FMCG firm Procter & 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.
"The Government of India has prohibited the manufacture for sale, sale and distribution of fixed-dose combination drugs (Paracetamol + Phenylephrine + Caffeine) with immediate effect," Pfizer said in a BSE filing.
It further said, "Our product 'Vicks Action 500 Extra' has the same fixed-dose combination and gets covered under notification. We have discontinued the manufacture and sale of all SKUs of 'Vicks Action 500 Extra with immediate effect."
On Monday, drug majors Pfizer and Abbott stopped the sale of their popular cough syrups Corex and Phensedyl respectively, after the government banned over 300 fixed-dose combinations (FDCs) drugs.
The two companies, however, said they are exploring "all options" to counter the impact of the ban.
According to a report by Reuters, the company plans to challenge the government ban and said that all its products, including Vicks Action 500 Extra, were backed by research to support their quality, safety and efficacy.
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.
"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.
Abbott India has also stopped the sale of its Phensedyl cough syrup. When contacted a company spokesperson said, "Abbott is complying with all legal requirements related to the government notification."
The company termed the Health Ministry's decision to ban "certain fixed-dose combinations drugs that have been already approved" as a "unilateral approach".
"Abbott has reviewed the Drug Controller General of India (DCGI) notification and we are concerned about the unilateral approach in prohibiting the manufacture, sale and distribution of certain fixed dose combinations that have already been approved for use by DCGI. We are evaluating the notification and exploring all available options," the spokesperson said.
Some of these formulations have been the treatment of choice for specific medical conditions, Abbott India said.
"We are concerned that patients may not have access to some medicines which have been approved by DCGI and safely and effectively used in India for years," Abbott spokesperson said.
In a gazette notification on March 10, the government had, among others, banned manufacture, sale and distribution of the fixed-dose combination of Chlopheniramine Maleate plus Codeine syrup which is used in the cough syrups.
The government had imposed ban on 344 drug combinations, including several antibiotics and analgesics, saying that a government-appointed panel of experts had found the combinations lacked "therapeutic justification".