3 weeks ago

India to Debar Drug Firms Submitting Fake Approval Data

India to Debar Drug Firms Submitting Fake Approval Data
Bitter pill: Govt to debar firms submitting fake data for drug approvals · livemint.com

The government of India made a new rule to help keep medicines safe.

Companies that make medicines must give the government scientific information to show their medicines work and are safe.

Sometimes companies give fake or made-up information to try to get approval faster.

That is not fair and can be dangerous.

Now, if a company is caught giving fake information, the government can stop it from asking for new approvals for a certain period of time.

Before this rule, the government could only reject the application or cancel an existing licence.

The company will first get a warning letter, and it can still ask the government to reconsider.

The rule applies to all applications made under the Drugs Rules from 1945.

The government hopes this will make companies more honest and make sure medicines are approved based on real information.

This helps protect everyone's health.

Key facts

Regulator
Union Health Ministry, Government of India
Amended legislation
Drugs Rules, 1945
Notification number
G.S.R. 756(E)
Related legislation
Drugs and Cosmetics Act, 1940
New power
Debar applicants from filing fresh applications for a specified period
Safeguards
Show-cause notice and appeal mechanism
Applicability
All applications submitted under the Drugs Rules, 1945
India's pharmaceutical market
$60 billion

Quotes

Ministry of Health and Family Welfare

Indian government health ministry

“"Submission of fake or fabricated data compromises the integrity of the regulatory process, casts aspersions over the quality of drugs and may pose serious risks to public health."”
livemint.com
“"Presently, an applicant submitting fabricated data faces enforcement actions such as rejection of applications and/or cancellation of existing licenses," the ministry said.”
livemint.com

Sources

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