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16 Mar 2016

India’s Health Ministry has banned 344 fixed dose combinations

The Health Ministry has banned 344 ‘Fixed Dose Combination’ (FDC) drugs, leading to an immediate suspension of the manufacturing and sale of some popular medicines in India.

What are Fixed Dose Combination drugs and why has the Ministry banned them?
Fixed-dose combination drugs are when a pharmaceutical combines two or more active drugs in a fixed ratio into a single dosage.

Introducing / Launching new FDCs as a part of the life-cycle extension strategy which is used by the many pharmaceutical companies. Specific to Indian market, you will be able to find lot of new fixed dose combinations. Ironically it is found and reported that many fixed dose combinations are not even approved by central government. Locally taken permission from state government. One more reason, companies launch new FDCs to keep its brand out of drug price control.

The degree of safety and FDC drugs’ effects on humans has been long under question.

A Reuters investigation revealed in December that a unit of Abbott in India was selling a combination of the antibiotics cefixime and azithromycin without approval from the central government. The combination is not approved for sale in major pharmaceutical markets, including the United States, United Kingdom, Germany, France and Japan.

After the ban, the company was forced to immediately stop the manufacture and sale of its powerful antibiotic.

Immediate Effect: 

There are many leading brands which may go off the shelf which includes leading Corex, Vicks Action 500 Extra, Zimnic AZ, etc.

Pfizer said it was suspending the manufacturing and sale of its popular Corex cough syrup which contains a combination of Chlopheniramine Maleate and Codeine syrup. However, after moving the Delhi High Court over the order, the HC has provided interim relief to the company until the next hearing date which hasn’t been announced yet.
The court also issued a notice to the Health ministry directing it to file a status report after taking instruction on the findings of the expert committee

Shares of many pharma giants including Pfizer and Procter and Gamble fell by about 3% on amid concerns over ban on their popular drug products. Stocks of a number of pharma companies were down, leading to overall decline of more than 3% in the sectoral index.

Pharma majors Abbott Healthcare and Macleods Pharmaceuticals on Tuesday got interim relief from the Delhi High Court which stayed till March 21 Government’s decision banning sale of certain combination medicines of the two companies.

FMCG firm Procter and Gamble (P&G) has discontinued manufacture and sale of its popular brand ‘Vicks Action 500 Extra’ with immediate effect after the government banned fixed dose combination drugs

Why this will be great concern for the Indian Pharmaceutical Industry?

  1. Many top leading brands has come under banned list. Therefore, this will hit the companies bottom line badly.
  2. As india appraching towards the financial year end (April 2015 – March 2016), all affected companies closing will be concern as stockist level already lot of hue-and-cry has started. Because of this companies may struggle to keep momentum going atleast for the next 2-3 months.
  3. The pharma sector in India could witness an immediate loss of Rs 1,000 crore due to the government ban on combination drugs that include cough syrups, anti-diabetic medicines and flu treatments. Abbott may take a hit of Rs 473 crore, Pfizer of Rs 366 crore and Macleods Pharma of Rs 338 crore, as a result of the ban on Fixed Dose Combinations (FDCs) drugs by the government.

1 lakh = 100,000|1 crore = 10 million|100 crore = 1 billion

List of Banned FDCs: Download XL File Containing List 

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