India’s drug regulation system is split between the central and state governments, which often leads to confusion and weak enforcement.
The children died in India over the past month after consuming cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit
The directive is similar to the one issued after India-made cough syrups were blamed for deaths of children in Gambia and Uzbekistan even as Coldrif toll climbs to 22 after two more children die
Regulators in the world's third-largest medicine-producing country have asked consumers to also avoid Respifresh TR and ReLife, apart from Coldrif
Following the deaths of 14 children from the contaminated cough syrup in India—and 70 earlier deaths in Africa—urgent questions emerge about quality control in the world's largest generic drug manufacturer
The health services agency said cough and cold medications should not be prescribed to children under the age of 2 years.
According to the families of the affected children, initially, the children suffered from colds, coughs, and fevers. After that, their kidneys become affected, and their condition worsens.
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The revised rules are expected to benefit companies focused on the domestic market. However, small companies may come under pressure because they may need a substantial capex to conform
Maiden Pharmaceuticals of India, whose cough syrups have been connected to the deaths of children in Gambia, denied tampering with test samples or bribing officials to do so on Saturday, as alleged in a complaint under investigation by local health officials.
"I have never changed the sample," Maiden founder Naresh Kumar Goyal told Reuters. "There is no evidence and no proof against us. I have not given a bribe."
The the Subject Expert Committee of the Central Drugs Standard Control Organisation recommended a precautionary measure, suggesting that the FDC should not be administered to children below 4 years
The central Asian nation has put on trial 21 people – 20 Uzbeks and one Indian – for the deaths.
The Food and Drug Administration has reprimanded at least 28 companies this year, saying they failed to prove sufficient testing of ingredients used in over-the-counter drugs and consumer products for the toxins ethylene glycol (EG) and diethylene glycol (DEG), according to a Reuters analysis of agency import alerts and warning letters to manufacturers.
21 people on trial - 20 of whom are Uzbeks and one Indian - over the deaths last week
The World Health Organization said last month that a batch of cough and cold syrup sold in Cameroon under the brand name Naturcold contained extremely high levels of a toxic ingredient.
In April, Indias government said its officials had held meetings in Africa to ensure its drug exports did not suffer after at least 70 children died in Gambia after ingesting the cough syrup last year.
In an exclusive interview with PTI video, the minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
Cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before the product is exported, effective June 1, the Directorate General of Foreign Trade (DGFT) said in a notification on Monday.
India exported cough syrups worth USD 17.6 billion in 2022-23 as against USD 17 billion in 2021-22.
India's health ministry received the proposal from the Central Drugs Standard Control Organisation(CDSCO) this month and is considering it, the news website quoted an unidentified ministry official as saying.
India's drugs regulator said in December its own tests found no toxins in the syrups, but its factory inspectors did earlier find that batches of medicine may have been incorrectly labeled, according to a notice it sent to Maiden seen by Reuters.
The Punjab Food And Drug Administration and the Drugs Controller General of India have collected the cough syrup's sample for tests. "The results are awaited, but we are confident of coming out clean," QP Pharmachem's MD said.