Vicks Action 500 Extra, a tablet commonly used for cold, has been discontinued by pharma giant Procter and Gamble. The tablet, manufactured by Proctor and Gamble (P&G), contains a particular combination of drugs which the government has banned.
On Tuesday, the US company said that it has discontinued the manufacture and sale of the tablet.
The medicine is a fixed dose combination of paracetamol (pain killer/ anti-pyretic), phenylephrine (nasal decongestant) and caffeine.
Not just Vicks Action 500 Extra, pharma company Pfizer said it has stopped the sale of its Corex cough syrup that garnered sales of Rs. 176 crore in the nine-month period ended December 31, and said the government’s move will have an adverse impact on it.
Abbott also stopped the sale of its Phensedyl cough syrup.
A company spokesperson said: “Abbott is complying with all legal requirements related to the government notification.”
So what is the issue with using combination drugs?
Combination medicines refer to drugs which contain multiple drugs used to treat different symptoms. For instance, someone suffering from cold may have a cough, but no headache or phlegm. However, the tablets usually prescribed have combinations of drugs used to treat all these symptoms. Hence, there is no medical justification for the intake of such medicines.
This is why the health ministry found “no therapeutic justification” for the usage of drugs which contain a fixed doze combination.
Companies say it's all safe
Procter and Gamble said that its products are approved by government regulators in 60 countries and enjoys safety record and are backed by research to support their quality.
“The company is exploring all available options at its disposal... The prohibition is likely to have an adverse impact on the revenue and profitability of the company,” Pfizer had said in a BSE filing.
In view of the government ban on manufacture and sale of Corex, the “company has discontinued the manufacture and sale of its drug ‘Corex’ with immediate effect,” Pfizer said adding that Corex has a well-established efficacy and safety profile in India for more than 30 years.
In 2014, the government set up an expert committee to review more 6,000 combinations that had entered the market, based on approvals from states. The committee gave drug makers a chance to prove the safety of their products. However, based on the responses from companies, the government has banned over 300 drugs. The full list is yet to be released.
In October 2015, Reuters reported that Indian drug regulators had asked pharma companies to self-regulate codeine-based cough syrups which were reportedly used for recreational purposes.