Skip to main content

Govt proposes abolishing clinical trials on proven drugs

Abolishing clinical trials for proven drugs will also lower the cost of medicines in India. Photo: Bloomberg

The move to abolish clinical trials of proven drugs will reduce time taken to introduce new drugs in India to just 45 days from 5-6 years.

In a move aimed at speeding up the availability of new drugs, the government has proposed doing away with clinical trials for drugs that have proved their efficacy in developed markets.

According to a proposed new set of rules, a part of which has been reviewed by Mint, the government suggested waiving local clinical trials for drugs that have not had any major adverse effects on patients.

These drugs should have been approved and marketed for at least two years in the European Union, UK, US, Australia, Canada and Japan. The ministry of health and family welfare has sent the draft proposal to the ministry of law and justice for vetting before it can be notified.

The move is expected to reduce the time taken by a company to introduce new drugs in the market from 5-6 years to as few as 45 days. According to the drug regulator, the move will also lower the cost of drugs.

"This will end unnecessary repetition of trials and speed up the availability of new drugs in the country—a win-win situation for both the industry and consumers," Drug Controller General of India G.N. Singh said in a phone interview.

Lengthy clinical trial and approval procedures deprive Indians of advanced medicines, said R.K. Vats, additional secretary in the health ministry.


Comments

Popular posts from this blog

FDA Restricts Use of Diabetes Drug Avandia

FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used.
By Daniel J. DeNoon
WebMD Health News

Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug.

The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval.

The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control.

New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos. Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia.

"Avandia will be available to new pat…

The Influence of TheTourniquet on blood draw

[1] Various methods are used to obtain specimens for hematocritdetermination in neonates. We evaluated arterial sampling andfound this method to be acceptable. Arterial values correlatedclosely with simultaneously obtained venous samples. Venousblood obtained with a tourniquet had a significantly higherhematocrit than that obtained without a tourniquet.[2] Influence of tourniquet application on venous blood sampling for serum chemistry, hematological parameters, leukocyte activation and erythrocyte mechanical propertiesBackground: Venous blood sampling is usually performed using a tourniquet to help locate and define peripheral veins to achieve successful and safe venipuncture. Despite widespread usage of tourniquets for venipuncture by medical and laboratory staff, very few are aware of the effects of tourniquet application on laboratory parameters. In addition, definitive guidelines regarding when and how to use a tourniquet for blood sampling are lacking. The aim of the present stu…

Isotretinoin in India: A tragedy in the offing

Isotretinoin in India: A tragedy in the offing
Wednesday, March 28, 2007 08:00 IST 
Seema Thakral

Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased risk …