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Tuesday, December 2, 2025
TopicFixed-dose combination drugs

Topic: fixed-dose combination drugs

Trial in India finds 2-drug combinations 5 times more effective than single pill in controlling hypertension

Amlodipine & perindopril, amlodipine & indapamide, and perindopril & indapamide achieved blood pressure control in 70 percent of patients to less than 140/90 mm Hg in six months.

Health ministry bans FDCs every few years. Ask how they enter the market in the first place

The medical rationale behind fixed-dose combination drugs soon gave into commercial interests that cared little for the health of patients. Government's only response has been to keep issuing ban orders since 1983.

Over 60% drug cocktails used for mental illnesses in India unapproved by apex regulator, finds study

Study by researchers from UK, India & Qatar was published this month, suggests unapproved fixed-dose combination drugs should be withdrawn and no longer manufactured.

1st US FDA-approved drug invented in India set for local launch as part of combination antibiotic

Combination of enmetazobactam, invented by scientists associated with Chennai-based pharma firm Orchid Pharma in 2008, and antibiotic cefipime is used to treat severe bacterial infection.

After prohibiting popular FDC for kids under 4, drug regulator scrutinises other cold & cough remedies

Following December notice prohibiting combination of chlorpheniramine maleate & phenylephrine hydrochloride, CDSCO has ‘decided to rope in paediatricians to review other permitted FDCs’.

Drug regulator gives conditional nod for sale of 5 FDCs, seeks efficacy & safety data for 3 of them

Popular brands using combinations under the scanner include D Cold Total and Dolo Cold. The five FDCs are part of 344 drug combinations that the government had first banned in 2016.

70% of antibiotic fixed-dose combination drugs sold in India unapproved or banned, finds study

Govt’s moves to curb irrational fixed-dose combinations may have been insufficient & lack enforcement, say researchers. Study published in Journal of Pharmaceutical Policy and Practice.

Drug price regulator NPPA worried about drug cocktails, flags ‘over-medication, profiteering’

The NPPA observations came this week as it took up applications to fix the prices of 34 new drugs, most of which were fixed-dose combination medicines or drug cocktails.

3 banned drug cocktails get all-clear from Modi govt but could have few takers in pharma sector

The three drugs were banned in the first round of the govt’s FDC crackdown in 2007, and hundreds of others have been outlawed since.

Govt approves manufacture of 471 cocktail drugs related to vitamins, minerals, micronutrients

The safety of these fixed drug combinations will be monitored regularly and any failure on the manufacturers' part to submit a periodic safety update will be deemed illegal.

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