38.6c New Delhi, India, Thursday, July 18, 2024

Govt. Bans Saridon And 327 Other Drugs Due To Health Risk.

By LawStreet News Network      13 September, 2018 12:00 AM      0 Comments
Govt. Bans Saridon And 327 Other Drugs Due To Health Risk.

The Ministry of Health on September 12, 2018, banned the manufacture for sale or distribution of 328 fixed-dose combination (FDC) drugs with immediate effect. The banned medicines include brands like Piramals Saridon, Alkem Laboratories Taxim AZ and Macleods Pharmas Panderm Plus cream.

Besides, banning 328 FDCs the ministry has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions, an official statement said.

Government sources said the move means that around 6,000 medicine brands belonging to different companies and with a combined market size of Rs. 2,000-2,500 crore may soon vanish from the drug market in the country. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

Earlier, on March 10, 2016, the Health Ministry, through a notification had prohibited the manufacture for sale and distribution for human use of 349 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940.

However, the matter was contested by the drug manufacturers in various high courts and the Supreme Court. The apex court on December 15, 2017, asked for the matter to be examined by an expert panel formed by the Drugs Technical Advisory Board (DTAB). The Board in its report to the Centre stated that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.

Further, DTAB said these combinations may lead to overuse. According to the technical body, there is no need to expose the patients to that many ingredients when one will do the work. The notification stated, Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDCany kind of regulation or restriction to allow for any use in patients is not justifiable.

The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in the larger public interest.


Share this article:

User Avatar

Leave a feedback about this

Trending Know The Law
Zero FIR: Here’s all you need to know!

Understanding Zero FIR: Bharatiya Nyaya Sanhita Section 154 allows FIR at any police station. E-FIR under Section 173 ensures efficient crime reporting in India.

17 July, 2024 01:25 PM
Trending Judiciary
Judicial activist Ashwini Upadhyay asks SC to declare amendment to Preamble as unconstitutional

Judicial activist Ashwini Upadhyay petitions SC to declare the 42nd Amendment to the Preamble, which added "Socialist," "Secular," and "Integrity," as unconstitutional.

17 July, 2024 05:14 PM


Trending Judiciary
Bombay High Court denies interim relief in plea against 1 year Pan Masala Ban [Read Order]

Bombay High Court denies interim relief to petitioners challenging the 1-year ban on pan masala, citing arguable questions and ongoing similar cases.

12 July, 2024 10:00 AM
Trending Judiciary
SC Collegium recommends appointment of Chief Justices of eight High Courts [Read Order]

SC Collegium recommends appointments of Chief Justices for Delhi, Himachal Pradesh, J&K, Kerala, Madhya Pradesh, Madras, and Meghalaya High Courts.

12 July, 2024 10:55 AM
Trending Judiciary
SC orders interim bail for Kejriwal in ED case, refers issues on arrest to larger bench

SC grants interim bail to Kejriwal in ED case, refers arrest issues to larger bench; AAP leader remains in jail due to separate CBI arrest in liquor scam.

12 July, 2024 11:21 AM
Trending Judiciary
Hathras incident: SC refuses to consider PIL on inquiry, adequate compensation

Supreme Court declines PIL on Hathras stampede inquiry and compensation, directs petitioner to approach High Court for addressing the issue.

12 July, 2024 01:38 PM


Join Group

Signup for Our Newsletter

Get Exclusive access to members only content by email