REGULATORY BODIES IN INDIA

                                    REGULATORY BODIES IN INDIA

 In India, the central government, via the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, largely works on developing standards and regulatory measures for drugs, diagnostics and devices; laying down regulatory measures by amending acts and rules; and regulating the market authorization of new drugs – all in an effort to standardize clinical research in India and bring safer drugs to the market.

CDSO Head Quarters New Delhi

Regulatory bodies in India involved in pharmaceutical regulation
	Body	Function
DCGI	Drug Control General India	Regulatory apex body under the government of India that oversees all
ICMR	Indian Council of Medical Research	Apex body that formulates, co-ordinates and promotes biomedical
GEAC	Genetic Engineering Approval Committee	Consists of experts in the field of genetic engineering and molecular biology; clinical trials involving the use of biotech products would be referred by DCGI to GEAC for recommendations
DBT	Department of Biotechnology	Apex body that oversees the new impetus to develop the field of modern biology and biotechnology in India
AERB	Atomic Energy Review Board	Authority that exercises regulatory control over the approval of new types of radiation equipment, and for the registration/commissioning of new radiation equipment, inspection and decommissioning of installations
BARC	Baba Atomic Research Centre	Apex body that oversees and approves all radiation related projects in India. DCGI refers all clinical trials that involve the use of radiopharmaceuticals to BARC for its expert opinion
DCC	Drugs Consultative Committee	Provides technical guidance to the Central Drugs Standard Control Organization
CDL	Central Drugs Laboratory	National statutory laboratory of the Indian government for quality control of drugs
DTAB	Drugs Technical Advisory Board	Provides technical guidance to the CDSCO

Stem Cell Breakthrough Puts Type 1 Diabetes Cure In Reach

Stem cells cures Diabetes

Stem cells are very special, powerful cells found in both humans and non-human animals. They have been called the centrepieces of regenerative medicine – medicine that involves growing new cells, tissues and organs to replace or repair those damaged by injury, disease or aging. Stem cells are the precursors of all cells in the human body. What makes stem cells special is that they are regenerative and malleable. They have the ability to replicate themselves and to repair and replace other tissues in the human body. Some tissues, like skin, need constant renewal, which could not take place without skin stem cells. Other stem cells repair damage to the body’s tissues, for example, rebuilding damaged or degenerating muscle tissue. New research also indicates that stem cell malfunction or damage may be responsible for certain cancers and even muscular-degeneration diseases like Muscular Dystrophy. Research on stem cell functioning is therefore a critical avenue to finding treatments for these and other diseases.

Most cells in the human body are differentiated, tissue specific cells. These cells have a specific identity and function that cannot be changed; they might be neural cells, skin cells, blood cells, muscle cells or some other kind of cell. Unlike other cells in the human body, stem cells are undifferentiated, which means they do not yet have a fixed identity and function. Consequently, they possess an ability to be manipulated in the laboratory in ways that may change their identity and function: they can turn into a number of different types of cells or tissues. This ability to change and be manipulated makes them powerful tools for research and therapy.

 

Stem Cell Breakthrough Puts Type 1 Diabetes Cure In Reach

 

Harvard scientists have announced a breakthrough that could eventually allow millions of diabetics to shed the yoke of daily insulin injections.

It took over 15 years of trial and error, but researcher Douglas Melton and his team have discovered a method to transform human embryonic stem cells into insulin-producing cells which can then be injected into the pancreas. The discovery has generated a new wave of momentum in the field, with research labs across the country already working to replicate and build upon Melton’s results.

“I think we’ve shown the problem can be solved,” Melton told National Geographic.

Building the Recipe

The researchers developed a 30-day, six-step process that transforms embryonic stem cells into pancreatic beta cells, the same sugar-regulating cells that are destroyed by the immune system of people with type 1 diabetes. The new cells can read the levels of sugars that enter the body after, say, a meal, and secrete the perfect dose of insulin to balance sugar levels.

Other researchers have had some success harvesting beta cells from cadavers and transplanting them into people with diabetes, but this method can’t round up enough of those cells to have a lasting effect.

Melton’s method produces millions of the insulin-secreting cells, which were then fed through a catheter to the kidney capsules of 37 diabetic mice.

“We can cure their diabetes right away — in less than 10 days,” Melton told NPR.

When the mice were later given glucose injections,  73 per cent showed increased levels of human insulin in their bloodstream, indicating that the beta cells were doing their job.

Taking it to the Next Level

As with many medical breakthroughs, Melton said they are still a few years away from putting this method to work in humans. One of the primary obstacles to overcome is to find a way to mask transplanted cells from an immune system that’s out to destroy them.

Susan Solomon, a chief of the New York Stem Cell Foundation, expects diabetes research to shift toward scaling Melton’s process, and overcoming the immune system problem.

“If you don’t solve the autoimmune attack that killed those cells in the first place you are basically doing stupid mouse tricks as they say,” Solomon told the Washington Post.

And with an estimated 30,000 Americans of all ages diagnosed with type 1 diabetes every year, the urgency of improving these mouse tricks is real.