INDIA — India is reportedly considering revising its pharmaceutical industry policy in response to the recent association of domestically manufactured cough syrups with the deaths of children abroad.
According to a document from Prime Minister Narendra Modi’s office, there is a recognition that “important things” within the industry have been “overlooked.”
The document, dated May 15 revealed that a brainstorming session was held in Hyderabad, a city in southern India, with the aim of finding a solution to the issue of exported cough syrups causing harm to children.
Health Minister Mansukh Mandaviya and federal and state regulators were said to have attended the session held in February, although the official statement from the Health Ministry did not specifically mention cough syrups.
The document from the Prime Minister’s office indicated that a policy adjustment was being considered, without providing further details.
However, an anonymous source familiar with the matter suggested that the potential policy change could involve increased oversight of India’s pharmaceutical industry, which is valued at US$41 billion and serves as the world’s largest supplier of generic medicines.
One of the measures under consideration is said to be enhanced testing of cough syrups, as well as raw materials used in drug production.
This statement, not previously reported, represents the first time the Prime Minister’s office has addressed the cough syrup controversy. Requests for comments from PM Modi’s office and the Health Ministry regarding the matter have gone unanswered.
According to reports, the Central Drugs Standard Control Organisation (CDSCO), India’s drug regulator, has proposed the testing of cough syrups in government laboratories before they are exported. News18.com recently published this information.
Last year, the World Health Organization (WHO) discovered that cough syrups manufactured by an Indian drugmaker contained dangerous levels of two known toxins, diethylene glycol and ethylene glycol, leading to the deaths of at least 70 children in Gambia.
Although India denies any connection between the syrups and the fatalities, the WHO is still attempting to identify the party responsible within the supply chain, as reported by Reuters earlier this month.
India has taken action against a second domestic company whose cough syrups were linked to the deaths of 19 children in Uzbekistan. This involved the arrest of three of its employees.
The WHO also found that a third Indian drugmaker had sold contaminated syrups to the Marshall Islands and Micronesia.
Indian health officials have expressed concerns that such incidents of tainted syrups may adversely impact the country’s pharmaceutical industry.
In a recent meeting of global drug regulators held in Indonesia, an Indian representative participated in discussions on ways to ensure the safety of the pharmaceutical supply chain.
A WHO spokesperson informed Reuters that the participating authorities expressed their firm commitment to taking immediate, short-term, medium-term, and long-term actions to strengthen regulatory systems and protect patients from medication contamination.
In an advisory sent by the Indian regulator CDSCO to all states on April 21, officials were urged to ensure that drugs meet the standards outlined in the Indian Pharmacopoeia (IP).
The advisory highlighted the need to comply with these standards after the CDSCO received a public complaint regarding the quality of drug ingredients in the country. It did not disclose the source of the complaint.
The advisory further stated that if a drug is not listed in the IP, the applicable standards for identity, purity, and strength would be those specified for drugs in the current edition of the Pharmacopoeia of any other country, as well as any prescribed standards.
The drugs controller general of India, Rajeev Singh Raghuvanshi, reiterated the need for compliance with the aforementioned standards in the advisory.
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