Govt Waives Clinical Trials for Several Drugs Approved in Major Western Markets
4 months, 2 weeks ago

Govt Waives Clinical Trials for Several Drugs Approved in Major Western Markets

News 18  

The central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union. According to the order issued by the drug regulatory agency of India, CDSCO, on Wednesday, the central government has permitted the waiver of “local clinical trials” for approval of new drugs. However, in 2012, a parliamentary standing committee expressed concerns in its 59th report about approving certain new drugs in the country without conducting local clinical trials. The committee had raised several red flags regarding how the drug controller general of India was approving new drugs without adequate clinical trials. According to T Prashant Reddy, co-author of The Truth Pill, “The move is good, overall.” But, he added, there may be certain medicines that require local clinical trials due to Indian conditions and genetic factors.

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History of this topic

‘CDSCO waives local clinical trials for new drugs approved in the US’
2 weeks, 3 days ago

‘CDSCO waives local clinical trials for new drugs approved in the US’

The Hindu  

All new drugs are approved by the Central Drugs Standard Control Organization without local clinical trials on case to case basis in consultation with Subject Expert Committee, Union Health Minister Anupriya Patel informed in response to question from Tirupati MP Maddila Gurumoorthy on Friday. The MP asked whether the Union Health Ministry has decided to waive the requirement of clinical …

Health Talk | Why India waiving off local clinical trials for globally approved new drugs is good news
4 months, 1 week ago

Health Talk | Why India waiving off local clinical trials for globally approved new drugs is good news

Hindustan Times  

On August 7, India’s drugs regulatory agency, Central Drugs Standard Control Organisation, issued an order that allowed waiving off local clinical trials for approval of certain categories of new and novel drugs in the Indian market that have already been approved for use globally by regulators of countries that follow strict quality control. Local clinical trials or bridging studies as …

Clinical trial: Government announces waiver for several drugs approved from select countries
4 months, 2 weeks ago

Clinical trial: Government announces waiver for several drugs approved from select countries

The Hindu  

In a decision that would make drugs manufactured outside India more accessible and affordable in the local market the Central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union. “Drugs including vaccines that fall in the category -- orphan drugs …

Clinical Trials: What is it?
1 year, 6 months ago

Clinical Trials: What is it?

The Hindu  

The development of new medicines and medical practices is at the forefront of medical research, with researchers endeavouring to find the best thing or way to manage or treat various conditions and diseases. Simply speaking, in a clinical trial, investigators enrol participants who meet certain qualifying criteria, then administer the intervention being tested, and finally measure the outcomes – all …

Explained | Why does India not have a law to recall bad drugs from the market?
1 year, 7 months ago

Explained | Why does India not have a law to recall bad drugs from the market?

The Hindu  

In a rare occurrence, on April 25, Abbot, a multinational pharmaceutical company, published a public notice in newspapers alerting people about a mislabelled batch of medicine that it had inadvertently shipped to the market. While such recalls take place regularly in the U.S., including by Indian companies, we have never witnessed domestic or foreign pharmaceutical companies recall substandard or mislabelled …

Gambia Incident: A Reminder To Clear The Mess India’s Current Drug Regulatory System Is In
2 years, 2 months ago

Gambia Incident: A Reminder To Clear The Mess India’s Current Drug Regulatory System Is In

News 18  

The country’s deficient drug regulation system has come under scrutiny again after 69 children in Gambia died after consuming cough syrups manufactured by a Haryana-based pharmaceutical company. It is not the first time that bad recordkeeping along with the passing of substandard medicines without proper quality checks has raised health concerns for people. It is obvious that pharmaceutical firms are …

Why India Is Becoming One Of The Most Preferred Destination For Clinical Drug Trials
2 years, 4 months ago

Why India Is Becoming One Of The Most Preferred Destination For Clinical Drug Trials

ABP News  

At a time when several infectious diseases are emerging and different variants of coronavirus are popping up across the globe, high quality clinical trials have become critical for pharma companies to ensure the efficacy and safety of a drug before it is rolled out for the public. The Covid-19 pandemic has re-emphasised the importance of high quality drug trials and …

Clinical Trial Regulation In India: Need For Accountability In Ethical Review
3 years, 4 months ago

