New Delhi: Pharmacists have raised questions on the procedure to handle several medicines that were recently banned for use in children below four years of age.
In a letter to the Drugs Controller General of India (DCGI), the Indian Pharmaceutical Association (IPA), a national body of pharmacists, has asked for clarity on the stock of banned cough syrups that is already in the distribution channel.
Citing safety and effectiveness concerns, India's apex drug regulatory agency had directed manufacturers to stop production, sale and distribution of those fixed dose combination (FDC) medicines with immediate effect. The banned cough syrup brands bearing certain composition and strengths that are widely prescribed and sold include Ascoril Flu and variants of Alex by pharma giant Glenmark, T-Mininc sold by Haleon (formerly GSK) and Maxtra by Zuventus.
The IPA has asked if the existing stocks should be returned to the manufacturers or sold till the stocks are exhausted. The body has also asked if the pharmacy can dispense the FDCs in case those are prescribed by a doctor for a child below the age of four years.
According to a government notification dated April 15, all formulations of fixed dose combination of chlorpheniramine maleate and phenylephrine hydrochloride have been restricted for manufacture, sale and distribution subject to a condition that the manufacturers will mention the warning "fixed dose combination shall not be used in children below four years of age" in the label and package insert or the promotional literature of the drug.
The IPA sought clear guidelines for the sale of combination drugs of paracetamol + chlorpheniramine maleate and phenylephrine hydrochloride. "We suggest that a notification incorporating necessary clarification will give better clarity to authorities, healthcare professionals as well as the public," it said, asking for a prompt response.
An industry executive said the government notification came as a surprise and they have sought more time to remove the existing products from the market. "The government should have given some time for this transition. How do they expect us to remove the product from the market with immediate effect... There is utter confusion as even the strengths are not mentioned in the notification," said a company executive on condition of anonymity.
In a letter to the Drugs Controller General of India (DCGI), the Indian Pharmaceutical Association (IPA), a national body of pharmacists, has asked for clarity on the stock of banned cough syrups that is already in the distribution channel.
Citing safety and effectiveness concerns, India's apex drug regulatory agency had directed manufacturers to stop production, sale and distribution of those fixed dose combination (FDC) medicines with immediate effect. The banned cough syrup brands bearing certain composition and strengths that are widely prescribed and sold include Ascoril Flu and variants of Alex by pharma giant Glenmark, T-Mininc sold by Haleon (formerly GSK) and Maxtra by Zuventus.
The IPA has asked if the existing stocks should be returned to the manufacturers or sold till the stocks are exhausted. The body has also asked if the pharmacy can dispense the FDCs in case those are prescribed by a doctor for a child below the age of four years.
According to a government notification dated April 15, all formulations of fixed dose combination of chlorpheniramine maleate and phenylephrine hydrochloride have been restricted for manufacture, sale and distribution subject to a condition that the manufacturers will mention the warning "fixed dose combination shall not be used in children below four years of age" in the label and package insert or the promotional literature of the drug.
The IPA sought clear guidelines for the sale of combination drugs of paracetamol + chlorpheniramine maleate and phenylephrine hydrochloride. "We suggest that a notification incorporating necessary clarification will give better clarity to authorities, healthcare professionals as well as the public," it said, asking for a prompt response.
An industry executive said the government notification came as a surprise and they have sought more time to remove the existing products from the market. "The government should have given some time for this transition. How do they expect us to remove the product from the market with immediate effect... There is utter confusion as even the strengths are not mentioned in the notification," said a company executive on condition of anonymity.
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