Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Drug Warning (India)

This article was originally published in PharmAsia News

Executive Summary

India's drug authorities may have a problem on their hands due to a series of drugs approved by the U.S. FDA being recalled recently, as well as alerts being issued on others. Several drugs are marketed in India solely on the strength of the U.S. FDA having approved them. Should the FDA's clearances themselves come under a cloud, so will the drug clearance process in India. Additionally, drug controllers in India must weigh what to do when the FDA recalls a drug or issues alerts about possible problems with the drug, as in the case of GlaxoSmithKline's Avandia, where the publication of a study in New England Journal of Medicine by a prominent U.S. cardiologist suggested that patients taking the drug had a higher chance of suffering a heart attack. While in some situations, such as when Merck's Vioxx and Pfizer's Bextra were withdrawn in the U.S. market, India followed up by banning them as well, in other recalls, like for drugs Zelnorm and Permax, the authorities in India have not banned them. Finally, even those medicines banned in India are not necessarily fully withdrawn from the market. One case is Nimesulide, which India banned more than a year ago, yet Nimulid doses are still available for children. One hindrance is the shortage of drug inspectors who are supposed to ensure that chemists do not stock banned medicines. Meanwhile, estimates of counterfeit drugs in the country vary from a fourth to 40 percent of the industry's turnover. Just a handful of government laboratories are authorized to check counterfeit drugs. India's counterfeiting problem is serious enough to have been put on the U.S. list of countries with poor intellectual property right protection. (Click here for more

You may also be interested in...

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 

Hair Supplement Linked To Cases Of Severe Hepatitis In France

France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.

AZ Will Sideline ‘Lucky Mistake’ Data To Secure COVID-19 Vaccine Approval

A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts