when compared to other emerging markets in Asia (China, Thailand, Malaysia etc) and East European countries. To cite an example, India possess 10,000 manufacturing units of pharmaceutical and Active Pharmaceutical Ingredients (API). Following these soaring trends of manufacturing units in India, even premium organization are looking at India as their global production and R&D base and outsourcing hub. The implementation of current amendment on the lines of recommendations by Hathi committee, Mashelkar Committee, National Drug Policy (1986-1994-2000) tends the curb the major gap and will give India its due share in Global Pharmaceutical Industry.