Clinical Trial Regulation In India: Need For Accountability In Ethical Review

Live Law  

Clinical trials are a type of research study conducted by pharmaceutical research teams that are designed to evaluate new drugs and treatments and their effects on human health outcomes, to evaluate interventions used to diagnose or treat certain conditions, or to examine methods to identify risk factors for a condition and improve the quality of life for people with chronic …

India scraps local trials for Covid shots, says Pfizer vaccine could arrive by July
3 years, 6 months ago

India scraps local trials for Covid shots, says Pfizer vaccine could arrive by July

India Today  

India scrapped local trials for "well-established" foreign coronavirus vaccines on Thursday as it tries to accelerate its vaccination rollout, with a government official saying Pfizer shots could arrive by July. Pfizer "remains committed to continuing our engagement with the Government of India towards making the Pfizer-BioNTech Covid-19 vaccine available for use in the country", a company representative said in a …

India scraps local trials for Covid vaccines to fast-track imports
3 years, 6 months ago

India scraps local trials for Covid vaccines to fast-track imports

Hindustan Times  

The Centre on Thursday scrapped local trials for "well-established" foreign coronavirus disease vaccines to fast-track imports, news agency Reuters reported. Last month, India pledged to fast-track approvals for foreign vaccines but its insistence on local trials was a key reason for stalled discussions with Pfizer. This was earlier announced by Niti Aayog member Dr VK Paul in a statement, which …

India scraps local trials for COVID shots to fast-track imports as it battles second wave
3 years, 6 months ago

India scraps local trials for COVID shots to fast-track imports as it battles second wave

Live Mint  

India on Thursday scrapped local trials for "well-established" foreign coronavirus vaccines to fast-track imports as it battles a devastating second wave of the pandemic that has killed tens of thousands of people. India has been inoculating its people with the AstraZeneca vaccine produced locally at the Serum Institute, Covaxin made by local firm Bharat Biotech, and has begun rolling out …

How Do COVID Vaccine Approval Processes Differ in US, UK & India?
3 years, 11 months ago

How Do COVID Vaccine Approval Processes Differ in US, UK & India?

The Quint  

For pandemic-like emergency situations, the rules have a provision for an ‘accelerated approval process’, which would allow approving drugs or vaccines that are still undergoing trials - if they provide sufficient benefit - which is decided based on the available data. This is particularly applicable if the drug shows ‘remarkable’ effectiveness even from phase-2 trials, based on which Bharat Biotech’s …

SII, Bharat Biotech Seek Emergency Approval: What Are the Rules?
4 years ago

SII, Bharat Biotech Seek Emergency Approval: What Are the Rules?

The Quint  

Much like the United States has the Food and Drug Administration, or Europe has the European Medicine Agency, CDSCO is a branch of the Ministry of Health and Family Welfare and aims to monitor the safety, effectiveness and quality of medicines, cosmetics and medical devices and to protect and promote public health. The Drugs Controller General of India is an …

SII, Bharat Biotech Seek Emergency Approval: What Next?
4 years ago

SII, Bharat Biotech Seek Emergency Approval: What Next?

The Quint  

Much like the United States has the Food and Drug Administration, or Europe has the European Medicine Agency, CDSCO is a branch of the Ministry of Health and Family Welfare and aims to monitor the safety, effectiveness and quality of medicines, cosmetics and medical devices and to protect and promote public health. The Drugs Controller General of India is an …

Understanding The Regulatory Regime For Clinical Trials In India
4 years, 4 months ago

Understanding The Regulatory Regime For Clinical Trials In India

Live Law  

The process of developing a new drug, which has preventive or curative effects on ailments, is known as a 'clinical trial'. It was only in Kalpana Mehta v. Union of India, that the Supreme Court came to note that the blatant violation of human rights that occurs when minor girls and other members from vulnerable communities are forced to become …

Bangladesh allows late-stage trial of China\'s Sinovac COVID-19 vaccine
4 years, 5 months ago

Bangladesh allows late-stage trial of China\'s Sinovac COVID-19 vaccine

Deccan Chronicle  

Dhaka: Bangladesh has approved the third-phase trial of a potential COVID-19 vaccine developed by China’s Sinovac Biotech Ltd, officials said on Monday, as infections continue to rise in the densely-populated South Asian country. Sinovac has been looking for volunteers outside of China as the number of coronavirus cases there has dwindled, said a member of Bangladesh’s national technical advisory committee …

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