As winter approaches and the demand for cough syrups is poised to surge, India’s health regulatory agency has asked drug makers to prioritise producing high-quality products free of ‘contamination’, News18 has learnt.
The move comes amid controversies surrounding tainted cough syrups and other medicinal products, which have cast doubt on the safety of Indian-made drugs for several months.
The regulatory body, Central Drugs Standard Control Organisation (CDSCO), issued an advisory to drug inspectors across India on December 5 to ensure compliance with good manufacturing practices in drug making with a sharp focus on ensuring the quality of raw materials, including active pharmaceutical ingredients and excipients.
The advisory signed by CDSCO’s chief, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, said “drug manufacturers are required to manufacture the drugs adhering strictly to the conditions of manufacturing license and prescribed Good Manufacturing Practices (GMPs) to ensure that the drugs manufactured for marketing are of quality standards and meets the parameters of quality, safety and efficacy”.
News18 has seen the advisory.
While it addresses potential concerns and emphasises compliance, it particularly highlights compliance in the manufacturing of cough syrups and asks manufacturers to use high-quality, pharma-grade raw materials to “avoid contamination”.
“In case of manufacture of cough syrups, various critical excipients like propylene glycol, glycerine, sorbitol etc. are used,” it said, adding that “the manufacturers are required to ensure that these excipients meet the regulatory standards of quality so as to avoid any contamination in the formulations manufactured by using such excipients”.
“During winter seasons, there may be an increase in the use of cough syrups in the country.”
On October 5, WHO declared that cough syrups manufactured in India might be linked to the deaths of over 60 children in The Gambia—an alarming assertion given India’s status as the “pharmacy to the world”.
Following the incident, several instances of these contaminants appearing in syrup-based formulations exported from India have led to reported fatalities in Uzbekistan, the Marshall Islands, Micronesia, and other nations, pushing India’s drug regulatory agency to uncover lapses and increase vigilance.
Source pharma-grade excipients from approved vendors only: DCGI
DCGI concludes the letter by advising the manufacturers to purchase and use “only pharma grade excipients from their approved sources or vendors which are of quality standards in accordance with the regulatory requirements under the provisions to ensure quality, safety and efficacy of the drug formulations”.
The advisory said it is of ‘paramount importance’ that formulations are manufactured in compliance with the prescribed standards not only in respect of API (Active Pharmaceutical Ingredients — which is the main raw material in drug making) but also various excipients used for manufacturing the formulations.
“Therefore, the quality, safety and efficacy of both APIs and the excipients are crucial,” it said.
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