About Careers Internship MedBlog Contact us

Several Fixed-dose Drug Combinations Sold in India Lack Regulatory Approval

by Shirley Johanna on May 14, 2015 at 11:20 AM
Font : A-A+

 Several Fixed-dose Drug Combinations Sold in India Lack Regulatory Approval

Many fixed-dose drug combinations widely sold in India to treat some conditions lack the necessary central regulatory approval, say British researchers.

These FDCs are being sold in substantial numbers in India, said the study led by Queen Mary University of London. FDCs include two or more active pharmaceutical ingredients combined in a single dosage form.


They are used as effective treatments for many conditions, including Parkinson's disease, HIV, malaria and tuberculosis. In 2012, the Parliamentary Standing Committee on Health & Family Welfare reported that a very large number of FDCs had been licensed by state drug authorities without approval by the Central Drugs Standard Control Organization (CDSCO).

It means these FDCs were not thoroughly tested and could put patients' lives at risk.

"India needs to ban the sale and manufacturing of fixed-dose drug combinations not approved by the CDSCO beginning with those which include drugs banned or unapproved internationally and, therefore, most likely to be harmful," explained Patricia McGettigan who led the study at Queen Mary University of London.

This study provides specific evidence in support of the 2012 committee report.

Using information from CDSCO on FDC formulations approved between 1961 and 2013, and FDC sales data between 2007 and 2012 from PharmaTrac (a database of drug sales in India), the researchers analyzed approval status and sales volumes of FDCs in four therapeutic areas.

Among 175 FDC formulations marketed in India between 2011-2012, the researchers found CDSCO approval for only 60 (34 percent).

While almost all Metformin FDC sales were from CDSCO-approved formulations, products with no record of CDSCO approval accounted for over two-thirds of anti-depressant/benzodiazepine FDC sales (69 percent), almost half of anti-psychotic FDC sales (43 percent) and more than a quarter of NSAID FDC sales (28 percent).

Multiple formulations included drugs which are restricted, banned or were never approved in other countries because of associations with serious adverse events including death.

The development of fixed-dose combination drugs is becoming increasingly important from a public health perspective and they are commonly used to manage some of the world's most infectious diseases.

"The well-being of patients is paramount. People taking these FDCs need to be reviewed and carefully switched to safe and appropriate alternatives," the authors noted.

In 2012, the Parliamentary Standing Committee on Health & Family Welfare has tabled before Parliament a unanimous 118-page report on the state of drug regulation in India and the manner in which it severely compromises the safety of Indian patients.

"Our research wholly supports the need for a complete overhaul of the new Drugs Bill and we urge the government of India to make this a priority," noted professor Allyson Pollock, global health expert and study co-author.

The paper was published in the journal PLOS Medicine.

Source: Medindia


Recommended Readings

Latest Drug News

AstraZeneca's Liver Cancer Drug Approved by CDSCO in India
The CDSCO has approved the intravenous administration of AstraZeneca Pharma India's liver cancer drug, Tremelimumab Concentrate.
 FDA Issues Warning About Compounded Diabetes Drug Semaglutide Products
The FDA advises consumers not to use compounded medications as an alternative to known diabetic and weight reduction medications Ozempic, Rybelsus, and Wegovy.
 Parkinson's Unmet Needs Creates Path for New Entrants into the Market
Addressing the unmet needs of Parkinson's Disease by providing disease-modifying therapies could bring about a major shift in the way that patients are treated.
How Microrobots Could Help Treat Bladder Diseases?
Microrobots could swirl through a person's blood stream, search for targeted areas to treat for various ailments.
How Can Multivitamin Supplements Slow Cognitive Aging?
Supplementation with multivitamins is an inexpensive way for older adults to slow down memory loss.
View All
This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close

Several Fixed-dose Drug Combinations Sold in India Lack Regulatory Approval Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests