The Government of India has prohibited the manufacturing, sale and distribution of fixed dose combination drugs, which includes Paracetamol + Phenylephrine + Caffeine with immediate effect, said Pfizer in a BSE filing.
Following the same, FMCG major Procter and Gamble (P&G) has shut manufacturing and sale of its popular brand Vicks Action 500 Extra in India with immediate effect.
Reportedly, the company says, "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."
Similarly, drug majors Pfizer and Abbott stopped sale of their popular cough syrups Corex and Phensedyl respectively.
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 ban.
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 also stopped 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 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 in specific medical conditions, Abbott 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 fixed does combination of chlopheniramine maleate plus codiene syrup which is used in the cough syrups.
